HUMAN MEDICINAL PRODUCTS REGISTER

HUMAN MEDICINE REGISTERED PRODUCTS

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No. Registration No. Product Brand Name Generic Name Dosage Strength Dosage Form Pack Size Packaging Type Shelf Life Manufacturer's Name Manufacturer's Address Manufacturer Country Marketing Authorization Holder(MAH) Local Technical Representative(LTR) Registration Date Expiry Date
1 RWANDA FDA-HMP-MA-1895 DYNACORT SUSPENSION Deflazacort Suspension 60ml 36 M/S SKYBIOTECH LIFESCIENCES PVT. LTD India STAR BIOTECH RWANDA 2029-08-16

2 Rwanda FDA-HMP-MA-0041 MELANOV-80 Gliclazide 80mg Tablets 3×10’s Tablets ALU-PVC BLISTER PACK. 48 Months MICRO LABS LIMITED Plot No.121 to 124, KIADB, Bommasandra Industrial Area, 4 th Phase, Bangalore-560 099. Anekal Taluk, India. INDIA. MICRO LABS LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2021-01-18 2026-01-18

Grace Period

3 Rwanda FDA-HMP-MA-0042 PHYTORAL SHAMPOO Ketoconazole 2% w/w Shampoo 100ml HDPE BOTTLE 18 Months MICRO LABS LIMITED Plot No.121 to 124, KIADB, Bommasandra Industrial Area, 4 th Phase, Bangalore-560 099. Anekal Taluk, India. INDIA. MICRO LABS LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2021-01-18 2026-01-18

Grace Period

4 Rwanda FDA-HMP-MA-0043 KETESSE Dexketoprofen Trometamol 50mg/2ml Solution For Injection 5 Ampoules Of 2ml Each AMBER AMPOULE PACKED IN BOX 60 Months MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., VIA SETTE SANTI, 3, 50131 FIRENZE-ITALY ITALY MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. PRAFIN RWANDA LTD 2021-01-18 2026-01-18

Grace Period

5 Rwanda FDA-HMP-MA-0045 BEKRACINE-100 Cefixime 100mg Powder For Suspension 60ml HDPE BOTTLE IN A CARTON 24 Months BAROQUE PHARMACEUTICALS PVT LTD 192/2&3, Sokhada-388620, Khamahat, Dist Anand Gujarat-India INDIA BEKRA PHARMA UK LTD MULTIPHAR UBIPHARM-RWANDA LTD 2021-01-18 2026-01-18

Grace Period

6 Rwanda FDA-HBP-MA-0046 AKEROL Desloratadine 5mg Tablets Blister Pack ALU/ALU PACK BLISTER 36 Months WEST-COAST PHARMACEUTICAL WORKS LTD F.P. No. 17 & 16/5, Meldi Estate, B/s Meldi Mata Temple, Near Gota Railway Crossing, At & Post Gota, Ahmedabad, – 382481. Gujarat State. INDIA BEKRA PHARMA UK LTD MULTIPHAR UBIPHARM-RWANDA LTD 2021-01-18 2026-01-18

Grace Period

7 Rwanda FDA-HMP-MA-0050 PDXANE®8000 ENOXAPARIN SODIUM 8000 ANTI-XA IU/0.8 ML SOLUTION FOR INJECTION 1ML PREFILLED GRADUATED SYRINGE Colorless TYPE 1 Borosilicate Glass pre-filled syringe fitted with an injection needle and needle cap. 24 Months POOYESH DAROU BIO PHARMACEUTICAL CO. 18 Fanavari Street, Pardis Tech-Park, Abali high way, 15th Tehran, IRAN IRAN HELVETIC BIOPHARMA SA MNR EAST AFRICA LIMITED 2021-03-17 2026-03-17

Grace Period

8 Rwanda FDA-HMP-MA-0048 DOLUTEGRAVIR (AS SODIUM), LAMIVUDINE, TENOFOVIR DISOPROXIL Dolutegravir (As Sodium), Lamivudine, Tenofovir Disoproxil Fumarate 50 mg, 300 mg, 300 mg Film Coated Tablet 30 And 90 Tablets WHITE HDPE CONTAINER 24 Months CIPLA LIMITED Cipla Goa Unit VII and (Unit VII PD II) Address: Plot No. S- 103 to S- 105, S-107 to S-112 & L-147, L-147/1 to L147/3, L-147/A & L-138, Verna Industrial Estate, Verna, Salcette, Goa – 403 722, India INDIA CIPLA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2021-03-17 2026-03-17

Grace Period

9 Rwanda FDA-HMP-MA-0049 FLORANORM® Saccharomyces Bouladii 250mg Creamy White Powder With Brown Colored Granules 1× 10 Sachets SACHETS 24 Months BHARAT BIOTRCH INTERNATIONAL LIMITED Genome Valley, Shameerpet Mandal, Medchal District-500078, Talangana, INDIA INDIA PRISMA PHARMA FZE PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2021-03-17 2026-03-17

Grace Period

10 Rwanda FDA-HMP-MA-0051 LUMET Artemether, Lumefantrine 20mg, 120mg Uncoated Tablets Blisterx6’s; Blisterx12’s; Blisterx18’s; Blisterx24’s ALU FILM/ ACLAR POLY VINYL CHLORIDE BLISTER PACK 36 Months CIPLA QUALITY CHEMICAL INDUSTRIES LTD Plot 1-7, 1st Ring Road, Luzira Industrial Park, UGANDA UGANDA CIPLA QUALITY CHEMICAL INDUSTRIES LTD SURGIPHARM (RWANDA) LTD 2021-03-17 2026-03-17

Grace Period

11 Rwanda FDA-HMP-MA-0052 GRAMOCEF-CV Cefixime, Clavulanic Acid 200mg, 125mg Film Coated Tablets 10 Tablets ALU/ALU BLISTER PACK 24 Months MICRO LABS LIMITED Plot No.121 to 124, KIADB, Bommasandra Industrial Area, 4 th Phase, Bangalore-560 099. Anekal Taluk, India. INDIA MICRO LABS LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2021-03-17 2026-03-17

Grace Period

12 Rwanda FDA-HMP-MA-0053 SIRTURO Bedaquiline Fumarate 100 mg Tablet 188 Tablets HDPE BOTTLE 36 Months RECIPHARM PHARMASERVICES PRIVATE LIMITED INDIA INDIA JANSSEN CILAG INTERNATIONAL NV, BELGIUM GILMED LIMITED 2021-03-17 2026-03-17

Grace Period

13 Rwanda FDA-HMP-MA-0054 VEMLIDY Tenofovir Alafenamide Fumarate Equivalent to Tenofovir Alafenamide 25 mg Film-Coated Tablets 30 Tablets HDPE BOTTLE OF 60 ML 24 Months GILEAD SCIENCES IRELAND UC IDA Businesses and Technology Park, Carrigtohill, Co.Cork, Ireland. IRELAND. GILEAD SCIENCES INC, USA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2021-03-17 2026-03-17

Grace Period

14 Rwanda FDA-HMP-MA-0055 SANTOCYN OXYTOCIN 10 IU/ML SOLUTION FOR INJECTION 10 X 1ML AMPOULE CLEAR TYPE I GLASS 18 Months PT SANBE FARMA STERILE PREPARATION PLANT Unit 3, Jl. Industri Cimarene No. 8, Desa Cimareme, Kecamatan Ngamprah, Kabupaten Bandung Barat – Indonesia INDONESIA PT. SANBE FARMA AFRI HEALTH CARE LTD 2021-04-27 2026-04-27

15 Rwanda FDA-HMP-MA-0062 PDXANE®4000 ENOXAPARIN SODIUM 40MG(4000 ANTI-XA) SOLUTION FOR INJECTION 0.4 ML Prefilled syringe, type I glass syringe barrel, Buthyl rubber stopper+ plunger rod+ hypodermic needle & needle shield. PVC/aluminum blister + paper box 24 Months POOYESH DAROU BIO PHARMACEUTICAL CO. 18 Fanavari Street, Pardis Tech-Park, Abali high way, 15th Tehran, IRAN IRAN HELVETIC BIOPHARMA SA MNR EAST AFRICA LIMITED 2021-06-01 2026-06-01

16 Rwanda FDA-HMP-MA-0063 DERISE-25 DARBEPOETIN ALFA 25MCG/0.42ML SOLUTION FOR INJECTION 1ML 1 ML PREFILLED SYRINGE BARREL WITH NEEDLE, 1 ML PLUNGER STOPPER AND 1 ML PLUNGER ROD 36 Months HETERO BIOPHARMA LIMITED Sy. No. 458 (part), TSIIC-Formulation SEZ, Polepally (Village), Jadcherla (Mandal), Mahaboobnagar (Disrtict)-509 301, Telangana State, India INDIA HETERO BIOPHARMA LIMITED BION PHARMA GROUP 2021-06-01 2026-06-01

17 Rwanda FDA-HMP-MA-0064 DERISE-40 DARBEPOETIN ALFA 40MCG/0.4ML SOLUTION FOR INJECTION 1ML 1 ML PREFILLED SYRINGE BARREL WITH NEEDLE, 1 ML PLUNGER STOPPER AND 1 ML PLUNGER ROD 36 Months HETERO BIOPHARMA LIMITED Sy. No. 458 (part), TSIIC-Formulation SEZ, Polepally (Village), Jadcherla (Mandal), Mahaboobnagar (Disrtict)-509 301, Telangana State, India INDIA HETERO BIOPHARMA LIMITED BION PHARMA GROUP 2021-06-01 2026-06-01

18 Rwanda FDA-HMP-MA-0056 COVERSYL Perindopril Arginine 5mg Tablets 30 Tablets LDPE CONTAINER 36 Months SERVIER EGYPT INDUSTRIES (SEI), LES LABORATOIRES SERVIER INDUSTRIE, FRANCE 6th October City, 1 st Industrial Zone,12566, Giza A.R.E, EGYPT, 905, route de Saran, 45520 Gidy, FRANCE EGYPT, FRANCE LES LABORATOIRES SERVIER (LLS), FRANCE KIPHARMA LTD 2021-06-01 2026-06-01

19 Rwanda FDA-HMP-MA-0057 COVERSYL Perindopril Arginine 10mg Tablets 30 Tablets LDPE CONTAINER 36 Months SERVIER EGYPT INDUSTRIES (SEI), LES LABORATOIRES SERVIER INDUSTRIE, FRANCE 6th October City, 1 st Industrial Zone,12566, Giza A.R.E, EGYPT, 905, route de Saran, 45520 Gidy, FRANCE EGYPT, FRANCE LES LABORATOIRES SERVIER (LLS), FRANCE KIPHARMA LTD 2021-06-01 2026-06-01

20 Rwanda FDA-HMP-MA-0058 DAFLON Esperidin (90 % Diosmin 10 % Of Flavonoids) 500 mg Tablets 30 Film-Coated Tablets ALUMINIUM/PVC BLISTER PACKS 36 Months SERVIER EGYPT INDUSTRIES (SEI), LES LABORATOIRES SERVIER INDUSTRIE, FRANCE 6th October City, 1 st Industrial Zone,12566, Giza A.R.E, EGYPT, 905, route de Saran, 45520 Gidy, FRANCE EGYPT, FRANCE LES LABORATOIRES SERVIER (LLS), FRANCE KIPHARMA LTD 2021-06-01 2026-06-01

21 Rwanda FDA-HMP-MA-0059 EFAVIRENZ, LAMIVUDINE & TENOFOVIR DISOPROXIL FUMARATE Efavirenz, Lamivudine & Tenofovir Disoproxil Fumarate 600mg, 300mg, 300mg Tablets 30 Tablets HDPE BOTTLE 24 Months CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED Plot 1-7, 1st Ring Road, Luzira Industrial Park, UGANDA UGANDA CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED SURGIPHARM (RWANDA) LTD 2021-06-01 2026-06-01

22 Rwanda FDA-HMP-MA-0060 LOSACAR-H 50/12.5 Losartan Potassium, Hydrochlorothiazide 50mg, 12.5mg Tablets 3 X 10’s BLISTER PACK 24 Months CADILA HEALTHCARE LTD Kundaim Industrial Estate, Plot No.203-213, Kundaim, Goa 403 115, INDIA INDIA CADILA HEALTHCARE LTD, ABACUS PHARMA (A) LTD 2021-06-01 2026-06-01

23 Rwanda FDA-HMP-MA-0061 LOSACAR-H 100/25 Losartan Potassium, Hydrochlorothiazide 100mg, 25mg Tablets 3 X 10’s BLISTER PACK 24 Months CADILA HEALTHCARE LTD Kundaim Industrial Estate, Plot No.203-213, Kundaim, Goa 403 115, INDIA INDIA CADILA HEALTHCARE LTD, ABACUS PHARMA (A) LTD 2021-06-01 2026-06-01

24 Rwanda FDA-HMP-MA-0065 DERMOFIX Sertaconazole Nitrate 2%/ 20mg/g Cream Tube TUBE LINED WITH A LACQUER OF EPOXIDE & PHENOLIC RESINS, CAP MADE OF HDPE 36 Months FERRER INTERNACIONAL, S.A Joan Buscalla 1-9-08173-Sant Cugat del Valles (Barcelona), Spain SPAIN FERRER INTERNACIONAL, S.A GOMHS LTD 2021-06-01 2026-06-01

25 Rwanda FDA-HMP-MA-0066 EMITINO Ondansetron 2mg/5ml Oral Solution 30 Ml AMBER COLOR PET BOTTLE 24 Months CACHET PHARMACEUTICALS PVT. LTD Village: Thana, Baddi, Himachal Pradesh-173 205, India INDIA CACHET PHARMACEUTICALS PVT. LTD STAR BIOTECH LIMITED 2021-06-01 2026-06-01

26 Rwanda FDA-HMP-MA-0067 EMITINO TABLETS Ondansetron 4mg Tablets 10 Tablets ALU-ALU BLISTER 24 Months CACHET PHARMACEUTICALS PVT. LTD Village: Thana, Baddi, Himachal Pradesh-173 205, India INDIA CACHET PHARMACEUTICALS PVT. LTD, INDIA STAR BIOTECH LIMITED 2021-06-01 2026-06-01

27 Rwanda FDA-HMP-MA-0068 LOREZE Loratadine 10mg Capsules 10 Capsules PVC/PVDC/ALU BLISTER PACK 24 Months MEGA LIFESCIENCES PUBLIC CO. LTD Site 1: 384 SOI 6, Bangpoo Industrial Estate, Pattana 3 Road, Moo 4, Phraeksa, Mueang, Samutprakarin 10280, Thailand THAILAND MEGA LIFESCIENCES PUBLIC CO. LTD ABACUS PHARMA (A) LTD 2021-06-01 2026-06-01

28 Rwanda FDA-HMP-MA-0069 TERBINOL Terbinafin Hydrochloride 250 mg Tablet 14tablets/Box PVC-PE-PVDC/ALU BLISTER 24 Months NOBEL ILAÇ SAN.VE TIC. A.? Sancaklar 81 100/ DÜZCE/ TURKEY TURKEY DAFRA PHARMA GMBH, SWITZERLAND MULTIPHAR UBIPHARM-RWANDA LTD 2021-06-01 2026-06-01

29 Rwanda FDA-HMP-MA-0070 ABACAVIR (AS SULFATE) AND LAMIVUDINE Abacavir, Lamivudine 120 mg, 60 mg Tablet 30 Tablets, 60 Tablets 50CC HDPE CONTAINER, 85CC HDPE CONTAINER 36 Months CIPLA LTD Plot No A – 33, A – 2 (Unit – I), MIDC, Patalganga District Raigad, Maharashtra and Plot No A - 42 (Unit-II), MIDC, Patalganga, District Raigad, India INDIA CIPLA LTD PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2021-06-01 2026-06-01

30 Rwanda FDA-HMP-MA-0071 AKURIT Rifampin, Isoniazid 150 mg, 75 mg Tablets Pack 24 X 28 Tablets ALU-ALU BLISTER 36 Months LUPIN LIMITED Block - 1, extended area of Block 1, A-28/1, M.I.D.C., Chikalthana, Aurangabad – 431 210, INDIA INDIA LUPIN LIMITED, INDIA AIVEEN (R) LTD 2021-06-01 2026-06-01

31 Rwanda FDA-HMP-MA-0072 AKURIT-3 Rifampin, Isoniazid, Ethambutol Hydrochloride 150 mg, 75 mg, 275 mg Tablets 24x14 Tablets ALU-ALU BLISTER PACK 36 Months LUPIN LIMITED Block - 1, extended area of Block 1, A-28/1, M.I.D.C., Chikalthana, Aurangabad – 431 210, INDIA INDIA LUPIN LIMITED, INDIA AIVEEN (R) LTD 2021-06-01 2026-06-01

32 Rwanda FDA-HMP-MA-0073 AKURIT-4 Rifampin, Isoniazid, Pyrazinamide And Ethambutol Hydrochloride 150mg, 75mg, 400 mg, 275 mg Tablets Pack 15 X 6 Tablets And 14x28 Tablets ALU-ALU BLISTER 36 Months LUPIN LIMITED Block - 1, A-28/1, M.I.D.C., Chikalthana, Aurangabad – 431 210. INDIA and EPIP, SIDCO Industrial Complex Kartholi, Bari Brahmana Jammu (J&K)- 181133, India INDIA LUPIN LIMITED, INDIA AIVEEN (R) LTD 2021-06-01 2026-06-01

33 Rwanda FDA-HMP-MA-0074 CIPROQUIN 500 Ciprofloxacin Hydrochloride 500mg Tablets 10 X 10 Tablets ALU/PVC 36 Months KOPRAN LIMITED Non Pen Plant, Village Savroli Taluka Khalapur, District Raigad – 410202, India INDIA KOPRAN LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2021-06-01 2026-06-01

34 Rwanda FDA-HMP-MA-0075 EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE 200MG/300MG TABLETS Emtricitabine, Tenofovir Disoproxil Fumarate 200mg, 300mg Film Coated Tablets 30 Tablets HDPE CONTAINER WITH 5G MOLECULAR SIEVE DESICCANT SACHET 24 Months LUPIN LIMITED Plot No. 6A1, 6A2, Sector-17, Special Economic Zone, MIHAN, Nagpur, Maharashtra-4411 08, India INDIA LUPIN LIMITED, INDIA AIVEEN (R) LTD 2021-06-01 2026-06-01

35 Rwanda FDA-HMP-MA-0099 U-TRYP Ulinastatin J.P I. U (Lyophilized) 100,000 i.u Powder For Injection 5ml Clear, colourless, USP type I (neutral borosilicate) tubular glass vial with concave bottom 24 Months BHARAT SERUMS & VACCINES LTD. Plot No. K-27, Jambivili Villaga, Anand Nagar, Additional M.ID.C, Ambernath (East). India INDIA BHARAT SERUMS & VACCINES LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2021-08-05 2026-08-05

36 Rwanda FDA-HMP-MA-0076 ZITO-500 Azithromycin 500 mg Film Coated Tablets 1x3 Tablets ALU-PVC BLISTER PACK. 36 Months ZIM LABORATORIES LIMITED B-21/22, MIDC Area, Kalmeshwar, Nagpur 441501, Maharashtra State, India. INDIA ZIM LABORATORIES LIMITED/INDIA SUN ENTERPRISES LTD 2021-08-05 2026-08-05

37 Rwanda FDA-HMP-MA-0077 ZITO SUSPENSION Azithromycin Dihydrate 200mg Powder For Oral Suspension 15 Ml HDPE BOTTLE 36 Months ZIM LABORATORIES LIMITED B-21/22, MIDC Area, Kalmeshwar, Nagpur 441501, Maharashtra State, India. INDIA ZIM LABORATORIES LIMITED/INDIA SUN ENTERPRISES LTD 2021-08-05 2026-08-05

38 Rwanda FDA-HMP-MA-0078 AMIFER JUNIOR SYRUP Iron Hydroxide Polymaltose Complex 50 mg/5 ml Syrup 150ml GLASS BOTTLE, CLOSED WITH PILFER PROOF PLASTIC CAP PACKED IN A CARDBOARD 36 Months SANTA FARMA ILAÇ SAN. A. S. Gebkim Tesisi, Gebkim Organize Sanayi Bölgesi Çerkesli Yolu Üzeri Erol Kiresepi Cad. No: 8, 41455 Dilovas? - Kocaeli, TURKEY DAFRA PHARMA GMBH SURGIPHARM (RWANDA) LTD 2021-08-05 2026-08-05

39 Rwanda FDA-HMP-MA-0079 ANZAVIR-R Atazanavir Sulfate & Ritonavir 300mg, 100mg Biconvex Tablet, Debossed With ‘M777’ 30 Tablets HDPE BOTTLE WITH WHITE OPAQUE CAP 36 Months MYLAN LABORATORIES LIMITED F- 4 & F-12, MIDC, Malegaon, Sinnar, Nashik -422 113, Maharashtra, India INDIA MYLAN LABORATORIES LIMITED PYRAMID PHARMA LIMITED 2021-08-05 2026-08-05

40 Rwanda FDA-HMP-MA-0080 LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE-300 /300 Lamivudine, Tenofovir Disoproxil Fumarate 300mg, 300mg Film-Coated Tablets Debossed “C 0” On One Side And Plain On The Other Side. 30 Tablets HDPE BOTTLE, COVERED WITH PP CRC WITH HEAT SEAL LINER 24 Months CELLTRION, INC./KOREA Cheongju Plant 82, 2 Sandan-ro, Ochang-eup, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do 28117, Republic of Korea SOUTH KOREA CELLTRION, INC./SOUTH KOREA KIPHARMA LTD 2021-08-05 2026-08-05

41 Rwanda FDA-HMP-MA-0081 COVERAM 5MG-5MG Perindopril Arginine, Amlodipine 5mg, 5mg Tablet, Engraved With"5/5" On One Face And On The Other Face 30 Tablets POLYPROPYLENE TUBE 36 Months SERVIER (IRELAND) INDUSTRIES LTD, Gorey Road, Arklow-Co.Wicklow, Ireland. IRELAND LES LABORATOIRES SERVIER/France KIPHARMA LTD 2021-08-05 2026-08-05

42 Rwanda FDA-HMP-MA-0082 COVERAM 5MG-10MG Perindopril Arginine, Amlodipine 5mg, 10mg Tablets, Engraved With"5/10" On One Face And On The Other Face 30 Tablets POLYPROPYLENE TUBE. 36 Months SERVIER (IRELAND) INDUSTRIES LTD, Gorey Road, Arklow-Co.Wicklow, Ireland. IRELAND LES LABORATOIRES SERVIER/France KIPHARMA LTD 2021-08-05 2026-08-05

43 Rwanda FDA-HMP-MA-0083 COVERAM 10MG-5MG Perindopril Arginine, Amlodipine 10mg, 5mg Tablet, Engraved With"10/5" On One Face And On The Other Face. 30 Tablets POLYPROPYLENE TUBE. 36 Months SERVIER (IRELAND) INDUSTRIES LTD, Gorey Road, Arklow-Co.Wicklow, Ireland. IRELAND LES LABORATOIRES SERVIER/France KIPHARMA LTD 2021-08-05 2026-08-05

44 Rwanda FDA-HMP-MA-0084 COVERAM 10MG-10MG Perindopril Arginine, Amlodipine 10mg, 10mg Tablet, Engraved With"10/10" On One Face And On The Other Face 30 Tablets POLYPROPYLENE TUBE. 36 Months SERVIER (IRELAND) INDUSTRIES LTD, Gorey Road, Arklow-Co.Wicklow, Ireland. IRELAND LES LABORATOIRES SERVIER/France KIPHARMA LTD 2021-08-05 2026-08-05

45 Rwanda FDA-HMP-MA-0086 DARUNAVIR)-600 Darunavir Ethanolate 600 mg Tablets Debossed With ‘Dnv’ On One Side And ‘600’ On Other Side 60 Tablets HDPE CONTAINER 24 Months CIPLA LIMITED Manufacturing Division At Plot D7- Bulk Drug II block &At Plot D27-API I Block, MIDC Industrial Area Kurkumbh Village; Taluka – Daund District – Pune (Maharashtra)- India INDIA CIPLA LIMITED/INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2021-08-05 2026-08-05

46 Rwanda FDA-HMP-MA-0087 EPCLUSA™ 400/100 Sofosbuvir, Velpatasvir 400mg, 100mg Tablets, Debossed With "Gsi" On One Side And "7916" On The Other Side. 28 Tablets POLYESTER PACKING MATERIAL. 24 Months GILEAD SCIENCES INC 333 Lakeside Drive Foster City, CA, 94404, United States. USA GILEAD SCIENCES INC/USA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2021-08-05 2026-08-05

47 Rwanda FDA-HMP-MA-0088 EVOKE-100 Sildenafil Citrate 100 mg Tablets 4 Tabets ALU/PVC 36 Months LABORATORY AND ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY AND ALLIED LIMITED/KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2021-08-05 2026-08-05

48 Rwanda FDA-HMP-MA-0089 EXFORGE HCT-5/160/12.5 Amlodipine, Valsartan, Hydrochlorothiazide 5mg, 160mg, 12.5mg Film-Coated Tablet, With Debossing “Nvr” On One Side And “Vcl” On The Other Side. 28 Film-Coated Tablets PVC/PVDC BLISTER PACK 24 Months NOVARTIS FARMACÉUTICA SA RONDA DE SANTA MARIA, NOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE 158 08210 Barberà del Vallès (Barcelona)Spain, 4332 Stein Switzerland SPAIN, SWITZERLAND NVS KENYA LIMITED/KENYA SURGIPHARM (RWANDA) LTD 2021-08-05 2026-08-05

49 Rwanda FDA-HMP-MA-0090 EXFORGE-5/160 Amlodipine, Valsartan 5 mg, 160mg Film-Coated Tablet Debossed With “Nvr” On One Side And “Ece” On The Other Side. 28 Tablets PVC/PVDC BLISTER PACK. 36 Months NOVARTIS FARMACÉUTICA SA RONDA DE SANTA MARIA, NOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE 158 08210 Barberà del Vallès (Barcelona)Spain, 4332 Stein Switzerland SPAIN, SWITZERLAND NVS KENYA LIMITED/KENYA SURGIPHARM (RWANDA) LTD 2021-08-05 2026-08-05

50 Rwanda FDA-HMP-MA-0091 EXFORGE-10/160 Amlodipine, Valsartan 10 mg, 160mg Film-Coated Tablet, Debossed “Nvr” On One Side And “Uic” On The Other Side. 28 Film-Coated Tablets PVC/PVDC BLISTER PACK 36 Months NOVARTIS FARMACÉUTICA SA RONDA DE SANTA MARIA, NOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE 158 08210 Barberà del Vallès (Barcelona)Spain, 4332 Stein Switzerland SPAIN, SWITZERLAND NVS KENYA LIMITED/KENYA SURGIPHARM (RWANDA) LTD 2021-08-05 2026-08-05

51 Rwanda FDA-HMP-MA-0092 EXFORGE HCT-10/160/12.5 Amlodipine, Valsartan, Hydrochlorothiazide 10 mg, 160mg, 12.5 mg Film-Coated Tablet, Debossed “Nvr” On One Side And “Vdl” On The Other Side. 28 Film-Coated Tablets PVC/PVDC BLISTER PACK 36 Months NOVARTIS FARMACÉUTICA SA RONDA DE SANTA MARIA, NOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE 158 08210 Barberà del Vallès (Barcelona)Spain, 4332 Stein Switzerland SPAIN, SWITZERLAND NVS KENYA LIMITED/KENYA SURGIPHARM (RWANDA) LTD 2021-08-05 2026-08-05

52 Rwanda FDA-HMP-MA-0093 GRAMOCEF-O-200 Cefixime 200mg Capsules 10 Capsules ALU/ALU BLISTERS 36 Months MICRO LABS LIMITED Plot No.121 to 124, KIADB, Bommasandra Industrial Area, 4 th Phase, Bangalore-560 099. Anekal Taluk, India. INDIA MICRO LABS LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2021-08-05 2026-08-05

53 Rwanda FDA-HMP-MA-0094 LOFNAC-100 Diclofenac Sodium 100mg Suppositories 2 X 5 Suppositories PVC/PE FOIL IN CARTON ALONG WITH PACK INSERTS 36 Months BLISS GVS PHARMA LTD. MUMBAI/INDIA 10, 11-A & 12, Dewan Udyog Nagar, Aliyali, Palghar, Maharashtra, 401 404, India. INDIA BLISS GVS PHARMA LTD. MUMBAI/INDIA SURYA DEPOT PHARMACY LIMITED 2021-08-05 2026-08-05

54 Rwanda FDA-HMP-MA-0095 SEKROL SYRUP ADULT Ambroxol Hydrochloride 30mg/5 ml Syrup 150 Ml AMBER COLOURED GLASS BOTTLE, TYPE III GLASS WITH A WHITE POLYETHYLENE SCREW CAP. 36 Months BILIM ILAÇ SANAYI VE TICARET A.S. (BILIM PHARMACEUTICALS), GOSB, 1900 Sokak N°1904, 41480 Gebze – Kocaeli, Turkey TURKEY DAFRA PHARMA GMBH/ SWITZERLAND MULTIPHAR UBIPHARM-RWANDA LTD 2021-08-05 2026-08-05

55 Rwanda FDA-HMP-MA-0096 SEKROL SYRUP PAEDIATRIC Ambroxol Hydrochloride 15 mg/5 ml Syrup 100 Ml AMBER COLOURED GLASS BOTTLE, TYPE III GLASS WITH A WHITE POLYETHYLENE SCREW CAP. 36 Months BILIM ILAÇ SANAYI VE TICARET A.?. (BILIM PHARMACEUTICALS) GOSB, 1900 Sokak N°1904, 41480 Gebze – Kocaeli, Turkey TURKEY DAFRA PHARMA GMBH, SWITZERLAND MULTIPHAR UBIPHARM-RWANDA LTD 2021-08-05 2026-08-05

56 Rwanda FDA-HMP-MA-0097 STERILISED WATER FOR INJECTIONS B.P Water For Injection 10ml Solution For Injection 50 Ampoules CARTON ALONG WITH PACKAGE INSERT. 48 Months AMANTA HEALTHCARE LIMITED Plot no: 876, N.H. No: 8, Hariala, Kheda-387411, Gujarat, India INDIA AMANTA HEALTHCARE LIMITED, INDIA SUN ENTERPRISES LTD 2021-08-05 2026-08-05

57 Rwanda FDA-HMP-MA-0098 SULPHATRIM-960 MG Sulphamethoxazole, Trimethoprim, 800mg, 160 mg Tablets 10 X 10 Tablets ALU-PVC BLISTER PACK 36 Months LINCOLN PHARMACEUTICALS LIMITED Trimul Estate, Khatraj, Taluka, Kalol, Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2021-08-05 2026-08-05

58 Rwanda FDA-HMP-MA-0100 ZIMAGRA ODS-50 Sildenafil Citrate 50 mg Oral Disintegrating Strips. 10 Sachets Pack In Carton. EACH STRIP PACKED IN ALUMINUM SACHET AND SUCH 24 Months ZIM LABORATORIES LIMITED. B-21/22, MIDC Area, Kalmeshwar, Nagpur 441501, Maharashtra State, India. INDIA ZIM LABORATORIES LIMITED/INDIA SUN ENTERPRISES LTD 2021-08-05 2026-08-05

59 Rwanda FDA-HMP-MA-0101 PAIDOFEBRIL Ibuprofen 100mg/5ml Oral Suspension 200ml PET AMBER BOTTLE 36 Months LABORATORIO ALDO-UNION, S.L Baronesa de Malda, 73 08950 Esplugues de LL. (Barcelone) Spain SPAIN LABORATORIO ALDO-UNION, S.L./SPAIN GOMHS LTD 2021-08-05 2026-08-05

60 Rwanda FDA-HMP-MA-0085 DARUNAVIR-400 Darunavir Ethanolate 400 mg Tablets, Debossed With ‘Dnv’ On One Side And ‘400’ On Other Side 60 Tablets. HDPE CONTAINER 24 Months CIPLA LIMITED Manufacturing Division At Plot D7- Bulk Drug II block &At Plot D27-API I Block, MIDC Industrial Area Kurkumbh Village; Taluka – Daund District – Pune (Maharashtra)- India INDIA CIPLA LIMITED/INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2021-08-06 2026-08-06

61 Rwanda FDA-HBP-MA-002 REPOITIN 4000 ERYTHROPOIETIN CONCENTRATED SOLUTION B.P 4000 IU/0.4 ML. SOLUTION FOR INJECTION UNIT PACK PRE-FILLED SYRINGE 24 Months SERUM INSTITUTE OF INDIA PVT. LTD 212/2, HADAPSAR, Pune -411028, India INDIA SERUM INSTITUTE OF INDIA PVT. LTD SUN ENTERPRISES LTD 2021-09-08 2026-09-08

62 Rwanda FDA-HBP-MA-003 BCG VACCINE (FREEZE-DRIED) LIVE ATTENUATED STRAINS OF MYCOBACTERIUM BOVIS 2 X 105 AND 8 X 105 C.F.U. LYOPHILIZED INJECTION 50X1ML VIAL HYDROLYTIC CLASS-I GLASS OF 4 ML + DILUENTS. 24 Months SERUM INSTITUTE OF INDIA PVT. LTD 212/2, HADAPSAR, Pune -411028, India INDIA SERUM INSTITUTE OF INDIA PVT. LTD SUN ENTERPRISES LTD 2021-09-08 2026-09-08

63 Rwanda FDA-HBP-MA-004 MEASLES VACCINE, LIVE ATTENUATED (FREEZE-DRIED) CLARIFIED VIRUS POOL OF MEASLES VIRUS 1000 CCID50 OF MEASLES VIRUS/ 0.5ML. LYOPHILIZED INJECTION VIALS + DILUENT 10 DOSE AMBER VIAL TYPE I with rubber stopper in grey bromobutyl and orange (pantone) aluminum caps 24 Months SERUM INSTITUTE OF INDIA PVT. LTD 212/2, HADAPSAR, Pune -411028, India INDIA SERUM INSTITUTE OF INDIA PVT. LTD SUN ENTERPRISES LTD 2021-09-08 2026-09-08

64 Rwanda FDA-HMP-MA-0102 ZYCEL 200 Celecoxib 200mg Capsule 1x10 Hard Gelatin Capsules ALU/ALU BLISTER PACK 36 Months CADILA HEALTHCARE LIMITED Kundaim Industrial Estate, Plot 203-213, Kundaim, GOA – 403 115, India. INDIA CADILA HEALTHCARE LIMITED ABACUS PHARMA (A) LTD 2022-03-22 2027-03-22

65 Rwanda FDA-HMP-MA-0103 ZYCEL 100 Celecoxib 100mg Capsule 1x10 Hard Gelatin Capsules ALU/ALU BLISTER PACK 36 Months CADILA HEALTHCARE LIMITED Kundaim Industrial Estate, Plot 203-213, Kundaim, GOA – 403 115, India. INDIA CADILA HEALTHCARE LIMITED ABACUS PHARMA (A) LTD 2022-03-22 2027-03-22

66 Rwanda FDA-HMP-MA-0104 ZYROVA 20 Rosuvastatin Calcium Ph. Eur. 20mg Biconvex Beveled Edged Film Coated Tablets 3 X 10 Tablets ALU-ALU BLISTER PACK 24 Months CADILA HEALTHCARE LIMITED Kundaim Industrial Estate, Plot 203-213, Kundaim, GOA – 403 115, India. INDIA CADILA HEALTHCARE LIMITED ABACUS PHARMA (A) LTD 2022-03-22 2027-03-22

67 Rwanda FDA-HMP-MA-0105 ZYROVA 10 Rosuvastatin Calcium Ph. Eur. 10mg Biconvex Beveled Edged Film Coated Tablets 3 X 10 Tablets ALU-ALU BLISTER PACK 24 Months CADILA HEALTHCARE LIMITED Kundaim Industrial Estate, Plot 203-213, Kundaim, GOA – 403 115, India. INDIA CADILA HEALTHCARE LIMITED ABACUS PHARMA (A) LTD 2022-03-22 2027-03-22

68 Rwanda FDA-HMP-MA-0106 DOLUTEGRAVIR SODIUM, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 50/300/300MG Dolutegravir Sodium 50, Lamivudine 300 And Tenofovir Disoproxil Fumarate 300mg 50/300/300mg Biconvex, Film Coated Tablets Debossed With “C” On One Side & Plain On Other Side 30 & 90 Tablet HDPE BOTTLE 24 Months CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED Address: Plot 1-7, pt Ring Road, Luzira Industrial Park, Uganda UGANDA CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED, SURGIPHARM (RWANDA) LTD 2022-03-22 2027-03-22

69 Rwanda FDA-HBP-MA-005 BEVAAS 100 BEVACIZUMAB 100MG/4ML CONCETRATE FOR SOLUTION FOR INJECTION 4ML VIAL USP TYPE I CLEAR GLASS 24 Months HETERO BIOPHARMA LIMITED Sy. No. 458 (part), TSIIC-Formulation SEZ, Polepally (Village), Jadcherla (Mandal), Mahaboobnagar (Disrtict)-509 301, Telangana State, India INDIA HETERO BIOPHARMA LIMITED BION PHARMA GROUP 2022-07-18 2027-07-17

70 Rwanda FDA-HBP-MA-006 BEVAAS 400 BEVACIZUMAB 400MG/16ML CONCETRATE FOR SOLUTION FOR INJECTION 16ML VIAL USP TYPE I CLEAR GLASS 24 Months HETERO BIOPHARMA LIMITED Sy. No. 458 (part), TSIIC-Formulation SEZ, Polepally (Village), Jadcherla (Mandal), Mahaboobnagar (Disrtict)-509 301, Telangana State, India INDIA HETERO BIOPHARMA LIMITED BION PHARMA GROUP 2022-07-18 2027-07-17

71 Rwanda FDA-HMP-MA-0107 IBUPROFEN DENK 400 Ibuprofen 400mg Film Coated Tablet 20 And 100 Tablets PVC/PVDC-ALU 48 Months DENK PHARMA GmbH & Co. KG Göllstr.l 84529 Tittmoning, Germany GERMANY DENK PHARMA GmbH & Co. KG ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2022-07-18 2027-07-17

72 Rwanda FDA-HMP-MA-0109 UNIBROL SYRUP Aminosidine (As Sulphate) 125mg/5ml Syrup 60ml AMBER COLOURED GLASS BOTTLE 36 Months UNIVERSAL CORPORATION LIMITED Club road, Plot No. 13777, P.O.Box 1748-000902 Kikuyu, Kenya KENYA UNIVERSAL CORPORATION LIMITED SUN ENTERPRISES LTD 2022-07-18 2027-07-17

73 Rwanda FDA-HMP-MA-0110 NEUROBA 300MG Gabapentin 300mg Capsule 3x10 Capsule ALU-ALU BLISTER STRIPS 36 Months UNIVERSAL CORPORATION LIMITED Club road, Plot No. 13777, P.O.Box 1748-000902 Kikuyu, Kenya KENYA UNIVERSAL CORPORATION LIMITED SUN ENTERPRISES LTD 2022-07-18 2027-07-17

74 Rwanda FDA-HMP-MA-0111 AVIBELA Levonorgestrel 52mg (20?g/24hrs) Ius 1 Sterile Unit POLYESTER BLISTER WITH A PEELABLE LID (TYVEK POLYETHYLENE) 60 Months ODYSSEA PHARMA S.A. Rue du travail, 16 B-4460 Grace-Hollogne-Belgium BELGIUM IMPACT RH360/USA PROLINE HEALTCARE AND SYSTEMS 2022-07-18 2027-07-17

75 Rwanda FDA-HMP-MA-0108 Q-TIB Isoniazid, Pyridoxine Hydrochloride Sulfamethoxazole And Trimethoprim 300/25/800/160 mg Tablets 30 Tablets WHITE 65 CC HDPE BOTTLE 36 Months CIPLA LIMITED Plot No A-42 (Unit II) MIDC, Patalganga, District - Raigad, Maharashtra, Pin code: 410 220, India INDIA CIPLA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2022-10-24 2027-10-23

76 Rwanda FDA-HMP-MA-0112 UVEX 500 Levofloxacin 500 mg Film Coated Tablets 10 Tablets BLISTER STRIP 36 Months MEYER ORGANICS PVT. LTD 10 D, Phase II, Peenya Industrial Area, Bangalore- 560058, India INDIA MEYER ORGANICS PVT. LTD SUN ENTERPRISES LTD 2022-10-24 2027-10-23

77 Rwanda FDA-HMP-MA-0113 LABCLAV 1G TABLETS Amoxicillin 875 Mg As Amoxicillin Trihydrate Bp And Clavulanic Acid 125 Mg As Potassium Clavulanate Bp 875mg/125mg Film Coated Tablets 1x10's, 2x7's & 2x10's ALU/ALU BLISTER 24 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2022-10-24 2027-10-23

78 Rwanda FDA-HMP-MA-0114 LABCLAV 625MG TABLETS Amoxicillin 500 Mg As Amoxicillin Trihydrate Bp And Clavulanic Acid 125 Mg As Potassium Clavulanate Bp 500mg/125mg Film Coated Tablets 1x10's, 2x7's & 2x10's ALU/ALU BLISTER 24 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2022-10-24 2027-10-23

79 Rwanda FDA-HMP-MA-0115 LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE FILM COATED TABLET 300/300 MG Lamivudine And Tenofovir Disoproxil Fumarate 300/300 mg Film Coated Tablets 30's Tablets HDPE CONTAINER 24 Months CIPLA LIMITED Plot No A-42 (Unit II) MIDC, Patalganga, District- Raigad, Maharashtra, Pin code: 410 220, India INDIA CIPLA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2022-10-24 2027-10-23

80 Rwanda FDA-HMP-MA-0116 TRICOZOLE TABLETS Metronidazole Bp 250mg Ffbe Tablets 10x10’s ALU/PVC BLISTER 36 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2022-10-24 2027-10-23

81 Rwanda FDA-HMP-MA-0117 AMITRIP 25MG TABLETS Amitriptyline Hydrochloride 25mg Film Coated Tablets 10x10’s ALU-PVC BLISTER 36 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2022-10-24 2027-10-23

82 Rwanda FDA-HMP-MA-0118 CLITH-500 TABLETS Clarithromycin BP 500mg Film Coated Tablets 1x10’s And 4x10’s BLISTER STRIPS (PVC PVDC) WITH ALUMINIUM FOIL 36 Months UNIVERSAL CORPORATION LIMITED Club Road, Plot No. 13777, Kikuyu Country: Kenya KENYA UNIVERSAL CORPORATION LIMITED SUN ENTERPRISES LTD 2022-10-24 2027-10-23

83 Rwanda FDA-HMP-MA-0119 EVAC SOLUTION Lactulose Concentrate USP Equivalent To Lactulose 3.35g/5ml Yellow Coloured Solution 100ml AMBER COLOURED PET BOTTLE WITH A MEASUREMENT CUP AND UNIT BOX 24 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2022-10-24 2027-10-23

84 Rwanda FDA-HMP-MA-0120 HYMET TABLETS Hydrochlorothiazide BP 50mg Tablets 10x10’s ALU-PVC BLISTER 36 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2022-10-24 2027-10-23

85 Rwanda FDA-HMP-MA-0121 TEXAVIR TABLETS Tenofovir Disoproxil Fumarate 300mg Film Coated Tablets 1x30 Tablets HDPE CONTAINER 36 Months CIPLA QUALITY CHEMICAL INDUSTRIES LTD Plot 1-7,1st Ring Road, Luzira Industrial Park, Kampala - Uganda UGANDA CIPLA QUALITY CHEMICAL INDUSTRIES LTD SURGIPHARM (RWANDA) LTD 2022-10-24 2027-10-23

86 Rwanda FDA-HMP-MA-0143 AMLO-DENK 10 Amlodipine 10mg 10mg Round, biconvex and scored on one side tablets 50 tablets PVC/PE/PVDC- Aluminium film blisters 24 Months DENK PHARMA GmbH & Co. KG, Göllstr1. , 84529 Tittmoning, Germany GERMANY DENK PHARMA GmbH & Co. KG, Germany ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2022-12-14 2027-12-13

87 Rwanda FDA-HMP-MA-0144 AMLO-DENK 5 Amlodipine 5mg 5mg Round, biconvex and scored on one side tablets 50 tablets PVC/PE/PVDC- Aluminium film blisters 24 Months DENK PHARMA GmbH & Co. KG, Göllstr1. , 84529 Tittmoning, Germany GERMANY DENK PHARMA GmbH & Co. KG, Germany ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2022-12-14 2027-12-13

88 Rwanda FDA-HMP-MA-0145 LOPINAVIR/ Lopinavir 200mg/ 200 mg/50 mg Film coated ovaloid tablets 120’s tablets HDPE Bottle 36 Months MYLAN LABORATORIES LIMITED, F-4& F-12, MIDC, Malegaon, Sinnar, Nashik-422 113, Maharashtra, India & Plot No. 11, 12& 13 Indore special economic zone, Pharma Zone, Phase-II, Sector-III, Pithampur-454775, Dist-Dhar, M.P., India INDIA MYLAN LABORATORIES LIMITED, INDIA PYRAMID PHARMA LIMITED 2022-12-14 2027-12-13

89 Rwanda FDA-HMP-MA-0147 PAIDOTERIN DECONGESTANT LIQUID Phenylephrine hydrochloride 5mg, Diphenhydramine hydrochloride 5mg, Chlorpheniramine maleate 0.75mg per dose (5ml) Syrup 5mg, 5mg, 0.75mg/5ml Syrup 100 ml Bottle Polyethylene terephthalate (PET) bottle 36 Months LABORATORIO ALDO-UNIÓN, S.L, Baronesa de Maldá, 73 08950 Esplugues de Llobregat Barcelona-Spain SPAIN LABORATORIO ALDO-UNIÓN, S.L, SPAIN GOMHS LTD 2022-12-14 2027-12-13

90 Rwanda FDA-HMP-MA-0171 LRJ EYE DROPS Pheniramine maleate (30mg) and Tetryzoline hydrochloride (5mg) 30mg and 5mg Eye drops 10ml Vial Vial 10ml sterile neutral LDPE and Dropper sterile neutral LDPE in box 24 Months LES LABORATOIRES MÉDIS, Route de Tunis, Km7-B.P.206 8000 Nabeul, Tunisia TUNISIA LES LABORATOIRES MÉDIS KIPHARMA LTD 2022-12-14 2027-12-13

91 Rwanda FDA-HMP-MA-0172 NASOALDO Mometasone Furoate 50mcg 50mcg Nasal spray suspension 140 doses in an opaque white plastic bottle Opaque plastic bottle equipped with a manual metering spray pump, a nasal adapter and a dust cap 36 Months LABORATORIO ALDO-UNIÓN, Baronesa de Maldá, 73. 08950 Esplugues de Llobregat Barcelona, Spain SPAIN LABORATORIO ALDO-UNIÓN, S.L. GOMHS LTD 2022-12-14 2027-12-13

92 Rwanda FDA-HMP-MA-0173 DEEXA Dexamethasone Sodium Phosphate USP 0.1 % 0.001 Ophthalmic drops, clear colourless solution 10 ml bottle Plastic dropper bottle 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2022-12-14 2027-12-13

93 Rwanda FDA-HMP-MA-0174 ANTHEL Albendazole USP, 400mg, Tablet 400mg Uncoated chewable tablets, 1Tablet Packed PVC blister, Aluminium foil 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2022-12-14 2027-12-13

94 Rwanda FDA-HMP-MA-0175 LORATOL ® TABLET Loratadine 10mg 10mg Tablets 10 tablets Transparent blister in PVC, covered with aluminum foil 36 Months NOBEL ILAÇ San.ve Tic. A.?, Sancaklar 81 100 DÜZCE, TURKEY TURKEY DAFRA PHARMA GmbH, Switzerland SUN ENTERPRISES LTD 2022-12-14 2027-12-13

95 Rwanda FDA-HMP-MA-0176 LORATOL ® ORAL SUSPENSION Loratadine 1mg/ml 1mg/ml Homogeneous suspension 100ml bottle Amber coloured glass bottle 24 Months NOBEL ILAÇ San.ve Tic. A.?, Sancaklar 81 100 DÜZCE, TURKEY TURKEY DAFRA PHARMA GmbH, Switzerland SUN ENTERPRISES LTD 2022-12-14 2027-12-13

96 Rwanda FDA-HMP-MA-0178 M-FORLIN 500 Metformin Hydrochloride BP, 500 mg 500mg Film coated tablets 10x10 Tablets Alu-PVC blister pack. Such 10 Blisters are packed in printed carton along with pack insert. 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2022-12-14 2027-12-13

97 Rwanda FDA-HMP-MA-0179 ROSUCHOL 20 Rosuvastatin 20mg 20mg Film coated tablets 3X10 Tablets Alu/alu blister pack, such 3 blisters are packed in a carton along with pack insert. 24 Months AJANTA PHARMA LIMITED, B-4-5-6, MIDC Industrial area paithan, Aurangabad, 431148, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2022-12-14 2027-12-13

98 Rwanda FDA-HMP-MA-0180 INSTACLOP PLUS Clopidogrel 75mg & Aspirin 75mg 75mg & 75 mg Hard gelatin capsules 3x10 Capsules Alu-Alu blister pack, such 3 blisters are packed in a printed carton 36 Months AJANTA PHARMA LIMITED, B-4-5-6, MIDC Industrial Area Paithan, Aurangabad, 431148 Dist: Aurangabad Maharashtra, India. INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2022-12-14 2027-12-13

99 Rwanda FDA-HMP-MA-0181 VILDARIL 50 Vildagliptin 50mg 50mg Uncoated Tablets 3X10 Tablets Alu/alu blister pack, such 3 blisters are packed in a printed carton along with pack insert. 24 Months AJANTA PHARMA LIMITED, B-4-5-6, MIDC Industrial area paithan, Aurangabad, 431148, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2022-12-14 2027-12-13

100 Rwanda FDA-HMP-MA-0122 ABACAVIR SULFATE/LAMIVUDINE TABLETS USP 600 MG/300 MG Abacavir Sulfate 600 mg/Lamivudine 300 mg 600 mg/ 300 mg Film Coated Tablets 30’s Tablets HDPE BOTTLE 48 Months MYLAN LABORATORIES LIMITED, F-4 & F-12, MIDC, Malegaon, Sinnar, Nashik-422 113, Maharashtra, India and Mylan Laboratories Limited, Plot No. 11,12 & 13 Indore SEZ, Phase-II, Sector-III, Pithampur-454775, Dist.-Dhar, M.P., India INDIA MYLAN LABORATORIES LIMITED, INDIA PYRAMID PHARMA LIMITED 2022-12-19 2027-12-18

101 Rwanda FDA-HMP-MA-0123 ACNOTIN 20 Isotretinoin 20 mg 20 mg Soft Gelatin Shell Capsules 3 X 10 Soft Gel Capsules ALU-ALU Aluminum Foil Blisters 24 Months MEGA LIFESCIENCES PUBLIC COMPANY LIMITED, 384 Moo 4, Soi 6, Bangpoo Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280, Thailand THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

102 Rwanda FDA-HMP-MA-0124 ATACAND PLUS 16/12.5 MG 16mg Candesartan Cilexetil and 12.5mg Hydrochlorothiazide 16mg and 12.5mg Biconvex Tablets 2x14’s Tablets PVC-PVDC/Al Blister Pack 36 Months AstraZeneca AB, Gartunavagen, SE-151 85, Sodertalje, Sweden SWEDEN AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2022-12-19 2027-12-18

103 Rwanda FDA-HMP-MA-0125 ATACAND 16 MG 16mg Candesartan Cilexetil 16mg Biconvex Tablets 2x14’s Tablets PVC-PVDC/Al Blister Pack 36 Months AstraZeneca AB, Gartunavagen, SE-151 85, Sodertalje, Sweden SWEDEN AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2022-12-19 2027-12-18

104 Rwanda FDA-HMP-MA-0126 ATACAND 8 MG 8 mg Candesartan Cilexetil 8 mg Biconvex Tablets 2x14’s Tablets PVC-PVDC/Al Blister Pack 36 Months AstraZeneca AB, Gartunavagen, SE-151 85, Sodertalje, Sweden SWEDEN AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2022-12-19 2027-12-18

105 Rwanda FDA-HMP-MA-0127 ATENOLOL DENK 50 Atenolol 50 mg 50 mg Film-Coated Tablet 100 Film-Coated Tablets BLISTER PACKS 36 Months ARTESAN PHARMA GmbH & Co. KG, Wendlandstraße 1 29439 Lüchow, Germany GERMANY DENK PHARMA GmbH & Co. KG ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2022-12-19 2027-12-18

106 Rwanda FDA-HMP-MA-0128 AVAMYS NASAL SPRAY Each Spray Actuation Delivers 27.5 Micrograms of Fluticasone Furoate 27.5 micrograms Nasal Spray White Suspension 1 Bottle Of 30, 60 Or 120 Sprays TYPE III AMBER GLASS BOTTLE 36 Months GLAXO OPERATIONS UK LIMITED (TRADING AS GLAXO WELLCOME OPERATIONS), GLAXO WELLCOME S.A., Harmire Road Barnard Castle Co. Durham, DL12 8DT, United Kingdom and/or Avenida De Extremadura 3, 09400 Aranda De Duero Burgos, Spain UNITED KINGDOM AND SPAIN GLAXOSMITHKLINE PHARMACEUTICAL KENYA LIMITED KIPHARMA LTD 2022-12-19 2027-12-18

107 Rwanda FDA-HMP-MA-0129 CATAFLAM 50MG SUGAR COATED TABLETS Diclofenac Potassium 50mg 50mg Sugar coated tablets, 20’s & 100’s tablets PVC/PE/PVDC (triplex) blister pack backed with an aluminium foil 24 Months NOVARTIS SAGLIK, Gida ve Tarim Urunleri San.Ve Tic. A. S Yenisehir Mahallesi Ihlara Vadisi Sokak No. 2 Pendik Istanbul TR 34912 Turkey TURKEY NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2022-12-19 2027-12-18

108 Rwanda FDA-HMP-MA-0130 FEVEREX TABLET Paracetamol 500mg BP 500mg Tablets 20’s & 100’s Tablets Alu/PVC blister 36 Months BETA HEALTHCARE INTERNATIONAL LTD, P.O. Box 42569- 00100, Plot No. L.R 209/6554, Mogadishu Road, Industrial Area, Nairobi, Kenya KENYA BETA HEALTHCARE INTERNATIONAL LTD SURGIPHARM (RWANDA) LTD 2022-12-19 2027-12-18

109 Rwanda FDA-HMP-MA-0131 TEGRETOL CR 200 Carbamazepine 200 mg 200 mg Film coated tablets 50’s Tablets PVC/PE/PVDC/Al foil 24 Months NOVARTIS FARMA S.p.A. Via Provinciale Schito 131, 80058 Torre Annunziata (NA), Italy ITALY NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2022-12-19 2027-12-18

110 Rwanda FDA-HMP-MA- 0132 MUSCUREL® Thiocolchicoside, 8mg 8mg Hard gelatin capsules 10 capsules PVC/Alu blister pack 36 Months BILIM ?LAÇ. SAN. VE TIC. A.?, GOSB 1900 Sokak, No: 1904 41480 Gebze, Kocaeli, TURKEY. TURKEY DAFRA PHARMA GmbH, Switzerland SUN ENTERPRISES LTD 2022-12-19 2027-12-18

111 Rwanda FDA-HMP-MA-0133 SONATEC MOUTHWASH MENTHOL FRESH (ALCOHOL FREE) Cetylpyridinium Chloride BP 0.05% w/v 0.05% w/v Clear free flowing liquid 250ml mouthwash bottle Clear plastic bottle (33 Finke) inner plug with siphoning tube 36 Months REGAL PHARMACEUTICALS LIMITED, Plot No.: 7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD, KENYA ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

112 Rwanda FDA-HMP-MA-0134 ABACAVIR (AS SULFATE)/LAMIVUDINE 120MG/60MG DISPERSIBLE TABLETS. Abacavir Sulfate USP 120mg/Lamivudine USP 60mg 120mg/60mg Biconvex tablets 30’s tablets HDPE bottle 36 Months MYLAN LABORATORIES LIMITED, F-4 & F-12, MIDC, Malegaon, Sinnar, Nashik-422 113, Maharashtra, India and Plot No. 11,12 & 13 Indore SEZ, Phase-II, Sector-III, Pithampur-454775, Dist.-Dhar, M.P., India INDIA MYLAN LABORATORIES LIMITED, INDIA PYRAMID PHARMA LIMITED 2022-12-19 2027-12-18

113 Rwanda FDA-HMP-MA-0135 AXA AQUA Sterile Water for Injection USP 10ml Solvent for parenteral use 48x10ml ampoules LDPE ampoules packed in a unit carton 36 Months AXA PARENTERALS LIMITED, Plot No 936, 937& 939, Vill. Kishanpur, Jamalpur, Roorkee-247667, Distt. Haridwar (Uttarakhand), India INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

114 Rwanda FDA-HMP-MA-0136 AXACIP Ciprofloxacin USP 200mg/100ml 200mg/100ml Solution for infusion 100 ml ampoules LDPE ampoules packed in a unit carton 36 Months AXA PARENTERALS LIMITED, Plot No 936, 937& 939, Vill. Kishanpur, Jamalpur, Roorkee-247667, Distt. Haridwar (Uttarakhand), India INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

115 Rwanda FDA-HMP-MA-0137 AXADEX D10 Glucose Intravenous Infusion BP 10% w/v 10% w/v Intravenous infusion 1X250ml bottle 300ml LDPE bottle 36 Months Axa Parenterals Limited, Plot No 936, 937& 939, Vill. Kishanpur, Jamalpur, Roorkee-247667, Distt. Haridwar (Uttarakhand), India. INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

116 Rwanda FDA-HMP-MA-0138 GXACIN Gentamicin Sulfate Ophthalmic Solution USP, (0.3% w/v) 0.3% w/v Ophthalmic Solution 1×10 ml vial LDPE vial packed in a carton along with pack insert 36 Months AXA PARENTERALS LIMITED, Plot No 936, 937& 939, Vill. Kishanpur, Jamalpur, Roorkee-247667, Distt. Haridwar (Uttarakhand), India INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

117 Rwanda FDA-HMP-MA-0139 MYHEP ALL Sofosbuvir and Velpatasvir Tablets 400 mg/100 mg 400mg/100 mg Tablets 28’s tablets HDPE bottle 24 Months MYLAN LABORATORIES LIMITED, F- 4 & F-12, MIDC, Malegaon, Sinnar, Nashik -422 113, Maharashtra, India INDIA MYLAN LABORATORIES LIMITED, INDIA PYRAMID PHARMA LIMITED 2022-12-19 2027-12-18

118 Rwanda FDA-HMP-MA-0140 METFORMIN DENK 1000 Metformin 1000 mg film-coated tablets 1000 mg Film-coated tablets 3x10’s tablets PVC/PVD foil/Alu foil Blister pack 36 Months DENK PHARMA GmbH & Co. KG, Prinzregentenstr. 79, 81675 München, Production site: Göllstr.1, 84529 Tittmoning, Germany GERMANY DENK PHARMA GmbH & Co. KG, Germany ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2022-12-19 2027-12-18

119 Rwanda FDA-HMP-MA-0141 METFORMIN DENK 500 Metformin 500 mg 500 mg Film-coated tablets 3x10’s & 10x10’s tablets PVC/PVD foil/Alu foil Blister pack 36 Months DENK PHARMA GmbH & Co. KG, Prinzregentenstr. 79, 81675 München, Production site: Göllstr.1, 84529 Tittmoning, Germany GERMANY DENK PHARMA GmbH & Co. KG, Germany ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2022-12-19 2027-12-18

120 Rwanda FDA-HMP-MA-0142 MONTEMAC 10 Montelukast Sodium 10 mg 10 mg Film coated tablet 3x10’s tablets Alu/Alu Blister packed in a carton along with pack insert 36 Months MACLEODS PHARMACEUTICALS LIMITED, Block N-2, Village Theda, Post Office Lodhimajra, Tehsil Baddi, Dist. Solan, Himachal Pradesh – 174101, India INDIA MACLEODS PHARMACEUTICALS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2022-12-19 2027-12-18

121 Rwanda FDA-HMP-MA-0162 APCALIS-SX 20 Tadalafil Tablets USP 20mg 20mg Film coated tablets 2X2 Tablets Alu- PVC blister pack, 2 such blisters are packed in a carton along with PIL 36 Months AJANTA PHARMA LIMITED, B-4/5/6, M.I.D.C. Area, Paithan, Dist. Aurangabad, Maharashtra-India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

122 Rwanda FDA-HMP-MA-0163 APFLU SYRUP Chlorphenamine Maleate BP 0.5mg, Paracetamol BP 120mg & Vitamin C BP 50mg 0.5mg, 120mg & 50mg SYRUP 100 ml bottle Amber Glass bottle in a carton along with pack insert 24 Months AJANTA PHARMA LIMITED, 31-0, M.I.D.C Area Chikalthana Aurangabad, 431 210 India. INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

123 Rwanda FDA-HMP-MA-0164 ARTEFAN 20/120 Artemether and Lumefantrine, 20/120mg tablets 20/120mg Dispersible tablets 1x6’s, 1x12’s, 30x6’s, 30x12’s tablets PVC-PVdC/ Aluminium blister packs 24 Months AJANTA PHARMA LIMITED, B-4/5/6, M.I.D.C. Area, Paithan, Dist. Aurangabad, 431148 Maharashtra-India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

124 Rwanda FDA-HMP-MA-0165 ARTEFAN 40/240 Artemether and Lumefantrine 40/240mg tablets 40/240mg Uncoated tablets 6 tablets ALU/PVC-PVdC blister Pack 24 Months AJANTA PHARMA LIMITED, B-4/5/6, M.I.D.C. Area, Paithan, Dist. Aurangabad, 431148 Maharashtra-India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

125 Rwanda FDA-HMP-MA-0166 ARTEFAN 80/480 Artemether and Lumefantrine, 80/480mg tablets 80/480mg Uncoated tablets 6 tablets ALU/PVC-PVdC Blister Pack 24 Months AJANTA PHARMA LIMITED, B-4/5/6, M.I.D.C. Area, Paithan, Dist. Aurangabad, Maharashtra-India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

126 Rwanda FDA-HBP-MA-007 CARBETOCIN FERRING CARBETOCIN 100MICROGRAMS/ML 100MICROGRAMS/ML SOLUTION FOR INJECTION 1MLX10 AMPOULES TYPE I GLASS AMPOULES WITH A WHITE ONE POINT CUT (OPC) DOT 48 Months FERRING PHARMACEUTICALS (CHINA) Co., Ltd, No.6, Hui Ling Lu (Ferring Road), National Health Technology Park, Zhongshan City, Guangdong Province, People’s Republic of China. PEOPLE’S REPUBLIC OF CHINA. FERRING INTERNATIONAL CENTER SA MULTIPHAR UNIPHARM-RWANDA LTD 2022-12-21 2027-12-20

127 Rwanda FDA-HMP-MA-0146 EPHEDRINE AGUETTANT 3 MG/ML, SOLUTION FOR INJECTION IN PREFILLED SYRINGE Ephedrine hydrochloride 3 mg/ml 3 mg/ml Solution for injection Box of 10 polypropylene pre-filled syringes of a capacity of 10 ml Polypropylene pre-filled syringes 36 Months LABORATOIRE AGUETTANT Address: 1, rue Alexander Fleming-69007 Lyon, France FRANCE LABORATOIRE AGUETTANT PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2022-12-21 2027-12-20

128 Rwanda FDA-HMP-MA-0148 ATROPINE SULFATE AGUETTANT 0.1 MG/ML, SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Atropine sulfate 0.1 mg/ml 0.1mg/ml Solution for injection Box of 10 polypropylene pre-filled syringes of a capacity of 5 ml Polypropylene pre-filled syringes 36 Months LABORATOIRE AGUETTANT Address: 1, rue Alexander Fleming-69007 Lyon, France FRANCE LABORATOIRE AGUETTANT PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2022-12-21 2027-12-20

129 Rwanda FDA-HMP-MA-0149 ADRENALINE AGUETTANT 0.1MG/ML SULPHITE FREE, SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Adrenaline tartrate 0.1 mg/ml 0.1mg/ml Solution for injection Box of 10 pre-filled syringes of 10ml Polypropylene pre-filled syringes 18 Months LABORATOIRE AGUETTANT Address: 1, rue Alexander Fleming-69007 Lyon, France FRANCE LABORATOIRE AGUETTANT PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2022-12-21 2027-12-20

130 Rwanda FDA-HMP-MA-0150 ROSUMAC 20 Rosuvastatin Calcium Ph. Eur 20mg 20mg Film-coated tablets 4X7 Tablets Alu/Alu Cold Forming Blister Packs 36 Months MACLEODS PHARMACEUTICALS LIMITED, Block N-2, Village: Theda, Post Office: Lodhimajra, Tehsil Baddi, Dist: Solan, Himachal Pradesh – 174 101, India INDIA MACLEODS PHARMACEUTICALS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2022-12-21 2027-12-20

131 Rwanda FDA-HMP-MA-0151 ROSUMAC 10 Rosuvastatin Calcium Ph. Eur 10mg 10mg Film-coated tablets 4X7 Tablets Alu/Alu Cold Forming Blister Packs 36 Months MACLEODS PHARMACEUTICALS LIMITED, Block N-2, Village: Theda, Post Office: Lodhimajra, Tehsil Baddi, Dist: Solan, Himachal Pradesh – 174 101, India INDIA MACLEODS PHARMACEUTICALS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2022-12-21 2027-12-20

132 Rwanda FDA-HMP-MA-0152 ISONIAZID AND RIFAPENTINE COATED TABLETS 300MG/300MG Isoniazid 300 mg and Rifapentine 300 mg 300mg and 300mg Film coated tablets 3 X 12 Tablets Alu-Alu strip packs in a carton along with pack insert 24 Months MACLEODS PHARMACUTICALS LIMITED, At Oxalis Labs Village Theda, P.O Lodhimajra, Baddi, Distt. Solan, Himachal Pradesh, 174101, India INDIA MACLEODS PHARMACEUTICALS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2022-12-21 2027-12-20

133 Rwanda FDA-HMP-MA-0153 COARTEM 20/120MG Artemether/Lumefantrine 20/120mg 20/120mg Tablets Pack of 18’s and 24’s tablets, Public packs 180,216,360,540 Tablets PVC/PE/PVDC, other side aluminium foil Blister packs 24 Months NOVARTIS SA?LIK, G?da ve Tar?m Ürünleri San. ve Tic. A.?.Yenisehir Mahallesi Ihlara Vadisi Sokak No. 2 Pendik Istanbul TR 34912 Turkey TURKEY NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2022-12-21 2027-12-20

134 Rwanda FDA-HMP-MA-0154 COARTEM 20/120MG DISPERSIBLE Artemether/Lumefantrine 20/120mg 20/120mg Dispersible Tablets Pack of 6’s and 12’s tablets, Public packs of 18,180,216,360,540 Tablets PVC/PE/PVDC, other side aluminium foil Blister packs 24 Months NOVARTIS SA?LIK, G?da ve Tar?m Ürünleri San. ve Tic. A.?.Yenisehir Mahallesi Ihlara Vadisi Sokak No. 2 Pendik Istanbul TR 34912 Turkey TURKEY NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2022-12-21 2027-12-20

135 Rwanda FDA-HMP-MA-0156 TASIGNA 200MG Nilotinib hydrochloride monohydrate 200mg 200mg Hard gelatin capsules 28’s, 40’s, 112(4x28), 120(3x40), 392(14x28) capsules PVC/PVDC/Alu Blister multiple packs 36 Months NOVARTIS PHARMA STEIN AG, Schaffhauserstrasse 4332 Stein, Switzerland SWITZERLAND NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2022-12-21 2027-12-20

136 Rwanda FDA-HMP-MA-0157 AVONZA Efavirenz/Lamivudine/ Tenofovir Disoproxil Fumarate Tablets/400 mg/300 mg/300 mg 400mg/300mg/300mg Film coated tablets 30 tablets and 90 tablets 30 tablets in white HDPE bottle and 90 tablets in blue HDPE bottle 24 Months MYLAN LABORATORIES LIMITED, Plot No.11, 12 & 13, Indore Special, Economic Zone, Pharma Zone, Phase-II, Sector-III, Pithampur-454775, Dist. Dhar, Madhya Pradesh, India INDIA MYLAN LABORATORIES LIMITED PYRAMID PHARMA LIMITED 2022-12-21 2027-12-20

137 Rwanda FDA-HMP-MA-0158 TEGRETOL CR 400 MG Carbamazepine 400 mg 400mg Film coated tablets 50’s tablets PVC/PE/PVdC/ Al foil 24 Months NOVARTIS FARMA S.p.A. Via Provinciale Schito 131, 80058 Torre Annunziata (NA), Italy ITALY NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2022-12-21 2027-12-20

138 Rwanda FDA-HMP-MA-0159 TOBRADEX Tobramycin 3mg/ml and Dexamethasone 1mg/ml 3mg/ml and 1mg/ml Eye Drops 5ml Bottle LDPE bottle 24 Months ALCON-COUVREUR NV Rijksweg 14 Puurs, 2870 Belgium BELGIUM NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2022-12-21 2027-12-20

139 Rwanda FDA-HMP-MA-0160 STROM-50 Tramadol Hydrochloride BP 50mg 50mg Capsules 10 x 10 capsules PVC blister foil packed in printed carton 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

140 Rwanda FDA-HMP-MA-0161 KONAZOL Ketoconazole BP 2.0 % w/w 2.0 % w/w Cream 15 GM Tube Aluminium Tube & Cap 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

141 Rwanda FDA-HMP-MA-0177 UROKA CAPSULES Dutasteride 0.5mg 0.5mg Soft gelatin capsules 3 x 10 capsules Alu-PVC/PVDC blisters in a unit carton along with a literature insert 48 Months MEGA LIFESCIENCES PUBLIC COMPANY LIMITED. Address: 384 Moo 4, Soi 6, Bangpoo Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280, Thailand THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

142 Rwanda FDA-HMP-MA-0184 ENEAS Enalapril maleate 10mg and Nitrendipine 20mg 10mg and 20mg Biconvex tablets 30 tablets Alu/Alu blister. PA/AL/PVC foil and Al foil 36 Months FERRER INTERNACIONAL, S.A Joan Buscallà 1-908173-Sant Cugat del Vallès (Barcelona), Spain SPAIN FERRER INTERNACIONAL, S.A. SPAIN GOMHS LTD 2022-12-21 2027-12-20

143 Rwanda FDA-HMP-MA-0185 NS Sodium Chloride Intravenous Infusion BP 0.9% w/v 0.9% w/v Intravenous infusion 1X500ml Bottle LDPE Bottle 36 Months AXA PARENTERALS LIMITED, Plot No 936,937,938, Vill. Kishanpur, jamalpur, roorkee247667, Distt. Haridwar (uttarakhand), India INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

144 Rwanda FDA-HMP-MA-0186 CARVEDI-DENK 6.25 Carvedilol Ph. Eur 6.25mg 6.25mg Tablets 30 tablets Alu-Alu Blister 36 Months ARTESAN PHARMA GmbH & Co. KG, Wendlandstraße 1, 29439 Lüchow, Germany GERMANY DENK PHARMA GmbH & Co. KG, Germany ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2022-12-21 2027-12-20

145 Rwanda FDA-HMP-MA-0187 CASODEX 50MG FILM-COATED TABLETS Bicalutamide 50mg 50mg Film-Coated Tablets 28 tablets (2 x 14 tablets) PVC/Al foil blisters 60 Months CORDEN PHARMA GmbH, Otto-hahn-Strasse, 68723, Plankstadt, Germany GERMANY AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2022-12-21 2027-12-20

146 Rwanda FDA-HMP-MA-0188 AXACOMOCATE Sodium Cromoglicate BP, 2% w/v 2% w/v Eye Drops 10 ml vial LPDE vial packed in a unit carton along with pack insert 24 Months AXA PARENTERALS LIMITED, Plot No.936, 937 & 939, Vill. Kishanpur, Jamalpur, Roorkee 247667, Distt. Haridwar (uttarakhand), India INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

147 Rwanda FDA-HMP-MA-0189 LCT KIT Lansoprazole USP 30mg, Clarithromycin USP 250mg, & Tinidazole BP 500 mg 30mg, 250mg, & 500 mg Delayed-Release Capsules & Tablets 2 Lansoprazole Delayed-Release Capsules, 2 Clarithromycin and 2 Tinidazole Tablets Blister Pack Blister Pack 24 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED/INDIA ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

148 Rwanda FDA-HMP-MA-0190 FEBRILEX JUNIOR SYRUP Paracetamol 125mg/5ml and Chlorphenamine maleate 1mg/5ml 125mg/5ml and 1mg/5ml Syrup 150 ml Bottle Amber-coloured PET bottle with ROPP cap 36 Months GRACURE PHARMACEUTICALS LIMITED, E-1105, Industrial Area, Phase-III BHIWADI, PIN-301019, Dist. Alwar, Rajasthan, India INDIA GRACURE PHARMACEUTICALS LIMITED, INDIA H&H PHARMA LTD 2022-12-21 2027-12-20

149 Rwanda FDA-HMP-MA-0191 NEOVAG Nystatin USP, 100000 IU 100000 IU Vaginal Tablets 10X10 tablets 10 tablets are strip packed. Such 10 strips are packed in a Printed Carton with Packing Insert. 36 Months Lincoln Pharmaceuticals Limited, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

150 Rwanda FDA-HMP-MA-0192 UNIBROL 250MG TABLETS Aminosidine (as sulphate) 250mg 250mg Tablets 2 x 6’s and 4 x 6’s Tablets ALU/ALU Foils. Aluminium flexible foils 36 Months UNIVERSAL CORPORATION LIMITED, Club road, plot No, 13777, P.O Box 1748-00902 Kikuyu, Kenya KENYA UNIVERSAL CORPORATION LIMITED, KENYA SUN ENTERPRISES LTD 2022-12-21 2027-12-20

151 Rwanda FDA-HMP-MA-0193 DAFRACLAV® BD 200/28 MG Amoxicillin 200mg and Clavulanic acid 28mg 200mg and 28mg Powder for oral suspension 100 ml Bottle Amber coloured, type III glass bottle packed with a spoon 36 Months BILIM PHARMACEUTICALS, Çerkezköy Organize Sanayi Bölgesi, Karaa?aç Mh. 5. Sk. No.6, Kapakl?- Tekirda?, 59510, Turkey TURKEY DAFRA PHARMA GmbH, Switzerland SUN ENTERPRISES LTD 2022-12-21 2027-12-20

152 Rwanda FDA-HMP-MA-0194 DAFRACLAV® BD 400/57MG Amoxicillin 400mg and Clavulanic acid 57mg 400mg and 57mg Powder for oral suspension 100 ml Bottle Amber coloured, type III glass bottle packed with a spoon 36 Months BILIM PHARMACEUTICALS, Çerkezköy Organize Sanayi Bölgesi, Karaa?aç Mh. 5. Sk. No.6, Kapakl?- Tekirda?, 59510, Turkey TURKEY DAFRA PHARMA GmbH, Switzerland SUN ENTERPRISES LTD 2022-12-21 2027-12-20

153 Rwanda FDA-HMP-MA-0195 HACTOSEC® SYRUP Levodropropizine 6mg/ml, Syrup 6mg/ml Syrup 150ml Bottle Amber coloured type III glass bottle with coloured LDPE joint 24 Months BILIM ILAÇ San.ve Tic. A.? GOSB 1900 Sokak, N° 1904 41480 Gebze, Kocaeli, Turkey TURKEY DAFRA PHARMA GmbH, Switzerland SUN ENTERPRISES LTD 2022-12-21 2027-12-20

154 Rwanda FDA-HMP-MA-0196 PREZISTA 75MG Darunavir (Ethanolate) 75mg 75mg Film-coated Tablets 480 tablets HDPE plastic 160 ml bottle 36 Months JANSSEN ORTHO LLC, State Road 933 KM 0.1, Mamey Ward Gurabo, Puerto Rico 00778, USA and Janssen-Cilag SpA Via C. Janssen, Loc. Borgo S. Michele, 04100 Latina (LT), Italy ITALY JANSSEN CILAG INTERNATIONAL NV, BELGIUM KIPHARMA LTD 2022-12-21 2027-12-20

155 Rwanda FDA-HMP-MA-0197 PREZISTA 150MG Darunavir (Ethanolate) 150mg 150mg Film-coated Tablets 240 tablets HDPE plastic 160 ml bottle 36 Months JANSSEN ORTHO LLC, State Road 933 KM 0.1, Mamey Ward Gurabo, Puerto Rico 00778, USA and Janssen-Cilag SpA Via C. Janssen, Loc. Borgo S. Michele, 04100 Latina (LT), Italy ITALY JANSSEN CILAG INTERNATIONAL NV, BELGIUM KIPHARMA LTD 2022-12-21 2027-12-20

156 Rwanda FDA-HMP-MA-0198 SAYANA PRESS 104 MG/0.65 ML Medroxyprogesterone Acetate, 104mg/0.65ml 104mg/0.65ml Suspension of injection Box of 1 or box of 200 Multilayered thermoformed plastic film reservoir whose product contact layer is LDPE 36 Months PFIZER MANUFACTURING BELGIUM NV, Rijksweg 12, 2870 PUURS, Belgium BELGIUM PFIZER LABORATORIES LTD, KENYA GILMED LIMITED 2022-12-21 2027-12-20

157 Rwanda FDA-HMP-MA-0199 LIDOCAINE INJECTION BP 2 % Lidocaine Hydrochloride BP 2 % 0.02 Solution for injection 30 ml clear glass (TYPE-III) vial and B/25 vials Clear glass (TYPE-III) vial, such 25 vials are packed in a printed carton 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat. India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

158 Rwanda FDA-HMP-MA-0200 AMLIN-10 Amlodipine Besylate USP 10mg 10mg Uncoated Tablets 10 tablets ALU-PVC blister pack 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat. India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

159 Rwanda FDA-HMP-MA-0202 NATRIXAM 1.5MG/10MG Indapamide 1.5mg and amlodipine besilate 13.87 mg equivalent to amlodipine10 mg 1.5mg and 10 mg Modified- release tablets 30 tablets Blisters in Aluminium/Polyamide-Aluminium-polyvinyl choride complex 24 Months LES LABORATOIRES SERVIER INDUSTRIE, 905 route de Saran 45520 Gidy, France FRANCE LES LABORATOIRES SERVIER, FRANCE KIPHARMA LTD 2022-12-21 2027-12-20

160 Rwanda FDA-HMP-MA-0203 NATRIXAM 1.5MG/5MG Indapamide 1.5mg and amlodipine besilate 6.935 mg equivalent to amlodipine 5mg 1.5mg and 5mg Modified- release tablets 30 tablets Blisters in Aluminium/Polyamide-Aluminium-polyvinyl choride complex 24 Months LES LABORATOIRES SERVIER INDUSTRIE, 905 route de Saran 45520 Gidy, France FRANCE LES LABORATOIRES SERVIER, FRANCE KIPHARMA LTD 2022-12-21 2027-12-20

161 Rwanda FDA-HMP-MA-0204 OMLINK-20 Omeprazole USP 20mg & Omeprazole Pellets 7.15% 20mg & 7.15% Hard Gelatin Capsules 10 X 10’s Tablets Alu-strip pack 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

162 Rwanda FDA-HMP-MA-0207 NUCOXIA-120 Etoricoxib 120mg 120mg Film-coated tablets 3x10 Tablets Alu-Alu Blister pack 24 Months CADILA HEALTHCARE LIMITED, Kundaim Industrial Estate, Plot 203-213, Kundaim, GOA – 403 115, India. INDIA CADILA HEALTHCARE LTD ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

163 Rwanda FDA-HMP-MA-0208 NOKLOT Clopidogrel Bisulfate 75 mg 75mg Film-coated tablets 3x10 Tablets Alu-Alu Blister pack 24 Months CADILA HEALTHCARE LIMITED, Kundaim Industrial Estate, Plot 203-213, Kundaim, GOA – 403 115, India INDIA CADILA HEALTHCARE LTD ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

164 Rwanda FDA-HMP-MA-0209 NUCOXIA-90 Etoricoxib 90 mg 90mg Film-coated tablets 3x10 Tablets Alu-Alu Blister 24 Months CADILA HEALTHCARE LIMITED, Kundaim Industrial Estate, Plot 203-213, Kundaim, GOA – 403 115, India. INDIA CADILA HEALTHCARE LTD ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

165 Rwanda FDA-HMP-MA-0210 NUCOXIA-60 Etoricoxib 60mg 60mg Film-coated tablets 3x10 Tablets Alu-Alu Blister 24 Months CADILA HEALTHCARE LIMITED, Kundaim Industrial Estate, Plot 203-213, Kundaim, GOA – 403 115, India. INDIA CADILA HEALTHCARE LTD ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

166 Rwanda FDA-HMP-MA-0211 DESLORA-DENK 5MG Desloratadine 5mg 5mg Film-coated tablets 10x10 Tablets PVC/Aclar - aluminium blister pack 24 Months DENK PHARMA GmbH & Co. KG, Prinzregentenstr. 79, 81675 München, Göllstr.1, 84529 Tittmoning, Germany GERMANY DENK PHARMA GmbH & Co. KG ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2022-12-21 2027-12-20

167 Rwanda FDA-HMP-MA-0212 MAXIDEX Dexamethasone 0.1% (1mg/ml) 0.1% (1mg/ml) Eye suspension 5ml Bottle LDPE bottle with a dispensing plug 24 Months S.A. ALCON-COUVREUR N. V, Rijksweg 14, B-2870 Puurs, Belgium BELGIUM NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2022-12-21 2027-12-20

168 Rwanda FDA-HMP-MA-0213 NOLVADEX TAMOXIFEN CITRATE, 20 mg 20mg Film-coated tablets, 30 film coated tablets Aluminium (Alu/PVC) blister pack 60 Months AstraZeneca UK LTD, Silk Road Business Park, Macclesfield, Cheshire, SK 10 2NA, United Kingdom UNITED KINGDOM AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2022-12-21 2027-12-20

169 Rwanda FDA-HMP-MA-0214 SOMAZINA 1000MG ORAL SOLUTION Citicoline sodium, 1000mg, oral solution 1000mg Oral solution 10 ml single sachets Aluminium single sachets 24 Months FERRER INTERNACIONAL, S.A. Joan Buscallà, 1-9 08173 Sant Cugat del Vallès (Barcelona), Spain SPAIN FERRER INTERNACIONAL, S.A., Spain GOMHS LTD 2022-12-21 2027-12-20

170 Rwanda FDA-HBP-MA- 008 LEVEMIR FLEXPEN INSULIN DETEMIR 100 U/ML 100 U/ml SOLUTION FOR INJECTION 5X3 ML IN CARTRIDGE (TYPE 1 GLASS) Cartridge (type 1 glass) with a plunger and a rubber closure contained in a pre-filled multidose disposable pen made of polypropylene 30 Months NOVO NORDISK PRODUCTION SAS, and NOVO NORDISK A/S 45 Avenue d’Orléans F-28000 Chartres, France and NOVO NORDISK A/S, Novo Allé, DK-2880 Bagsværd, Denmark FRANCE AND DENMARK NOVO NORDISK A/S, DENMARK WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-01-25 2028-01-24

Registered

171 Rwanda FDA-HBP-MA- 009 TETGLOB 250 I.U. TETANUS IMMUNOGLOBULIN BULK POWDER 250 IU 250 IU Liquid Injection Clear or slightly opalescent, colorless or pale-yellow or light brown liquid 2 ML TUBULAR FLINT GLASS VIAL Tubular Flint Glass vial, Rubber Bung 13mm Chlorobutyl plain and Aluminum Flip off Seal 13mm yellow 36 Months BHARAT SERUMS & VACCINES LTD. Address: Plot No. K-27, K-27 part and K-27/1, Anand Nagar, Jambivili Village, Additional MIDC, Ambernath (East), Thane 421501 Maharashtra State, India INDIA BHARAT SERUMS AND VACCINES LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-01-25 2028-01-24

172 Rwanda FDA-HMP-MA-0201 RL Sodium Lactate solution BP Eq. to Sodium Lactate 0.32% w/v Sodium Chloride BP 0.60% w/v Potassium Chloride BP 0.04% w/v Calcium Chloride Dihydrate BP 0.027% w/v Water for Injections BP q.s. 0.32% w/v 0.60% w/v 0.04% w/v 0.027% w/v Intravenous infusion 1x500ml Bottle LDPE Bottle 36 Months AXA PARENTERALS LIMITED Plot No 936, 937& 939 Vill. Kishanpur, Jamalpur, Roorkee-247667 Distt. Haridwar (Uttarakhand), India. INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-01-25 2028-01-24

173 Rwanda FDA-HMP-MA-0215 ACNOTIN-10 Isotretinoin 10mg 10mg Soft gelatin capsules 3 x 10 soft gelatin capsules ALU-ALU Aluminum foil blisters 24 Months MEGA LIFESCIENCES Public Company Ltd. Address: 384 Moo 4, Soi 6, Bangpoo Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280, Thailand THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LTD ABACUS PHARMA (A) LTD 2023-01-25 2028-01-24

174 Rwanda FDA-HMP-MA-0216 DAPIRING Dapivirine 25 mg 25 mg Flexible, off-white vaginal ring 1 ring and 3 rings Opaque 106 mm x 106 mm heat-sealed, metalized polyester pouches (FlexiFree™ 7153). Then 1 ring/carton or 3 rings/carton 60 Months QPHARMA AB, Agneslundsvägen 27, Malmö Sweden SWEDEN INTERNATIONAL PARTNERSHIP FOR MICROBICIDES INC. (IPM) SOUTH AFRICA NPC WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-01-25 2028-01-24

175 Rwanda FDA-HMP-MA-0217 ZIDOVUDINE ORAL SOLUTION USP 50 MG/5ML Zidovudine USP 50mg/5ml 50mg/5ml Colourless to pale yellow, strawberry flavoured liquid 240 ml HDPE Container HDPE Container 24 Months AUROBINDO PHARMA LIMITED Unit III, Sy. No. 313 & 314, Bachupally, Bachupally Mandal, Medchal-Malkajgiri District, Telangana State, India INDIA AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2023-01-25 2028-01-24

176 Rwanda FDA-HMP-MA-0218 LUMITER DT Artemether 20 mg and Lumefantrine 120 mg 20mg and 120mg Dispersible tablet 6 tablets per blister card, 17 blisters per carton. 6 tablets per blister card, 30 blisters per carton. 12 tablets per blister card, 30 blisters per carton. PVC/PE/PVDC-Alu blister packs 36 Months MACLEODS PHARMACEUTICALS LIMITED, At, Oxalis Labs G Block, Village Theda, P.O Lodhimajra, Baddi, Distt. Solan, Himachal Pradesh, 174101, India INDIA MACLEODS PHARMACEUTICALS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-01-25 2028-01-24

177 Rwanda FDA-HMP-MA-0220 PHENYLEPHRINE AGUETTANT 50 MICROGRAMS/ML, SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Phenylephrine hydrochloride, 50 micrograms/ml 50 micrograms/ml Solution for injection in pre-filled syringe Box of 10 pre-filled syringes Colourless polypropylene pre-filled syringes of a capacity of 10 ml 36 Months LABORATOIRE AGUETTANT Address: 1, rue Alexander Fleming- 69007 Lyon, France FRANCE LABORATOIRE AGUETTANT PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2023-01-25 2028-01-24

178 Rwanda FDA-HBP-MA-0010 ZABDENO SUSPENSION FOR INJECTION. EBOLA VACCINE (AD26.ZEBOV-GP [RECOMBINANT]) AND MVABEA SUSPENSION FOR INJECTION. EBOLA VACCINE (MVA-BN-FILO [RECOMBINANT]) Ad26.ZEBOV, MVA-BN-Filo, 0.5 mL, NLT 0.7x108 Infectious units 0.5 mL, NLT 0.7x108 Infectious units Suspension for Injection Single dose Type I glass Vial, with a rubber stopper, aluminium crimp and red plastic cap for Zabdeno and with yellow plastic cap for Mvabea 48 Months IDT BIOLOGIKA GmbH, Am Pharmapark 06861 Dessau-Rosslau, Germany GERMANY JANSSEN-CILAG INTERNATIONAL NV, BELGIUM KIPHARMA LTD 2023-03-13 2028-03-12

179 Rwanda FDA-HMP-MA-0234 VAST-20 Atorvastatin Calcium, 20mg 20mg Film coated tablet 10x10’s & 3x10’s Tablets Alu-Alu Blister Pack. Such 3 and 10 Alu-Alu blisters are packed in a printed carton along with packing insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar, Gujarat Country: India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

180 Rwanda FDA-HMP-MA-0235 I-PILL Levonorgestrel BP/Ph.Eur 1.5mg 1.5mg Uncoated tablets 1 tablet Aluminium foil/ PVC/PE/PVDC blister strip 24 Months CIPLA LTD, Unit VIII.S-103 to S-105, S-107 to S-112, L-138, L-147, L-147/1 to L-147/3, L-147-A, Verna Industrial Estate, Verna, Salcette, Goa 403 722, India. INDIA CIPLA LTD, INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

181 Rwanda FDA-HMP-MA-0236 GLIMEPIRIDE DENK 2 Glimepiride 2mg 2mg Uncoated tablet 30 Tablets PVC/PVDC/aluminium blisters 48 Months DENK PHARMA GmbH & Co. KG, Göllstr. 1, 84529 Tittmoning., Germany GERMANY DENK PHARMA GMBH & CO. KG ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-05-12 2028-05-11

182 Rwanda FDA-HMP-MA-0237 GLIMEPIRIDE DENK 3 Glimepiride 3mg 3mg Uncoated tablet 30 Tablets PVC/PVDC/aluminium blisters 48 Months DENK PHARMA GmbH & Co. KG, Göllstr. 1, 84529 Tittmoning., Germany GERMANY DENK PHARMA GMBH & CO. KG ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-05-12 2028-05-11

183 Rwanda FDA-HMP-MA-0238 SITAPRIL 100 Sitagliptin 100mg 100mg Film coated tablets 3X10 tablets Blisters in a printed carton along with Pack Insert 24 Months AJANTA PHARMA LIMITED, B B-4-5-6, MIDC Industrial Area Paithan, Aurangabad, 431148 Dist: Aurangabad Maharashtra-India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

184 Rwanda FDA-HMP-MA-0239 SITAPRIL 50 Sitagliptin 50mg 50mg Film coated tablets 3X10 tablets Blisters in a printed carton along with Pack Insert 24 Months AJANTA PHARMA LIMITED, B B-4-5-6, MIDC Industrial Area Paithan, Aurangabad, 431148 Dist: Aurangabad Maharashtra-India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

185 Rwanda FDA-HMP-MA-0240 SITAPRIL 25 Sitagliptin 25mg 25mg Film coated tablets 3X10 tablets Blisters in a printed carton along with Pack Insert 24 Months AJANTA PHARMA LIMITED, B B-4-5-6, MIDC Industrial Area Paithan, Aurangabad, 431148 Dist: Aurangabad Maharashtra-India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

186 Rwanda FDA-HMP-MA-0241 DEEXA Dexamethasone Sodium Phosphate Injection USP, 4 mg/ml 4 mg/ml Solution for injection 10 X 10 X 2 ml Ampoules in blister pack 2ml transparent glass ampoule. Such 10 ampoules are packed in blister pack. Such 10 blisters are packed in Plain white inner with packaging insert 36 Months LINCOLN PHARMACEUTICALS LIMITED Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

187 Rwanda FDA-HMP-MA-0242 TRIPLIXAM 5 MG/ 1.25 MG/ 10 MG Perindopril arginine 5 mg / Indapamide 1.25 mg / Amlodipine besilate 10 mg 5 mg/ 1.25 mg/ 10 mg Film-coated tablets 30 film-coated tablets Polypropylene tablet container equipped with low density polyethylene floe reducer and low density polyethylene stopper 24 Months SERVIER (IRELAND) INDUSTRIES LTD, LES LABORATOIRES SERVIER (LSI), Moneylands, Gorey Road, Arklow, Co. Wicklow, Ireland and 905 Route de saran, 45520 Gidy, FRANCE IRELAND, FRANCE LES LABORATOIRES SERVIER (LLS), FRANCE KIPHARMA LTD 2023-05-12 2028-05-11

188 Rwanda FDA-HMP-MA-0243 PHLEBODIA® 600 MG, FILM-COATED TABLETS Diosmin, 600 mg 600 mg Film-coated tablets 15 or 30 tablets Box of PVC/aluminium blister 60 Months INNOTHERA CHOUZY, Rue René Chantereau, Chouzy-SurCisse, 41150 Valloire-Sur-Cisse, France FRANCE LABORATOIRE INNOTECH INTERNATIONAL MEDIASOL PHARMACEUTICAL DEPOT LTD 2023-05-12 2028-05-11

189 Rwanda FDA-HMP-MA-0244 LOSA-50 Losartan Potassium USP 50 mg 50 mg Film-coated tablets 3 x 10 tablets Alu-Alu Blister Pack. Such 3 Alu-Alu blisters are packed in a printed carton along with packing insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar, Gujarat, India. INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

190 Rwanda FDA-HMP-MA-0245 DOLUTEGRAVIR TABLETS 50MG Dolutegravir Sodium 50mg 50mg Film-coated tablets 30 Tablets 40cc white HDPE Container with 33mm polypropylene child resistant Cap 24 Months STRIDES PHARMA SCIENCE LIMITED, KRS Gardens Tablet Block 36/7, Suragajakkanahalli, Indlavadi cross, Anekal Taluk, Bengaluru – 562 106 INDIA INDIA STRIDES PHARMA SCIENCE LIMITED, India SUN ENTERPRISES LTD 2023-05-12 2028-05-11

191 Rwanda FDA-HMP-MA-0246 BETOPTIC 5% EYE DROPS Betaxolol base (equivalent to 5.6 mg betaxolol hydrochloride) 0.05 Sterile Ophthalmic clear colorless solution 5 ml Bottle Low density polyethylene (LDPE) Bottle & dispensing plug and the closure is made of white polypropylene (PP) 36 Months S.A. ALCON-COUVREUR N.V. Rijksweg 14 B-2870 Puurs, Belgium BELGIUM NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

192 Rwanda FDA-HMP-MA-0247 NEVIRAPINE ORAL SUSPENSION Nevirapine hemihydrate, 50mg/5ml 50mg/5ml Oral Suspension 240ml and 100ml Bottles HDPE Bottle 36 Months AUROBINDO PHARMA LIMITED (UNIT III), Survey no: 313 & 314, Bachupally, Bachupally Mandal, Medchal-Malkajgiri Dist, Telangana State, India INDIA AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

193 Rwanda FDA-HMP-MA-0248 PLENDIL 5MG Felodipine, 5mg 5mg Film-coated tablets 30 Tablets HDPE Bottle 36 Months AstraZeneca AB, Gartunavagen, SE-151 85 Sodertalje, Sweden SWEDEN AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

194 Rwanda FDA-HMP-MA-0249 PLENDIL 10MG Felodipine, 10mg 10mg Film-coated tablets 30 Tablets HDPE Bottle 36 Months AstraZeneca AB, Gartunavagen, SE-151 85 Sodertalje, Sweden SWEDEN AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

195 Rwanda FDA-HMP-MA-0250 PRENATAL Vitamin A 4,000.00 IU, Vitamin D 400.00 IU, Vitamin B1 2.00 mg, Vitamin B2 2.00 mg, Nicotinamide 10.00 mg, Vitamin B6 2.00 mg, Calcium Pantothenate 2.00 mg, Folic Acid 0.25 mg, Vitamin C 37.50 mg, Vitamin B12 2.00 mcg, Calcium (As Calcium Carbonate) 100.00 mg, Vitamin E 1.00 IU, Iron (As Ferrous Sulphate) 20.00 mg, Copper (As Copper Sulphate) 0.50 mg, Iodine (As Potassium Iodide) 0.05 mg, Magnesium (As Magnesium Sulphate) 1.00 mg, Manganese (As Manganese Sulphate) 0.10 mg, Potassium (As Potassium Sulphate) 1.00 mg And Zinc (As Zinc Sulphate) 0.15 mg. 4,000.00 IU, 400.00 IU, 2.00 mg, 2.00 mg, 10.00 mg, 2.00 mg, 2.00 mg, 0.25 mg, 37.50 mg, 2.00 mcg, 100.00 mg, 1.00 IU, 20.00 mg, 0.50 mg, 0.05 mg, 1.00 mg, 0.10 mg, 1.00 mg and 0.15 mg. Soft Shell Gelatin Capsules 30s and 60s Capsules HDPE Bottle 24 Months MEGA LIFESCIENCES PUBLIC COMPANY LTD, 384 MOO 4, SOI 6, Bangpoo Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakan 10280, Thailand THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LTD ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

196 Rwanda FDA-HMP-MA-0251 PILL-72 Levonorgestrel BP/Ph.Eur 0.75 mg 0.75 mg Uncoated tablets 2 tablets Aluminium foil/ PVC/PE/PVDC Blister strip 36 Months CIPLA LIMITED, Unit VIII, (Unit-8) Plot No: L-139, S-103 & M-62, Verna Industrial Estate, Salcette, Goa 403722, India INDIA CIPLA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

197 Rwanda FDA-HMP-MA-0252 ANASTROZOLE 1 MG FILM-COATED TABLETS Anastrozole 1 mg 1 mg Film-coated tablets 1x30 tablets PVC/Aluminium blister 60 Months SALUTAS PHARMA GmbH, Otto-von-Guericke-Allee 1 39179 Barleben, Germany Germany SANDOZ GmbH, KUNDL SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

198 Rwanda FDA-HMP-MA-0253 EFAVIRENZ TABLETS 600MG Efavirenz USP 600mg 600mg Film-coated tablets 1x30’s Tablets White opaque HDPE container 36 Months STRIDES SHASUN LIMITED, No 36/7, Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore-562 106, India INDIA STRIDES SHASUN LIMITED, INDIA SUN ENTERPRISES LTD 2023-05-12 2028-05-11

199 Rwanda FDA-HMP-MA-0254 CARVILIN-6.25 Carvedilol USP 6.25mg 6.25mg Film-coated tablets 14 tablets Alu-PVC Blisters packed in a printed carton with a packing insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

200 Rwanda FDA-HBP-MA- 0013 ZARZIO 30 MU/0.5 ML SOLUTION FOR INJECTION OR INFUSION IN PRE-FILLED SYRINGE Filgrastim 30 MU/0.5 mL 30 MU/0.5 mL Solution for injection or infusion 1, 3, 5 or 10 pre-filled syringes containing 0.5 ml solution 1, 3, 5 or 10 pre-filled syringes (type I glass) with injection needle (stainless steel), with or without a needle safety guard, containing 0.5 ml solution 36 Months SANDOZ GmbH Biochemiestr 10 A-6336 Langkampfen Austria AUSTRIA SANDOZ PHARMACEUTICALS D.D. SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

201 Rwanda FDA-HMP-MA-0256 DUOCETZ Paracetamol 325mg & Tramadol Hydrochloride 37.5mg 325mg & 37.5mg Film-coated tablets 3 x 10 film-coated tablets ALU-PVC/PVDC blisters packed in a cardboard carton along with a pack insert 24 Months MEGA LIFESCIENCES PUBLIC COMPANY LTD 515/1 MOO 4, SOI 8, Bangpoo Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280. Thailand THAILAND MEGA LIFE SCIENCES PUBLIC COMPANY LTD, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

202 Rwanda FDA-HBP-MA- 0014 ZARZIO 48 MU/0.5 ML SOLUTION FOR INJECTION OR INFUSION IN PRE-FILLED SYRINGE Filgrastim 48 MU/0.5 mL 48 MU/0.5 mL Solution for injection or infusion 1, 3, 5 or 10 pre-filled syringes containing 0.5 ml solution 1, 3, 5 or 10 pre-filled syringes (type I glass) with injection needle (stainless steel), with or without a needle safety guard, containing 0.5 ml solution 36 Months SANDOZ GmbH Biochemiestr 10 A-6336 Langkampfen Austria AUSTRIA SANDOZ PHARMACEUTICALS D.D. SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

203 Rwanda FDA-HMP-MA-0257 CLOPI-DENK 75 Clopidogrel 75mg 75mg Film-coated tablets 30 film-coated tablets Aluminium/aluminium blisters 18 Months ARTESAN PHARMA GmbH Co. KG, Wendlandstr. 1, 29439 Lüchow, Germany GERMANY DENK PHARMA GmbH & Co. KG, Germany ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-05-12 2028-05-11

204 Rwanda FDA-HBP-MA- 0015 THYMOGAM Anti-thymocyte Globulin (Equine),250 mg / 5ml liquid injection 250 mg / 5ml Liquid for Injection 5 ml vial Vial made from USP Type I, neutral, colorless glass 24 Months BHARAT SERUMS & VACCINES LTD Plot No. K-27, K-27 part and K-27/1, Anand Nagar, Jambivili Village, Additional MIDC, Ambernath (East), Thane 421501 Maharashtra State, India INDIA BHARAT SERUMS AND VACCINES LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

205 Rwanda FDA-HMP-MA-0259 DOLUTEGRAVIR SODIUM TABLET FOR ORAL SUSPENSION (DISPERSIBLE TABLETS) 10MG Dolutegravir Sodium Tablet for Oral Suspension (Dispersible Tablets) 10mg 10mg Tablet for Oral Suspension (Dispersible Tablets) 90 tablets HDPE container packed in a carton along with pack insert 24 Months MACLEODS PHARMACEUTICALS LIMITED, Block N2, Village Theda, Post Office Lodhimajra, Tehsil Baddi, Distt. Solan, Himachal Pradesh, 174101, India. INDIA MACLEODS PHARMACEUTICALS LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

206 Rwanda FDA-HBP-MA- 0016 PATIZRA 10 MG/ML SOLUTION FOR INJECTION Ranibizumab 10 mg/mL 10 mg/mL Solution for injection Vial with filter needle -0.23 mL Glass vial (colorless type I glass) with chlorobutyl rubber stopper and filter needle. Pre-filled syringe-0.165 mL sterile solution in a pre-filled syringe (type I glass) 36 Months ALCON-COUVREUR NV Rijksweg 14 Puurs, 2870, Belgium BELGIUM NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

207 Rwanda FDA-HMP-MA-0261 DOLUTEGRAVIR/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE 50/300/300MG TABLETS Dolutegravir sodium/Lamivudine USP/Tenofovir Disoproxil Fumarate 50mg/300mg/300mg 50mg/300mg/300mg Film coated tablets 30, 90, 100, & 180 tablets HDPE containers and CT Closure with 3x3 gm silica sachets in carton with leaflet 24 Months MACLEODS PHARMACEUTICALS LIMITED, Block N 2, Village Theda P.O. Lodhi Majra, Tehsil Baddi Dist.: Solan, Himachal Pradesh, 174101, India INDIA MACLEODS PHARMACEUTICALS LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

208 Rwanda FDA-HBP-MA- 0017 ACTRAPID®100IU/ML ,10 ML VIAL Human Insulin(rDNA) 100UI/ml 100UI/ml Aqueous solution 1 and 5 vials of 10ml Vial 10HN 30 Months NOVO NORDISK A/S, NOVO ALLE, Novo Nordisk Production SAS, DK-2880 Bagsvaerd, Denmark, 45 Avenue d’Orléans, F-28000 Chartres, France DENMARK , FRANCE NOVO NORDISK PHARMA GULF FZ-LLC/DUBAI, UAE WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

209 Rwanda FDA-HMP-MA-0262 SITAPRIL M 50/1000 Sitagliptin Phosphate Monohydrate 50 mg and Metformin Hydrochloride USP 1000 mg 50 mg and 1000 mg Film coated tablets 3*10 tablets Packed in blisters and 3 such blisters in a printed carton along with Pack Insert 24 Months AJANTA PHARMA LIMITED, B B-4-5-6, MIDC Industrial Area Paithan, Aurangabad, 431148 Dist: Aurangabad Maharashtra-India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

210 Rwanda FDA-HBP-MA- 0018 NOVOMIX 30 FLEXPEN Insulin Aspart 100 U/ml 100 U/ml Suspension for Injection 5x3 ml in cartridge Cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene 24 Months NOVO NORDISK A/S, AND NOVO NORDISK PRODUCTION SAS NOVO NORDISK A/S, Novo Alle, DK-2880 Bagsvaerd, Denmark and NOVO NORDISK PRODUCTION SAS, 45 Avenue d'Orleans, F-2000 Chartres, France FRANCE AND DENMARK NOVO NORDISK A/S, DENMARK WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

Registered

211 Rwanda FDA-HMP-MA-0263 NELGRA-100 Sildenafil (as Citrate) 100 mg 100 mg Film coated tablets 1 x 4’s tablets PVC/ALU Blister 36 Months UNIVERSAL CORPORATION LIMITED, Club Road, Past Kikuyu, P.O Box 1748-00902, Kikuyu Town, Kenya Kenya UNIVERSAL CORPORATION LIMITED SUN ENTERPRISES LTD 2023-05-12 2028-05-11

212 Rwanda FDA-HBP-MA- 0019 BSV HUMOG 75 HP Menotrophin BP, 75 I.U 75 I.U Lyophilized injection white powder or cake 2 ml Vial. Each vial is accompanied by an ampoule containing 1ml of chloride injection BP USP Type I, Tubular Flint Vial of 2 ml containing sterile, freeze dried white powder having 75 I.U, activity of each FSH and LH. 36 Months BHARAT SERUMS AND VACCINES LIMITED, Plot No. K-27, K-27 Part and K-27/1, Anand Nagar, Jambivili Village, Additional MIDC, Ambernath (East), Thane 421506, Maharashtra State, India. INDIA BHARAT SERUMS AND VACCINES LIMITED, WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

213 Rwanda FDA-HMP-MA-0264 KIPEL 4 Montelukast Sodium 4 mg 4 mg Chewable tablets 3x10's tablets Pack sealed with printed cold forming made up of Aluminium foil (Lid foil) 24 Months MSN LABORATORIES PRIVATE LTD, Plot No. 42, Anrich Industrial Estate, Bollaram, Sangareddy District – 502 325, Telangana, India. INDIA MEGA LIFESCIENCES (AUSTRALIA) PTY LTD ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

214 Rwanda FDA-HBP-MA- 0020 FOLIGRAF 75 I.U (FREEZE DRIED) Recombinant -Human Follicle Stimulating Hormone for Injection, 75 I.U 75 I.U Lyophilized injection, white to off white or cake 2 ml Vial USP Type I clear, colorless tubular flint glass vial of 2 ml 24 Months BHARAT SERUMS AND VACCINES LIMITED, Plot No. K-27, K-27 Part and K-27/1, Anand Nagar, Jambivili Village, Additional MIDC, Ambernath (East), Thane 421506, Maharashtra State, India INDIA BHARAT SERUMS AND VACCINES LIMITED, WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

215 Rwanda FDA-HMP-MA-0265 KIPEL 10 Montelukast Sodium 10 mg 10 mg Film coated tablets 3x10's tablets Pack sealed with printed cold forming made up of Aluminium foil (Lid foil). 24 Months MSN LABORATORIES PRIVATE LTD Plot No.: 42, ANRICH Industrial Estate, Bollaram, Sangareddy District, Pin Code – 502325, Telangana., India . INDIA MEGA LIFESCIENCES (AUSTRALIA) PTY LTD ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

216 Rwanda FDA-HBP-MA-0021 MIXTARD (R) 30, 100IU/ML Insulin Human, 100IU/ML 100IU/ML Suspension for injection 10ml in the glass vial Vial 10 ml, [glass type I] and rubber closure with snap-off cap 30 Months NOVO NORDISK PRODUCTION SAS, 45 Avenue d'Orleans, F-28000 Chartes, France. FRANCE NOVO NORDISK SAS, DENMARK WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

217 Rwanda FDA-HMP-MA-0266 ISONIAZID TABLETS BP 100MG Isoniazid BP, 100mg 100mg Uncoated tablets 10x10’s tablets PVC/PVDC Blister in Aluminium seal, such 10 blisters are packed in carton 24 Months LUPIN LIMITED, A-28/1, M.I.D.C Chikalthana, Aurangabad 431210, Maharashtra State, INDIA. INDIA LUPIN LIMITED, INDIA AIVEEN (R) LTD 2023-05-12 2028-05-11

218 Rwanda FDA-HMP-MA-0267 G-OUT 0.5 Colchicine 0.5 mg 0.5 mg Uncoated tablets 3X10 tablets, 30/100 tablets Alu/PVC/PVdC Blister pack of 10 tablets, such 1/3/10 Blisters packed in a carton along with pack insert, & HDPE container pack of 30/100 tablets. 24 Months MACLOEDS PHARMACEUTICALS LTD, Block N-2, Village: Theda, PO: Lodhimajra, Tehsil Baddi, Dist: Solan, Himachal Pradesh – 174 101, India INDIA MACLEODS PHARMACEUTICALS LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

219 Rwanda FDA-HMP-MA-0268 BICALUTAMIDE 50 MG Bicalutamide 50 mg 50 mg Film coated Tablet 20,28,30,50,60,84,90,98 or 100 film-coated tablets PVC/Aclar/Aluminium blisters 24 Months SALUTAS PHARMA GmbH Otto-von-Guericke-Allee 1, 39179, Barleben, Germany GERMANY SANDOZ GmbH, KUNDL, Austria. SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

220 Rwanda FDA-HMP-MA-0269 LUMEDEX Dexamethasone Sodium Phosphate Ophthalmic Solution USP 0.1%w/v 0.1%w/v Clear Colourless solution 1x10 ml vial LDPE vial packed in unit carton along with pack insert 24 Months AXA PARENTERALS LIMITED, Plot No.936, 937 & 939, Vill. Kishanpur, Jamalpur, Roorkee 247667, Distt. Haridwar (uttarakhand), India. INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

221 Rwanda FDA-HMP-MA-0270 SYMBICORT TURBUHALER Budesonide micronised, 160 ?g and Formoterol fumarate dihydrate, 4.5 ?g 160 ?g and 4.5 ?g Inhalation powder 60 doses and 120 doses Turbuhaler 24 Months AstraZeneca AB, Forskargatan 18, SE-151 85 Södertälje, Sweden SWEDEN AstraZeneca AB SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

222 Rwanda FDA-HMP-MA-0271 EUGLIM-2 Glimepiride USP 2mg 2mg Uncoated tablets 10x10 tablets Alu-Alu Blister pack 24 Months CADILA HEALTHCARE LIMITED, Kundaim industrial estate, Plot No.203-213, Kundaim, Goa 403 115, India INDIA CADILA HEALTHCARE LIMITED ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

223 Rwanda FDA-HMP-MA-0272 EUGLIM-4 Glimepiride USP 4mg 4mg Uncoated tablets 10x10 tablets Alu-Alu Blister pack 24 Months CADILA HEALTHCARE LIMITED, Kundaim industrial estate, Plot No.203-213, Kundaim, Goa 403 115, India INDIA CADILA HEALTHCARE LIMITED ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

224 Rwanda FDA-HMP-MA-0273 METFORMIN DENK 850 Metformin hydrochloride 850 mg equivalent to 662.8 mg metformin 850 mg Film Coated Tablets 30 and 120 film-coated tablets Blister packaging of PVC foil –Aluminium foil 60 Months DENK PHARMA GmbH & Co. KG, Prinzregentenstr. 79, 81675 München, Production site: Göllstr.1, 84529 Tittmoning, Germany GERMANY DENK PHARMA GmbH & Co. KG, Germany ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-05-12 2028-05-11

225 Rwanda FDA-HMP-MA-0274 GABALIN 300 Gabapentin Capsules USP 300 mg 300 mg Hard gelatin capsule 10 Capsules Alu-PVDC blister packed in a printed carton with packing insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

226 Rwanda FDA-HMP-MA-0275 SITAPRIL M 50/500 Sitagliptin Phosphate Monohydrate 50 mg and Metformin Hydrochloride USP 500 mg 50 mg and 500 mg Film coated tablets 3x10’s tablets Alu/Alu blister pack, 3 such blisters in a printed carton along with pack insert 24 Months AJANTA PHARMA LIMITED, B-4/5/6, MIDC Industrial Area Paithan, Aurangabad, 431148 Dist: Aurangabad Maharashtra state, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

227 Rwanda FDA-HMP-MA-0276 MACSART 80 Telmisartan USP, 80 mg 80 mg Uncoated tablets 3x10 tablets Alu/Alu Cold Forming Blister pack. Such 3 blisters packed in a carton along with a pack insert 24 Months MACLEODS PHARMACEUTICALS LIMITED, Block N-2, Theda, Lodhimajra, Tehsil Baddi, Dist: Solan, Himachal Pradesh – 174 101, India INDIA MACLEODS PHARMACEUTICALS LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

228 Rwanda FDA-HMP-MA-0277 CARVILIN-12.5 Carvedilol USP 12.5 mg 12.5 mg Film coated tablet 2X14 tablets Alu-PVC Blister Pack. Such 2 Blisters are packed in a printed carton with a packing insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khantraj, Taluka: Kalol, District: Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

229 Rwanda FDA-HMP-MA-0278 NIFEDI-DENK RETARD Nifedipine 20 mg 20 mg Film coated tablets 3 x 10 or 10 x 10 tablets PVC/PVDC/aluminium blister, such 3 or 10 blisters are packed in carton with a pack insert 36 Months DENK PHARMA GmbH & Co. KG, Göllstr.1, 84529 Tittmoning, Germany GERMANY DENK PHARMA GmbH & CO. KG ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-05-12 2028-05-11

230 Rwanda FDA-HMP-MA-0279 LOPAGEN Loperamide Hydrochloride USP 2 mg 2 mg Hard gelatin capsule 10x10 Capsules Blisters are packed in a printed carton with packing insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India. INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

231 Rwanda FDA-HMP-MA-0280 AXAPARA Paracetamol Intravenous Infusion BP 1.0%w/v 1.0%w/v Intravenous infusion 100 ml bottle LDPE bottle packed in a Unit Carton, along with the pack insert 24 Months AXA PARENTERALS LIMITED, Plot No.936, 937 & 939, Vill. Kishanpur, Jamalpur, Roorkee 247667, Distt. Haridwar (Uttarkhand) India INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

232 Rwanda FDA-HMP-MA-0281 TRAMAPA Tramadol Hydrochloride, Paracetamol 37.5mg/325mg 37.5mg/325mg Tablets 20 Tablets Aluminum/ Polyethylene strips or Aluminium/ PVC/PVDC blister packs 36 Months FERRER INTERNACIONAL, S.A. Joan Buscalla, 1-9 Sant cugat del Valles (Barcelona) Spain. SPAIN FERRER INTERNACIONAL S.A. GOMHS LTD 2023-05-12 2028-05-11

233 Rwanda FDA-HMP-MA-0282 DECLOT Warfarin Sodium USP 5mg 5mg Uncoated tablets 100’s tablets HDPE container 24 Months MACLEODS PHARMACEUTICALS LIMITED, 304, Atlanta Arcade, Marol Church road, Andheri (East), India INDIA MACLEODS PHARMACEUTICALS LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

234 Rwanda FDA-HMP-MA-0283 TADALIN-20 Tadalafil 20 mg 20 mg Film coated tablets 4 tablets ALU-PVC Blister packed in a printed baby Carton with Packing Insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

235 Rwanda FDA-HMP-MA-0284 GALVUS MET 50/500MG Vildagliptin 50mg/Metformin Hydrochloride 500mg 50mg/ 500mg Film coated tablets 30’s, 60’s, 10’s, 120’s, 180’s, 360’s tablets PA/AL/PVC, Aluminium foil blisters 18 Months NOVARTIS PHARMA PRODUKTIONS GmbH, Address: Öflinger Strasse 44,79664 Wehr, Germany. GERMANY NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

236 Rwanda FDA-HMP-MA-0285 GALVUS MET 50/850MG FILM-COATED TABLET Vildagliptin 50mg/Metformin Hydrochloride 850mg 50mg/ 850mg Film coated tablets 30’s, 60’s, 10’s, 120’s, 180’s, 360’s tablets PA/AL/PVC, Aluminium foil blisters 18 Months NOVARTIS PHARMA PRODUKTIONS GmbH, Address: Öflinger Strasse 44,79664 Wehr, Germany. GERMANY NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

237 Rwanda FDA-HMP-MA-0286 GALVUS MET 50/1000MG FILM-COATED TABLET Vildagliptin 50mg/Metformin Hydrochloride 1000mg 50mg/ 1000mg Film coated tablets 30’s, 60’s, 10’s, 120’s, 180’s, 360’s tablets PA/AL/PVC, Aluminium foil blisters 18 Months NOVARTIS PHARMA PRODUKTIONS GmbH, Address: Öflinger Strasse 44,79664 Wehr, Germany. GERMANY NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

238 Rwanda FDA-HMP-MA-0287 NEXIUM 10 MG SACHETS Esomeprazole magnesium trihydrate, 10mg 10mg Oral suspension 28 sachets Sachets made from aluminium laminate 36 Months AstraZeneca AB, Gärtunavägen SE-151 85 Södertälje, Sweden SWEDEN AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

239 Rwanda FDA-HMP-MA-0288 NEXIUM 20MG TABLETS Esomeprazole magnesium trihydrate, 20 mg 20 mg Film coated tablets 14 tablets and 28 tablets Aluminium blister pack 30 Months AstraZeneca AB, Gärtunavägen SE-151 85 Södertälje, Sweden SWEDEN AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

240 Rwanda FDA-HMP-MA-0289 NEXIUM 40MG TABLETS Esomeprazole magnesium trihydrate,40 mg 40 mg Film coated tablets 14 tablets Aluminium blister pack 30 Months AstraZeneca AB, Gärtunavägen SE-151 85 Södertälje, Sweden SWEDEN AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

241 Rwanda FDA-HMP-MA-0290 VALAZYD-H 172.5 Valsartan and Hydrochlorothiazide tablet 160mg/12.5mg 160mg/12.5mg Film coated tablets 3x10 tablets Blister pack 24 Months CADILA HEALTHCARE LIMITED, Kundaim Industrial Estate, Plot No.203-213, Kundaim, Goa 403 115, India. INDIA CADILA HEALTHCARE LIMITED, ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

242 Rwanda FDA-HMP-MA-0291 UNISTEN HC CREAM Clotrimazole BP 1% w/w and Hydrocortisone BP 1% w/w 1% w/w and 1% w/w Cream 20g tube Aluminium tube with a white cap and packed in unit carton 36 Months REGAL PHARMACEUTICALS LIMITED, Plot No: 7879/18, Off Baba Dogo Road, Ruaraka Post address: P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

243 Rwanda FDA-HMP-MA-0292 ANOL-100 Atenolol BP, 100mg 100mg Uncoated tablets 10x10 tablets Alu-Alu blister pack. Such 10 blisters are packed in printed carton with pack insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist.- Gandhinagar, Gujarat. India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

244 Rwanda FDA-HMP-MA-0293 ENOXA 2000 UI, ANTI-XA/0.2ML Enoxaparin Sodium 20mg/0.2ml Solution for Injection Box of 2 pre-filled syringes of 0.2 ml Pre-filled syringes 24 Months LES LABORATOIRES MÉDIS, Km 7 route de Tunis, BP 206 8000 Nabeul, TUNISIA TUNISIA LES LABORATOIRES MÉDIS, TUNISIA KIPHARMA LTD 2023-05-12 2028-05-11

245 Rwanda FDA-HMP-MA-0294 ENOXA 8000 UI, ANTI-XA/0.8ML Enoxaparin sodium 80mg/0.8ml Solution for Injection Box of 2 pre-filled syringes of 0.8 ml Pre-filled syringes 24 Months LES LABORATOIRES MÉDIS, Km 7 route de Tunis, BP 206 8000 Nabeul, TUNISIA TUNISIA LES LABORATOIRES MÉDIS, TUNISIA KIPHARMA LTD 2023-05-12 2028-05-11

246 Rwanda FDA-HMP-MA-0295 LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 300MG AND 300MG FILM-COATED TABLETS Lamivudine and Tenofovir Disoproxil Fumarate tablets 300mg and 300mg 300mg and 300mg Film-Coated Tablets 30 tablets HDPE bottle with a silica gel desiccant 24 Months LUPIN LIMITED, Unit 1, block-1, Plot No. 6A, Sector-17, Special Economic Zone, MIHAN Notified Area, Nagpur, Maharashtra-4411 08, India. INDIA LUPIN LIMITED, INDIA AIVEEN (R) LTD 2023-05-12 2028-05-11

247 Rwanda FDA-HMP-MA-0296 AXADEX D5 Glucose Anhydrous Intravenous Infusion BP 5% w/v 5% w/v Solution for Intravenous Infusion 1x500ml bottle LDPE bottle 36 Months AXA PARENTERALS LIMITED, Plot No.936, 937 & 939, Vill. Kishanpur, Jamalpur, Roorkee 247667, Distt. Haridwar (uttarakhand), India. INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

248 Rwanda FDA-HMP-MA-0297 AXADEX D50 Glucose Anhydrous Intravenous Infusion BP 50% w/v 50% w/v Solution for Intravenous Infusion 1x500ml bottle LDPE bottle 24 Months AXA PARENTERALS LIMITED, Plot No.936, 937 & 939, Vill. Kishanpur, Jamalpur, Roorkee 247667, Distt. Haridwar (uttarakhand), India INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

249 Rwanda FDA-HMP-MA-0298 ANOL-50 Atenolol BP, 50mg 50mg Uncoated tablets 10x10 tablets Alu-Alu blister pack. Such 10 blisters are packed in printed carton with pack insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist.- Gandhinagar, Gujarat. India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

250 Rwanda FDA-HMP-MA-0299 DAZEL KIT Azithromycin Tablets 1g, Secnidazole Tablets 1g and Fluconazole Tablets 150mg 1g, 1g and 150mg Film coated tablets 4 tablets Alu/PVC-PvdC blister packed in printed carton along with pack insert. 36 Months AJANTA PHARMA LIMITED, B-4/5/6, M.I.D.C. Area, Paithan, Dist. Aurangabad, 4 of 5 Maharashtra, India. INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

251 Rwanda FDA-HMP-MA-0300 ENOXA 4000 UI, ANTI-XA/0.4ML Enoxaparin Sodium 4000 UI/0.4ml 4000 UI/0.4ml Solution for injection 2 pre-filled syringes of 0.4 ml Box of 2 pre-filled syringes of 0.4 ml 24 Months LES LABORATOIRES MEDIS, Km 7 route de Tunis, BP 206, 8000 Nabeul, TUNISIA TUNISIA LES LABORATOIRES MEDIS. KIPHARMA LTD 2023-05-12 2028-05-11

252 Rwanda FDA-HMP-MA-0301 PAMISCAN 370, 100 ML Iopamidol 370 mg, 100ml 370 mg, 100ml Viscous liquid 1x 100 ml bottle 100 ml bottle filled in type I Transparent glass vial, then packed in an outer carton 24 Months LES LABORATOIRES MEDIS, Km 7 route de Tunis, BP 206, 8000 Nabeul, TUNISIA TUNISIA LES LABORATOIRES MEDIS. KIPHARMA LTD 2023-05-12 2028-05-11

253 Rwanda FDA-HMP-MA-0302 PAMISCAN 370, 50 ML Iopamidol 370 mg, 50ml 370 mg, 50ml Viscous liquid 1x 50 ml bottle 50 ml bottle filled in type I Transparent glass vial, then packed in an outer carton 24 Months LES LABORATOIRES MEDIS, Km 7 route de Tunis, BP 206, 8000 Nabeul, TUNISIA TUNISIA LES LABORATOIRES MEDIS. KIPHARMA LTD 2023-05-12 2028-05-11

254 Rwanda FDA-HMP-MA-0303 MACSART 40 Telmisartan USP, 40 mg 40 mg Uncoated tablets 3x10 tablets Alu/Alu Blister pack. Such 3 blisters are packed in a carton along with a pack insert 24 Months MACLEODS PHARMACEUTICALS LIMITED, Block N-2, Theda, Lodhimajra, Tehsil Baddi, Dist: Solan, Himachal Pradesh – 174 101, India INDIA MACLEODS PHARMACEUTICALS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

255 Rwanda FDA-HMP-MA-0304 UNIGENTYL Secnidazole 500 mg 500 mg Film coated tablets 1 x 4’s tablets PVC/Alu Blister. Such 1 blister is packed in a carton along with a pack insert 36 Months UNIVERSAL CORPORATION LIMITED, Club road, Plot No. 13777, P.O.Box 1748-000902 Kikuyu, Kenya KENYA UNIVERSAL CORPORATION LIMITED SUN ENTERPRISES LTD 2023-05-12 2028-05-11

256 Rwanda FDA-HMP-MA-0306 CASODEX Bicalutamide, 150mg 150mg Film coated tablets 28 tablets Alu-PVC foil blister 48 Months CORDEN PHARMA GmbH, Otto-hahn-Strasse, 68723, Plankstadt, Germany GERMANY AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

257 Rwanda FDA-HMP-MA-0307 NEXIUM IV INJECTION Esomeprazole magnesium trihydrate, 40 mg 40 mg Solution for injection/infusion 5ml in colourless glass vial Glass vial sealed with a bromobutyl rubber stopper and an aluminium cap with plastic flip-off seal 24 Months AstraZeneca AB, Gärtunavägen SE-151 85 Södertälje, Sweden SWEDEN AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

258 Rwanda FDA-HMP-MA-0308 ZIRIN Cetirizine Dihydrochloride 10mg 10mg Soft gelatin capsules 5 x 10 softgel capsules Alu-PVC/PVDC blisters packed in a catch cover, contained in a unit carton with a leaflet 24 Months, MEGA LIFESCIENCES PUBLIC COMPANY LIMITED, 384 MOO 4, SOI 6, BANG POO Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280. Thailand THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED GOMHS LTD 2023-05-12 2028-05-11

259 Rwanda FDA-HMP-MA-0309 ZOLCER KIT Omeprazole USP 20mg, Tinidazole BP 500mg, Clarithromycin USP 250mg 20mg, 500mg, 250mg Capsules, tablets, 7x 2 capsules of omeprazole /2 tablets each of Tinidazole & Clarithromycin Blister pack & 7 such kit in a Carton 24 Months AUROCHEM LABORATORIES (INDIA) PVT. LTD. Plot No.8, Palghar Taluka, Industrial Co.-op. Estate Ltd. Palghar – 401 404, District Thane, Maharashtra, INDIA INDIA AUROCHEM LABORATORIES (INDIA) PVT. LTD MULTIPHAR UBIPHARM-RWANDA LTD 2023-05-12 2028-05-11

260 Rwanda FDA-HMP-MA-0310 ENOXA 6000 UI, ANTI-XA/0.6ML Enoxaparin sodium 60mg/0.6ml Solution for Injection Box of 2 pre-filled syringes of 0.6 ml Pre-filled syringes 24 Months LES LABORATOIRES MÉDIS, Km 7 route de Tunis, BP 206 8000 Nabeul, TUNISIA TUNISIA LES LABORATOIRES MÉDIS, TUNISIA KIPHARMA LTD 2023-05-12 2028-05-11

261 Rwanda FDA-HMP-MA-0311 AVIR-200 Acyclovir USP, 200 mg 200 mg Uncoated tablets 10 Tablets Alu-PVC Blister Pack, packed in a printed Carton with Packing Insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat-India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

262 Rwanda FDA-HMP-MA-0312 XARELTO 10MG Rivaroxaban 10mg 10mg Film coated tablets 1x10 tablets PP/ALU Blister Carton 36 Months BAYER AG, Leverkusen, Bayer AG, Kaiser-Wilhelm-Allee 51368 Leverkusen, Germany GERMANY BAYER EAST AFRICA LIMITED SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

263 Rwanda FDA-HMP-MA-0313 XARELTO 15MG Rivaroxaban 15mg 15mg Film coated tablets 1x14 tablets PP/ALU Blister Carton 36 Months BAYER AG, Leverkusen, Bayer AG, Kaiser-Wilhelm-Allee 51368 Leverkusen, Germany GERMANY BAYER EAST AFRICA LIMITED SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

264 Rwanda FDA-HMP-MA-0314 XARELTO 2.5MG Rivaroxaban 2.5 mg 2.5 mg Film coated tablets 2x14 tablets PP/ALU Blister Carton 36 Months BAYER AG, Leverkusen, Bayer AG, Kaiser-Wilhelm-Allee 51368 Leverkusen, Germany GERMANY BAYER EAST AFRICA LIMITED SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

265 Rwanda FDA-HMP-MA-0315 EDURANTTM 25 MG FILM-COATED TABLETS Rilpivirine hydrochloride equivalent to 25 mg rilpivirine 25 mg Film coated tablets 30 tablets HDPE bottle with a polypropylene (PP) child resistant closure and induction seal liner 36 Months JANSSEN-CILAG S.p. A Via C. Janssen Borgo S. Michele 04100 Latina, Italy ITALY JANSSEN CILAG INTERNATIONAL NV KIPHARMA LTD 2023-05-12 2028-05-11

266 Rwanda FDA-HMP-MA-0317 INTACYCLINE SKIN OINTMENT Tetracycline hydrochloride BP 3% w/w 3% w/w Ointment 15g tube Aluminium collapsible tubes. The tubes are then put into unit packets and then wrapped in polythene film in dozens which are packed in outer cartons 24 Months REGAL PHARMACEUTICALS LIMITED Plot No.7879/18, Off Baba Dogo Road, Ruaraka, Postal address: P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

267 Rwanda FDA-HMP-MA-0318 TRIPLIXAM 10MG/ 2.5 MG/ 5 MG Perindopril arginine 10 mg / Indapamide 2.5 mg / Amlodipine besilate 5 mg 10mg/ 2.5 mg/ 5 mg Film coated tablets 30 tablets Polypropylene tablet container equipped with a LDPE flow reducer and a LDPE stopper containing a desiccant 24 Months SERVIER (IRELAND) INDUSTRIES LTD, Les Laboratoires Servier (LSI), Moneylands, Gorey Road, Arklow, Co. Wicklow, Ireland and 905 Route de saran, 45520 Gidy, France IRELAND, FRANCE LES LABORATOIRES SERVIER (LLS), FRANCE KIPHARMA LTD 2023-05-12 2028-05-11

268 Rwanda FDA-HMP-MA-0319 KIPEL 5 Montelukast Sodium, 5 mg 5 mg Chewable tablets 3x10's tablets Packed in sealed with printed cold forming made up of Aluminium foil (Lid foil) 24 Months MSN LABORATORIES PRIVATE LTD, Formulation Division, Plot No. 42, Anrich Industrial Estate, Bollaram, Sangareddy District-502325, Telangana, India INDIA MEGA LIFESCIENCES (AUSTRALIA) PTY LTD ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

269 Rwanda FDA-HMP-MA-0320 KOMEFAN 140 Artemether/Lumefantrine 20mg/120mg 20mg/120mg Tablets 6’s, 18’s, 24’s, tablets Cold form (Desiccant embedded) blister pack, Cold form blister pack, PVC/Aclar blister pack and PVC/PE/PVdC blister pack 36 Months MYLAN LABORATORIES LIMITED, F- 4 & F-12, MIDC, Malegaon, Sinnar, Nashik-422 113, Maharashtra, India INDIA MYLAN LABORATORIES LIMITED, INDIA. PYRAMID PHARMA LIMITED 2023-05-12 2028-05-11

270 Rwanda FDA-HMP-MA-0321 METFORMIN 500MG FILM-COATED TABLETS Metformin hydrochloride 500 mg equivalent to 390 mg metformin base 500 mg Film Coated Tablets 60 Film-coated tablets Alu/PVC Blister Pack 36 Months LEK S.A, ul. Podlipie 16, 95-010 Stryków, Poland POLAND SANDOZ GmbH, Kundl, Austria. SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

271 Rwanda FDA-HMP-MA-0322 GAMALATE B6 ORAL SOLUTION 2.0 g Magnesium Glutamate Hydrobromide (MGH), 1.0 g Pyridoxine hydrochloride (Vitamin B6), 1.0 g ?-amino-?-hydroxy-butyric acid (GABOB), 2.0 g ? -Aminobutyric Acid (GABA) 2.0 g, 1.0 g, 1.0 g, 2.0 g ORAL SOLUTION 100ml Bottle A carton box containing a topaz colour moulded glass with an aluminum cap (closure type “Pilfer-Proof”) 36 Months FERRER INTERNACIONAL, S.A, c/Joan Buscalla 1-9-08173-Sant Cugat del Valles (Barcelona), Spain SPAIN FERRER INTENACIONAL, S.A, Spain GOMHS LTD 2023-05-12 2028-05-11

272 Rwanda FDA-HMP-MA-0323 GAMALATE COATED TABLET Magnesium Glutamate Hydrobromide (MGH) 75mg, Pyridoxine hydrochloride (Vitamin B6) 37mg, ?-amino-?-hydroxy-butyric acid (GABOB) 37mg, ? -Aminobutyric Acid (GABA) 75mg 75mg, 37mg, 37mg, 75mg TABLETS Box with 20 and 60 coated tablets AL/AL foil Blisters. The blisters strips are packed in a carton box 60 Months FERRER INTERNACIONAL, S.A. Joan Buscalla 1-9-08173-Sant Cugat del Valles (Barcelona), Spain SPAIN FERRER INTENACIONAL, S.A, Spain GOMHS LTD 2023-05-12 2028-05-11

273 Rwanda FDA-HMP-MA-0324 VASTEN 75 Cinnarizine Tablets 75 mg 75 mg TABLETS 10x10 Tablets Blister Pack (ALU-PVC Blister foil). 24 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

274 Rwanda FDA-HMP-MA-0325 INTAPLEX TABLETS Nicotinamide BP 15mg; Riboflavin BP 1mg; Thiamine Hydrochloride BP 1 mg 15mg, 1mg, & 1 mg TABLETS 10x10 tablets Alu Foil (152mm) PVC Reel 160mm blister packs, packed in cartons 24 Months REGAL PHARMACEUTICALS LIMITED, Plot No.7879/18, Off Baba Dogo Road, Ruaraka, Postal address: P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

275 Rwanda FDA-HMP-MA-0326 UNISTEN CREAM Clotrimazole 1 % w/w 1 % w/w Cream 20g tube Aluminium tube with a white cap and packed in unit carton 36 Months REGAL PHARMACEUTICALS LIMITED, Plot No: 7879/18, Off Baba Dogo Road, Ruaraka Post address: P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

276 Rwanda FDA-HMP-MA-0327 UNISTEN COMBI PACK Clotrimazole BP 500mg and Clotrimazole 1 % w/w 500mg and 1 % w/w Vaginal Tablet & Cream 1x1tablet, 1x20gm tube 1x1tablet in a blister pack, 1x20gm aluminium tube and 1plastic applicator in one carton 36 Months REGAL PHARMACEUTICALS LIMITED, Plot No:7879/18, Off Baba Dogo Road, Ruaraka Post address: P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

277 Rwanda FDA-HMP-MA-0328 CIALIS 20 MG FILM-COATED TABLETS Tadalafil, 20 mg 20 mg Film-coated tablets 2, 4, 8, 10 and 12 tablets Aluminium/PVC blisters in cartons 36 Months LILLY S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Espagne ESPAGNE ELI LILLY EXPORT SA KIPHARMA LTD 2023-05-12 2028-05-11

278 Rwanda FDA-HMP-MA-0329 ENDOPROST 250MCG Carboprost Tromethamine Injection USP 250 mcg 250 mcg Solution for injection 2ml vial USP type I (Neutral borosilcate) tubular glass vial with concave bottom 24 Months BHARAT SERUMS AND VACCINES LIMITED, K-27, K-27 PART and K-27/1, Jambivili village, Anand Nagar, Additional M.I.D.C, Thane 421506 Maharashtra State INDIA BHARAT SERUMS & VACCINES LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

279 Rwanda FDA-HMP-MA-0330 ENDOPROST 125MCG Carboprost Tromethamine Injection USP 125 mcg 125 mcg Solution for injection 2ml vial USP type I (Neutral borosilcate) tubular glass vial with concave bottom 24 Months BHARAT SERUMS AND VACCINES LIMITED, K-27, K-27 PART and K-27/1, Jambivili village, Anand Nagar, Additional M.I.D.C, Thane 421506 Maharashtra State INDIA BHARAT SERUMS & VACCINES LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

280 Rwanda FDA-HMP-MA-0221 PREZISTA 400MG Darunavir (Ethanolate) 400mg 400mg Film coated tablets 60 tablets HDPE bottle fitted with polypropylene (PP) child resistant closure 36 Months JANSSEN ORTHO LLC, JANSSEN-CILAG SpA State Road 933 KM 0.1, Mamey Ward Gurabo, Puerto Rico 00778, USA and Via C. Janssen, Loc. Borgo S. Michele, 04100 Latina (LT), Italy USA, JANSSEN CILAG INTERNATIONAL NV, BELGIUM KIPHARMA LTD 2023-05-12 2028-05-11

281 Rwanda FDA-HMP-MA-0223 LOPINAVIR 100 MG AND RITONAVIR 25 MG TABLETS USP Lopinavir 100 mg and Ritonavir 25 mg 100 mg and 25 mg Film coated tablets 60 Tablets Heavy weight HDPE bottle with polypropylene child-resistant closure 24 Months MACLEODS PHARMACEUTICALS LIMITED Block No 2, Village Theda P.O. Lodhi Majra, Tehsil Baddi, Dist. Solan, Himachal Pradesh, 174101, India INDIA MACLEODS PHARMACEUTICALS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

282 Rwanda FDA-HMP-MA-0224 ZINC SULFATE TABLETS USP 20MG Zinc Sulfate Monohydrate 20 mg 20 mg Uncoated Tablets 10x10 Tablets PVC/PVdC-Alu blister of 10 tablets, such 10 blisters in a carton along with the pack insert 48 Months MACLEODS PHARMACEUTICALS LIMITED Block N-2, Village: Theda, Post Office: Lodhimajra, Tehsil Baddi, Dist: Solan, Himachal Pradesh – 174 101, India INDIA MACLEODS PHARMACEUTICALS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

283 Rwanda FDA-HMP-MA-0225 RESTOCIN Paracetamol BP 500 mg+ Phenylephrine Hydrochloride BP 5 mg + Chlorphenamine Maleate BP 2 mg + Anhydrous Caffeine BP 30 mg 500 mg + 5 mg + 2 mg + 30 mg Uncoated Tablets 4x50 Tablets 4 Tablets are packed in a strip Pack. Such 1 strip is packed in a printed catch cover. Such 50 catch covers are packed in a printed carton with a packing insert. 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

284 Rwanda FDA-HMP-MA-0226 DAFRACLAV ® 1000 MG BD Amoxicillin 875 mg - Clavulanic acid 125 mg 875mg & 125 mg Film-coated tablets 2x5 Tablets Alu/Alu blister 36 Months BILIM PHARMACEUTICALS, Çerkezköy Organize Sanayi Bölgesi, Karaa?aç Mh. 5. Sk. No.6, Kapakl?Tekirda?, 59510, Turkey TURKEY DAFRA PHARMA GmbH, Switzerland SUN ENTERPRISES LTD 2023-05-12 2028-05-11

285 Rwanda FDA-HMP-MA-0227 DAFRACLAV ® 625 MG Amoxicillin 500 mg - Clavulanic acid 125 mg 500 mg & 125 mg Film-coated tablets 3x5 Tablets Alu/Alu blister 36 Months BILIM PHARMACEUTICALS, Çerkezköy Organize Sanayi Bölgesi, Karaa?aç Mh. 5. Sk. No.6, Kapakl?Tekirda?, 59510, Turkey TURKEY DAFRA PHARMA GmbH, Switzerland SUN ENTERPRISES LTD 2023-05-12 2028-05-11

286 Rwanda FDA-HMP-MA-0228 MYHEP 400 Sofosbuvir, 400mg 400mg Film-coated tablets 28 Tablets Blue high density polyethylene (HDPE) 36 Months MYLAN LABORATORIES LIMITED F- 4 & F-12, MIDC, Malegaon, Sinnar, Nashik -422 113 Maharashtra, India. INDIA MYLAN LABORATORIES LIMITED, INDIA PYRAMID PHARMA LIMITED 2023-05-12 2028-05-11

287 Rwanda FDA-HMP-MA-0230 FEBRILEX® TABLETS Paracetamol BP, Phenylephrine hydrochloride, Chlorphenamine maleate BP 500mg/5mg/2 mg 500mg/5mg/2 mg Uncoated tablets Pouch of 4 tablets in Alu-Alu strip. Box of 50 pouches or 20 pouches. Alu-Alu strip. Box of 50 pouches or 20 pouches. 36 Months MILÂN LABORATORIES (INDIA) PRIVATE LIMITED, Plot N° 35, 36, 63, 64, 65, 67 & 87, Jawahar Co-op Ind. Estate Ltd. Kamothe, Raigad-410209 Maharashtra, India INDIA EXPHAR S.A., Belgium H&H PHARMA LTD 2023-05-12 2028-05-11

288 Rwanda FDA-HMP-MA-0231 DUOSKIN® CREAM Isoconazole nitrate 10mg/g (1%) and Diflucortolone valerate 1mg/g (0.1%) 10mg/g (1%) and 1mg/g (0.1%) Cream 15 g Lacquered aluminium tube closed with a HDPD screw-cap 36 Months BILIM ILAÇ SANAYI VE TICARET A.?. (BILIM PHARMACEUTICALS), GOSB, 1900 Sokak N°1904, 41480 Gebze – Kocaeli,Turkey TURKEY DAFRA PHARMA GmbH, Switzerland SUN ENTERPRISES LTD 2023-05-12 2028-05-11

289 Rwanda FDA-HMP-MA-0232 NEPIN-SR-20 Nifedipine BP, 20 mg 20 mg Film coated sustained release tablets 10x10 tablets PVC blister pack. Such 10 PVC blisters are packed in a printed carton along with packing insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khantraj, Taluka: Kalol, District: Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

290 Rwanda FDA-HMP-MA- 0233 LUMARTEM-DT (ARTEMETHER AND LUMEFANTRINE TABLETS 20/120 MG) Artemether 20 mg and Lumefantrine 120 mg dispersible tablets 20 mg and 120 mg Dispersible tablets 1x6’s, 1x12’s, 30x6’s and 30 x 12’s tablets PVC/ACLAR/PVC strip sealed with Aluminium foil 36 Months CIPLA LIMITED, CIPLA LTD UNIT- IV INDORE, Plot No. 9, 10 and 15, Indore Special Economic Zone, Phase II, Pithampur, District Dhar, Pin code: 454775, Madhya Pradesh, India INDIA CIPLA LIMITED, INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

291 Rwanda FDA-HBP-MA- 0022 NOVORAPID FLEXPEN 1 ml of the solution contains 100 U of insulin aspart (equivalent to 3.5 mg).1 pre-filled pen contains 3 ml equivalent to 300 U 100U/ML & 300U/ML Solution for injection 3 ml solution in cartridge Cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/ polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene 30 Months NOVO NORDISK PRODUCTION SAS, and Novo Nordisk A/S Novo Allé 45 Avenue d’Orléans F-28000 Chartres, France and DK-2880 Bagsværd, Denmark FRANCE, DENMARK NOVO NORDISK S/A WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-06-26 2028-06-25

292 Rwanda FDA-HMP-MA-0331 PEITEL 0.25% CREAM 1 g of cream contains: 2.5 mg of prednicarbate (INN) in an oil-in-water emollient (O/A) 2.5 mg CREAM 30 g tubes Flexible aluminium tubes 36 Months FERRER INTERNACIONAL, S.A, Joan Buscallà, 1- 9, 08173 Sant Cugat Del Valles (Barcelona), Spain SPAIN FERRER INTERNACIONAL, S.A. GOMHS LTD 2023-06-26 2028-06-25

293 Rwanda FDA-HMP-MA-0332 ATAZANAVIR (AS SULFATE) AND RITONAVIR TABLETS 300MG AND 100MG Atazanavir Sulfate equivalent to Atazanavir 300 mg, Ritonavir USP 100 mg 300 mg and 100 mg Film coated tablets 30 Tablets 120CC HDPE Bottle 24 Months LUPIN LIMITED, Plot No. 6A, Sector-17, Special Economic Zone, MIHAN notified Area, Nagpur, Maharashtra-4411 08, India INDIA LUPIN LIMITED AIVEEN (R) LTD 2023-06-26 2028-06-25

294 Rwanda FDA-HMP-MA-0333 GOFEN 400MG SOFT GEL CAPSULES Ibuprofen 400mg (Present as Free Acid and Potassium Salt) 400mg Soft gelatin shell capsules 6x10 capsules Aluminium foil/PVC/PVDC in printed cardboard carton 24 Months MEGA LIFESCIENCES PUBLIC COMPANY LIMITED 384 Moo 4, Soi 6, Bangpoo Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280, Thailand THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2023-06-26 2028-06-25

295 Rwanda FDA-HMP-MA-0334 TRIMEX MUCOLYTIC SYRUP Salbutamol sulphate BP 2.4mg/ Bromhexine HCL BP 4mg/ Guaifenesin BP 100mg 2.4mg, 4mg and 100mg Syrup 100ml bottle Glass amber colored bottle packed in unit carton together with a leaflet titled 36 Months REGAL PHARMACEUTICALS LTD, P.O box 44421-00100 GPO, Nairobi-Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2023-06-26 2028-06-25

296 Rwanda FDA-HMP-MA-0335 PREDNI Prednisolone Acetate Ophthalmic Suspension USP, 1% w/v 1% w/v Ophthalmic Suspension 10ml bottle Sterile non transparent plastic dropper bottle with white plastic cap and plastic nozzle. packed in the printed carton with packing insert 24 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar, Gujarat-India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-06-26 2028-06-25

297 Rwanda FDA-HMP-MA-0336 METFORMIN 1000MG FILM COATED TABLETS Metformin hydrochloride 1000mg 1000 MG Film Coated Tablets 20, 30, 60, 90 (only for DE/H/1808), 100, 120, 180(only for DE/H/1808), 200(only for DE/H/1808) and 300 film-coated tablets PVC/aluminum, and HDPE bottles with LDPE caps 36 months LEK S.A., 16 Podlipie Str, 95-010 Strykow, Poland POLAND SANDOZ GmbH, Kundl SURGIPHARM (RWANDA) LTD 2023-06-26 2028-06-25

298 Rwanda FDA-HMP-MA-0337 FLUCOMOL Paracetamol BP 500 mg + Dextromethorphan Hydrobromide BP 15 mg + Chlorphenamine Maleate BP 2mg + Phenylephrine Hydrochloride BP 10 mg / Capsule 500 mg + 15 mg + 2mg + 10 mg Hard Gelatin Capsule 10´10 capsules Blister packed. Such 1 blister is packed in a printed baby carton with a packaging insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar, Gujarat-India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-06-26 2028-06-25

299 Rwanda FDA-HMP-MA-0338 LOSA-H Losartan Potassium USP 50 mg and Hydrochlorothiazide 12.5 mg BP 50 mg and 12.5 mg Film coated tablets 3X10 tablets Alu-Alu blister pack. Such 3 Alu-Alu blisters are packed in a printed carton with packing insert 36 Months LINCOLN PHARMACEUTICALS LIMITED Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-06-26 2028-06-25

300 Rwanda FDA-HMP-MA-0339 ABACAVIR SULFATE AND LAMIVUDINE Abacavir Sulfate 60mg and Lamivudine 30mg 60mg and 30mg Uncoated tablets 60 tablets HDPE container 36 Months CIPLA LIMITED, Patalganga Plot No A - 42 (UnitII), MIDC, Patalganga, District Raigad, India INDIA CIPLA LTD, INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2023-06-26 2028-06-25

301 Rwanda FDA-HMP-MA-0340 CILOXAN EYE DROPS Ciprofloxacin hydrochloride 0.3% w/v 0.3% w/v EYE DROPS 5ml bottle LDPE bottle with a dispensing plug 24 Months ALCON-COUVREUR, Rijksweg 14, B-2870 Puurs Belgium. BELGIUM NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-06-26 2028-06-25

302 Rwanda FDA-HMP-MA-0222 MYLTEGA DT Dolutegravir Sodium 10 mg 10 mg Film coated tablets 90’s & 30’s tablets HDPE Bottle (with & without desiccant) 24 Months MYLAN LABORATORIES LIMITED Plot No. Il,12 & 13, Indore Special Economic Zone, Pharma Zone, Phase-II, Sector-III, Pithampur - 454775, Dist.-Dhar, Madhya Pradesh, India INDIA MYLAN LABORATORIES LIMITED PYRAMID PHARMA LIMITED 2023-06-26 2028-06-25

303 Rwanda FDA-HBP-MA-0023 RITUXIMAB (RIXIMYO) Rituximab, 100mg/10ml 100mg/10ml Solution for infusion 2 or 3 vials of 10ml Clear Type I glass vials with butyl rubber stopper 36 Months LEK PHARMACEUTICALS D.D. & Sandoz GmbH Ljubljana Verovskova 57 1526 Ljubljana, Slovenia and Batch release by Sandoz GmbH Schaftenau Biochemiestrasse 10 6336 Langkampfen, Austria AUSTRIA SANDOZ PHARMACEUTICALS D.D. SURGIPHARM (RWANDA) LTD 2023-07-08 2028-07-07

304 Rwanda FDA-HBP-MA-0024 Rituximab (Riximyo) Rituximab, 500mg/ 50ml 500mg/ 50ml Solution for infusion 1 or 2 vials of 50ml Clear Type I glass vials with butyl rubber stopper 36 Months LEK PHARMACEUTICALS D.D. & Sandoz GmbH Ljubljana Verovskova 57 1526 Ljubljana, Slovenia and Batch release by Sandoz GmbH Schaftenau Biochemiestrasse 10 6336 Langkampfen, Austria AUSTRIA SANDOZ PHARMACEUTICALS D.D. SURGIPHARM (RWANDA) LTD 2023-07-08 2028-07-07

305 Rwanda FDA-HMP-MA-0025 PHESGO® Pertuzumab 1200 mg + Trastuzumab 600 mg 1200 mg + 600 mg Solution for injection 15 ml Vial 20 mL USP/ Ph. Eur.JP Type I borosilicate glass, colorless, tapered with fluororesin-laminated rubber stopper 18 Months F. HOFFMANN-LA ROCHE LTD, Wurmisweg, 4303 Kaiseraugst, Switzerland SWITZERLAND F. HOFFMANN-LA ROCHE LTD KIPHARMA LTD 2023-07-08 2028-07-07

306 Rwanda FDA-HMP-MA-0026 PHESGO® Pertuzumab 600 mg + Trastuzumab 600 mg 600 mg + 600 mg Solution for injection 15 ml Vial 20 mL USP/ Ph. Eur.JP Type I borosilicate glass, colorless, tapered with fluororesin-laminated rubber stopper 18 Months F. HOFFMANN-LA ROCHE LTD, Wurmisweg, 4303 Kaiseraugst, Switzerland SWITZERLAND F. HOFFMANN-LA ROCHE LTD KIPHARMA LTD 2023-07-08 2028-07-07

307 Rwanda FDA-HMP-MA-0027 HERCEPTIN SOLUTION FOR INJECTION 600MG/5ML Trastuzumab 600mg/5ml 600mg/5ml Solution for injection 6 mL glass vial Glass vial (type 1 glass) closed by means of a rubber. Stopper (rubber laminated with fluoro-resin) and an aluminum Overseal with flip-off disk 21 months F. HOFFMANN-LA ROCHE LTD, Wurmisweg, 4303 Kaiseraugst, Switzerland SWITZERLAND F. HOFFMANN-LA ROCHE LTD KIPHARMA LTD 2023-07-08 2028-07-07

308 Rwanda FDA-HMP-MA-0028 GAMMA IV- 5 Human Normal Immunoglobulin for Intravenous use BP (Bulk).5g / Vial 5g/Vial Solution for injection 100 ml Vial USP Type – I, moulded flint glass vial. 24 Months BHARAT SERUMS & VACCINES LTD, Plot No. K-27, K-27 Part and K-27/1, Anand Nagar, Jambivili Village, Additional MIDC, Ambernath (East), Thane 421506, Maharashtra State, India INDIA BHARAT SERUMS & VACCINES LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-07-08 2028-07-07

309 Rwanda FDA-HMP-MA-0371 EQUIRAB 1000IU Rabies Antiserum Equine 1000 I.U. 1000 I.U. Solution for injection 5ml Vial Clear colorless Glass USP Type I Moulded flint Vial covered a Rubber Bung 20mm clotted chlorobutyl and a 20mm Aluminium Flip off seal Violet 36 Months BHARAT SERUMS AND VACCINES LIMITED, Plot No. K-27, K-27 Part and K-27/1, Anand Nagar, Jambivili Village, Additional MIDC, Ambernath East, Thane 421506, Maharashtra, India INDIA BHARAT SERUMS & VACCINES LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-07-08 2028-07-07

310 Rwanda FDA-HMP-MA-0341 CONTRASAFE Medroxyprogesterone acetate USP 150mg/ml 150mg/ml Suspension 2ml vial Type I clear tubular glass vial with grey bromobutyl rubber stopper and white flip-off aluminium seal 36 Months MYLAN LABORATORIES LIMITED, Plot No. 20 & 21, Pharmez, Sarkhej – Bavla National Highway No. 8-A, Nr. Village – Matoda, TalSanand, Dist. – Ahmedabad, 382213, INDIA INDIA MYLAN LABORATORIES LIMITED, India PYRAMID PHARMA LIMITED 2023-07-08 2028-07-07

311 Rwanda FDA-HMP-MA-0343 CARBOPLATIN EBEWE Carboplatin 450mg/45ml 450mg/45ml Solution for infusion 1x45 ml, amber vials Amber vials of glass which are sealed with Aluminium crimp caps 18 Months FAREVA UNTERACH GmbH, Mondseestrasse 11 4866 Unterach-Austria AUSTRIA SANDOZ PHARMACEUTICALS D.D. SURGIPHARM (RWANDA) LTD 2023-07-08 2028-07-07

312 Rwanda FDA-HMP-MA-0344 CARBOPLATIN EBEWE Carboplatin 150mg/15ml 150mg/15ml Solution for infusion 1x15 ml, amber vials Amber vials of glass which are sealed with Aluminium crimp caps 18 Months FAREVA UNTERACH GmbH, Mondseestrasse 11 4866 Unterach-Austria AUSTRIA SANDOZ PHARMACEUTICALS D.D. SURGIPHARM (RWANDA) LTD 2023-07-08 2028-07-07

313 Rwanda FDA-HMP-MA-0345 MyDekla 60 Daclatasvir Dihydrochloride 60mg 60mg Film-Coated Tablets 28 tablets HDPE bottle 36 Months MYLAN LABORATORIES LIMITED, F- 4 & F-12, MIDC, Malegaon, Sinnar, Nashik -422 113, Maharashtra, India INDIA MYLAN LABORATORIES LIMITED, India PYRAMID PHARMA LIMITED 2023-07-08 2028-07-07

314 Rwanda FDA-HMP-MA-0346 HepBest Tenofovir Alafenamide Fumarate 25mg 25mg Film-Coated Tablets 30’s and 90’s tablets HDPE bottle 36 Months MYLAN LABORATORIES LIMITED, Plot No.11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase-II, Sector-III, Pithampur-454775. Dist. Dhar, Madhya Pradesh, India INDIA MYLAN LABORATORIES LIMITED, India PYRAMID PHARMA LIMITED 2023-07-08 2028-07-07

315 Rwanda FDA-HMP-MA-0347 LAMIVUDINE/ZIDOVUDINE TABLETS USP 150 MG/300 MG Lamivudine 150 mg /Zidovudine 300 mg 150 mg / 300 mg Film-Coated Tablets 60’s tablets HDPE bottle 60 Months MYLAN LABORATORIES LIMITED, F- 4 & F-12, MIDC, Malegaon, Sinnar, Nashik-422 113, Maharashtra, India INDIA MYLAN LABORATORIES LIMITED, India PYRAMID PHARMA LIMITED 2023-07-08 2028-07-07

316 Rwanda FDA-HMP-MA-0348 DEPO-PROVERA Medroxyprogesterone Acetate 150mg/ml 150mg/ml Suspension for subcutaneous injection 25’s Pre-filled disposable syringe Pre-filled disposable syringe 60 Months Pfizer Manufacturing Belgium, Address: Rijksweg 12, 2870 PUURS, Belgium BELGIUM PFIZER LABORATORIES LIMITED/KENYA GILMED LIMITED 2023-07-08 2028-07-07

317 Rwanda FDA-HMP-MA-0349 DOLUTEGRAVIR TABLETS 50MG Dolutegravir 50mg 50mg Film Coated Tablets 30 tablets HDPE bottles 36 Months MYLAN LABORATORIES LIMITED Plot no: 11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase-II, Sector-III, Pithampur – 454775 Dist. Dhar (MP) India. INDIA MYLAN LABORATORIES LIMITED, INDIA PYRAMID PHARMA LIMITED 2023-07-08 2028-07-07

318 Rwanda FDA-HMP-MA-0350 ESOMEX-40 Esomeprazole Magnesium Tri-hydrate BP 40mg 40mg Enteric Coated Tablets 3X10 Tablets Alu-Alu Blister Pack. Such 3 Alu-Alu Blisters are packed in a printed Carton with Packing Insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Address: Trimul Estate, Khantraj, Taluka: Kalol, District: Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED/ INDIA ABACUS PHARMA (A) LTD 2023-07-08 2028-07-07

319 Rwanda FDA-HMP-MA-0351 CAPRIL-25 Captopril BP 25 mg 25 mg Uncoated tablets 10X10 Tablets Alu-PVC Blister Pack. Such 10 Blisters are packed in printed Carton with Packing Insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED/ INDIA ABACUS PHARMA (A) LTD 2023-07-08 2028-07-07

320 Rwanda FDA-HMP-MA-0352 CLOTRINE 100MG PESSARY Clotrimazole 100mg 100mg Pessaries 1 x 6’s Pessaries PCV/Aluminium blister. The blister and an applicator are enclosed in unit box 36 Months UNIVERSAL CORPORATION LIMITED, P.O. Box 1748-00902, Kikuyu-Kenya KENYA UNIVERSAL CORPORATION LIMITED, KENYA SUN ENTERPRISES LTD 2023-07-08 2028-07-07

321 Rwanda FDA-HMP-MA-0353 AXAGYL Metronidazole USP 500mg/100ml 500mg/100ml Intravenous Injection 100 ml bottle LDPE bottle 36 Months AXA PARENTERALS LIMITED, Address: Plot No.936, 937 & 939, Vill. Kishanpur, Jamalpur, Roorkee247667, Distt. Haridwar (Uttarakhand), India INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-07-08 2028-07-07

322 Rwanda FDA-HMP-MA-0354 KLARO-500 Clarithromycin Tablets USP 500mg 500mg Film Coated Tablets 1X10 tablets Blister, such a 1 blister packed in printed baby carton with packing insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-07-08 2028-07-07

323 Rwanda FDA-HMP-MA-0355 LOSAR-DENK 50 Losartan, 50mg losartan potassium salt, equivalent to 45.8 mg losartan 50mg Film Coated Tablets 28 tablets Opaque white Al/PVC/PE/PVdC blister packs 36 Months DENK PHARMA GmbH & Co. KG, Prinzregentenstr. 79, 81675 München, Göllstr.1, 84529 Tittmoning, Germany GERMANY DENK PHARMA GmbH & Co. KG, Germany ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-07-08 2028-07-07

324 Rwanda FDA-HMP-MA-0356 VIVIAN Diclofenac Diethylamine BP, 1.0 %w/w, Topical Gel 1.0 %w/w Topical Gel 15 gm or 30 gm Aluminium collapsible tube packed in a printed carton with packing insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-07-08 2028-07-07

325 Rwanda FDA-HMP-MA-0358 GLYFERON 1000 Metformin Hydrochloride 1000 mg 1000 mg Film Coated Tablets 30 film-coated tablets Transparent PVC coated with PE- PVDC and aluminium foil 24 Months Bilim Ilaç San.ve Tic. A.?, Turkey Turkey DAFRA PHARMA GmbH, Germany MULTIPHAR UBIPHARM-RWANDA LTD 2023-07-08 2028-07-07

326 Rwanda FDA-HMP-MA-0360 TRIPLIXAM 10mg/ 2.5mg/ 10mg Perindopril arginine 10mg / Indapamide 2.5mg / Amlodipine besilate 10 mg 10mg / 2.5mg / 10 mg Film-Coated Tablets 30 tablets Polypropylene tablet container equipped with LDPE floe reducer and stopper containing a desiccant. 24 Months Servier (Ireland) Industries Ltd, & Laboratoires Servier (LSI), Moneylands, Gorey Road, Arklow, Co. Wicklow, Ireland and Les & 905 Route de saran, 45520 Gidy, FRANCE IRELAND, FRANCE LES LABORATOIRES SERVIER (LLS), FRANCE KIPHARMA LTD 2023-07-08 2028-07-07

327 Rwanda FDA-HMP-MA-0361 UNIPEN 250MG TABLETS Phenoxymethylpenicillin Potassium, 250mg 250mg Tablets 10x10 tablets Al printed Foil and PVC Foil. 10x10 tab in a unit carton 36 Months REGAL PHARMACEUTICALS LIMITED, Plot No.:7879/18, Off Baba Dodo Road, Ruaraka. P.O.Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD/KENYA ABACUS PHARMA (A) LTD 2023-07-08 2028-07-07

328 Rwanda FDA-HMP-MA-0363 BISACODYL 5MG TABLETS Bisacodyl BP, 5mg 5mg Enteric Coated Tablets 10x10’s tablets Alu/PVC blister pack 36 Months LABORATORY & ALLIED LTD, Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa road, P.O. Box 42875 GPO 00100, Nairobi, Kenya. KENYA LABORATORY & ALLIED LTD, KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2023-07-08 2028-07-07

329 Rwanda FDA-HMP-MA-0364 AZARGA® 10 mg/mL brinzolamide / 5 mg/mL timolol 10 mg/mL / 5 mg/mL Eye Drops 5ml Droptainer Plastic Droptainer 24 Months S.A. ALCON-COUVREUR N.V., Rijksweg 14, B-2870 Puurs, Belgium BELGIUM NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-07-08 2028-07-07

330 Rwanda FDA-HMP-MA-0365 LOPINAVIR 100 AND RITONAVIR 25 MG USP TABLETS Lopinavir 100 mg and Ritonavir 25 mg USP tablets 100 mg and 25 mg Film-coated tablets 60’s tablets HDPE container 36 Months AUROBINDO PHARMA LIMITED, Unit-III, Survey No: 313 & 314, Bachupally, Bachupally Mandal, Medchal-Malkajgiri District, Telangana, India INDIA AUROBINDO PHARMA LIMITED, INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2023-07-08 2028-07-07

331 Rwanda FDA-HMP-MA-0366 PANTO-40 (PANTOPRAZOLE SODIUM DELAYED RELEASE TABLETS USP 40 MG) Pantoprazole sodium delayed release BP 40 mg 40mg Enteric Coated Tablets 1 x 10 Tablets Alu-Alu Blister Pack 36 Months STALLION LABORATORIES Pvt. Ltd, C-1B, 305/2, 3, 4 & 5, G.I.D.C. Kerala (Bavla), Dist. Ahmedabad-382 220, Gujarat, India. INDIA STALLION LABORATORIES Pvt. Ltd/ India GLAXO PHARMA WHOLESALE LTD 2023-07-08 2028-07-07

332 Rwanda FDA-HMP-MA-0367 SIMVA-DENK 40 Simvastatin 40mg 40mg Film-Coated Tablets 30 Tablets Blister strips of clear transparent PVC film coated uniformly with PVdC on inner side with a backing of aluminium foil coated with heat seal lacquer 36 Months DENK PHARMA GmbH & Co. KG, Prinzregentenstr. 79, 81675 München, Production site: Göllstr.1, 84529 Tittmoning, Germany GERMANY DENK PHARMA GmbH&Co. KG/ Germany ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-07-08 2028-07-07

333 Rwanda FDA-HMP-MA-0368 ACNESOL CREAM Tretinoin 0.5mg 0.5mg Cream 25gm Collapsible aluminium tube which are then packed in unit boxes 36 Months M/s UNIVERSAL CORPORATION LIMITED Address: P.O. Box 1748-00902, Kikuyu - Kenya. KENYA UNIVERSAL CORPORATION LIMITED SUN ENTERPRISES LTD 2023-07-08 2028-07-07

334 Rwanda FDA-HMP-MA-0369 AMLIN-5 Amlodipine Besylate USP 5 mg 5 mg Uncoated tablets 10 tablets ALU-PVC blister pack 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat. India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-07-08 2028-07-07

335 Rwanda FDA-HMP-MA-0370 ANTALGEX T® Paracetamol BP & Tramadol hydrochloride BP 325 mg/37.5 mg 325 mg/37.5 mg Hard gelatin capsule 2X10 capsules PVC-Aluminium blisters 24 months GRACURE PHARMACEUTICALS LIMITED, E-1105, Industrial Area, Phase-III BHIWADI, PIN-301019, Dist. Alwar, Rajasthan, India INDIA EXPHAR S.A H&H PHARMA LTD 2023-07-08 2028-07-07

336 Rwanda FDA-HMP-MA-0372 KNAC 75MG TABLETS Diclofenac Potassium 75mg 75mg Film Coated Tablets 30’s tablets ALU/ALU blisters which are then packed in unit boxes 36 Months M/s UNIVERSAL CORPORATION LIMITED Address: P.O. Box 1748-00902, Kikuyu - Kenya. KENYA UNIVERSAL CORPORATION LIMITED SUN ENTERPRISES LTD 2023-07-08 2028-07-07

337 Rwanda FDA-HMP-MA-0375 ODIMONT L Montelukast and Levocetirizine Dihydrochloride 10mg/5mg 10mg/5mg Film coated tablets 3 x 10 tablets Alu-Alu blister packs 24 Months CADILA HEALTHCARE LIMITED, Kundaim Industrial Estate, Plot No.203-213, Kundaim, Goa 403 115, INDIA INDIA CADILA HEALTHCARE LIMITED ABACUS PHARMA (A) LTD 2023-07-08 2028-07-07

338 Rwanda FDA-HMP-MA-0376 TRIPLIXAM 5 MG/ 1.25 MG/ 5 MG Perindopril arginine 5 mg / Indapamide 1.25 mg / Amlodipine besilate 5 mg 5 mg/ 1.25 mg/ 5 mg Film coated tablets 30 tablets Polypropylene tablet container equipped with LDPE flow reducer and stopper containing a desiccant 36 Months Servier (Ireland) Industries Ltd, and Les Laboratoires Servier (LSI), Moneylands, Gorey Road, Arklow, Co. Wicklow, Y14E284, Ireland and 905 Route de saran, 45520 Gidy, FRANCE IRELAND, FRANCE LES LABORATOIRES SERVIER (LLS), FRANCE KIPHARMA LTD 2023-07-08 2028-07-07

339 Rwanda FDA-HMP-MA-0377 RIDMAL 40/320 Dihydroartemisinin 40mg and Piperaquine Phosphate 320mg Tablets 40mg and 320mg Film coated tablets 3, 6, 9, & 12 tablets BLISTERS 24 Months AJANTA PHARMA LIMITED, B-4/5/6, M.I.D.C. Area, Paithan, Dist. Aurangabad, Maharashtra, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-07-08 2028-07-07

340 Rwanda FDA-HMP-MA-0378 EFAVIRENZ 400MG, LAMIVUDINE 300MG AND TENOFOVIR DISOPROXIL FUMARATE 300MG Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 400 mg / 300 mg / 300 mg 400 mg / 300 mg / 300 mg Film coated tablets 30, 90, 180’s tablets HDPE Bottle 24 Months MACLEODS PHARMACEUTICALS LIMITED, Block N 2, Village Theda, P.O. Lodhi Majra, Tehsil Baddi Dist.: Solan, Himachal Pradesh, 174101, India INDIA MACLEODS PHARMACEUTICALS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-07-08 2028-07-07

341 Rwanda FDA-HMP-MA-0379 MOXIFLOXACIN TABLETS USP 400 MG Moxifloxacin (as hydrochloride) 400 mg tablets 400 mg Film-Coated Tablets 10 tablets PVC/PVDC Blister Pack 24 Months LUPIN LIMITED, EPIP, SIDCO Industrial Complex, Kartholi, Bari Brahmana, Jammu (J&K) –181133. India INDIA LUPIN LIMITED AIVEEN (R) LTD 2023-07-08 2028-07-07

342 Rwanda FDA-HMP-MA-0380 LOPINAVIR AND RITONAVIR TABLETS USP 200MG/50MG Lopinavir and Ritonavir tablets USP 200mg/50mg 200mg/50mg Film-coated Ovaloid tablets 120’s tablets HDPE Container 36 Months AUROBINDO PHARMA LIMITED, Unit-III; Survey No: 313 & 314, Bachupally, Bachupally Mandal, Medchal-Malkajgiri District, Telangana, India INDIA AUROBINDO PHARMA LIMITED, INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2023-07-08 2028-07-07

343 Rwanda FDA-HMP-MA-0381 BISOPROLOL Bisoprolol fumurate, 2.5 mg 2.5 mg Film-Coated Tablets 2x15 tablets Tablets Packed in Blisters in single Carton 24 Months Salutas Pharma GmbH, & LEK S.A., Otto-von-Guericke-Allee 139179 Barleben, Germany & 16, Podlipie Str.,95-010 Stryków, Poland GERMANY, POLAND Sandoz GmbH, Kundl, Austria SURGIPHARM (RWANDA) LTD 2023-07-08 2028-07-07

344 Rwanda FDA-HMP-MA-0382 BISOPROLOL Bisoprolol fumurate, 5 mg 5 mg Film-Coated Tablets 4x25 tablets Tablets Packed in Bottles in single Carton 24 Months Salutas Pharma GmbH, & LEK S.A., Otto-von-Guericke-Allee 139179 Barleben, Germany & 16, Podlipie Str.,95-010 Stryków, Poland GERMANY, POLAND Sandoz GmbH, Kundl, Austria SURGIPHARM (RWANDA) LTD 2023-07-08 2028-07-07

345 Rwanda FDA-HMP-MA-0383 BISOPROLOL Bisoprolol fumurate, 10 mg 10 mg Film-Coated Tablets 100 tablets Tablets Packed in Blisters 24 Months Salutas Pharma GmbH, & LEK S.A., Otto-von-Guericke-Allee 139179 Barleben, Germany & 16, Podlipie Str.,95-010 Stryków, Poland GERMANY, POLAND Sandoz GmbH, Kundl, Austria SURGIPHARM (RWANDA) LTD 2023-07-08 2028-07-07

346 Rwanda FDA-HMP-0384 AMLODIPINE 5 MG Amlodipine besilate 5mg 5mg Tablets 30 Tablets AL/OPA/Al/PVC Blister park and in carton along with the leaflet 36 Months LEK PHARMACEUTICALS D.D. Verovškova 57 SI - 1526 Ljubljana, Slovenia SLOVENIA Sandoz GmbH/ Austria SURGIPHARM (RWANDA) LTD 2023-07-08 2028-07-07

347 Rwanda FDA-HMP-MA-0385 XATRAL LP 5 mg Alfuzosin 5mg 5mg Film-Coated Tablets 56’s tablets PVC /ALU Blister pack 36 Months SANOFI WINTHROP INDUSTRIE, 30-36 Avenue Gustave Eiffel 37100 Tour France FRANCE SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2023-07-08 2028-07-07

348 Rwanda FDA-HBP-MA-0029 AMPHONEX-50 Amphotericin B 50mg/vial Lyophilized Powder for injection 50mg/vial Lyophilized powder for injection 20ml Vial 20ml clear, colorless, USP-Type I (Neutral Borosilicate) Tubular Vial 36 Months BHARAT SERUMS & VACCINES LTD, Plot No. K-27, K-27 Part and K-27/1, Anand Nagar, Jambivili Village, Additional MIDC, Ambernath East, Thane 421506, Maharashtra, India INDIA BHARAT SERUMS & VACCINES LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-08-24 2028-08-23

349 Rwanda FDA-HMP-MA- 0357 GLYFERON 850 Metformin Hydrochloride 850 mg 850 mg Film Coated Tablets 30 film-coated tablets Transparent PVC coated with PE-PVDC and aluminium foil. 24 Months BILIM ILAÇ SAN.VE TIC. A.?, Turkey Turkey DAFRA PHARMA GMBH, GERMANY SUN ENTERPRISES LTD 2023-08-24 2028-08-23

350 Rwanda FDA-HMP-MA-0359 CIPRO-DENK 500 Ciprofloxacin 500 mg 500 mg Film Coated Tablets 10 film-coated tablets Blister trays of PVC/PVDC compound foil sealed with aluminium foil. packed into carton boxes 36 Months ALLPHAMED PHARBIL ARZNEIMITTEL GmbH, Hildebrandstr. 12, 37081 Göttingen, Hildebrandstr. 10-12, 37081 Göttingen, Germany GERMANY DENK PHARMA GmbH & Co. KG. GERMANY ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-08-24 2028-08-23

351 Rwanda FDA-HMP-MA-0373 LESS-K POWDER Calcium Polystyrene Sulfonate 5grams 5grams Fine powder for suspension 5gram powder sachet Aluminium sachets in duplex board unit box. 24 Months MEGA LIFESCIENCES PUBLIC COMPANY LIMITED, 384 MOO 4, Soi 6, Bangpoo Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280, Thailand. THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

352 Rwanda FDA-HMP-MA-0374 NUCLEO-CMP FORTE CAPSULES CMP disodium salt/UTP trisodium salt, 5mg/3mg 5mg/3mg Hard gelatin capsules 3 x 10 Capsules 10 Capsules are packed in aluminium/PVC-Aclar-PVC blister. Such 3 blisters are packed in a printed carton with pack insert 24 Months FERER INTERNATIONAL, S.A, Joan Buscalla 1-9,08173 –Saint Cugat del Valles, Spain. SPAIN FERRER INTERNATIONAL, S.A. GOMHS LTD 2023-08-24 2028-08-23

353 Rwanda FDA-HMP-MA-0389 FOLIC ACID 5MG TABLET Folic acid BP 5mg 5mg Tablets 10 x 10 tablets ALU-PVC blisters packed in a unit carton 36 Months LABORATORY & ALLIED LIMITED, East gate road off, Mombasa Road, Opp Sameer Africa, Plot No. 209/10349, Kenya KENYA LABORATORY & ALLIED LIMITED, DEPOT PHARMACEUTIQUE LE MEDICAL 2023-08-24 2028-08-23

354 Rwanda FDA-HMP-MA-0391 MAGNOMIT SUSPENSION Magnesium Trisilicate BP 500mg and Aluminium Hydroxide BP 250mg suspension 500mg and 250mg Suspension 100ml Bottle Round amber glass bottle with 25mm Roop cap and 25mm measuring cap packed in 100ml unit carton 36 Months REGAL PHARMACEUTICAL LTD, Plot No.7879/18, Off baba Dogo Road, Ruakara, Nairobi, Kenya. KENYA REGAL PHARMACEUTICAL LIMITED /KENYA ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

355 RWANDA FDA-HMP-MA-0392 MAGNOMINT TABLETS Magnesium Trisilicate BP 250 mg and Dried Aluminium Hydroxyde Gel BP 125 mg 250 mg and 125 mg Tablets 10x10 Tablets Alu-Alu brister pack 48 Months REGAL PHARMACEUTICALS LTD, P.O Box 44421-00100 GPO, Nairobi, Kenya KENYA REGAL PHARMACEUTICAL LIMITED /KENYA ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

356 Rwanda FDA-HMP-MA-0393 FLUOXINE 500® Ciprofloxacin hydrochloride USP 500mg 500mg Film-coated tablets 10 tablets PVC/Aluminium blisters 36 Months GRACURE PHARMACEUTICALS LIMITED, E-1105, Industrial Area, Phase-III BHIWADI, PIN-301019, Dist. Alwar, Rajasthan, India INDIA EXPHAR S.A, BELGIUM H&H PHARMA LTD 2023-08-24 2028-08-23

357 Rwanda FDA-HMP-MA-0394 ORASOL Dextrose anhydrous BP 75mmol/litre, Sodium chloride 75mmol/litre, Chlorides 65mmol/litre, Potassium 20mmol/litre, Citrate 10mmol/litre 75mmol/litre, 75mmol/litre, 65mmol/litre, 20mmol/litre, 10mmol/litre Powder for Oral Solution 25 Sachets and 50 Sachets 25 Sachets in 1 litre box, 50 Sachets in 500ml box 36 Months BIODEAL LABORATORIES LIMITED, Plot No. 123, Lunga Lunga Road, P.O. Box 32040- 00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LIMITED, KENYA CAPITAL PHARMACEUTICAL SUPPLIES LIMITED 2023-08-24 2028-08-23

358 Rwanda FDA-HMP-MA-0395 REXE-DINE ANTISEPTIC MOUTH WASH Povidone Iodine 1% w/v 1% w/v Solution 100ml Bottle Amber colored PET bottles and aluminium closure 36 Months UNIVERSAL CORPORATION LIMITED, P.O. BOX 1748-00902, KIKUYU, KENYA KENYA UNIVERSAL CORPORATION LIMITED SUN ENTERPRISES LTD 2023-08-24 2028-08-23

359 Rwanda FDA-HMP-MA-0396 DOXY-DENK 200 Doxycycline 200mg 200mg Film-coated tablets 8 film-coated tablets PVC/PE/PVDC/aluminium blisters 18 Months DENK PHARMA GmbH & Co. KG Address: Göllstr.1 84529 Tittmoning Country: Germany GERMANY DENK PHARMA GmbH & Co. KG, Germany ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-08-24 2028-08-23

360 Rwanda FDA-HMP-MA-0397 D50 Glucose Intravenous Infusion 50% W/V BP 50% W/V Solution for infusion 100ml Bottle Low density polyethylene bottles which are packed in baby cartons and then packed in mother cartons 24 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LIMITED (APDL), UGANDA ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

361 Rwanda FDA-HMP-MA-0398 CURAM 625 Amoxicillin trihydrate 500mg and clavulanate potassium 125mg Film-coated Tablets 500mg and 125mg Film-coated Tablets 10, 12,14,16,20,24,30,36, 100x1 film-coated tablets Hospital pack of 100 film-coated tablets. Aluminium Foil, soft, 30 µm, with PE Coating, Printed 24 Months SANDOZ GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria AUSTRIA SANDOZ GmbH, KUNDL/Austria SURGIPHARM (RWANDA) LTD 2023-08-24 2028-08-23

362 Rwanda FDA-HMP-MA-0399 CONCOR AMLO 10+10 Bisoprolol Fumarate 10 mg and Amlodipine Besilate 10 mg 10 mg and 10 mg Tablets 30 Tablets OPA/Al/PVC/Al blister pack 36 Months EGIS PHARMACEUTICALS PLC, Bökényföldi út 118-120 1165 Budapest, Hungary HUNGARY MERCK (PTY) LTD, South Africa SURGIPHARM (RWANDA) LTD 2023-08-24 2028-08-23

363 Rwanda FDA-HMP-MA-0400 CONCOR AMLO 5+10 Bisoprolol Fumarate 5 mg and Amlodipine Besilate 10 mg 5 mg and 10 mg Tablets 30 Tablets OPA/Al/PVC/Al blister pack 36 Months EGIS PHARMACEUTICALS PLC, Bökényföldi út 118-120 1165 Budapest, Hungary HUNGARY MERCK (PTY) LTD, South Africa SURGIPHARM (RWANDA) LTD 2023-08-24 2028-08-23

364 Rwanda FDA-HMP-MA-0401 CONCOR AMLO 10+5 Bisoprolol Fumarate 10 mg and Amlodipine Besilate 5 mg 10 mg and 5 mg Tablets 30 Tablets OPA/Al/PVC/Al blister pack 36 Months EGIS PHARMACEUTICALS PLC, Bökényföldi út 118-120 1165 Budapest, Hungary HUNGARY MERCK (PTY) LTD, South Africa SURGIPHARM (RWANDA) LTD 2023-08-24 2028-08-23

365 Rwanda FDA-HMP-MA-0402 CONCOR AMLO 5+5 Bisoprolol Fumarate 5 mg and Amlodipine Besilate 5 mg 5 mg and 5 mg Tablets 30 Tablets OPA/Al/PVC/Al blister pack 36 Months EGIS PHARMACEUTICALS PLC, Bökényföldi út 118-120 1165 Budapest, Hungary HUNGARY MERCK (PTY) LTD, South Africa SURGIPHARM (RWANDA) LTD 2023-08-24 2028-08-23

366 Rwanda FDA-HMP-MA-0403 CAPTOPRIL DENK 25 Captopril 25 mg 25 mg Tablets 20 tablets or 100 tablets PVC/PVDC/aluminium blisters packaged along with the patient information leaflet into cardboard Boxes 18 Months DENK PHARMA GmbH & Co. KG, Göllstr.1 84529 Tittmoning, Germany GERMANY DENK PHARMA GmbH & Co. KG, Germany ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-08-24 2028-08-23

367 Rwanda FDA-HMP-MA-0404 VERZOL® Albendazole USP 400 mg 400 mg Uncoated tablets 1 tablet PVC-Aluminium blister in a cardboard box 36 Months GRACURE PHARMACEUTICALS LIMITED, E-1105, Industrial Area, Phase-III BHIWADI, PIN-301019, Dist. Alwar, Rajasthan, India INDIA EXPHAR S.A. H&H PHARMA LTD 2023-08-24 2028-08-23

368 Rwanda FDA-HMP-MA-0405 GENTASOL® EYE DROPS SUSPENSION Gentamicin sulfate BP 0.3% 0.003 eye drops solution 5ml bottle LDPE bottle in carton box with leaflet 36 Months and 1 month after first opening the container AHLCON PARENTERALS (INDIA) LTD, SP 918, Phase III Bhiwadi 301019 Rajasthan, India INDIA EXPHAR S.A. H&H PHARMA LTD 2023-08-24 2028-08-23

369 Rwanda FDA-HMP-MA-0406 ACTION TABLETS Aspirin 600mg, Paracetamol 300mg and Caffeine 50mg 600mg, 300mg and 50mg Tablets 20’s and 100’s Tablets Polypaper on a unit carton made of chipboard 60 Months BETA HEALTHCARE INTERNATIONAL LTD, Plot No. L.R 209/6554 Mogadishu Road, Industrial Area, Nairobi, Kenya KENYA BETA HEALTHCARE INTERNATIONAL LTD SURGIPHARM (RWANDA) LTD 2023-08-24 2028-08-23

370 Rwanda FDA-HMP-MA-0407 FERRO-B COMPLEX SYRUP Ferric Ammonium Citrate 200 mg, Thiamine Hydrochloride 2.0 mg, Riboflavin 0.5 mg, Vitamin B12 2.5 mcg and Nicotinamide 5.0 mg 200 mg, 2.0 mg, 0.5 mg, 2.5 mcg and 5.0 mg Syrup 100 ml bottle Amber glass bottle, having 25 mm neck, and is free from visible spots. The bottle is placed in a labelled outer carton with leaflet 24 Months REGAL PHARMACEUTICALS LTD, Plot 7879/18, off Baba dogo road, Ruaraka, Bostal, P.O Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

371 Rwanda FDA-HMP-MA-0408 SWFI Sterilized water for injections BP, 100.0%w/v 100.0%w/v Solvent for parenteral use 10 ml and 5ml bottles LDPE Bottles 36 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O.Box 31376, Kampala, Uganda. UGANDA ABACUS PARENTERAL DRUGS LTD (APDL), UGANDA ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

372 Rwanda FDA-HMP-MA-0409 ALLTERA 50 Lopinavir/Ritonavir Granules Oral 40mg/10mg 40mg/10mg Creamish granular powder 120 sachets Sachet Pack comprises of printed triple laminated roll with AL foil, soft, dull side PET and bright side laminated to PE film 24 Months MYLAN LABORATORIES LIMITED, F- 4 & F-12, MIDC, Malegaon, Sinnar, Nashik -422 113, Maharashtra, India INDIA MYLAN LABORATORIES LIMITED/INDIA PYRAMID PHARMA LIMITED 2023-08-24 2028-08-23

373 Rwanda FDA-HMP-MA-0411 MEDIVEN CREAM Betamethasone valerate 0.1% w/w 0.1% w/w Cream 15g tube Aluminium tube 36 Months REGAL PHARMACEUTICALS LIMITED, Plot No.: 7879/18, Off Baba Dogo Road, Ruaraka, Nairobi, KENYA KENYA REGAL PHARMACEUTICALS LIMITED, KENYA ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

374 Rwanda FDA-HMP-MA-0412 INTUSSED COUGH SUPPRESSANT Each 5 ml contains: Ephedrine Hydrochloride BP 8mg, Dextromethorphan Hydrobromide BP 8mg, Promethazine Hydrochloride BP 4mg syrup each 5 ml contains: 8mg, 8mg, 4mg Syrup 60ml Bottle Glass Bottle 36 Months REGAL PHARMACEUTICALS LIMITED, P.O. Box 4421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LIMITED, KENYA ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

375 Rwanda FDA-HMP-MA-0413 ABAGYL Metronidazole Intravenous Infusion 0.5 % w/v B.P. 0.5 % w/v Solution for Infusion 100 ml Bottle LDPE (Low Density Polyethylene) bottles of 100 ml which are flow wrapped in BOPP (Polypropylene bags). The final product is packed in corrugated boxes 24 Months ABACUS PARENTERAL DRUGS LTD (APDL) BLOCK 191, PLOT NO.114, KINGA MUKONO, P.O.BOX 31376, KAMPALA, UGANDA UGANDA ABACUS PARENTERAL DRUGS LTD (APDL), UGANDA ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

376 Rwanda FDA-HMP-MA-0414 VIROPIL Dolutegravir/ Lamivudine/Tenofovir Disoproxil Fumarate Tablets, 50mg/300 mg/ 300 mg 50mg/300 mg/ 300 mg Film-coated tablets 30 Tablets and 90 Tablets HDPE Container 24 Months EMCURE PHARMACEUTICALS LTD, Plot No. P-1&P-2. I.T.B.T Park, Phase II, M.I.D.C, Hinjwadi, Pune – 411 057, India INDIA EMCURE PHARMACEUTICALS LTD/ INDIA ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

377 Rwanda FDA-HMP-MA-0415 FERROLIC-LF TABLETS Ferrous Sulphate (Dried) BP 200mg and Folic Acid BP 0.40mg 200mg and 0.40mg Film-coated tablets 10 x 10 Tablets Alu-PVC blisters packed in a unit carton with alongside literature insert 36 Months LABORATORY & ALLIED LTD, Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD, KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2023-08-24 2028-08-23

378 Rwanda FDA-HMP-MA-0416 PAROL® ORAL SUSPENSION Paracetamol, 250 mg/5 ml 250 mg/5 ml Suspension 100 ml Bottle Amber coloured glass bottle, closed with a white plastic cap 36 Months ATABAY KIMYA SAN. VE TIC. A.?., Dilovas? Sanayi Bölgesi, 4, K?s?m Sakarya Caddesi, No:28 Gebze/KOCAEL?, Turkey TURKEY DAFRA PHARMA GmbH, Switzerland SUN ENTERPRISES LTD 2023-08-24 2028-08-23

379 Rwanda FDA-HMP-MA-0420 TRIXON-1 GM Ceftriaxone Sodium USP, 1 gm/vial 1 gm/vial Powder for injection Powder filled in a 10 ml vial USP type-III vial. The vial is packed in Printed Carton with Packing Insert & Clear, colorless sterile water for injection is filled in 10 ml plastic ampoule pack 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat. India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

380 Rwanda FDA-HMP-MA-0422 ZINNAT GRANULES Cefuroxime Axetil, 125mg/5ml 125mg/5ml Granules for Oral Suspension 40 ml and 80 ml bottles Amber glass bottles with a closure containing a heat-seal induction membrane and a re-seal liner 24 Months GLAXO OPERATIONS UK LIMITED, Harmire Road, Barnard Castle, County Durham DL12 8DT, United Kingdom UNITED KINGDOM GLAXO SMITHKLINE PHARMACEUTICAL KENYA LIMITED KIPHARMA LTD 2023-08-24 2028-08-23

381 Rwanda FDA-HMP-MA-0423 CARBOSOL Sodium carboxymethylcellulose, 0.5% 0.005 Eye drops 10 ml Bottle Green Opaque LDPE Bottle 24 Months M/s AHLCON PARENTERALS (INDIA) LTD, SP-917 & 918, Phase III, TIICO industrial Area, Bhiwadi, Dist. Alwar, 301019, Rajasthan, India INDIA EXPHAR S.A. /BELGIUM. H&H PHARMA LTD 2023-08-24 2028-08-23

382 Rwanda FDA-HMP-MA-0424 OPELE LOTION Benzyl Benzoate emulsion, 25% w/v 25% w/v Emulsion 50ml bottle P40 50ml clear glass bottles which are sealed with 22mm aluminum ROPP cap and labelled and packed in chipboard unit carton 36 Months BETA HEALTHCARE INTERNATIONAL LTD, Plot No. L.R 209/6554 Mogadishu Road, Industrial Area, Nairobi, Kenya KENYA BETA HEALTHCARE INTERNATIONAL LTD SURGIPHARM (RWANDA) LTD 2023-08-24 2028-08-23

383 Rwanda FDA-HMP-MA-0425 LINEZOLID TABLETS 600MG Linezolid tablets 600mg 600mg Film coated Tablet 10x10 tablets CLEAR PVC blister pack 36 Months LUPIN LIMITED, EPIP, SIDCO Industrial Complex, Kartholi, Bari Brahmana, Jammu (J&K)- 181133, India INDIA LUPIN LIMITED AIVEEN (R) LTD 2023-08-24 2028-08-23

384 Rwanda FDA-HMP-MA-0426 SULPHUR OINTMENT Precipitated Sulphur BP 10.0 % w/w 10.0 % w/w Ointment 25g tube Aluminium tube with a white cap and packed in unit carton 36 Months REGAL PHARMACEUTICALS LIMITED, Address: Plot No.: 7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi. Country: Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

385 Rwanda FDA-HMP-MA-0427 AMOXICILLIN 250MG DISPERSIBLE TABLETS Amoxicillin Trihydrate, 250mg 250mg Dispersible tablets 10, 20, 30 and 100 tablets PVC/PVDC-Alu blister PVC/ACLAR/ALU blisters then packed in box 30 Months SANDOZ GmbH, Biochemiestr. 10, A-6250 Kundl, Austria AUSTRIA SANDOZ GmbH, KUNDL Biochemiestrasse 106250. Austria. SURGIPHARM (RWANDA) LTD 2023-08-24 2028-08-23

386 Rwanda FDA-HMP-MA-0428 DELASED CHESTY COUGHS NON-DROWSY Each 5ml contain Guaifenesin Ph. Eur 100 mg, Menthol 1.1mg. Each 5ml contain 100 mg, 1.1mg Syrup 100 ml Bottles Amber glass bottles 36 Months REGAL PHARMACEUTICALS LIMITED. Address: Plot No.: 7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi. Country: Kenya KENYA REGAL PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

387 Rwanda FDA-HMP-MA-0429 DELASED DRY COUGH SYRUP Each 5ml contain Diphenhydramine HCl BP 14mg, Dextromethorphan HBr BP 6.5mg, Sodium Citrate BP 57mg, Menthol BP 2mg Each 5ml contain 14mg, 6.5mg, 57mg, 2mg Syrup 100 ml Bottles Amber glass bottles 36 Months REGAL PHARMACEUTICALS LIMITED. Address: Plot No.: 7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi. Country: Kenya KENYA REGAL PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

388 Rwanda FDA-HMP-MA-0430 DELASED PAEDIATRIC SYRUP Each 5ml contain Diphenhydramine HCI BP 7 mg, Sodium citrate 28.5mg, Menthol 0.55 mg Each 5ml contain 7 mg, 28.5mg, 0.55 mg Syrup 100 ml Bottles Amber glass bottles 36 Months REGAL PHARMACEUTICALS LIMITED. Address: Plot No.: 7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi. Country: Kenya KENYA REGAL PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

389 Rwanda FDA-HMP-MA-0431 HEDON TABLETS Aspirin BP 300mg, Paracetamol BP 250 mg& Caffeine Anhydrous BP 30 mg 300mg, 250 mg & 30 mg Tablets 50 x 2’s tablets Hedon Printed Polypaper – Front and Hedon Printed Polypaper – Back in S/P Unit Carton 36 Months REGAL PHARMACEUTICALS LIMITED. Address: Plot No.: 7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi. Country: Kenya KENYA REGAL PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

390 Rwanda FDA-HMP-MA-0433 ACICLOVIR 200MG Aciclovir 200mg 200mg Tablets 25 tablets PVC/PVDC/Aluminium blisters 48 Months DENK PHARMA GmbH & Co. KG Göllstr. 184529 Tittmoning, Germany GERMANY Denk Pharma GmbH & Co. KG ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-08-24 2028-08-23

391 Rwanda FDA-HMP-MA-0434 TIMOLOL® 0.5% SOLUTION One mL of the 0.5% eye drop solution contains 6.8 mg timolol maleate corresponding to 5 mg timolol 0.005 Eye drops 5ml Bottle LDPE bottle with a dispensing plug 36 Months S.A. ALCON-COUVREUR N.V. Rijksweg 14 B-2870 Puurs Belgium BELGIUM NOVARTIS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-08-24 2028-08-23

392 Rwanda FDA-HMP-MA-0435 MAXITROL EYE OINTMENT 1 g of ointment contains dexamethasone 1 mg, neomycin sulfate 3,500 IU and polymyxin B sulfate 6,000 IU 1 mg, 3,500 IU and 6,000 IU Eye Ointment 3.5g Tube Aluminium Tube packed in carton 36 Months S.A. ALCON-COUVREUR N.V. Rijksweg 14 B-2870 Puurs Belgium BELGIUM NOVARTIS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-08-24 2028-08-23

393 Rwanda FDA-HMP-MA-0436 GOFEN 200 Each Soft Gelatin Capsule Contains: Ibuprofen Equivalent to Ibuprofen 200mg (Present as Free Acid and Potassium Salt) 200mg Soft Gelatin Shell Capsule 6 x 10 capsules Aluminium foil/PVC/PVDC blister 24 Months MEGA LIFESCIENCES PUBLIC COMPANY LIMITED. Address: 384 moo 4, soi 6, bang poo industrial estate, pattana 3 road, phraeksa, mueang, samutprakarn 10280. Thailand THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

394 Rwanda FDA-HMP-MA-0437 CODIMEX-CT TABLETS Cetirizine Dihydrochloride 10 mg 10 mg Film coated tablets 1x10 Tablets, 10x10 Tablets Aluminium foil, PVC Blisters in a unit carton 36 Months REGAL PHARMACEUTICALS LTD, Plot No.: 7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

395 Rwanda FDA-HMP-MA- 0438 GASTRICID® Famotidine BP 10 mg, Magnesium hydroxide BP 165 mg, Calcium carbonate BP 800 mg 10 mg, 165 mg, 800 mg Chewable tablet Pouch of 4 tablets, 20 or 50 tablets Pouch of 4 tablets packaged in Alu-Alu strips and 20 or 50 in a display box. 36 months MILAN LABORATORIES (INDIA) PVT. LTD, Jawhar Co-Op Industrial Estate Ltd., Kamothe, Panvel (Navi Mumbai), Maharashtra – 410209, India INDIA EXPHAR S.A H&H PHARMA LTD 2023-08-24 2028-08-23

396 Rwanda FDA-HMP-MA-0439 ANGINOVAG Dequalinium chloride 1mg, Tyrothricin 4mg, ? -glycyrrhetinic acid (Enoxolone) 0.6mg & Hydrocortisone acetate 0.6mg and Lidocaine hydrochloride 1mg 1mg, 4mg, 0.6mg, 0.6mg and 1mg Oromucosal spray solution 20 ml Bottle Plastic bottle sealed with a plastic metered dose pump containing 10 or 20 ml 48 Months FERRER INTERNACIONAL, S.A. Joan Buscalla, 1-9 08173 Sant Cugat Del Vallés Barcelona, Spain SPAIN FERRER INTERNACIONAL, S.A. GOMHS LTD 2023-08-24 2028-08-23

397 Rwanda FDA-HMP-MA-0440 BETRIM FORTE Sulfamethoxazole BP 800 mg, Trimethoprim BP 160 mg 800 mg, 160 mg Tablets 10x10 tablets Alu-PVD Blisters packed in carton along with insert 36 Months MILAN LABORATORIES (INDIA) PVT LTD, Plot no. 35/36/63/64/65/67/87, J.C.I.E. Ltd., Kamothe, Panvel, Navi Mumbai, India INDIA MILAN LABORATORIES (INDIA) PVT LTD SIGMA PHARMA RWANDA LIMITED 2023-08-24 2028-08-23

398 Rwanda FDA-HMP-MA-0441 BETRIM-480 (CO-TRIMOXAZOLE TABLETS BP 480MG) Sulfamethoxazole BP 400mg and Trimethoprim BP 80mg 400mg and 80mg Tablets 10x10 tablets Alu-PVD Blisters packed in carton along with insert 36 Months MILAN LABORATORIES (INDIA) PVT LTD, Plot no. 35/36/63/64/65/67/87, J.C.I.E. Ltd., Kamothe, Panvel, Navi Mumbai, India INDIA MILAN LABORATORIES (INDIA) PVT LTD SIGMA PHARMA RWANDA LIMITED 2023-08-24 2028-08-23

399 Rwanda FDA-HMP-MA-0442 ROSUCHOL 10MG Rosuvastatin 10mg 10mg Film coated tablets 3 x 10 tablets ALU/PVC Blisters 24 Months AJANTA PHARMA LIMITED, B-4-5-6, MIDC Industrial Area Paithan, Aurangabad, 431148, Maharashtra state, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

400 Rwanda FDA-HMP-MA-0443 CETAMOL TABLETS Paracetamol 500mg 500mg Tablets 3 x 10 and 100 x 10 tablets ALU/PVC Blisters REGAL PHARMACEUTICALS LIMITED, Plot No: 7879/18, Off baba Dogo Road, Ruaraka, P.O. Box 4421-0010, Nairobi, Kenya. KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

401 Rwanda FDA-HMP-MA-0444 FLUCAZOL® CAPSULES Fluconazole, 100 mg 100 mg Hard Gelatin Capsule 10 capsules PVC Aluminum blister of 10 capsules packed in a cardboard box 36 Months GRACURE PHARMACEUTICALS LIMITED, E-1105, R11, co, Industrial Area, Phase-III Bhiwadi, Rajasthan India INDIA EXPHAR S.A, BELGIUM H&H PHARMA LTD 2023-08-24 2028-08-23

402 Rwanda FDA-HMP-MA-0445 FLUCAZOL® POWDER FOR ARAL SUSPENSION Fluconazole, 50 mg/5 ml 50 mg/5 ml Powder for oral suspension 1 x 60 ml bottle, Bottle with a colorless plastic dosage cap (2.5, 5 and 10 ml) packed along with pack insert in Boxes 36 Months GRACURE PHARMACEUTICALS LIMITED, E-1105, R11, co, Industrial Area, Phase-III Bhiwadi, Rajasthan India INDIA EXPHAR S.A, BELGIUM H&H PHARMA LTD 2023-08-24 2028-08-23

403 Rwanda FDA-HMP-MA-0446 MICOZAL® CREAM Ketoconazole 2 %w/v 2 %w/v Cream 15 g tubes Collapsible Aluminium tubes 36 Months GRACURE PHARMACEUTICALS LIMITED, E-1105, R11 Industrial Area, Phase-III Bhiwadi, Rajasthan, India INDIA EXPHAR S.A, BELGIUM H&H PHARMA LTD 2023-08-24 2028-08-23

404 Rwanda FDA-HMP-MA-0447 TAVIN-EM Tenofovir Disoproxil Fumarate 300mg & Emtricitabine 200 mg 300mg & 200 mg Film coated tablets 30 tablets HDPE bottle 24 Months EMCURE PHARMACEUTICALS LTD, Plot No. P1 & P2, I.T.B.T. Park, Phase II, M.I.D.C. Hinjawadi, Pune – 411057, India. INDIA EMCURE PHARMACEUTICALS LTD, ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

405 Rwanda FDA-HMP-MA-0448 AMINOPHYLLINE Aminophylline Hydrate BP 250 mg/10ml 250 mg/10ml Solution for Injection 5x10 ml Ampoules Clear Glass Ampoules (Such 5 Labeled Ampoules are packed in a HIPS Tray Pack. Such 1 Tray is packed in a Printed Carton with Packing Insert. 24 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal-Kalol, Gandhinagar Gujarat, India. INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

406 Rwanda FDA-HMP-MA-0449 TENOFOVIR DISOPROXIL FUMARATE AND LAMIVUDINE TABLETS Tenofovir Disoproxil Fumarate 300 mg and Lamivudine 300 mg 300 mg and 300 mg film coated tablets 30 tablets HDPE bottle along with desiccant 24 Months MYLAN LABORATORIES LIMITED, F? 4 & F?12, MIDC, Malegaon, Sinnar, Nashik ? 422 113 Maharashtra, India INDIA MYLAN LABORATORIES LIMITED, INDIA PYRAMID PHARMA LIMITED 2023-08-24 2028-08-23

407 Rwanda FDA-HMP-MA-0450 CROMSOL ® EYE DROPS Cromoglicate (cromolyn) sodium USP, 2 % 0.02 Eye drops solution 5 ml bottle LDPE bottle with white cap in carton 36 Months AHLCON PARENTERALS (INDIA) LTD, SP 917&918, Phase III, TIICO Industrial Area, Bhiwadi, Dist. Alwar Rajasthan-India INDIA EXPHAR S.A, BELGIUM H&H PHARMA LTD 2023-08-24 2028-08-23

408 Rwanda FDA-HMP-MA-0453 BACTOX 250MG/5ML Amoxicillin Trihydrate 250mg/5ml 250mg/5ml Powder for Suspension 60 ml bottle Amber glass bottle with a graduated measuring spoon (polypropylene) at 2.5 ml and 5 ml in Box 24 months SANDOZ GmbH, and INNOTHERA CHOUZY, Biochemistrasse 10-6250-Kundl, AUSTRIA and Rue Rene Chanterau, Chouzy-sur-Cisse, 41150 Valloiere-sur-Cisse France AUSTRIA and FRANCE LABORATOIRE INNOTECH INTERNATIONAL, FRANCE MEDIASOL PHARMACEUTICAL DEPOT LTD 2023-08-24 2028-08-23

409 Rwanda FDA-HMP-MA-0454 ABCHLOR EYE DROPS Chloramphenicol B.P 0.5% W/V + Phenyl mercuric Nitrate B.P 0.002%W/V 0.5% W/V + 0.002%W/V Eye drop solution 5ml and 10ml LDPE container and in carton 36 months ABACUS PARENTERAL DRUGS LTD (APDL) Block 191, Plot No.114, Kinga Mukono Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL)/ UGANDA ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

410 Rwanda FDA-HMP-MA-0455 ABCHLOR EAR DROPS Chloramphenicol B.P 0.5% W/V + Phenyl mercuric Nitrate B.P 0.002%W/V 0.5% W/V + 0.002%W/V Ophthalmic solution 5 ml and 10 ml vial LDPE vial and in carton 36 Months, 28 days after opening ABACUS PARENTERAL DRUGS LTD (APDL) Block 191, Plot NO.114, Kinga Mukono Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL)/ UGANDA ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

411 Rwanda FDA-HMP-MA-0456 HYCORUM CREAM HYDROCORTISONE BP 1%w/w 1%w/w CREAM 1X15G Tube Collapsible Aluminium collapsible Tubes 36 Months LABORATORY & ALLIED LIMITED, Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LIMITED, KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2023-08-24 2028-08-23

412 Rwanda FDA-HMP-MA-0457 LECOTRIM TABLETS Sulphamethoxazole BP 80 mg and Trimethoprim BP 400 mg 80 mg and 400 mg Tablets 10 x 10 tablets Alu-PVC Blister 36 Months LABORATORY AND ALLIED LIMITED, Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa road, P.O. Box 4275 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LIMITED, KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2023-08-24 2028-08-23

413 Rwanda FDA-HMP-MA-0459 TRAMACEL TABLETS Acetaminophen and Tramadol 325mg+37.5mg 325mg+37.5mg Film coated tablets 10 tablets Alu PVC Blister and such 1 blister packed in a printed monocarton with pack insert 24 Months CACHET PHARMACEUTICALS PRIVATE LIMITED, Thana, Baddi, Himachal Pradesh-173 205, INDIA INDIA CACHET PHARMACEUTICALS PRIVATE LIMITED. SUN ENTERPRISES LTD 2023-08-24 2028-08-23

414 Rwanda FDA-HMP-MA-0460 LOOBID TABLETS Ofloxacin USP 200mg, Ornidazole 500mg and Lactic Acid Bacillus 60 million pores as enteric coated granules, tablets 200mg, 500mg and 60 million pores Tablets 10 tablets ALU/PVC Blister and such Blister packed in monocarton with pack insert. 24 Months CACHET PHARMACEUTICALS PRIVATE LIMITED. Thana, Baddi, Himachal Pradesh-173 205. INDIA INDIA CACHET PHARMACEUTICALS PRIVATE LIMITED SUN ENTERPRISES LTD 2023-08-24 2028-08-23

415 Rwanda FDA-HMP-MA-0461 OM CAPSULES Omeprazole 20mg pellets 20mg Hard Gelatin Capsules 10x10’s capsules ALU-PVC blisters of hard gelatin capsules containing white pellets with a Patient Information Literature Insert 36 months LABORATORY & ALLIED LIMITED, Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LIMITED, KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2023-08-24 2028-08-23

416 Rwanda FDA-HMP-MA-0462 LABSTATIN TABLETS Nystatin BP 100,000 IU 100,000 IU TABLETS 15 Tablets Packed in 15’s with applicator, contained in a unit box with literature insert. 36 Months LABORATORY & ALLIED LTD, East gate road off, Mombasa Road, Opp Sameer Africa, Plot No. 209/10349, Kenya KENYA LABORATORY & ALLIED LTD, KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2023-08-24 2028-08-23

417 Rwanda FDA-HMP-MA-0463 TRICOZOLE SUSPENSION Metronidazole Benzoate 125mg/5ml 125mg/5ml Suspension 100ml /60ml amber glass/ bottles Amber glass/PET bottle and contained in a unit box 36 Months LABORATORY & ALLIED LTD, East gate road off, Mombasa Road, Opp Sameer Africa, Plot No. 209/10349, Kenya KENYA LABORATORY & ALLIED LTD, KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2023-08-24 2028-08-23

418 Rwanda FDA-HMP-MA-0464 AZOPT EYE DROPS Brinzolamide 10 mg/ml Eye Drops, Suspension 10 mg/ml Eye Drops Suspension 5 ml Bottle LDPE bottle with a dispensing plug / carton 24 Months S.A. ALCON-COUVREUR N.V., Rijksweg 14 B-2870 Puurs, Belgium BELGIUM NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-08-24 2028-08-23

419 Rwanda FDA-HMP-MA-0466 ALMAX® FORTE ORAL SUSPENSION Almagate, 1.5g 1.5 g Oral Suspension 30 Sachets Paper/aluminium foil/polyethylene complex sachets consisting of heat sealing aluminium foil (20 ?m) and polyethylene 60 Months INDUSTRIAS FARMACÉUTICAS ALMIRALL, S.A. (IFA, S.A.), Ctra. Nacional II, km 593 E-08740 Sant Andreu de la Barca Barcelona Spain SPAIN ALMIRALL, S.A, SPAIN ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-08-24 2028-08-23

420 Rwanda FDA-HMP-MA-0467 FLATORIL® CAPSULES Clebopride malate / Simeticone, (0.68 mg clebopride 200 mg simeticone) 0.68 mg, 200 mg Capsules 45 capsules PVC/aluminium blisters packed in Box 36 Months INDUSTRIAS FARMACÉUTICAS ALMIRALL, S.A. Citra, Nacional II, km 5983 E-08740, sant Andreu de la Barca Barcelona, Spain SPAIN ALMIRALL, S.A, SPAIN ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-08-24 2028-08-23

421 Rwanda FDA-HMP-MA-0468 ML-COTRI SUSPENSION Sulfamethoxazole 200mg and Trimethoprim 40mg 200mg and 40mg Suspension 100ml bottle Amber colored glass bottle with PP cap in carton 36 Months MILAN LABORATORIES (INDIA) PVT. LTD, Plot No. 35,36,63,64,65,67,87, J.C.I.E. Ltd., Kamothe, Panvel, Navi Mumbai, 410 209, India INDIA MILAN LABORATORIES (INDIA) PVT. LTD, INDIA PYRAMID PHARMA LIMITED 2023-08-24 2028-08-23

422 Rwanda FDA-HMP-MA-0469 PODOSAL OINTMENT Podophyllum resin 20% w/w, Salicylic acid 25% w/w 20% w/w, 25% w/w Ointment 10g Tube Aluminium Tube 36 Months BIODEAL LABORATORIES LTD, Address: 123, Lunga P.O Box 32040-00600, Nairobi Country: Kenya KENYA BIODEAL LABORATORIES LTD, KENYA CAPITAL PHARMACEUTICAL SUPPLIES LIMITED 2023-08-24 2028-08-23

423 Rwanda FDA-HMP-MA-0470 PREZISTA DARUNAVIR (Ethanolate) 600mg film-coated tablet 600mg Film-coated tablet 60 tablets White HDPE plastic, 160 ml bottle containing 60 tablets, fitted with polypropylene (PP) child resistant closure 36 Months JANSSEN ORTHO LLC, and JANSSEN-CILAG State Road 933 KM 0.1, Mamey Ward Gurabo, Puerto Rico 00778, USA and SpA Via C. Janssen, Loc. Borgo S. Michele, 04100 Latina (LT), Italy USA, and ITALY JANSSEN CILAG INTERNATIONAL NV, BELGIUM GILMED LIMITED 2023-08-24 2028-08-23

424 Rwanda FDA-HMP-MA-0472 ALMAX ORAL SUSPENSION Almagate 1g/7.5ml 1g/7.5ml Oral Suspension 225 ml bottle Amber glass bottle 60 Months INDUSTRIAS FARMACÉUTICAS ALMIRALL, S.A. (IFA, S.A.), Ctra. Nacional II, km 593 E-08740 Sant Andreu de la Barca Barcelona, Spain SPAIN ALMIRALL, S.A, SPAIN MULTIPHAR-UBIPHARM-RWANDA LTD 2023-08-24 2028-08-23

425 Rwanda FDA-HMP-MA-0473 TENOFOVIR DISOPROXIL FUMARATE/LAMIVUDINE/EFAVIRENZ TABLETS 300MG/300MG/600MG Tenofovir Disoproxil Fumarate/ Lamivudine/ Efavirenz Tablets 300mg/300mg/600mg 300mg/300mg/600mg Film coated tablets 30 and 90 Tablets 30’s in White opaque wide mouth HDPE bottle with a white opaque cap. and 90’s in Blue opaque wide opaque HDPE bottle with a blue opaque cap 36 Months MYLAN LABORATORIES LIMITED H-12 & H-13, MIDC, Waluj, Aurangabad - 431136, Maharashtra, India; F-4 & F-12, Malegaon MIDC, Sinnar, Nashik -422113, Maharashtra, India; Plot No. 11,12 & 13 Indore SEZ, Phase - II, Sector - III, Pithampur - 454775, Dist.- Dhar, M.P., India INDIA MYLAN LABORATORIES LIMITED PYRAMID PHARMA LIMITED 2023-08-24 2028-08-23

426 Rwanda FDA-HMP-MA-0474 SULPHATRIM 480 Trimethoprim BP 80 mg & Sulfamethoxazole BP 400 mg 80 mg & 400 mg Tablets 10 x 10 tablets ALU-PVC blister pack. Such 10 blisters packed in printed unit carton with package insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat. India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

427 Rwanda FDA-HMP-MA-0477 TRAVATAN EYE DROPS Travoprost, 40 micrograms/ml 40 micrograms/ml Eye Drops Solution 5 ml Plastic Droptainer Plastic Droptainer, LDPE. 36 Months S.A. ALCON-COUVREUR N.V., Rijksweg 14 B-2870 Puurs, Belgium BELGIUM NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-08-24 2028-08-23

428 Rwanda FDA-HMP-MA-0478 DUOTRAV EYE DROPS Travoprost, 40 micrograms/ml and Timolol mareate 6.8 mg/ml 40 micrograms/ml and 6.8 mg/ml Eye Drops Suspension 5 ml Bottle LDPE bottle with dispensing plug 24 Months S.A. ALCON-COUVREUR N.V., Rijksweg 14 B-2870 Puurs, Belgium BELGIUM NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-08-24 2028-08-23

429 Rwanda FDA-HMP-MA-0479 NEVANAC EYE DROPS Nepafenac 1mg/ml 1mg/ml Ophthalmic suspension 10 Bottles LDPE Bottle in polyethylene bag with dispensing plug and PP closure S.A. ALCON-COUVREUR N.V., Rijksweg 14 B-2870 Puurs, Belgium BELGIUM NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-08-24 2028-08-23

430 Rwanda FDA-HMP-MA-0480 AXAMOL Salbutamol Sulfate BP, 2.5mg/2.5ml 2.5mg/2.5ml Respules, A clear colourless solution 4x5x2.5ml LDPE respule. LDPE respule wraped in a foil pouch packed in a unit carton. 24 Months AXA PARENTERALS LIMITED, Plot No.936,937&939 Vill. Kishanpur,Jamalpur,Roorkee 247667, Distt. Haridwar(Uttarakhand), India INDIA AXA PARENTERALS LIMITED ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

431 Rwanda FDA-HMP-MA-0481 ABNAL NASAL DROPS Sodium Chloride 0.9 % w/v 0.9 % w/v A clear colourless solution 1x10 ml bottle LDPE bottle 24 Months ABACUS PARENTERAL DRUGS LTD (APDL) Address: Block 191, Plot No.114, Kinga Mukono P.O.Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

432 Rwanda FDA-HMP-MA0508 TENOFOVIR DISOPROXIL FUMARATE TABLETS 300 MG Tenofovir Disoproxil Fumarate 300mg equivalent to 245 mg of Tenofovir Disoproxil 300mg Film coated tablets 1x30 tablets white opaque HDPE container 24 Months STRIDES SHASUN LIMITED, Address: No 36/7, Suragajakkanahali, Indlavadi Cross, Anekal Taluk, Bangole-562106, India INDIA STRIDES SHASUN LIMITED SUN ENTERPRISES LTD 2023-09-06 2028-09-05

433 Rwanda FDA-HMP-MA-0509 SEKISAN SYRUP Cloperastine fendizoate 3.54 mg /ml 3.54 mg /ml Syrup 120ml Bottles Amber PVC bottles with "pilfer proof" cap 60 Months INDUSTRIAS FARMACÉUTICAS ALMIRALL, S.A. Ctra. Nacional Il, km 593 E-08740 Sant Andreu de la Barca Barcelona Spain SPAIN ALMIRALL, S.A MULTIPHAR-UBIPHARM-RWANDA LTD 2023-09-06 2028-09-05

434 Rwanda FDA-HMP-MA-0510 BLOKIUM 100 mg Tablets Atenolol 100 mg 100 mg Tablets 15 tablets and 30 tablets PVC-PVDC/Aluminium blisters 36 Months INDUSTRIAS FARMACÉUTICAS ALMIRALL, S.A. (IFA), Ctra. Nacional II, km 593 E-08740 Sant Andreu de la Barca Barcelona, Spain SPAIN ALMIRALL, S.A, SPAIN MULTIPHAR-UBIPHARM-RWANDA LTD 2023-09-06 2028-09-05

435 Rwanda FDA-HMP-MA-0386 XATRAL 2.5 mg Alfuzosin 2.5mg 2.5mg Film-Coated Tablets 30 tablets PVC /ALU Blister pack 24 Months SANOFI WINTHROP INDUSTRIE, 30-36 Avenue Gustave Eiffel 37100 Tour France FRANCE SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2023-09-06 2028-09-05

436 Rwanda FDA-HMP-MA-0388 INTAMINE CREAM Mepyramine Maleate BP. 2.0% W/W 2.0% W/W CREAM 25 g tube Aluminium tube 36 Months REGAL PHARMACEUTICALS LTD, 7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD., KENYA ABACUS PHARMA (A) LTD 2023-09-06 2028-09-05

437 Rwanda FDA-HMP-MA-0417 FLUCON EYE DROPS Fluorometholone 1mg/ml 1mg/ml Eye Drops suspension 5ml Bottle LDPE bottle with a dispensing plug/carton 24 Months S.A. ALCON-COUVREUR N.V. Rijksweg 14, B- 2870 Puurs, Belgium BELGIUM NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-09-06 2028-09-05

438 Rwanda FDA-HMP-MA-0418 RINALIN SYRUP Chlorpheniramine maleate, 2mg/5ml 2mg/5ml Syrup 60 ml and 100 ml Bottles Amber Glass Bottles, ROPP CAPS 25 mm Measuring Cup 10ml (25mm) 36 Months REGAL PHARMACEUTICALS LTD, 7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD, KENYA. ABACUS PHARMA (A) LTD 2023-09-06 2028-09-05

439 Rwanda FDA-HMP-MA-0419 ABGENTA Eye/Ear drops Gentamicin sulphate Eye/Ear drops 0.3% w/v BP 0.3% w/v Ophthalmic and otic clear, faintly yellow solution 10 ml bottles LDPE bottles with a screw cap which is then packed in a mono-carton 36 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot no.114, Kinga Mukono, P.O.BOX 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-09-06 2028-09-05

440 Rwanda FDA-HMP-MA-0421 XATRAL LP 10 mg Alfuzosin 10 mg 10 mg Film-Coated Tablets 30 tablets PVC /ALU Blister pack 36 Months SANOFI WINTHROP INDUSTRIE, 30-36 Avenue Gustave Eiffel 37100 Tours, France FRANCE SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2023-09-06 2028-09-05

441 Rwanda FDA-HMP-MA-0432 COLOSAR?DENK 100/12.5 Losartan potassium 100 mg and Hydrochlorothiazide 12.5 mg 100 mg and 12.5 mg Film coated tablets 28 tablets Alu/Alu blister 36 Months DENK PHARMA GmbH & Co. KG Göllstr. 184529 Tittmoning, Germany GERMANY DENK PHARMA GmbH & Co. KG ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-09-06 2028-09-05

442 Rwanda FDA-HMP-MA-0458 FEVEREX TOTO SUSPENSION Paracetamol 120mg/5ml 120mg/5ml Suspension 60ml Bottles Amber glass bottles that are sealed with aluminium caps. 36 Months BETA HEALTHCARE INTERNATIONAL LIMITED, Plot No. L.R 209/6554, Mogadishu Road, Industrial Area, Nairobi, Kenya KENYA BETA HEALTHCARE INTERNATIONAL LIMITED SURGIPHARM (RWANDA) LTD 2023-09-06 2028-09-05

443 Rwanda FDA-HMP-MA-0465 BLOKIUM 50 MG TABLETS Atenolol 50 mg 50 mg Tablets 30 or 15 tablets PVC-PVDC/Aluminium blisters 36 Months INDUSTRIAS FARMACÉUTICAS ALMIRALL, S.A. (IFA), Ctra. Nacional II, km 593 E-08740 Sant Andreu de la Barca Barcelona, Spain SPAIN ALMIRALL, S.A, SPAIN MULTIPHAR-UBIPHARM-RWANDA LTD 2023-09-06 2028-09-05

444 Rwanda FDA-HMP-MA-0471 TAMOXIFEN Tamoxifen citrate 20mg 20mg Film coated tablet 30 Tablets Aluminium - Aluminium blister 36 Months SALUTAS PHARMA GmbH, Otto-von-GuerickeAllee 139179 Barleben Germany GERMANY SANDOZ GmbH BIOCHEMIESTRASSE SURGIPHARM (RWANDA) LTD 2023-09-06 2028-09-05

445 Rwanda FDA-HMP-MA-0475 Predilone 5mg Prednisolone 5mg 5mg Tablets 10x10s, 100x10 tablets Blister packs 48 Months REGAL PHARMACEUTICALS LTD, 7879/18, Off Baba Dogo Road, Ruaraka, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2023-09-06 2028-09-05

446 RwandaFDA-HMP-MA-0482 CRESTOR 10 MG Rosuvastatin Calcium 10 mg 10 mg Film-coated tablets 28 tablets Al/Al Blister 24 Months IPR PHARMACEUTICALS Inc, Carr 188 Lote 17, San Isidro Industrial Park, P.O. Box 1624, Canovanas, Puerto Rico, 00729, USA USA ASTRAZENECA UK LIMITED, MACCLESFIELD, CHESHIRE, UNITED KINGDOM SURGIPHARM (RWANDA) LTD 2023-09-06 2028-09-05

447 RwandaFDA-HMP-MA-0483 CRESTOR 5MG Rosuvastatin Calcium 5 mg 5 mg Film-coated tablets 28 tablets Al/Al Blister 24 Months IPR PHARMACEUTICALS Inc, Carr 188 Lote 17, San Isidro Industrial Park, P.O. Box 1624, Canovanas, Puerto Rico, 00729, USA USA ASTRAZENECA UK LIMITED, MACCLESFIELD, CHESHIRE, UNITED KINGDOM SURGIPHARM (RWANDA) LTD 2023-09-06 2028-09-05

448 RwandaFDA-HMP-MA-0484 CRESTOR 20 MG Rosuvastatin Calcium 20 mg 20 mg Film-coated tablets 28 tablets Al/Al Blister 24 Months IPR PHARMACEUTICALS Inc, Carr 188 Lote 17, San Isidro Industrial Park, P.O. Box 1624, Canovanas, Puerto Rico, 00729, USA USA ASTRAZENECA UK LIMITED, MACCLESFIELD, CHESHIRE, UNITED KINGDOM SURGIPHARM (RWANDA) LTD 2023-09-06 2028-09-05

449 RwandaFDA-HMP-MA-0485 DOLUTEGRAVIR (SODIUM) / LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE Dolutegravir (sodium)/ lamivudine/ tenofovir disoproxil fumarate 50mg/ 300mg/ 300mg 50mg/ 300mg/ 300mg Film coated tablets 30’s and 90 Tablets HDPE Bottles 24 Months CELLTRION PHARM, INC. 82, 2 sanda-ro, Ochangeup, Cheongwon-gu, Cheonju-si, Chung-cheongbukdo, Republic of Korea REPUBLIC OF KOREA CELLTRION, INC. KIPHARMA LTD 2023-09-06 2028-09-05

450 Rwanda FDA-HMP-MA-0500 NEBILONG-AM Nebivolol 5mg and Amlodipine 5 mg 5mg and 5 mg Uncoated, bi-layered tablets 3X10 tablets ALU/ PVC Blisters. Such 3 Blisters are packed in a printed outer carton along with a pack insert 36 Months MICRO LABS LIMITED, 92, Sipcot, Hosur-635 126, India. INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-09-11 2028-09-10

451 Rwanda FDA-HMP-MA-0501 CANDID V GEL Clotrimazole USP 2% w/w 2% w/w White semisolid smooth gel 30 g Tube A printed carton containing a leaflet, applicator and a printed 30 g aluminium collapsible tube 36 Months GLENMARK PHARMACEUTICALS LIMITED, Plot No. E-37, 39, D-Road, MIDC, Satpur, Nashik – 422007, Maharashtra, India INDIA GLENMARK PHARMACEUTICALS LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-09-11 2028-09-10

452 Rwanda FDA-HMP-MA-0502 CANDITRAL Itraconazole 100 mg 100 mg Capsules 4X10 Capsules A Blister strip (PVC/Alu) of 4’s packed in a carton. 10 such cartons are packed in an outer carton 30 Months GLENMARK PHARMACEUTICALS LIMITED, Plot No. E-37, 39, D-Road, MIDC, Satpur, Nashik – 422007, Maharashtra, India INDIA GLENMARK PHARMACEUTICALS LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-09-11 2028-09-10

453 Rwanda FDA-HMP-MA-0511 FLOXSOL ® Norfloxacin 0.3%, eye drops solution 0.003 Eye drops solution 5ml Bottle Box of 1 bottle, 5ml. Bottle made of clear low-density polyethylene. Plastic cap of white low-density polyethylene 36 Months AHLCON PARENTERALS (INDIA) LTD, SP 918, Phase III Bhiwadi 301019 Rajasthan, India INDIA EXPHAR S.A, BELGIUM H&H PHARMA LTD 2023-09-11 2028-09-10

454 Rwanda FDA-HMP-MA-0512 FENTANYL MEDIS 0.1MG/2ML Fentanyl citrate. 0.1mg/2ml 0.1mg/2ml Injectable solution 10 ampoules of 2ml, Type I transparent stretch glass serigraphy ampoules with breakpoint (OPC) of capacity 2 ml, in a box 36 Months LES LABORATOIRES MÉDIS, Km 7 route de Tunis, BP 206, 8000, Nabeul, Tunisia TUNISIA LES LABORATOIRES MÉDIS, TUNISIA KIPHARMA LTD 2023-09-11 2028-09-10

455 Rwanda FDA-HMP-MA-0513 DERMIDEX CREAM Miconazole Nitrate BP 2% w/w 2% w/w Cream 15g tube Aluminium tube with a white cap and packed in unit cartons 36 Months REGAL PHARMACEUTICALS LTD, P.O BOX 44421- 00100 GPO, NAIROBI, KENYA KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2023-09-11 2028-09-10

456 Rwanda FDA-HMP-MA-0538 TIMOSOL® Timolol maleate 0.5% 0.005 Eye drops solution 5 ml Bottle (flacon) LDPE transparent bottle with white cap 36 Months AHLCON PARENTERALS (INDIA) LTD, SP 918, Phase III Bhiwadi 301019 Rajasthan, India INDIA EXPHAR S.A, BELGIUM H&H PHARMA LTD 2023-09-11 2028-09-10

457 Rwanda FDA-HBP-MA-0033 INSULATARD® Insulin Human 100 IU/ml 100 IU/ml Suspension for injection 10ml, Vial Glass vial 30 Months NOVO NORDISK PRODUCTION SAS, and Novo Nordisk A/S 45 Avenue d’Orléans F-28000 Chartres, France and Novo Nordisk A/S Novo Allé DK-2880 Bagsværd, Denmark FRANCE AND DENMARK NOVO NORDISK A/S WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-09-11 2028-09-10

458 Rwanda FDA-HMP-MA-0564 LEVOBACT-750 Levofloxacin Hemihydrate 750 mg 750 mg Film coated tablets 1x10 Tablets Alu/Alu blister pack 36 Months MICRO LABS LIMITED, 92, Sipcot, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-09-11 2028-09-10

459 Rwanda FDA-HMP-MA-0571 MAXITROL EYE DROPS Dexamethasone 1 mg, polymyxin B 6000 IU sulfate, neomycin sulfate 3500 IU 1 mg, 6000 IU, 3500 IU Eye Drops Suspension 5ml Bottle LDPE bottle with a dispensing plug 24 Months S.A. ALCON-COUVREUR N.V. Rijksweg 14 B-2870 Puurs Belgium BELGIUM NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-09-11 2028-09-10

460 Rwanda FDA-HMP-MA-0574 URYSOREN-5 Solifenacin Succinate Tablets 5 mg 5 mg Film coated tablets 1x10 Tablets Alu/PVC blister pack 36 Months MICRO LABS LIMITED, 92, Sipcot, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-09-11 2028-09-10

461 Rwanda FDA-HMP-MA-0575 NEBILONG-H Nebivolol 5mg and Hydrochlorothiazide 12.5mg 5mg and 12.5mg Tablets 3x10 Tablets Alu/Alu blister pack 24 Months MICRO LABS LIMITED, 92, Sipcot, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-09-11 2028-09-10

462 Rwanda FDA-HMP-MA-0576 URYSOREN-10 Solifenacin Succinate Tablets 10 mg 10 mg Tablets 1x10 Tablets Alu/PVC blister pack 36 Months MICRO LABS LIMITED, 92, Sipcot, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-09-11 2028-09-10

463 Rwanda FDA-HMP-MA-0577 OMEFLUX CAPSULES Omeprazole 20mg Capsules 20mg Capsules 3 x 10 Capsules Alu-Alu Blisters of 3 x 10’s inserted in unit boxes 36 Months BIODEAL LABORATORIES LTD, Plot No.123, Lunga Lunga Road, P.O BOX 32040-00600, Nairobi. Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICAL SUPPLIES LTD 2023-09-11 2028-09-10

464 Rwanda FDA-HMP-MA-0578 AXALINE-N Sodium Chloride BP 0.9%w/v 0.9%w/v Nasal Drops 10ml Vial LDPE vial packed in a unit carton a long with pack insert 24 Months AXA PARENTERALS LIMITED, Plot No.936, 937 & 939, Vill. Kishanpur, Jamalpur, Roorkee247667, Distt. Haridwar (Uttarakhand), India. INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-09-11 2028-09-10

465 Rwanda FDA-HMP-MA-0579 PETHIDINE HYDROCHLORIDE 50MG/ML Pethidine Hydrochloride 50mg/ml 50mg/ml Solution for Injection 10 ampoules of 1ml solution Type 1 clear glass ampoules 24 Months Macarthys Laboratories Limited, T/A Martindale Pharma, Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom UNITED KINGDOM MACARTHYS LABORATORIES T/A MARTINDALE PHARMA KIPHARMA LTD 2023-09-11 2028-09-10

466 Rwanda FDA-HMP-MA-0491 MELMET 1000 SR Metformin 1000 mg 1000 mg Uncoated sustained release tablets 3X10 Tablets ALU/ PVC Blists 36 Months MICRO LABS LIMITED, (ML 01) 92, Sipcot Industrial Complex, Hosur – 635 126, India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-09-11 2028-09-10

467 Rwanda FDA-HMP-MA-0498 PETHIDINE HYDROCHLORIDE 100MG/2ML Pethidine Hydrochloride 100 mg/ 2ml 100 mg/ 2ml Solution for injection 10 ampoules of 2ml solution Type 1 clear glass ampoules 24 Months Macarthys Laboratories Limited, T/A Martindale Pharma, Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom UNITED KINGDOM MACARTHYS LABORATORIES T/A MARTINDALE PHARMA KIPHARMA LTD 2023-09-11 2028-09-10

468 Rwanda FDA-HMP-MA-0499 DIAPRIDE PLUS 2 Glimepiride USP 2 mg and Metformin Hydrochloride BP 500 mg sustained release 2 mg and 500 mg Uncoated bi-layered sustained release tablets 3X10 tablets ALU/ PVC Blisters. Such 3 Blisters are packed in a printed outer carton along with a pack insert 36 Months MICRO LABS LIMITED, 92, Sipcot, Hosur-635 126, India. INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-09-11 2028-09-10

469 Rwanda FDA-HMP-MA-0504 IBUMEX 200MG TABLET Ibuprofen 200mg 200mg Tablets 10x10 B/P, 100x10 B/P, 100’s in Blister pack, secondary packaging is carton. 48 Months REGAL PHARMACEUTICALS LIMITED, Plot No. 7879/18, Off Baba Dogo Road, Ruaraka, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2023-10-05 2028-10-04

470 Rwanda FDA-HMP-MA-0506 ABPARA Paracetamol 1.0% W/V 1.0% W/V Solution for infusion 100ml Bottles LDPE Bottles 24 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-10-05 2028-10-04

471 Rwanda FDA-HMP-MA-0514 LAXALINK Lactulose Concentrate USP equivalent to Lactulose 3.35mg/5ml 3.35mg/5ml Oral solution 150 ml solution bottle 170 ml amber PET bottle having 25 mm "LPL" logo Printed Aluminium P.P. Cap & 10 ml measuring cup. Such one labelled bottle is packed in a printed carton with packing insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-10-05 2028-10-04

472 Rwanda FDA-HMP-MA- 0519 D5 Glucose anhydrous 5.0% w/v 5.0% w/v Solution for infusion 500 ml & 250 ml Bottles LDPE bottles 36 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-10-05 2028-10-04

473 RwandaFDA-HMP-MA-0524 ZENTEL SUSPENSION Albendazole 4% w/v 4% w/v Suspension 10 ml bottle HDPE bottles 24 Months ASPEN BAD OLDESLOE GmbH, Industriestrasse 32–36 23843 Bad Oldesloe, Germany. GERMANY GLAXOSMITHKLINE PHARMACEUTICAL KENYA LIMITED KIPHARMA LTD 2023-10-05 2028-10-04

474 Rwanda FDA-HMP-MA-0255 DUOVIR Lamivudine and Zidovudine 150 /300mg 150 /300mg Film-coated tablets 60 Tablets HDPE container 42 Months CIPLA LIMITED, Goa Unit VII, Plot No. S- 103 to S -105, S- 107 to S-112 & L-147 to L-147-1; Goa Unit III & IV, Plot No. L-139 to L -146; Verna Industrial Estate, Verna, Salcette, Goa 403722; Indore Unit IV, Plot No. 9, 10 & 15, Indore Special Economic Zone, Phase II, Pithampur, District Dhar, Pin Code: 454775, Madhya Pradesh, I, India INDIA CIPLA LIMITED, INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2023-10-05 2028-10-04

475 Rwanda FDA-HMP-MA-0525 FUROSEMIDE 40MG Furosemide 40mg 40mg Tablets 10, 12, 14, 20, 28, 30, 50, 56, 60, 84, 100 and 250 tablets Polypropylene/Aluminium blisters 36 Months SALUTAS PHARMA GmbH, Otto-von-Guericke-Allee 1; 39179 Barleben Germany GERMANY SANDOZ GmbH, KUNDL SURGIPHARM (RWANDA) LTD 2023-10-05 2028-10-04

476 Rwanda FDA-HMP-MA-0526 XSONE Dexamethasone Sodium Phosphate 0.1% w/v 0.1% w/v Ophthalmic solution 10ml and 5ml plastic ampoules Sealed transparent plastic ampoules 36 Months ABACUS PARENTERAL DRUGS LTD. (APDL), Block 191, Plot No.114, Kinga Mukono P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-10-05 2028-10-04

477 Rwanda FDA-HMP-MA-0527 UNITRIM TABLETS Sulfamethoxazole B.P 400mg & Trimethoprim B.P 80mg 400mg & 80mg Tablets 10 x 10 tablets Aluminium foil. PVC Reel 48 Months REGAL PHARMACEUTICALS LIMITED, Plot No: 7879/18, Off Baba Dogo Road, Ruaraka, P.O BOX 44421-00100, NAIROBI-KENYA KENYA REGAL PHARMACEUTICALS LTD, KENYA ABACUS PHARMA (A) LTD 2023-10-05 2028-10-04

478 Rwanda FDA-HMP-MA-0529 CANDID V1 TABLET Clotrimazole USP 500 mg 500 mg Vaginal uncoated tablet 1 tablet Printed carton with leaflet, applicator packed in polypropylene bag and a printed aluminium strip of 1 tablet 48 Months GLENMARK PHARMACEUTICALS LIMITED, Plot No. E-37, 39, Droad, MIDC, Satpur, Nashik- 422007, Maharashtra State, India INDIA GLENMARK PHARMACEUTICALS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-10-05 2028-10-04

479 Rwanda FDA-HMP-MA-0530 BIFRIL 30MG Zofenopril calcium 30mg 30mg Film coated tablet 4X7 Tablets The blisters are PVC/PVDC/ALU. Blisters are packed in a carton box 36 Months A. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L., Via Campo di Pile,67100, L’ Aquila, Italy ITALY A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A PRAFIN RWANDA LTD 2023-10-05 2028-10-04

480 Rwanda FDA-HMP-MA-0531 SODIUM CHLORIDE INTRAVENOUS INFUSION (NS) Sodium Chloride 0.9% w/v 0.9% w/v Solution for infusion 500 ml & 250 ml Bottles LDPE bottles 36 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-10-05 2028-10-04

481 Rwanda FDA-HMP-MA-0532 CIFIN Ciprofloxacin Injection 0.2% w/v 0.2% w/v Solution for infusion. 100 ml Bottles LDPE bottles 24 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-10-05 2028-10-04

482 Rwanda FDA-HMP-MA-0535 DOXORUBICIN HYDROCHLORIDE Doxorubicin hydrochloride 2mg/ml 2mg/ml Concentrate solution for infusion 1 Vial Type I amber glass vial, closed with rubber stoppers and subsequently sealed with aluminium crimp caps. 24 Months FAREVA UNTERACH GmbH, Mondseestraße 11, 4866 Unterach, Austria. AUSTRIA SANDOZ GmbH, Kundl SURGIPHARM (RWANDA) LTD 2023-10-05 2028-10-04

483 Rwanda FDA-HMP-MA-0537 HYDROCHLOROTHIAZIDE TABLETS USP 50 MG Hydrochlorothiazide 50mg 50mg Uncoated tablets 10x10 Tablets PVC Aluminum foil blister. 10 blisters are packed in a carton box 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-10-05 2028-10-04

484 Rwanda FDA-HMP-MA-0543 BIFRIL PLUS Zofenopril 30mg calcium/hydrochlorothiazide 12.5mg. 30mg /12.5mg Film coated tablet 7 and 28 Film-Coated tablets Polyvinyl chloride/Polyvinylidene chloride/Aluminium packed in in cardboard box 36 Months A. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L., Via Campo di Pile,67100, L’ Aquila, Italy ITALY A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A PRAFIN RWANDA LTD 2023-10-05 2028-10-04

485 Rwanda FDA-HMP-MA-0546 NIFLURIL CAPSULE Niflumic acid 250 mg 250 mg Capsules 30 capsules Aluminium foil packed in box 36 Months UPSA SAS. 979, Avenue des Pyrenees, 47520, Le Passage - France FRANCE UPSA, FRANCE KIPHARMA LTD 2023-10-05 2028-10-04

486 Rwanda FDA-HMP-MA-0554 TORSINEX-10 Torsemide 10 mg 10 mg Uncoated tablets 3x10 Tablets Alu/Alu blister pack and carton 36 Months MICRO LABS LIMITED, 92, Sipcot, Hosur-635 126, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-10-05 2028-10-04

487 Rwanda FDA-HMP-MA-0555 NYSKA Nystatin tablets USP 500,000IU 500,000IU Film coated tablets 10x10 tablets 10 tablets in a strip and 10 such strips along with the insert in the Carton 24 Months S KANT HEALTHCARE LTD. Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat, India. INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2023-10-05 2028-10-04

488 Rwanda FDA-HMP-MA-0556 FUNGARIN Miconazole Oromucosal Gel 2% 0.02 Oral gel 30g tubes Aluminium collapsible tubes with epoxy phenol lacquered with latex lining 24 Months S KANT HEALTHCARE LTD. Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat., India INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2023-10-05 2028-10-04

489 Rwanda FDA-HMP-MA-0557 NYSKA-V Nystatin, 100,000IU 100,000IU Tablets (vaginal inserts) 1x14 tablets 1x14’s strip pack along with the insert in the Carton 24 Months S KANT HEALTHCARE LTD. Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat., India INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2023-10-05 2028-10-04

490 Rwanda FDA-HMP-MA-0558 DOLIMEX ® PERF Paracetamol for Injection 10mg/ml 10mg/ml Solution for injection 100ml flexible bag Flexible bag 24 Months CARELIDE Rue Michel Raillard 59420 Mouvaux, France. FRANCE IMEX PHARMA KIPHARMA LTD 2023-10-05 2028-10-04

491 Rwanda FDA-HMP-MA-0559 VIFEX SYRUP Salbutamol Sulphate BP 1 mg, Bromhexine hydrochloride BP 2 mg and Guaifenesin BP 50 mg. 1 mg, 2 mg and 50 mg Syrup 100 ml Bottle Amber coloured Polyethylene Terephthalate (PET) bottle and the bottle is sealed with Caps. One measuring cup is placed on the bottle 36 Months EMCURE PHARMACEUTICALS LIMITED, Lane No.3, Phase-II, SIDCO Industrial Complex, Bari-Brahmana, Jammu – 181 133, India INDIA EMCURE PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-10-05 2028-10-04

492 Rwanda FDA-HMP-MA-0560 MYCOBAN CREAM Clotrimazole USP 1%w/w, Anhydrous Beclomethasone Dipropionate BP 0.025% w/w 1%w/w, 0.025% w/w Cream 15 g tube Aluminium tube 36 Months AUROCHEM LABORATORIES (I) PVT. LTD. 8, Palghar Taluka Ind. Co-op. Estate Ltd. Biosar Road, Palghar, Thane – 401404, Dist – Thane- Zone 4, India INDIA OCHOA LABORATORIES SUN ENTERPRISE LTD 2023-10-05 2028-10-04

493 Rwanda FDA-HMP-MA-0562 MIDAZOLAM KALCEKS 5MG/ML Midazolam 5mg/ml 5mg/ml Sterile, clear colourless solution 10 ampoules Type I colourless glass ampoules with one point cut containing 1 ml or 3 ml solution 48 Months HBM PHARMA S.R.O., Sklabinska 30, Martin, Slovak Republic SLOVAK REPUBLIC AS KALCEKS, LATVIA ACTIVIS PHARMA 2023-10-05 2028-10-04

494 Rwanda FDA-HMP-MA-0565 PACLITAXEL 100MG/16.7ML INJECTION Paclitaxel 100mg/16.7ml 100mg/16.7ml Solution for injection 20 ml Vial 20 mm Type I Clear Glass Vial, closed with elastomeric closures and aluminium seals with flip-off tops. 18 Months HOSPIRA AUSTRALIA PTY LTD, 1 – 5, 7 – 23 and 25 - 39 Lexia Place, Mulgrave, Victoria, 3170, Australia AUSTRALIA PFIZER LABORATORIES LTD, KENYA GILMED LIMITED 2023-10-05 2028-10-04

495 Rwanda FDA-HMP-MA-0566 PACLITAXEL 300MG/50ML INJECTION Paclitaxel 300mg/50ml 300mg/50ml Solution for injection 50 ml Vial 20 mm Type I Clear Glass Vial, closed with elastomeric closures and aluminium seals with flip-off tops. 18 Months HOSPIRA AUSTRALIA PTY LTD, 1 – 5, 7 – 23 and 25 - 39 Lexia Place, Mulgrave, Victoria, 3170, Australia AUSTRALIA PFIZER LABORATORIES LTD, KENYA GILMED LIMITED 2023-10-05 2028-10-04

496 Rwanda FDA-HMP-MA-0567 CANDID CREAM Clotrimazole cream USP 1% w/w 1% w/w Cream 20 gm tube A printed aluminium collapsible tube containing white semi-solid cream in a printed carton containing a leaflet 48 Months GLENMARK PHARMACEUTICALS LIMITED, Plot No. E-37, 39, Droad, MIDC, Satpur, Nashik- 422007, Maharashtra State, India INDIA GLENMARK PHARMACEUTICALS LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-10-05 2028-10-04

497 Rwanda FDA-HMP-MA-0568 ALUKON® 10MG Montelukast 10 mg 10 mg Film-coated tablet 14 tablets Alu/Alu blister, 36 Months BILIM ILAÇ SAN.VE TIC. A.?, and Dafra Pharma GmbH S, GOSB 1900 Sokak, N° 1904, 41480 Gebze, Kocaeli, Turkey and Dafra Pharma GmbH, Site address: Mühlenberg 7, 4052 Basel, Switzerland TURKEY AND SWITZERLAND DAFRA PHARMA GmbH SUN ENTREPRISES LTD 2023-10-05 2028-10-04

498 Rwanda FDA-HMP-MA-0570 CANDIFEM VAGINAL CREAM Ornidazole 2% w/v (21g) and Miconazole 2% w/v, 20g 2% w/v (21g) and 2% w/v, 20g Vaginal Cream 30 g Tube Tube of 30 g packed in a unit carton 24 Months MEYER ORGANICS PVT. LTD, 10 D, IInd Phase, Peenya Industrial Area, Bangalore. 560 058 Postal address (if different): A-177, Road No. 16-Z, Wagle Estate, Thane. 400604 (Mumbai), India INDIA MEYER ORGANICS PVT. LTD, INDIA SUN ENTREPRISES LTD 2023-10-05 2028-10-04

499 Rwanda FDA-HMP-MA-0573 ZINNIA F Levonorgestrel 0.15 mcg and Ethinyl oestradiol 0.03 mcg Tablets with ferrous fumarate tablets 75 mg 0.15 mcg and 0.03 mcg, 75 mg Tablet 28 tablets PVC film blister coated with PVDC and foil made of Aluminum. 36 Months MYLAN LABORATORIES LIMITED, Plot No: 1606-1609, G.I.D.C, Sarigam, Tal-Umergam, Dist-Valsad_396155, Gujarat, India INDIA MYLAN LABORATORIES LIMITED PYRAMID PHARMA LTD 2023-10-05 2028-10-04

500 Rwanda FDA-HMP-MA-0581 FENTANYL KALCEKS Fentanyl 0.05 mg/ml 0.05 mg/ml Solution for injection 10 Ampoules of 2ml Type 1 hydrolytic class colourless glass ampoules with one point cut. 10 Ampoules are packed in the liner. Liners are packed into a cardboard box 60 Months HBM PHARMA S.R.O. from Sklabinska 30, Martin, 036 80, Slovakia SLOVAKIA AS KALCEKS, LATVIA ACTIVIS PHARMA 2023-10-05 2028-10-04

501 Rwanda FDA-HMP-MA- 0582 CAFFEINE CITRATE 10MG/ML SOLUTION FOR INJECTION Each 1ml of solution contains, 10mg Caffeine Citrate, equivalent to 5mg of Caffeine 10mg/ml Solution for Injection 10 Ampoules of 1ml Type I Clear glass ampoule containing 1ml in packs of 10 ampoules 36 Months MACARTHYS LABORATORIES T/A MARTINDALE PHARMA, Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom UNITED KINGDOM MACARTHYS LABORATORIES T/A MARTINDALE PHARM KIPHARMA LTD 2023-10-05 2028-10-04

502 Rwanda FDA-HMP-MA-0583 MORPHINE SULPHATE 10MG/ML SOLUTION FOR INJECTION Morphine Sulphate 10mg/ml 10mg/ml Solution for Injection 1ml ampoule Type I clear glass ampoule, containing 1ml of solution 36 Months MACARTHYS LABORATORIES T/A MARTINDALE PHARMA, Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom UNITED KINGDOM MACARTHYS LABORATORIES T/A MARTINDALE PHARM KIPHARMA LTD 2023-10-05 2028-10-04

503 Rwanda FDA-HMP-MA-0584 SUXAMETHONIUM CHLORIDE 50MG/ML SOLUTION FOR INJECTION/INFUSION Each ml of solution for injection or infusion contains 50 mg of suxamethonium chloride dihydrate (equivalent to 36.55 mg of suxamethonium) 50mg/ml Solution for Injection/Infusion 10 Ampoules of 2ml Type I clear glass 2 ml ampoule. 10 ampoules are packed in one carton 18 months MACARTHYS LABORATORIES T/A MARTINDALE PHARMA, Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom UNITED KINGDOM MACARTHYS LABORATORIES T/A MARTINDALE PHARM KIPHARMA LTD 2023-10-05 2028-10-04

504 Rwanda FDA-HMP-MA-0586 VONADAY Efavirenz, Lamivudine, Tenofovir Disoproxil Fumarate 600mg/300 mg/ 300 mg 600mg/300 mg/ 300 mg Film-coated tablets 30 tablets 120 cc HDPE container and a carton 24 Months EMCURE PHARMACEUTICALS LTD, Plot No. P-2. I.T.B.T Park, Phase II, M.I.D.C, Hinjwadi, Pune – 411 057, India INDIA EMCURE PHARMACEUTICALS LTD, INDIA ABACUS PHARMA (A) LTD 2023-10-05 2028-10-04

505 RwandaFDA-HMP-MA-0486 ORILAM ODT-100 Lamotrigine USP 100 mg 100 mg Tablets 3×10’s Tablets Alu/Alu blister pack 24 Months MICRO LABS LIMITED, 92, Sipcot, Hosur-635 126, Tamil Nadu, India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICAL (RWANDA) LTD 2023-10-05 2028-10-04

506 Rwanda FDA-HMP-MA-0487 ORILAM ODT-25 Lamotrigine USP 25 mg 25 mg Tablets 3×10’s Tablets Alu/Alu blister pack 24 Months MICRO LABS LIMITED, 92, Sipcot, Hosur-635 126, Tamil Nadu, India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICAL (RWANDA) LTD 2023-10-05 2028-10-04

507 Rwanda FDA-HMP-MA-0489 DAPZIN 10 Dapagliflozin 10mg 10mg Film-coated Tablets 3 x 10 Tablets ALU/ALU blister pack & carton along with a pack insert 24 Months MICRO LABS LIMITED, 92, Sipcot, Hosur-635 126, Tamil Nadu, India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICAL (RWANDA) LTD 2023-10-05 2028-10-04

508 Rwanda FDA-HMP-MA-0490 DAPZIN 10-M PLUS Dapagliflozin 10 mg / Metformin Hydrochloride USP 1000 mg 10 mg / 1000 mg Film-coated Tablets 3 x 10 Tablets ALU/ALU blister pack & carton along with a pack insert 24 Months MICRO LABS LIMITED, 92, Sipcot, Hosur-635 126, Tamil Nadu, India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICAL (RWANDA) LTD 2023-10-05 2028-10-04

509 Rwanda FDA-HMP-MA-0507 IBUMEX GEL Ibuprofen BP 5.0% w/w 5.0% w/w Gel 25 g tube Aluminium tubes 36 Months REGAL PHARMACEUTICALS LTD, Plot No.: 7879/18, off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD, KENYA ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12

510 Rwanda FDA-HMP-MA-0516 DUXCOSPAN Hyoscine butyl bromide 10 mg tablets 10 mg Film-coated tablets 10 x 10 Tablets PVC/Aluminium blisters 36 Months UNIVERSAL CORPORATION LIMITED, Club Road, Plot No. 13777 P.O Box 1748-00902, Kikuyu, Kenya KENYA UNIVERSAL CORPORATION LIMITED, KENYA SUN ENTERPRISES LIMITED 2023-10-13 2028-10-12

511 Rwanda FDA-HMP-MA-0517 SALCOF SYRUP Salbutamol 1.0mg, Bromhexine HCl 2.0mg, Guaifenesin 50mg 1.0mg, 2.0mg, 50mg Syrup 100ml Bottles PET Amber colored bottles 36 Months UNIVERSAL CORPORATION LIMITED, P.O. Box 1748-00902, Kikuyu, Kenya KENYA UNIVERSAL CORPORATION LIMITED, KENYA SUN ENTERPRISES LTD 2023-10-13 2028-10-12

512 Rwanda FDA-HMP-MA-0520 DOXY-DENK 100 Doxycycline 100 mg 100 mg Tablets 20 tablets PVC/PE/PVDC/aluminium blisters 36 Months ARTESAN PHARMA GmbH & Co. KG Wendlandstr. 1, 29439 Lüchow Production site: Wendlandstr. 1, 29439 Lüchow, Germany GERMANY DENK PHARMA GmbH & Co. KG ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-10-13 2028-10-12

513 Rwanda FDA-HMP-MA-0521 DERMOBACTER Benzalkonium chloride solution 0.985 g corresponding to Benzalkonium chloride 0.500 g/chlorhexidine digluconate solution 1.065 g corresponding to chlorhexidine digluconate 0.200 g 0.985 g/1.065 g Viscous liquid 125 ml, 300 ml bottles Brown PVC Bottles with a stopper (white PE) 12 Months INNOTHERA CHOUZY, Rue René Chantereau, Chouzy-Sur-Cisse 41150, Valloire-Sur-Cisse, France FRANCE LABORATOIRE INNOTECH INTERNATIONAL MEDIASOL PHARMACEUTICAL DEPOT LTD 2023-10-13 2028-10-12

514 Rwanda FDA-HMP-MA-0522 ABCROM EYE DROPS Sodium Cromoglicate eye drops 2.0%w/v 2.0%w/v Ophthalmic solution 5ml & 10ml Vials Clear colourless LDPE vials 24 Months ABACUS PARENTERAL DRUGS LTD (APDL) Block 191, Plot No.114, Kinga Mukono P.O Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12

515 Rwanda FDA-HMP-MA- MA-0523 LOVENOX 6000 IU Enoxaparin Sodium 6000 IU (60mg)/0.6 ml 6000 IU (60mg)/0.6 ml Solution in pre-filled syringes 2 syringes – 1.0 mL syringe 1.0 mL syringe barrel in type I clear glass fitted with needle shield and rigid plastic cap 24 Months SANOFI WINTHROP INDUSTRIE, Maisons Alfort; 180 rue Jean Jaurès, 94700 Maisons-Alfort- France FRANCE SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2023-10-13 2028-10-12

516 Rwanda FDA-HMP-MA-0528 BISPANOL TABLETS Hyoscine Butyl Bromide BP 10mg 10mg Tablets 10 x 10, 100 x 10 Tablets Aluminium foil (152mm). PVC Reel 160mm 48 Months REGAL PHARMACEUTICALS LIMITED, Plot No: 7879/18, Off Baba Dogo Road, Ruaraka, P.O BOX 44421-00100, NAIROBI-KENYA KENYA REGAL PHARMACEUTICALS LTD, KENYA ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12

517 Rwanda FDA-HMP-MA-0533 CISPLATIN 50MG/50ML Cisplatin 1mg/ml in formulations of 50mg/50ml 50mg/50ml Solution for infusion 1 vial containing 50 ml concentrate for solution for infusion Amber type I glass vial with chlorobutyl rubber stopper with aluminium overseal 24 Months FAREVA UNTERACH GmbH, Mondseestrasse 11, 4866 Unterach, Austria AUSTRIA SANDOZ GmbH, KUNDL SURGIPHARM (RWANDA) LTD 2023-10-13 2028-10-12

518 Rwanda FDA-HMP-MA-0536 ADRENALINE INJECTION BP 0.1% Adrenaline acid tartrate BP 1 mg/ ml 1 mg/ml Liquid Injection 5 Ampoules Blister Pack Using “LPLl” Logo Paper Foil, such 1 Blister is Packed in Printed Carton with Packing Insert 18 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khantraj, Taluka: Kalol, District: Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED. INDIA ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12

519 Rwanda FDA-HMP-MA-0539 ARBITEL 80MG Telmisartan 80mg 80mg Tablets 3x10’s tablets Alu/Alu blister pack 36 Months MICRO LABS LIMITED, API – Division (ML-15) Plot No.43-45, KIADB Jigani – Bommasandra Link Road Anekal Taluk, Bangalore – 560 10 Karnataka, India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-10-13 2028-10-12

520 Rwanda FDA-HMP-MA-0540 NEBILET PLUS Nebivolol 5mg and Hydrochlorothiazide 25mg 5mg and 25mg Film-coated tablets 28’s tablets and 4’s tablets Blisters (PP/COC/PP/Aluminium) 36 Months BERLIN CHEMIE AG, Menarini Group, Tempelhofer Weg 83, D-12347 Berlin, Germany GERMANY MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A PRAFIN RWANDA LTD 2023-10-13 2028-10-12

521 Rwanda FDA-HMP-MA-0541 ABACOFF COUGH SYRUP Diphenhydramine Hydrochloride BP, Ammonium Chloride BP, Sodium Citrate BP & Menthol USP 14.08mg, 138mg, 57.03mg, 0.900mg Syrup 100 ml Bottle Amber bottle having 25 mm "LPL" logo Printed Aluminium P.P. Cap & 10 ml measuring cup 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12

522 Rwanda FDA-HMP-MA-0542 RL Sodium lactate B.P 0.320% w/v, Sodium chloride B.P. 0.600 % w/v, Potassium chloride B.P 0.040 % w/v, Calcium chloride dehydrate B.P. 0.027 % w/v 0.320% w/v, 0.600 % w/v, 0.040 % w/v, 0.027 % w/v Solution for infusion 500ml/250ml, bottles LDPE bottles 36 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12

523 Rwanda FDA-HBP-MA-0037 BORTEZOMIB NEAPOLIS 3.5MG Bortezomib 3.5mg 3.5mg Solution for injection 10 ml Vial Type I transparent glass vial with a grey bromobutyl stopper diameter 20 mm and aluminium seal with a flip off cap diameter 20 mm 24 Months NEAPOLIS PHARMA, Route de Tunis, Km7-B.P.206, 8000 Nabeul, Tunisia TUNISIA NEAPOLIS PHARMA, TUNISIA KIPHARMA LTD 2023-10-13 2028-10-12

524 Rwanda FDA-HMP-MA-0548 TERBINAFORCE-250 Terbinafine Hydrochloride 250 mg 250 mg Uncoated tablets 10x10 Tablets Alu/Alu blister. Such blisters 10 are packed in a carton along with package insert 24 Months MANKIND PHARMA LIMITED; Unit-II, Village Kishanpura, P.O. Jamniwala, Tehsil-Paonta Sahib; Activities District Sirmour-173025, Himachal Pradesh, India. INDIA MANKIND PHARMA LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-10-13 2028-10-12

525 Rwanda FDA-HMP-MA-0551 MIDAZOLAM B. BRAUN C Midazolam Hydrochloride 1mg/ml 1mg/ml Solution for injection/infusion 20 x 5ml Ampoules (Mini-Plasco® connect) The blow-moulded plastic ampoules are made of polyethylene 24 Months B. BRAUN MELSUNGEN Mistelweg 2 12 357 Berlin, Germany GERMANY B. BRAUN MELSUNGEN AG KIPHARMA Ltd 2023-10-13 2028-10-12

526 RwandaFDA-HMP-MA-0569 NICARDIN- SR FILM-COATED TABLET Nifedipine BP 20 mg 20 mg Film-coated tablet 10x10 Tablets PVC Aluminum foil blister packs which are enclosed in a carton box 36 Months LABORATORY & ALLIED LIMITED, East gate road, off Mombasa, Opp, Sameer Africa, Plot N° 209/10349, Kenya KENYA LABORATORY & ALLIED LIMITED, KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2023-10-13 2028-10-12

527 Rwanda FDA-HMP-MA-0587 FASTUM GEL Ketoprofen 2.5%g/g 2.5%g/g Gel 20 g, 30 g and 50 g Tubes Dispenser: 100 g Collapsible Aluminum tube, internally lined with atoxicepoxyphenolic resins, and externally printed and closed with a polypropylene or polyethylene (PP/PE) Screw cap and Rigid dispenser 60 Months A.    MENARINI INDUSTRY FARMACEUTICHE RIUNITE S.R.L, 3 Via Sette Santi 50131, Florence, Italy ITALY A. MENARINI INDUSTRY FARMACEUTICHE RIUNITE S.R.L 3 PRAFIN RWANDA LTD 2023-10-13 2028-10-12

528 Rwanda FDA-HMP-MA-0588 ERYTHROKANT-250 Erythromycin Stearate, 250mg 250mg Film coated tablets 10x10 Tablets 10 blisters along with the insert are packed in the Carton 36 Months S KANT HEALTHCARE LTD. Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat, India INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12

529 Rwanda FDA-HMP-MA-0591 BRONQUIDIAZINA CR ORAL SUSPENSION Trimethoprim 80mg, Sulfamethoxazole 400mg, BromhexineHcl 4mg, Sodium Benzoate 250mg and Tolu Balsam Syrup 325mg/5ml 80mg, 400mg, 4mg, 250mg and 325mg/5ml Oral suspension 150ml Bottle Cylindrical glass (type III) bottle, which is amber, no printed and without imperfections and strange particles inside the bottle. 24 Months FAES FARMA, S.A; Address: Maximo Aguirre 14-48940 Leioa (Biscay), Spain SPAIN FAES FARMA, S.A, SPAIN GOMHS LTD 2023-10-13 2028-10-12

530 Rwanda FDA-HMP-MA-0592 LIOTON GEL Heparin 1000IU/g 1000IU/g Gel 15 g and 30 g tubes Aluminum tubes 36 Months A. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L, Via Sette Santi, 3, 50131 Firenze, Italy ITALY A. MENARINI INDUSTRIE FAMACEUTICHE RIUNITE PRAFIN RWANDA LTD 2023-10-13 2028-10-12

531 Rwanda FDA-HMP-MA-0593 DINAC GEL Diclofenac Diethylamine BP, 1.16% 0.0116 Gel 20gm Tube Collapsible Aluminium Tube 36 Months S KANT HEALTHCARE LTD. Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat, India INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12

532 Rwanda FDA-HMP-MA-0595 ZEDCAL ORAL SUSPENSION Zinc Sulphate Monohydrate (2 mg), Calcium Carbonate (150 mg), Magnesium Hydroxide (25 mg), Vitamin D3 (200IU) 2 mg, 150 mg, 25 mg, 200IU Oral Suspension 200 ml Bottle PET bottle 36 Months MEYER ORGANICS PVT. LTD, 10 D, 2nd Phase, Peenya Ind. Area, Bangalore- 560 058, India INDIA MEYER ORGANICS PVT. LTD SUN ENTERPRISES LTD 2023-10-13 2028-10-12

533 Rwanda FDA-HMP-MA-0596 LOVENOX-4000IU Enoxaparin Sodium; 4000 IU (40mg/0.4 ml) 4000 IU (40mg/0.4 ml) Solution for injection in pre-filled syringes 2 syringes of 1.0ml Syringe barrel in type I clear glass fitted with needle shield and rigid plastic cap. 24 Months SANOFI WINTHROP INDUSTRIE – Maisons Alfort Address:180 rue Jean Jaurès, 94700 Maisons-Alfort, France FRANCE SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2023-10-13 2028-10-12

534 Rwanda FDA-HMP-MA-0597 LOVENOX-2000 IU Enoxaparin Sodium 2000IU (20mg)/0.2ml 2000IU (20mg)/0.2ml Solution for injection in pre-filled syringes 2 syringes of 1.0ml Syringe barrel in type I clear glass fitted with needle shield and rigid plastic cap. 24 Months SANOFI WINTHROP INDUSTRIE – Maisons Alfort Address:180 rue Jean Jaurès, 94700 Maisons-Alfort, France FRANCE SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2023-10-13 2028-10-12

535 Rwanda FDA-HMP-MA-0598 LOVENOX 8000 IU Enoxaparin Sodium 8000IU (80mg)/0.8ml 8000IU (80mg)/0.8ml Solution for injection in pre-filled syringes 2 syringes of 1.0ml Syringe barrel in type I clear glass fitted with needle shield and rigid plastic cap. 24 Months SANOFI WINTHROP INDUSTRIE – Maisons Alfort Address:180 rue Jean Jaurès, 94700 Maisons-Alfort, France FRANCE SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2023-10-13 2028-10-12

536 Rwanda FDA-HMP-MA-0599 LOMOH 60 Enoxaparin Sodium 60mg/0.6ml 60mg/0.6ml Solution for Injection 1ml Syringe Clear, glass USP Type I syringe 24 Months EMCURE PHARMACEUTICALS LIMITED, Plant IV, Plot No. P1 & P-2. I.T.B.T Park, Phase II, M.I.D.C, Hinjwadi, Pune – 411 057, Maharashtra, India INDIA EMCURE PHARMACEUTICAL LIMITED ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12

537 Rwanda FDA-HMP-MA-0600 DEPAKINE 57.64 SYRUP Sodium Valproate (57.64 mg/ml) 57.64 mg/ml Syrup 150 ml Bottle Amber glass bottle (type III) of 150 mL closed with child-proof cap with a polyethylene (PE) seal. 36 Months UNITHER LIQUID MANUFACTURING, 1-3 allée de la Neste Z.I d’En Sigal 31770 Colomiers - France FRANCE SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2023-10-13 2028-10-12

538 Rwanda FDA-HMP-MA-0601 AVARIN Simethicone 300mg and Alverine Citrate 60mg 300mg and 60mg Soft Gelatin Capsule 5 x 10 Tablets PVC/PVDC–Aluminium blister-packed softgel capsules packed in a catch covers and contained in unit cartons 24 Months MEGA LIFESCIENCES PUBLIC COMPANY LIMITED. 384 MOO 4, SOI 6, Bangpoo Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280, Thailand THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12

539 Rwanda FDA-HMP-MA-0602 CANDID MOUTH PAINT Clotrimazole USP 1% w/w 1% w/w Viscous liquid 15 ml Bottle LDPE labeled bottle fitted with a plug and red coloured HDPE cap in a printed carton containing a leaflet 24 Months GLENMARK PHARMACEUTICALS LIMITED, Plot No. E-37, 39, D-road, MIDC, Satpur, Nashik- 422007, Maharashtra State, India INDIA GLENMARK PHARMACEUTICALS LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-10-13 2028-10-12

540 Rwanda FDA-HMP-MA-0603 DOLIPRANE 2.4% SUSPENSION Paracetamol, 24 mg/ml 24 mg/ml Suspension 100ml Bottle Amber glass (type III) bottles sealed with a childproof screw cap and tamper-evident ring. 24 Months A. NATTERMANN & Cie. GmbH, Nattermannallee 1 50829 Köln, Germany GERMANY SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2023-10-13 2028-10-12

541 Rwanda FDA-HMP-MA-0604 D10 Glucose intravenous infusion BP 10%w/v 10%w/v Solution for infusion 500 ml & 250 ml Bottles LDPE Bottles 30 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL), ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12

542 Rwanda FDA-HMP-MA-0605 ALUKON® 4 MG, GRANULES Montelukast, 4 mg 4 mg Granular (powder) 14 sachets Polyester-Al-PE foil, 14 sachets in the carton box 36 Months BILIM ILAÇ SAN.VE TIC. A.?, S, and DAFRA PHARMA GmbH, GOSB 1900 Sokak, N° 1904, 41480 Gebze, Kocaeli, Turkey and DAFRA PHARMA GmbH, Site address: Mühlenberg 7, 4052 Basel, Switzerland TURKEY AND SWITZERLAND DAFRA PHARMA GmbH SUN ENTREPRISES LTD 2023-10-13 2028-10-12

543 Rwanda FDA-HMP-MA-0606 DYSEN FORTE TABLET Secnidazole, 1000 mg tablet 1000 mg Film coated tablet 2 tablets Alu-PVC blister pack. Each blister of is packed in printed carton 48 Months NABIQASIM INDUSTRIES (PVT) LTD. Factory:17/24, Korangi Industrial Area, Karachi-Pakistan Pakistan NABIQASIM INDUSTRIES (PVT) LTD AFRI HEALTH CARE LTD 2023-10-13 2028-10-12

544 Rwanda FDA-HMP-MA-0410 ACRIPTEGA Lamivudine, Tenofovir disoproxil fumarate and Dolutegravir Tablets 300 mg/300 mg/50 mg 300 mg/300 mg/50 mg Tablets 30's, 90's and 180's Tablets HDPE Bottle pack 24 Months MYLAN LABORATORIES LIMITED. Plot No.1l, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase-ll, Sector-lll, Pithampur -45477 5. Dist. Dhar, Madhya Pradesh, India INDIA MYLAN LABORATORIES LIMITED. INDIA PYRAMID PHARMA LIMITED 2023-10-13 2028-10-12

545 Rwanda FDA-HMP-MA-0492 ACEFORCE SP Aceclofenac 100mg, Paracetamol 325mg & Serratiopeptidase 15mg Tablets 100mg, 325mg & 15mg Film-coated tablets 10x10 tablets Alu/Alu blister, and such 10 blisters are packed in a printed carton 24 Months AKUMS DRUGS & PHARMACEUTICALS LTD. 19, 20 & 21 Sector 6A, IIE, SIDCUL, Ranipur, Haridwar-249403, Uttarakhand, India INDIA UNOSOURCE PHARMA LTD, INDIA ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12

546 Rwanda FDA-HMP-MA-0494 WILCREAS-50 Vildagliptin 50 mg 50 mg Tablets 3 x 10 Tablets Alu/Alu Blisters which are packed in a printed outer carton 24 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur - 635 126 (Tamilnadu), India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICAL (RWANDA) LTD 2023-10-13 2028-10-12

547 Rwanda FDA-HMP-MA-0495 OVOID Misoprostol Dispersion USP 200 mcg 200 mcg Uncoated tablets 3 x 10 Tablets Alu/Alu Blisters which are packed in a printed outer carton 24 Months AKUMS DRUGS & PHARMACEUTICALS LTD. 19, 20 & 21 Sector 6A, IIE, SIDCUL, Ranipur, Haridwar-249403, Uttarakhand, India INDIA UNOSOURCE PHARMA LTD, INDIA ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12

548 Rwanda FDA-HMP-MA-0496 ES-LOPROT 40MG IV INJECTION Esomeprazole Sodium, 40mg 40mg Injection 1 Vial + 1 Ampoule of 10ml Sodium Chloride 0.9% Vial + Ampoule of 10ml Sodium Chloride 0.9% Injection in transparent tubular glasses 24 Months NABIQASIM INDUSTRIES (PVT) LTD, 17/24, Korangi Industrial Area, Korangi, Karachi-Pakistan PAKISTAN NABIQASIM INDUSTRIES (PVT) LTD AFRI HEALTH CARE LTD 2023-10-13 2028-10-12

549 Rwanda FDA-HMP-MA-0547 DAPZIN-5 TABLETS Dapagliflozin 5mg 5mg Film coated tablets 3x10’s tablets Alu/Alu blister pack. Such 3 blisters are packed in a printed carton with packing insert 24 Months MICRO LABS LIMITED, 92, SIPCOT, Industrial Complex, Hosur-635 126, Tamil Nadu, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICAL (RWANDA) LTD 2023-12-02 2028-12-01

550 Rwanda FDA-HMP-MA-0609 LINCODYL Bisacodyl BP 5mg 5mg Enteric coated tablets 10x10’s tablets Alu/PVC blister pack. Such 10 blisters are packed in a printed carton with packing insert 36 Months LINCOLN PHARMACEUTICALS LIMITED. Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-12-02 2028-12-01

551 Rwanda FDA-HMP-MA-0611 UNICONTIN 400 Theophylline BP 400mg 400mg Scored uncoated tablets 10x10 tablets Blister strips comprising of PVDC coated PVC Film backed with aluminum foil 36 Months MODI-MUNDIPHARMA PRIVATE LIMITED, Modipuram -250110 Uttar Pradesh, India INDIA MODI-MUNDIPHARMA PVT. LTD SURGIPHARM (RWANDA) LTD 2023-12-02 2028-12-01

552 Rwanda FDA-HMP-MA-0612 UNICONTIN 600 Theophylline BP 600mg 600mg Scored uncoated tablets 10x10 tablets Blister strips comprising of PVDC coated PVC Film backed with aluminum foil 36 Months MODI-MUNDIPHARMA PRIVATE LIMITED, Modipuram -250110 Uttar Pradesh, India INDIA MODI-MUNDIPHARMA PVT. LTD SURGIPHARM (RWANDA) LTD 2023-12-02 2028-12-01

553 Rwanda FDA-HMP-MA-0613 VALCONTIN 200 Sodium Valproate BP 133.5 mg, Valproic Acid USP, 58 mg. Both together correspond to Sodium Valproate 200 mg 200 mg Film coated tablets 10x10 tablets Printed Aluminum Foil: Width: 188 mm to 190 mm & Grammage: 97.2 to 118.8 g. Aluminum Foil Plain: Width: 188 mm to 190 mm & Grammage: 97.2 to 118.8 g 24 Months MODI-MUNDIPHARMA PRIVATE LIMITED, Modipuram -250110 Uttar Pradesh, India INDIA MODI-MUNDIPHARMA PVT. LTD SURGIPHARM (RWANDA) LTD 2023-12-02 2028-12-01

554 Rwanda FDA-HMP-MA-0614 VALCONTIN 500 Sodium Valproate B.P 333 mg and Valproic acid U.S.P. 145 mg. Both together correspond to Sodium Valproate 500 mg 500 mg Film coated tablets 10x10 tablets Printed Aluminum Foil: Width: 200 mm to 202 mm & Grammage: 97.2 to 118.8 g and Aluminum Foil Plain: Width: 200 mm to 202 mm & Grammage: 97.2 to 118.8 g 24 Months MODI-MUNDIPHARMA PRIVATE LIMITED, Modipuram -250110 Uttar Pradesh, India INDIA MODI-MUNDIPHARMA PVT. LTD SURGIPHARM (RWANDA) LTD 2023-12-02 2028-12-01

555 Rwanda FDA-HMP-MA-0618 CEFERO 500 Cefuroxime Axetil (Amorphous), 500 mg 500 mg Film coated tablets 1 x 10 film coated tablets Alu-Alu blister pack 24 Months ZIM LABORATORIES LTD, B-21/22, MIDC Area, Kalmeshwar, Nagpur 441501, Maharashtra state, India INDIA ZIM LABORATORIES LIMITED, INDIA SUN ENTERPRISES LTD 2023-12-02 2028-12-01

556 Rwanda FDA-HMP-MA-0619 DOLUTEGRAVIR 50 MG FILM-COATED TABLETS Dolutegravir (as dolutegravir sodium) 50 mg 50 mg Film-coated tablets 30 tablets and 90 tablets 50 cc white HDPE Bottle 24 Months CIPLA LIMITED, Indore Unit-IV Plot: No.9, 10 and 15, Indore Special Economic Zone, Phase II, Pithampur, District Dhar, India INDIA CIPLA LIMITED, INDIA PHILLIPS PHARMACEUTICALS RWANDA LTD 2023-12-02 2028-12-01

557 Rwanda FDA-HMP-MA-0620 MEDITROL Calcitriol 0.25 mcg 0.25 mcg Opaque soft gelatin shell capsules 3x10’s capules, Alu/Alu foil 24 Months MEGA LIFESCIENCES PUBLIC COMPANY LIMITED, 384 MOO 4, SOI 6, Bangpoo Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280, Thailand THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2023-12-02 2028-12-01

558 Rwanda FDA-HMP-MA-0636 DYGLI-50 Sitagliptin Tablets USP 50 50 mg Film coated tablets 3x10’s Tablets Alu/Alu blister pack (printed Aluminium foil/Sliver Base Foil). Such 3 blisters are packed in a printed carton with packing insert 24 Months BAFNA PHARMACEUTICALS LTD., Unit II, No.147, Madhavaram Redhills High Road, Grantlyon, Vadakarai Post, Chennai – 600 052. India. INDIA PRISMA PHARMA FZE PRAFIN RWANDA LTD 2023-12-02 2028-12-01

559 Rwanda FDA-HMP-MA-0637 DYGLI-100 Sitagliptin Tablets USP 100 100 mg Film coated tablets 3x10’s Tablets Alu/Alu blister pack (printed Aluminium foil/Sliver Base Foil). Such 3 blisters are packed in a printed carton with packing insert 24 Months BAFNA PHARMACEUTICALS LTD., Unit II, No.147, Madhavaram Redhills High Road, Grantlyon, Vadakarai Post, Chennai – 600 052. India. INDIA PRISMA PHARMA FZE PRAFIN RWANDA LTD 2023-12-02 2028-12-01

560 Rwanda FDA-HMP-MA-0638 AGOCIM-200 Cimetidine BP, 200 mg 200 mg Film coated tablets 10x10’s Tablets Printed Alu/PVC foil blister pack 36 Months AGOG PHARMA LTD. Plot No. 33, Sector II, The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-02 2028-12-01

561 Rwanda FDA-HMP-MA-0639 AGOCIM-400 Cimetidine BP, 400 mg 400 mg Film coated tablets 10x10’s Tablets Printed Alu/PVC foil blister pack 36 Months AGOG PHARMA LTD. Plot No. 33, Sector II, The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-02 2028-12-01

562 Rwanda FDA-HMP-MA-0640 TAMCONTIN 0.4 CONTROLLED RELEASE TABLETS Tamsulosin Hydrochloride BP 0.4 mg 0.4 mg Enteric coated tablets 10x10’s Tablets Aluminium strips made up of printed Aluminium foil and plain foil 24 Months MODI-MUNDIPHARMA PRIVATE LIMITED, Modipuram -250110 Uttar Pradesh, India INDIA MODI-MUNDIPHARMA PVT. LTD SURGIPHARM (RWANDA) LTD 2023-12-02 2028-12-01

563 Rwanda FDA-HMP-MA-0641 ZINNAT TABLETS Cefuroxime Axetil, 250 mg 250 mg Film coated tablets 1X8’s Tablets Double foil blister pack comprising of a cold formed aluminium laminate base material and a hard tempered aluminium foil/heat seal lacquer lid 36 Months GLAXO OPERATIONS UK LIMITED (TRADING AS GLAXO WELLCOME OPERATIONS), Harmire Road, Barnard Castle, Durham, Dl12 8dt, United Kingdom UNITED KINGDOM GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD KIPHARMA LTD 2023-12-02 2028-12-01

564 Rwanda FDA-HMP-MA-0643 FEVERLET FORTE Aceclofenac BP 100 mg, Paracetamol BP 325 mg, Chlorzoxazone USP 250 mg 100 mg, 325 mg, 250 mg Film coated tablets 1x12’s tablets Alu/PVC blister pack, 1 such blister in a carton 36 Months AUROCHEM LABORATORIES (INDIA) PVT. LTD, at 58, Palghar Taluka, Industrial Co.-op. Estate Ltd. Palghar-401 404, District Thane, Maharashtra, India INDIA AUROCHEM LABORATORIES (INDIA) PVT. LTD UBIPHARM-RWANDA LTD 2023-12-02 2028-12-01

565 Rwanda FDA-HMP-MA-0644 CHONDROFLEX Glucosamine Sulfate Potassium Chloride USP 500 mg, Chondroitin Sulphate Sodium USP 400 mg 500 mg, 400 mg Hard gelatin capsules 1x10’s capsules Blister pack. 3 such blisters are packed in a carton 36 Months AUROCHEM LABORATORIES (INDIA) PVT. LTD, at 58, Palghar Taluka, Industrial Co.-op. Estate Ltd. Palghar-401 404, District Thane, Maharashtra, India INDIA AUROCHEM LABORATORIES (INDIA) PVT. LTD UBIPHARM-RWANDA LTD 2023-12-02 2028-12-01

566 Rwanda FDA-HMP-MA-0645 CALCID-DENK Each effervescent tablet contains 1,000 mg calcium (as calcium carbonate) and 22 ?g colecalciferol (vitamin D3, equivalent to 880 I.U.) 1,000 mg and 880 I.U. Effervescent tablets 20 effervescent tablets per tube Propylene Tube 36 Months LOSAN PHARMA GmbH, Otto-Hahn-Str. 13, 15, 79395 Neuenburg Production site: Otto-Hahn-Str. 13, 15, 79395 Neuenburg, Germany GERMANY DENK PHARMA GmbH & Co. KG, GERMANY ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-12-02 2028-12-01

567 Rwanda FDA-HMP-MA-0653 FENTANYL CITRATE Fentanyl Citrate 50 mcg per ml 50 mcg/ml Solution for Injection 500mcg in 10ml solution for Injection Type-1 clear glass ampoule 36 Months MACARTHYS LABORATORIES LIMITED, Bampton Road, Harold Hill, Romford, RM3 8UG United Kingdom UNITED KINGDOM MACARTHYS LABORATORIES LIMITED, UNITED KINGDOM KIPHARMA LTD 2023-12-02 2028-12-01

568 Rwanda FDA-HMP-MA-0654 SULPHATRIM Trimethoprim BP 40 mg & Sulfamethoxazole BP 200mg 40 mg & 200mg Oral suspension 100 ml bottle Amber PET bottle packed in printed carton with a packaging insert 36 Months LINCOLN PHARMACEUTICALS LTD, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat-India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-12-02 2028-12-01

569 Rwanda FDA-HMP-MA-0655 NEBIMAC-5 Nebivolol Hydrochloride 5mg 5mg Uncoated tablets 4X7 Tablets Alu/Clear PVC/ PVDC Blister pack of 7 Tablets. Such 4 blisters packed in a carton along with a pack insert 24 Months MACLEODS PHARMACEUTICALS LIMITED, Block N-2, Village: Theda, PO: Lodhimajra, Tehsil Baddi, Dist: Solan, Himachal Pradesh – 174 101, India INDIA MACLEODS PHARMACEUTICALS LIMITED INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-02 2028-12-01

570 Rwanda FDA-HMP-MA-0656 HYDROCHLOROTHIAZIDE-25 Hydrochlorothiazide 25mg 25mg Tablets 30 tablets Packed in blister and carton along with a pack insert 36 Months SALUTAS PHARMA GmbH, & LEK S.A. Otto-von-Guericke-Allee 1 D-39179 Barleben, Germany, and Podlipie 16, 95-010 Strykow Poland GERMANY AND POLAND SANDOZ GmbH, AUSTRIA SURGIPHARM (RWANDA) LTD 2023-12-02 2028-12-01

571 Rwanda FDA-HMP-MA-0657 NITROCONTIN-2.6 Nitro-glycerine 2.6mg 2.6mg Uncoated tablets 25 Tablets Packed in polypropylene bottle 24 Months MODI-MUNDIPHARMA PVT. LT, Modipuram- 250110, U.P., India INDIA MODI-MUNDIPHARMA PVT. LTD, INDIA SURGIPHARM (RWANDA) LTD 2023-12-02 2028-12-01

572 Rwanda FDA-HMP-MA- 0658 DAFRAZOL® Omeprazole 20mg 20mg Capsules 14’s or 28’s, 7 capsules Alu/Alu blister. 2 or 4 blisters in a cardboard box 24 Months NOBEL ILAÇ San.ve Tic. A. ?, Sancaklar, Mah.Eski Akçakoca Cad. N°299, 811000 Düzce, Turkey TURKEY DAFRA PHARMA GmbH /SWITZERLAND SUN ENTERPRISES LTD 2023-12-02 2028-12-01

573 Rwanda FDA-HMP-MA-0664 AGOMOL SUSPENSION Paracetamol BP 125 mg/5ml 125 mg/5ml Oral Suspension 60 ml bottle & 100 ml bottle PET bottle with PP cap and measuring cup are packed in export worthy 36 Months AGOG PHARMA LTD, Plot No. 33, Section II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai(E). Dist. Thane-401208, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-02 2028-12-01

574 Rwanda FDA-HMP-MA-0665 AGOFULVIN-125 Griseofulvin 125mg 125mg Uncoated tablets 10X10 tablets Printed Aluminium foil/PVC foil blister. Such blisters packed in carton along with its package insert 36 Months AGOG PHARMA LTD, Plot No. 33, Section II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai(E). Dist. Thane-401208, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-02 2028-12-01

575 Rwanda FDA-HMP-MA-0666 AGOFULVIN-250 Griseofulvin 250 mg 250 mg Uncoated tablets 10X10 tablets Printed Aluminium foil/PVC foil blister. Such blisters packed in carton along with its package insert 36 Months AGOG PHARMA LTD, Plot No. 33, Section II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai(E). Dist. Thane-401208, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-02 2028-12-01

576 Rwanda FDA-HMP-MA-0667 INDOS-25 Indomethacin Capsules BP 25 mg 25 mg Hard gelatin capsules 10x10 Capsules Printed Aluminum foil/PVC foil blister. Such 10 blisters packed in carton along with its package insert 36 Months AGOG PHARMA LTD, Plot No. 33, Section II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai(E). Dist. Thane-401208, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-02 2028-12-01

577 Rwanda FDA-HMP-MA-0668 CIPRO-250 Ciprofloxacin Tablets BP 250mg 250mg Film coated tablets 10 x 10 Tablets Printed Aluminum foil/PVC foil blister. Such 10 blisters are packed in unit printed duplex board carton along with its package insert 36 Months AGOG PHARMA LTD, Plot No. 33, Section II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai(E). Dist. Thane-401208, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-02 2028-12-01

578 Rwanda FDA-HMP-MA-0669 VITA-100 Thiamine tablets BP 100mg 100mg Uncoated tablets 50 tablets Poly Bag having dimension 3 x 4.5 inches & such Poly Bag is packed in a 50 ml HDPE Jar 36 Months AGOG PHARMA LTD, Plot No. 33, Section II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai(E). Dist. Thane-401208, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-02 2028-12-01

579 Rwanda FDA-HMP-MA-0670 AGOVIR-200 Aciclovir BP, 200 mg 200 mg Uncoated tablets 10 x 10 Tablets Printed Aluminum foil/PVC foil blister. Such 10 blisters are packed in unit printed duplex board carton along with its package insert 36 Months AGOG PHARMA LTD, Plot No. 33, Section II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai(E). Dist. Thane-401208, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-02 2028-12-01

580 Rwanda FDA-HMP-MA-0671 AGO-AMIN TABLET Aminophylline Tablets BP 100 mg 100 mg Uncoated tablets 10X10 tablets Printed Aluminium foil/PVC foil blister. Such blisters packed in carton along with its package insert 36 Months AGOG PHARMA LTD, Plot No. 33, Section II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai(E). Dist. Thane-401208, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-02 2028-12-01

581 Rwanda FDA-HMP-MA-0672 OMESK Omeprazole delayed release Capsules USP 20mg 20mg Hard gelatin capsules 10x10 Capsules a Alu-Alu strip, such 10 strips in a printed carton with a printed insert 36 Months S KANT HEALTHCARE LTD, Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat, India INDIA S KANT HEALTHCARE LTD, INDIA ABACUS PHARMA (A) LTD 2023-12-02 2028-12-01

582 Rwanda FDA-HMP-MA-0673 ESOFAG-20 Esomeprazole Magnesium Trihydrate BP 20mg 20mg Enteric coated tablets 3X10 tablets Alu-Alu blister, such 3blister is packed in a printed outer carton along with a pack insert. 36 Months MICRO LABS LIMITED, 92, SIPCOT, Hosur- 635 126, Tamil Nadu India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-02 2028-12-01

583 Rwanda FDA-HMP-MA-0674 PROPOFOL - LIPURO 10 MG/ML Propofol, 10 mg/ml 10 mg/ml Emulsion for injection or infusion 20 ml, 50 ml or 100 ml of emulsion Colourless Type II glass vials sealed with bromobutyl rubber stoppers and aluminium caps 18 Months A.   BRAUN MESUNGEN AG, Mistelweg 2, 12 357 Berlin, Germany GERMANY B. BRAUN MESUNGEN AG KIPHARMA Ltd 2023-12-02 2028-12-01

584 Rwanda FDA-HMP-MA-0675 LEVO-25 TABLETS Levomepromazine Tablets BP 25 mg 25 mg Uncoated tablets 2 x 10 Tablets Aluminum foil/PVC foil blister. Such 2 blisters packed in carton along with its package insert 36 Months AGOG PHARMA LTD, Plot No. 33, Section II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai(E). Dist. Thane-401208, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-02 2028-12-01

585 Rwanda FDA-HMP-MA-0451 ZOLADEX 10.8 MG Goserelin Acetate 10.8 mg 10.8 mg Implant 1 prefilled syringe Prefilled syringe per carton 36 Months AstraZeneca UK Limited, Silk road business Park Macclesfield, Cheshire, SK10 2NA United Kingdom UNITED KINGDOM AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2023-12-02 2028-12-01

586 Rwanda FDA-HMP-MA-0452 ZOLADEX 3.6 MG Goserelin Acetate 3.6 mg 3.6 mg Implant 1 prefilled syringe Prefilled syringe per carton 36 Months AstraZeneca UK Limited, Silk road business Park Macclesfield, Cheshire, SK10 2NA United Kingdom UNITED KINGDOM AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2023-12-02 2028-12-01

587 Rwanda FDA-HBP-MA-0100 POLY-MXB Polymyxin B Sulphate USP 500000 Units 500000 Units Cake/powder for reconstitution 5 ml Glass vial Amber coloured, USP Type-I (neutral borosilicate) tubular glass vial 36 months BHARAT SERUMS AND VACCINES LIMITED, Plot No. K-27, K-27 part and K-27/1, Anand Nagar, Jambivili Village, Additional MIDC, Ambernath (East), Thane 421501 Maharashtra State, India INDIA BHARAT SERUMS & VACCINES LTD, INDIA WESSEX PHARMACEUTICAL (RWANDA) LTD 2023-12-10 2028-12-09

588 Rwanda FDA-HBP-MA-0101 LUPRODEX 3.75 Leuprolide Acetate 3.75 mg 3.75 mg Lyophilized powder for Injection 5 ml Glass vial Clear, Colourless, USP Type I Glass vial 36 months BHARAT SERUMS AND VACCINES LIMITED, Plot No. K-27, K-27 part and K-27/1, Anand Nagar, Jambivili Village, Additional MIDC, Ambernath (East), Thane 421501 Maharashtra State, India INDIA BHARAT SERUMS & VACCINES LTD, INDIA WESSEX PHARMACEUTICAL (RWANDA) LTD 2023-12-10 2028-12-09

589 Rwanda FDA-HMP-MA- 0552 NEBILONG 2.5 Nebivolol Tablets 2.5mg 2.5mg Tablets 3 x 10 Tablets. Alu/Alu blister pack of 3 x 10's. 36 Months MICRO LABS LIMITED, 92, SIPCOT, Industrial Complex, Hosur-635 126, Tamil Nadu India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-10 2028-12-09

590 Rwanda FDA-HMP-MA-0608 DERIVA AQUEOUS GEL Adapalene 0.1% w/w 0.1% w/w Gel Printed aluminum collapsible tube of 15 g Printed aluminum collapsible tube of 15 g packed in a paper carton 36 Months GLENMARK PHARMACEUTICALS LIMITED, Plot No. E-37, 39, D-Road, Midc, Satpur, Nashik – 422007, Maharashtra, India INDIA GLENMARK PHARMACEUTICALS LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-10 2028-12-09

591 Rwanda FDA-HMP-MA- 0610 CARDIURINE Captopril USP 50 mg/Hydrochlorothiazide BP 25 mg 25 mg Tablets 3X 10 tablets PVC/Aluminium blisters. 3 such blisters are packaged together in a cardboard box 36 Months GRACURE PHARMACEUTICALS LIMITED, E- 1105, R11 co, Industrial, phase-III Bhiwadi, Rajasthan, India INDIA EXPHAR S.A, BELGIUM H&H PHARMA LTD 2023-12-10 2028-12-09

592 Rwanda FDA-HMP-MA-0616 PA-12 Paracetamol 1000 mg Sustained Release Tablets 1000 mg Sustained Release Tablets 10x12 Tablets Alu-clear PVC Blister x12’s packed in individual monocarton (Box of 120’s) 36 months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-12-10 2028-12-09

593 Rwanda FDA-HMP-MA-0621 MUMFER SYRUP (IRON (III)-HYDROXIDE POLYMALTOSE COMPLEX SYRUP) Each 5 ml contains Iron (III) Hydroxide Polymaltose Complex Equivalent to Elemental Iron 50.000 mg 50.000 mg/5ml Syrup (oral solution) 150 ml bottle A printed carton containing an insert and amber coloured labeled sealed PET bottle 150 ml with 10 ml measuring cup 30 Months GLENMARK PHARMACEUTICALS LIMITED, Plot No. E-37, 39, D-Road, MIDC, Satpur, Nashik – 422007, Maharashtra, India INDIA GLENMARK PHARMACEUTICALS LTD, INDIA WESSEX PHARMACEUTICAL (RWANDA) LTD 2023-12-10 2028-12-09

594 Rwanda FDA-HMP-MA-0622 ALUKON® 5 MG Montelukast 5 mg 5 mg Pink chewable tablet 28 tablets Alu/Alu blistes 36 Months BILIM ILAÇ SAN.VE TIC. A.?, GOSB 1900 Sokak, N° 1904, 41480 Gebze, Kocaeli, Turkey and DAFRA PHARMA GmbH, Site address: Mühlenberg 7, 4052 Basel, Switzerland TURKEY AND SWITZERLAND DAFRA PHARMA GmbH, Switzerland SUN ENTERPRISES LTD 2023-12-10 2028-12-09

595 Rwanda FDA-HMP-MA-0623 CEFTAZIDIME AVIBACTAM Pfizer Ceftazidime pentahydrate 2gr & Avibactam Sodium 0.5gr 2gr & 0.5gr Powder for concentrate for solution for infusion 10 vials of 20 mL Type I glass vial with a fluorinated polymer coated halobutyl rubber stopper, Carton Pack size of 10 vials. 36 Months ACS DOBFAR SPA, Via Alessandro Fleming 2 Verona 37135, Italy ITALY Pfizer UK LIMITED GILMED LIMITED 2023-12-10 2028-12-09

596 Rwanda FDA-HMP-MA-0624 BI-PRETERAX 10/2.5MG Perindopril Arginine 10mg & Indapamide 2.5mg 10mg & 2.5mg Film Coated Tablets 30 Film Coated Tablets POLYPROPYLENE CONTAINER 36 Months SERVIER (IRELAND) INDUSTRIES LTD (SII), Goey Road, Arklow-Co. Wicklow, Ireland IRELAND LES LABORATOIRES SERVIER, FRANCE KIPHARMA LTD 2023-12-10 2028-12-09

597 Rwanda FDA-HMP-MA-0625 AZINOWEL 500 Azithromycin Dihydrate USP, 500 mg 500 mg Film Coated Tablets 1X3 tablets Alu-PVC blister; such 1 blister packed in a printed carton with pack insert 36 Months AKUMS DRUGS AND PHARMACEUTICALS LTD, Plot No. 19,20 & 21, Sector-6A, IIE., SidcuL, Ranipur, Haridwar-249403, Uttarakhand, India INDIA UNOSOURCE PHARMA LTD, INDIA AIVEEN RWANDA LTD 2023-12-10 2028-12-09

598 Rwanda FDA-HMP-MA-0626 ZEFCOLIN Dextromethorphan Hydrobromide 10mg, Phenylephrine Hydrochloride 5mg, Cetirizine Hydrochloride 5mg and Menthol 1.5mg 10mg, 5mg, 5mg and 1.5mg Syrup 100 ml Bottle Amber colour glass bottle with Aluminium ROPP Cap, Measuring Cup and with pack insert in a carton 24 Months THE MADRAS PHARMACEUTICALS, No.137-B, Old Mahabalipuram Road, Karappakkam, Chennai-600 096, Tamil Nadu, India INDIA PRISMA PHARMA FZE, U.A.E PRAFIN (RWANDA) LTD 2023-12-10 2028-12-09

599 Rwanda FDA-HMP-MA-0627 AGOPHENOL CAPSULES Chloramphenicol BP 250 mg 250 mg Capsules 10 Capsules Alu foil Blister. Such blister packed in unit carton along with its package insert 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane-401208, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-10 2028-12-09

600 Rwanda FDA-HMP-MA-0628 AGOMETROL SUSPENSION Metronidazole benzoate BP 125 mg/5 ml 125 mg/5 ml Suspension 100 ml Bottle Amber coloured PET bottle with PP cap packed in a carton along with its package insert. 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane-401208, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-10 2028-12-09

601 Rwanda FDA-HMP-MA-0629 PROMETHAZINE HYDROCHLORIDE TABLETS Promethazine Hydrochloride BP 25 mg 25 mg Sugar Coated Tablets 10X10 tablets 10 tablets packed in one Blister. 10 Blisters packed in unit of carton along with its package insert 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane-401208, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-10 2028-12-09

602 Rwanda FDA-HMP-MA-0630 AGOSCAB Benzyl Benzoate Application BP 25% W/V 25% W/V Emulsion 100 ml Bottle PET Clear Bottle 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane-401208, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-10 2028-12-09

603 Rwanda FDA-HMP-MA-0632 MICONAZOLE CREAM Miconazole Nitrate BP 2 %w/w 2 %w/w Cream 30 gm Tube Printed Laminated tube of 30 gm 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane-401208, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-10 2028-12-09

604 Rwanda FDA-HMP-MA-0633 ORILAM ODT-50 Lamotrigine USP 50 mg 50 mg Uncoated tablets 3x10’s Tablets, Alu-Alu blister Pack 24 Months MICRO LABS LIMITED, 92, SIPCOT, Hosur- 635 126, Tamil Nadu India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-10 2028-12-09

605 Rwanda FDA-HMP-MA-0634 PODOSAL PAINT Podophyllum resin 20% w/w 20% w/w Viscous liquid 10ml Bottle Amber coloured glass bottle 36 Months BIODEAL LABORATORIES LTD, 123, Lunga Lunga. P.O Box 32040-00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICALS SUPPLIES LTD 2023-12-10 2028-12-09

606 Rwanda FDA-HMP-MA-0635 NEBILET PLUS Nebivolol 5mg (as Nebivolol hydrochloride) & hydrochlorothiazide 12.5 mg 5mg & 12.5 mg Film-coated tablets 28’s tablets and 4’s tablets PP/COC/PP/Aluminium Blisters 36 Months BERLIN CHEMIE AG, MENARINI GROUP, Leipziger Strasse 7-13, 01097 – Dresden, Germany GERMANY MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. PRAFIN RWANDA LTD 2023-12-10 2028-12-09

607 Rwanda FDA-HMP-MA-0642 FLIXONASE AQUEOUS NASAL SPRAY Fluticasone Propionate (micronized), 0.05 % 0.0005 Nasal spray suspension 1 Bottle Amber glass bottle fitted with a metering, atomizing spray pump 24 Months GLAXO WELLCOME S.A., Avenida de Extremadura 309400 Aranda de Duero Burgos, Spain SPAIN GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD KIPHARMA LTD 2023-12-10 2028-12-09

608 Rwanda FDA-HMP-MA- 0646 TURBOVAS-10 Rosuvastatin Calcium 10mg 10mg film coated tablets 3x10 Tablets Alu/Alu blister pack. Such 3 blisters are packed in carton along with pack insert 24 Months MICRO LABS LIMITED, 92, SIPCOT, Industrial Complex, Hosur-635 126, Tamil Nadu India INDIA MICRO LABS LIMITED, INDIA. WESSEX PHARMACEUTICAL (RWANDA) LTD 2023-12-10 2028-12-09

609 Rwanda FDA-HMP-MA-0647 UPSA-C 1000 Ascorbic acid, 1000 mg 1000 mg Tablets 1 Tablet Polypropylene tube closed with a polyethylene stopper containing a desiccant 24 Months UPSA, 979, Avenue des Pyrénées 47520 Le Passage – France FRANCE PROPHARMED INTERNATIONAL UBIPHARM-RWANDA LTD 2023-12-10 2028-12-09

610 Rwanda FDA-HMP-MA-0648 AMLODIPINE GP 5MG Amlodipine 5mg 5mg Tablets 60 Tablets PVC-PVDC/Al Blisters 36 Months FARMALABOR- PRODUTOS FARMACEUTICOS, S.A. Zona Industrial de condeixa-a-Nova 3150-194 condeixa-a-Nova, Portugal PORTUGAL GP- GENERICOS PORTUGUESES, LDA UBIPHARM-RWANDA LTD 2023-12-10 2028-12-09

611 Rwanda FDA-HMP-MA-0649 AMLODIPINE GP 10 Amlodipine 10mg 10mg Tablets 60 Tablets PVC-PVDC/Al Blisters 36 Months FARMALABOR- PRODUTOS FARMACEUTICOS, S.A. Zona Industrial de condeixa-a-Nova 3150-194 condeixa-a-Nova, Portugal PORTUGAL GP- GENERICOS PORTUGUESES, LDA UBIPHARM-RWANDA LTD 2023-12-10 2028-12-09

612 Rwanda FDA-HMP-MA-0650 TOSSEQUE Bromhexine 0.8mg/ml 0.8mg/ml Syrup 200ml Bottle Type III amber glass bottles closed with white polyethylene caps 36 Months FARMALABOR- PRODUTOS FARMACEUTICOS, S.A. Zona Industrial de condeixa-a-Nova 3150-194 Condeixa-a-Nova, Portugal PORTUGAL MEDINFAR CONSUMER HEALTHCARE-PRODUTOS FARMACEUTICOS, LDA, PORTUGAL UBIPHARM-RWANDA LTD 2023-12-10 2028-12-09

613 Rwanda FDA-HMP-MA-0651 CINET Domperidone 1mg/ml 1mg/ml Suspension 100 ml and 200 ml Packed in a Type III amber glass bottles with a child-resistant polyethylene cap 36 Months FARMALABOR-PRODUTOS FARMACEUTICOS, S.A., Zona Industrial de Condeixia-a-Nova, 3150-194 Condeixia-a-Nova, Portugal PORTUGAL LABORATÓRIO MEDINFAR – PRODUTOS FARMACÊUTICOS, S.A, PORTUGAL UBIPHARM-RWANDA LTD 2023-12-10 2028-12-09

614 Rwanda FDA-HMP-MA-0652 ESOFAG-D Esomeprazole 40mg and Domperidone 30mg 40mg and 30mg Hard gelatin capsules 3 x 10’s capsules Alu-Alu strip pack of 3 x 10’s capsules 24 Months MICRO LABS LIMITED, 92, SIPCOT, Hosur- 635 126, Tamil Nadu India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-10 2028-12-09

615 Rwanda FDA-HMP-MA-0659 KEMOXYL FORTE DRY SUSPENSION Amoxicillin Trihydrate BP 250mg/5ml 250mg/5ml Dry Powder for Suspension 100 ml Bottle Amber glass /HDPE bottle and contained in a unit box with literature insert 36 Months LABORATORY & ALLIED LTD, Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY AND ALLIED LIMITED DEPOT PHARMACEUTIQUE LE MEDICAL 2023-12-10 2028-12-09

616 Rwanda FDA-HMP-MA-0660 IDEOS Calcium carbonate 500 mg/Cholecalciferol 400 IU 500 mg/ 400 IU Chewable tablets 2 or 4 tubes of 15 tablets Polypropylene tube and polyethylene stopper with silica gel desiccant containing 15 tablets 24 Months INNOTHERA CHOUZY, Rue Rene Chantereau, Chouzy-Sur-Cisse 41150 Valloire-Sur-Cisse, France FRANCE LABORATOIRE INNOTECH INTERNATIONAL DEPOT PHARMACEUTIQUE LE MEDICAL 2023-12-10 2028-12-09

617 Rwanda FDA-HMP-MA-0661 COLDRIL CAPSULE Pseudoephedrine 30mg, Paracetamol 500mg, and Chlorpheniramine Maleate 2mg 30mg, 500mg, and 2mg Hard gelatin capsules 2X10 capsules PVC film Aluminum foil blister pack. Such 2 blisters are packed in carton with package insert 36 Months BETA HEALTHCARE INTERNATIONAL LTD, Plot No. LR 209/6554, Mogadishu Road, Off Lunga Road, Industrial Area, Nairobi, Kenya KENYA BETA HEALTHCARE INTERNATIONAL LTD SURGIPHARM (RWANDA) LTD 2023-12-10 2028-12-09

618 Rwanda FDA-HMP-MA-0662 LOZISART 50 Losartan Potassium 50 mg 50 mg Film coated tablets 10×10 Tablets Alu- Alu Blister Pack 36 Months ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar, Nagpur 441 501, Maharashtra State, India INDIA ZIM LABORATORIES LIMITED SUN ENTERPRISES LTD 2023-12-10 2028-12-09

619 Rwanda FDA-HMP-MA-0663 COLCIBID-100 Celecoxib 100 mg 100 mg Hard gelatin capsules 10X10 capsules Alu-PVC Blister Pack 36 Months ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar, Nagpur 441 501, Maharashtra State, India INDIA ZIM LABORATORIES LIMITED SUN ENTERPRISES LTD 2023-12-10 2028-12-09

620 Rwanda FDA-HMP-MA-0676 CANDID-B CREAM Clotrimazole USP 1% w/w, Anhydrous Beclometasone Dipropionate BP 0.025% w/w 1% w/w, & 0.025% w/w Cream 15 g Tube Aluminium Collapsible Tube of 15 g 36 Months GLENMARK PHARMACEUTICALS LIMITED, Plot No. E-37, 39, D-Road, MIDC, Satpur, Nashik – 422007, Maharashtra, India INDIA GLENMARK PHARMACEUTICALS LTD, INDIA WESSEX PHARMACEUTICAL (RWANDA) LTD 2023-12-10 2028-12-09

621 Rwanda FDA-HMP-MA-0677 HYDROCHLOROTHIAZIDE TABLETS USP 25MG Hydrochlorothiazide USP 25 mg 25 mg Uncoated tablets 10x10 tablets Alu-PVC Blister Pack. Such 10 Alu-PVC Blisters are packed in a printed carton along with package insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-12-10 2028-12-09

622 Rwanda FDA-HMP-MA-0678 TERBINOL® CREAM Terbinafine Hydrochloride 1% (10 mg/g) 1% (10 mg/g) Cream 15 g Tube Aluminium tube closed with a plastic screw cap in cardboard box 24 Months NOBEL ILAÇ SAN.VE TIC. A. ?, Sancaklar, Mah.Eski Akçakoca Cad. N°299, 811000 Düzce, Turkey TURKEY DAFRA PHARMA GmbH /SWITZERLAND SUN ENTERPRISES LTD 2023-12-10 2028-12-09

623 Rwanda FDA-HMP-MA-0679 NORISTERAT® Norethisterone enantate, 200 mg 200 mg Solution 100 x 1 ml ampoules Brown glass ampoule, type I OPC 60 Months Bayer Ag, Berlin, Müllerstraße 178, 13 353 Berlin, Germany GERMANY BAYER EAST AFRICA LTD SURGIPHARM (RWANDA) LTD 2023-12-10 2028-12-09

624 Rwanda FDA-HMP-MA-0680 EASCOF EXPECTORANT Bromhexine Hydrochloride BP 4 mg, Salbutamol Sulphate BP equivalent to Salbutamol 2mg, Guaifenesin BP 100 mg and Menthol BP 1 mg 4 mg, 2mg, 100 mg and 1 mg Syrup 100 ml Bottle Orange colored PET Bottle sealed with 25 mm EPE WAD Cap 24 Months CACHET PHARMACEUTICALS. PVT. LTD, Village-Thana, Near Baddi, Tehsil- Nalagarh, Dist.- Solan, Himachal Pradesh -173205, India INDIA CACHET PHARMACEUTICALS. PVT. LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-10 2028-12-09

625 Rwanda FDA-HMP-MA-0681 BACTOX 500 Amoxicillin Trihydrate 500 mg 500 mg Capsules 12 capsules Alu/PVC/PVDC blister pack 24 Months INNOTHERA CHOUZY, Rue Rene Chanterau, Chouzy-sur-Cisse, 41150 Valloiere-sur-Cisse France FRANCE LABORATOIRE INNOTECH INTERNATIONAL DEPOT PHARMACEUTIQUE LE MEDICAL 2023-12-10 2028-12-09

626 Rwanda FDA-HMP-MA- 0682 DOLOACT GEL Ketoprofen BP 2.50 % w/w and Capsicum Oleoresin USP 0.25 % w/w 2.50 % w/w and 0.25 % w/w Gel 30g gel Tube Aluminiun tube 24 Months AUROCHEM LABORATORIES (I) PVT LTD, 8, Palghar Taluka Ind. Co-op. Est. Ltd. Palghar-401 404, India INDIA OCHOA LABORATORIES, INDIA SUN ENTERPRISES LTD 2023-12-10 2028-12-09

627 Rwanda FDA-HMP-MA-0683 FEBRILEX SYRUP 5ml syrup contains Paracetamol 125 mg, Dextrometorphan hydrobromide5 mg, Chlorphenamine maleate 1 mg 125 mg, 5 mg, & 1 mg/5ml Syrup 150 ml Bottle Amber-coloured PET bottles with ROPP cap 36 Months GRACURE PHARMACEUTICALS LIMITED, E- 1105, R11 co, Industrial, phase-III Bhiwadi, Rajasthan, India INDIA EXPHAR S.A, BELGIUM H&H PHARMA LTD 2023-12-10 2028-12-09

628 Rwanda FDA-HMP-MA-0684 BROZELIN Ambroxol Hydrochloride BP 30mg, Salbutamol BP 2mg, Guaiphenesin BP 50mg and Menthol USP 1mg 30mg, 2mg, 50mg and 1mg Syrup 100ml Bottle Amber colour glass bottle 36 Months M/S THE MADRAS PHARMACEUTICALS, No.137-B, Old Mahabalipuram Road, Karappakkam, Chennai-600 096.Tamil Nadu, India INDIA PRISMA PHARMA FZE, U.A.E PRAFIN (RWANDA) LTD 2023-12-10 2028-12-09

629 Rwanda FDA-HMP-MA- 0476 SPEGRA Dolutegravir 50mg, Emtricitabine 200mg and Tenofovir Alafenamide 25mg 50mg, 200mg and 25mg Film coated tablets 30 tablets and 90 tablets 30 tablets in 60 cc HDPE Container and 90 tablets in 150 cc HDPE Container 36 months EMCURE PHARMACEUTICALS LTD, Plot No. P-1. & P-2, I.T.B.T Park, Phase II, M.I.D.C, Hinjwadi, Pune – 411 057, India INDIA Emcure Pharmaceuticals Ltd, India ABACUS PHARMA (A) LTD 2023-12-10 2028-12-09

630 Rwanda FDA-HMP-MA-0685 LAMIVUDINE AND ZIDOVUDINE TABLETS FOR ORAL SUSPENSION 30 MG/60 MG Lamivudine and Zidovudine 30 mg/60 mg 30 mg/60 mg Uncoated tablets 60’s Tablets HDPE container 24 Months CIPLA LIMITED, Goa Unit VII, Plot No. S- 103 to S -105, S- 107 to S-112 & L-147 to L-147-1, Verna Industrial Estate, Verna, Salcette, Goa 403722, India INDIA CIPLA LIMITED, INDIA PHILLIPS PHARMACEUTICALS RWANDA LTD 2023-12-15 2028-12-14

631 Rwanda FDA-HMP-MA-0686 PARDOPA 250MG/25MG Levodopa BP 250mg, Carbidopa BP equivalent to anhydrous Carbidopa 25mg 250mg, 25mg Uncoated tablets 3x 10’s Tablets ALU/ ALU Strip 36 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-15 2028-12-14

632 Rwanda FDA-HMP-MA-0687 CEFERO 250 Cefuroxime Axetil (Amorphous) 250mg 250mg Film coated tablets 1 x 10 Tablets Alu-Alu blister pack 24 Months ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar, Nagpur 441501, Maharashtra state, India INDIA ZIM LABORATORIES LIMITED, INDIA SUN ENTERPRISES LTD 2023-12-15 2028-12-14

633 Rwanda FDA-HBP-MA-0103 ADSORBED TETANUS VACCINE B.P TETANUS TOXOID 1 DOSE Tetanus Toxoid, Each single 0.5 ml human dose contains: Tetanus Toxoid ?5 Lf (? 40 IU) Adsorbed onto Aluminium Phosphate, Al3+? 1.25 mg 0.5ml/1 dose ? 40 IU, +? 1.25 mg 0.5ml/1 dose Suspension for Injection 1 blister containing 10 ampoules 1 blister containing 10 OPC Type I glass ampoules (Single dose) packed in a corrugated box 36 Months SERUM INSTITUTE OF INDIA PRIVATE LIMITED, 212/2, Hadapsar Pune- 411028, India INDIA SERUM INSTITUTE OF INDIA LTD, INDIA SUN ENTERPRISE LTD 2023-12-30 2028-12-29

634 Rwanda FDA-HBP-MA-0104 BINOCRIT 4000IU/0.4ML Epoetin alfa 4000IU per 0.4ml 4000IU per 0.4ml Sterile solution for injection 1 and 6 in pre-filled syringes Glass type I pre-filled syringes 24 Months IDT BIOLOGIKA GmbH, Am Pharma Park 06861 Dessau-Rosslau Germany GERMANY SANDOZ PHARMACEUTICALS D.D. SURGIPHARM (RWANDA) LTD 2023-12-30 2028-12-29

635 Rwanda FDA-HBP-MA-0110 BINOCRIT 8000IU/0.8ML Epoetin alfa 8000IU per 0.8ml 8000IU/0.8ML Solution for injection 6 syringes Pre-filled in type I colorless glass syringes, closed with bromobutyl rubber stoppers which are laminated with a fluorocarbon layer. Such 6 syringes are packed in a carton 24 Months IDT BIOLOGIKA GmbH, Am Pharmapark 06861 DessauRo?lau, Germany GERMANY SANDOZ PHARMACEUTICALS D.D., SLOVENIA SURGIPHARM (RWANDA) LTD 2023-12-30 2028-12-29

636 Rwanda FDA-HMP-MA-0689 EVATOCIN Oxytocin 5 I.U./ ml 5 I.U./ ml Solution for Injection 2x5 ampoules 2 aluminium blisters containing 5 flint USP type I ampoule, 1ml each; packed in a carton box 24 Months M/S NEON LABORATORIES LIMITED, Plot no. 29 to 32 & 57, 60, The Palghar Taluka Industrial Estate Co-Op Estate Ltd., Boisar road, Palghar -401404 Maharashtra State, India. INDIA M/S NEON LABORATORIES LIMITED, INDIA SUN ENTERPRISES LTD 2023-12-30 2028-12-29

637 Rwanda FDA-HMP-MA-0690 UNITRIM DS TABLETS Sulfamethoxazole BP 800mg and Trimethoprim BP 160mg 800mg and 160mg Tablets 10x10’s tablets Alu/PVC blister pack 36 Months REGAL PHARMACEUTICALS LIMITED, Plot 7879/18, off Baba dogo road, Ruaraka, P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-12-30 2028-12-29

638 Rwanda FDA-HMP-MA-0691 BECOACTIN SYRUP 200ML Cyproheptadine Hydrochloride USP/ Thiamine Hydrochloride BP/Riboflavin BP/ Pyridoxine Hydrochloride BP/ Niacinamide BP (Nicotinamide)/ Cyanocobalamin BP, (2 mg/1 mg/ 0.5 mg/0.5 mg/10 mg/1 mcg) 2 mg/1 mg/ 0.5 mg/0.5 mg/10 mg/1 mcg Syrup 200ml Bottle PET Bottle of 200ml in a printed carton 24 Months MEYER ORGANICS PVT. LTD, A-177, Road No. 16- Z, Wagle Industrial Estate Thane (W) – 400 604 (India).10D, 2nd phase, Peenya Industrial Area Bangalore – 560058 B INDIA MEYER ORGANICS PVT LTD SUN ENTERPRISES LTD 2023-12-30 2028-12-29

639 Rwanda FDA-HMP-MA-0692 DOLOWIN-PLUS Aceclofenac 100mg and Paracetamol 500mg 100mg and 500mg Film-coated tablets 1x10’s Tablets Alu/PVC blister pack 36 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-30 2028-12-29

640 Rwanda FDA-HMP-MA-0695 LUCIN CREAM Hydrocortisone, 1%w/w 1%w/w Cream 15gm Tube Aluminium collapsible tube in unit carton 36 Months REGAL PHARMACEUTICALS LIMITED, Plot No.: 7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-12-30 2028-12-29

641 Rwanda FDA-HMP-MA-0696 PRAZIM 20MG Omeprazole 20 mg 20 mg Hard gelatin capsules 10 × 10 hard gelatin capsules Alu-Alu strip 36 Months ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar, Nagpur 441501, Maharashtra state, India INDIA ZIM LABORATORIES LIMITED, INDIA SUN ENTERPRISES LTD 2023-12-30 2028-12-29

642 Rwanda FDA-HMP-MA-0697 BACTOX 125MG/5ML Amoxicillin Trihydrate 125 mg/5ml 125 mg/5ml Powder for oral suspension 60 ml Bottle Amber glass bottles of 60 ml with screw closure and sealing membrane and with a measuring spoon graduated at 2.5 ml and 5 ml 36 Months SANDOZ GmbH, KUNDL, Biochemistrasse 10, A- 6250-Kundl, Austria AUSTRIA LABORATOIRE INNOTECH INTERNATIONAL, FRANCE MEDIASOL PHARMACEUTICAL DEPOT LTD 2023-12-30 2028-12-29

643 Rwanda FDA-HMP-MA-0698 BACTOX 500MG/5ML Amoxicillin Trihydrate 500 mg/5ml 500 mg/5ml Powder for oral suspension 60 ml Bottle Amber glass bottles of 60 ml with screw closure and sealing membrane and with a measuring spoon graduated at 2.5 ml and 5 ml 36 Months SANDOZ GmbH, KUNDL, Biochemistrasse 10, A- 6250-Kundl, Austria AUSTRIA LABORATOIRE INNOTECH INTERNATIONAL, FRANCE MEDIASOL PHARMACEUTICAL DEPOT LTD 2023-12-30 2028-12-29

644 Rwanda FDA-HMP-MA-0699 TRAMAZIM Tramadol BP 50 mg 50 mg Hard gelatin capsules 10 × 10 Capsules Alu- PVC Blister Pack 36 Months ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar, Nagpur 441501, Maharashtra state, India INDIA ZIM LABORATORIES LIMITED, INDIA SUN ENTERPRISES LTD 2023-12-30 2028-12-29

645 Rwanda FDA-HMP-MA-0700 EXXIB TABLET Celecoxib 200mg 200mg Tablets 10 Tablets Blister (PVC/PVdC-Aluminium) of 10 tablets in a cardboard box 36 Months GRACURE PHARMACEUTICALS LIMITED, E-1105, Industrial Area, Phase-III Bhiwadi, PIN-301019, Dist. Alwar. Rajasthan, India INDIA EXPHAR S.A, BELGIUM H&H PHARMA LTD 2023-12-30 2028-12-29

646 Rwanda FDA-HMP-MA-0703 NUSAR-H Losartan potassium USP 50mg & Hydrochlorothiazide BP. 12.5mg 50mg & 12.5mg Film coated tablets 3X10 tablets Bister strip (VMCH coated printed Aluminium foil / PVC foil). 3 such strips are packed in a carton along with a package insert 36 Months EMCURE PHARMACEUTICALS LTD, Lane No. 3. Phase-II, SIDCO Industrial Complex Bari – Brahmana, Jammu (J&K) - 181133 INDIA INDIA EMCURE PHARMACEUTICALS LTD, INDIA ABACUS PHARMA (A) LTD 2023-12-30 2028-12-29

647 Rwanda FDA-HMP-MA-0704 ZITHROCARE 500 Azithromycin dehydrate 500mg 500mg Film coated tablets 3x10’s tablets Alu/Alu blister pack of 3x10’s tablets in a carton 36 Months MEYER ORGANICS PVT. LTD, A-177, Road No: 16-Z, Wagle Estate, Thane-400604(Mumbai), INDIA INDIA MEYER ORGANICS PVT. LTD SUN ENTERPRISES LTD 2023-12-30 2028-12-29

648 Rwanda FDA-HMP-MA-0705 XBETA Betamethasone sodium phosphate 0.1% w/v 0.1% w/v Solution 5ml &10ml Bottles LDPE Bottles 30 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O.Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-12-30 2028-12-29

649 Rwanda FDA-HMP-MA-0706 XBETA N Betamethasone sodium phosphate 0.1%w/v and Neomycin Sulphate 0.5% w/v 0.1%w/v and 0.5% w/v Solution 5ml &10ml Bottles LDPE Bottles 30 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O.Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-12-30 2028-12-29

650 Rwanda FDA-HMP-MA-0707 ABTOL Mannitol 20% w/v 20% w/v Solution 100ml Bottles LDPE Bottles 36 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O.Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-12-30 2028-12-29

651 Rwanda FDA-HMP-MA-0708 RANEXA 750MG Ranolazine 750 mg 750 mg Tablets 60 Tablets packed in PVC/Alu blister 24 Months MENARINI -VON HEYDEN GmbH, Leipziger Stra?e 7-13 01097 Dresden, Germany GERMANY MENARINI INTERNATIONAL OPERATIONAL LUXEMBOURG S.A PRAFÌN RWANDA LTD 2023-12-30 2028-12-29

652 Rwanda FDA-HMP-MA-0709 GABAZIM 300 Gabapentin 300mg 300mg Hard gelatin capsules 1 × 10 hard gelatin capsules Alu-PVC blister pack 24 Months ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar, Nagpur 441501, Maharashtra state, India INDIA ZIM LABORATORIES LIMITED, INDIA SUN ENTERPRISES LTD 2023-12-30 2028-12-29

653 Rwanda FDA-HMP-MA-0711 MACLAR 500 Clarithromycin tablets USP 500 mg 500 mg Film coated tablets 5X3X4’S Tablets Blister strip (PV/PE/PVDC) 24 Months Glenmark Pharmaceuticals Limited, Plot No. E-37, 39, D-Road, MIDC, Satpur, Nashik – 422007, Maharashtra, India INDIA GLENMARK PHARMACEUTICALS LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-30 2028-12-29

654 Rwanda FDA-HMP-MA-0713 LYDIA POSTIL Levonorgestrel, 1.5mg 1.5mg Tablets 1 Tablet PVC/Aluminium foil 24 Months NAARI PHARMA PRIVATE LIMITED, Plot No. 14-16, 55-57, Sector-5, IIE Pantnagar, Rudrapur-263153, Udham Singh Nagar, Uttarakhand, India INDIA NAARI PHARMA PRIVATE LIMITED CROWN HEALTHCARE (R) LTD 2023-12-30 2028-12-29

655 Rwanda FDA-HMP-MA-0714 LAZAIN 25 Chlorpromazine injection BP 25mg/ml 25mg/ml Liquid injection 10 x 2 ml ampoules Type-I glass ampoules in a carton 36 Months KWALITY PHARMACEUTICALS LTD, Vill. Nag kalan, majitha road, Amritsar– 143601, India INDIA SUN ENTERPRISES LTD, RWANDA SUN ENTERPRISES LTD 2023-12-30 2028-12-29

656 Rwanda FDA-HMP-MA-0752 RHEUMAC TABLETS Diclofenac Sodium 50mg 50mg Film coated tablets 10x10’s Tablets Aluminium foil blisters of 10x10’s in a unit box container with literature insert 36 Months LABORATORY & ALLIED LTD, Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD, KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2023-12-30 2028-12-29

657 Rwanda FDA-HMP-MA-0754 MIPRAM Imipramine tablets BP 25mg 25mg Sugar-coated tablets 100 tablets Packed in poly bag. Such poly bag packed in round jar with its package insert. Such Jar packed in export worthy shipper 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-30 2028-12-29

658 Rwanda FDA-HMP-MA-0757 RALEF 60 Etoricoxib Tablets 60 mg 60 mg Film coated tablets 7 tablets Alu-PVC/PVDC blister, 1 such blister is packed in a carton along with Patient Information Leaflet 24 Months AJANTA PHARMA LIMITED, Plot No. B-4/5/6, MIDC, Paithan, Aurangabad Maharashtra 431148, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-12-30 2028-12-29

659 Rwanda FDA-HMP-MA-0758 AMLOZAAR Amlodipine 50mg and Losartan potassium 50 mg 50mg and 50 mg Film coated tablets 3 X 10’s Tablets Alu/Alu blister pack 36 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-30 2028-12-29

660 Rwanda FDA-HMP-MA-0761 ALDAZ-400 Albendazole, 400 mg 400 mg Chewable uncoated tablets 50 × 1 x 1 Chewable uncoated Tablets Alu-PVC Blister pack 36 Months ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar, Nagpur 441501, Maharashtra state, India INDIA ZIM LABORATORIES LIMITED, INDIA SUN ENTERPRISES LTD 2023-12-30 2028-12-29

661 Rwanda FDA-HMP-MA-0762 DAPZIN 5-M Dapagliflozin 5mg and Extended-Release Metformin Hydrochloride USP 500mg 5mg and 500mg Film coated tablets 3X10’s Tablets Alu/Alu blister pack. Such 3 blisters are packed in a printed outer carton along with a pack insert 24 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-30 2028-12-29

662 Rwanda FDA-HMP-MA-0763 DAPZIN 10-M Dapagliflozin 10mg and Extended-Release Metformin Hydrochloride USP 500mg 10mg and 500mg Film coated tablets 3X10’s Tablets Alu/Alu blister pack. Such 3 blisters are packed in a printed outer carton along with a pack insert 24 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-30 2028-12-29

663 Rwanda FDA-HMP-MA-0764 CLARIZIM-500 Clarithromycin Tablets USP 500 mg 500 mg Film coated tablets 10x1x4 Tablets Alu-PVC Blister pack 36 Months ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar, Nagpur 441 501, Maharashtra State, India INDIA ZIM LABORATORIES LIMITED, INDIA SUN ENTERPRISES LTD 2023-12-30 2028-12-29

664 Rwanda FDA-HMP-MA- 0765 CEFAZIM-DS Cefixime Trihydrate 100mg/5ml 100mg/5ml Powder granules when reconstituted it gives light orange coloured suspension 30 mL Bottle HDPE Bottle 24 Months ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar, Nagpur 441 501, Maharashtra State, India INDIA ZIM LABORATORIES LIMITED, INDIA SUN ENTERPRISES LTD 2023-12-30 2028-12-29

665 Rwanda FDA-HMP-MA- 0766 TURBOVAS-20 Rosuvastatin Calcium 20mg 20mg Film coated tablets 3x10’s Tablets Alu/Alu blister pack. Such 3 blisters are packed in carton along with pack insert. 36 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-30 2028-12-29

666 Rwanda FDA-HMP-MA-0767 DOLOWIN-SR Aceclofenac 200mg 200mg Film-coated sustained release tablets 3x10’s Tablets Alu/Alu blister pack. Such 3 blisters are packed in carton along with pack insert. 36 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-30 2028-12-29

667 Rwanda FDA-HMP-MA-0776 BETAPYN TABLETS Paracetamol 450mg, caffeine 50mg, Codeine phosphate 10mg and Doxylamine succinate 5mg 450mg, 50mg, 10mg and 5mg Tablets 18 tablets PVC/Aluminium foil blister packs 24 Months ADCOCK INGRAM LIMITED (INDIA) 49, (C&D) Bommasandra Industrial Area, Anekal Taluk, Bangalore, 560099, Karnataka, India INDIA ADCOCK INGRAM LIMITED, SOUTH AFRICA SURGIPHARM (RWANDA) LTD 2023-12-30 2028-12-29

668 Rwanda FDA-HMP-MA-0777 ZOLEDRA Zoledronic Acid monohydrate 4.26mg (4mg on Anhydrous) 4mg Powder for solution for infusion 1 vial of 15ml Type I glass vial of 15 ml, Unit pack containing 1 vial 24 Months LES LABORATOIRES MÉDIS, Km 7 route de Tunis, BP 206 8000 Nabeul, Tunisia TUNISIA LES LABORATOIRES MÉDIS, TUNISIA KIPHARMA LTD 2023-12-30 2028-12-29

669 Rwanda FDA-HMP-MA-0778 VAROXA-10 Rivaroxaban tablets 10 mg 10 mg Uncoated tablets 3x10 tablets Alu/Alu Blisters 36 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-30 2028-12-29

670 Rwanda FDA-HMP-MA-0779 VAROXA-20 Rivaroxaban Tablets 20 mg 20 mg Film coated tablets 3x10 tablets Alu/Alu Blisters 36 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-30 2028-12-29

671 Rwanda FDA-HMP-MA-0780 URYDOS-4 Silodosin 4 mg 4 mg Hard gelatin capsules 1x10 capsules Alu/Alu blister pack. Such a blister is placed in a carton along with the pack insert 24 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-30 2028-12-29

672 Rwanda FDA-HMP-MA-0497 KETESSE 25MG Dexketoprofen Trametamol, 25mg 25mg Film coated tablets 4 Tablets and 20 Tablets PVC-Aluminium foil 24 Months LABORATORIOS MENARINI S.A, Dompé farmaceutici S.p.A., Menarini Group Via Campo di Pile, Alfonso XII, 587, E-08918 Badalona, Barcelona, Spain and Menarini Group Via Campo di Pile, L’Aquila, Italy; Dompé farmaceutici S.p.A., Via Campo di Pile, L’Aquila, Italy SPAIN AND ITALY MENARINI INTERNATIONAL OPERATIONS LUXEMBOURGS S.A PRAFIN RWANDA LTD 2023-12-30 2028-12-29

673 Rwanda FDA-HBP-MA-0107 RILAST 500 Rituximab 500mg/50 mL 500mg/50 mL Concentrate for solution for injection 50 ml vial Clear glass vial neutral (USP Type 1) with butyl rubber stopper 30 Months HETERO BIOPHARMA LIMITED; Sy. No. 458 (part), TSIICFormulation SEZ, Polepally (Village), Jadcherla (Mandal), Mahaboobnagar (District) – 509 301, Telangana State, India INDIA M/S Hetero Biopharma Limited, India Vine Pharma LimiteD 2024-01-05 2029-01-04

674 Rwanda FDA-HBP-MA-0108 RILAST 100 Rituximab 100mg/10 mL 100mg/10 mL Concentrate for solution for injection 10 ml vial Clear glass vial neutral (USP Type 1) with butyl rubber stopper 30 Months HETERO BIOPHARMA LIMITED; Sy. No. 458 (part), TSIICFormulation SEZ, Polepally (Village), Jadcherla (Mandal), Mahaboobnagar (District) – 509 301, Telangana State, India INDIA M/S Hetero Biopharma Limited, India Vine Pharma LimiteD 2024-01-05 2029-01-04

675 Rwanda FDA-HMP-MA-0730 FEXOGLOB 120 Fexofenadine Hydrochloride USP 120 mg tablets 120 mg Film coated tablets 10 Tablets Packed in one Alu-PVC Blister 36 Months GLOBELA PHARMA PVT. LIMITED, Plot No. 357- 358, G.I.D.C, Sachin, Road no. 3, Surat, Gujarat, India INDIA GLOBELA PHARMA PVT. LIMITED, INDIA AFRIPHARM LTD 2024-01-05 2029-01-04

676 Rwanda FDA-HMP-MA-0735 HISTALIN COUGH EXPECTORANT Chlorpheniramine Maleate BP 1.0mg, Promethazine HCl BP 2.5mg, Diphenhydramine HCl BP 5.0mg, Ephedrine HCl BP 7.5mg, Ammonium Chloride BP 90.0mg, Sodium Citrate BP 45.0mg 1.0mg, 2.5mg, 5.0mg, 7.5mg, 90.0mg, 45.0mg Viscous free flowing liquid 60ml Bottle Amber glass bottles 36 Months REGAL PHARMACEUTICALS LTD, Plot No: 7879/18, off Baba Dogo Road Ruaraka, Kenya KENYA REGAL PHARMACEUTICALS LTD, KENYA ABACUS PHARMA (RWANDA) LTD 2024-01-05 2029-01-04

677 Rwanda FDA-HMP-MA-0737 BECOACTIN TABLET Cyproheptadine Hydrochloride U.S.P. 4 mg (anhydrous), Vitamin B1 (as Thiamine Nitrate B.P.) 2 mg, Vitamin B2 (as Riboflavin B.P.) 0.5 mg, Vitamin B6 (as Pyridoxine Hydrochloride B.P.) 1 mg, Nicotinamide B.P 10 mg, Vitamin B12 1 mcg, Glycine B.P. 40 mg, Elemental Iron (as Ferrous Fumarate B.P.) 8 mg, Elemental Zinc 6 mg (as Zinc Sulphate Monohydrate U.S.P.) 4 mg, 2 mg, 0.5 mg, 1 mg, 10 mg, 1 mcg, 40 mg, 8 mg, 6 mg Sugar coated tablets 3X10’s Tablets Aluminium/PVC blister 24 Months MEYER ORGANICS PRIVATE LIMITED, 10D, 2nd phase, Peenya Industrial Area, Bangalore-560058, India INDIA MEYER ORGANICS PRIVATE LIMITED, INDIA SUN ENTERPRISES LTD 2024-01-05 2029-01-04

678 Rwanda FDA-HMP-MA-0738 CANDID V6 Clotrimazole 100mg 100mg Vaginal uncoated tablet 6 Tablets Printed aluminium strip 48 Months GLENMARK PHARMACEUTICALS LTD, Plot No. E-37, 39, D-Road, MIDC, Satpur, Nashik – 422007, Maharashtra, India INDIA GLENMARK PHARMACEUTICALS LTD WESSEX PHARMACEUTICAL (RWANDA) LTD 2024-01-05 2029-01-04

679 Rwanda FDA-HMP-MA-0741 FERVEX SUGAR FREE Paracetamol 500mg, Ascorbic acid (Vitamin C) 200mg and Pheniramine 25mg 500mg, 200mg and 25mg Granulated oral powder 8 sachets Sachets made of paper/aluminium/polyethylene complex enclosed in a carton box 36 Months UPSA SAS, 979, Avenue des Pyrénées 47520 Le Passage – France FRANCE PROPHARMED INTERNATIONAL KIPHARMA LTD 2024-01-05 2029-01-04

680 Rwanda FDA-HMP-MA-0742 DURART 600 Darunavir Ethanolate 600mg 600mg Film coated tablets 60 Tablets High Density Polyethylene (HDPE) bottle 36 Months MYLAN LABORATORIES LIMITED, Plot No. H-12 and H-13, MIDC, Waluj Industrial Area, Aurangabad-431136, Maharashtra, India INDIA MYLAN LABORATORIES LIMITED, INDIA PYRAMID PHARMA LIMITED 2024-01-05 2029-01-04

681 Rwanda FDA-HMP-MA-0743 AMITRYP-25 Amitriptyline HCl 25mg 25mg Film coated tablets 10x10 Tablets Alu-PVC Blister Pack and Such 10 Blisters are packed in a printed Carton with Packing Insert 36 Months LINCOLN PHARMACEUTICALS LIMITED; Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat; India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2024-01-05 2029-01-04

682 Rwanda FDA-HMP-MA-0751 POLYGYNAX VIRGO Neomycin sulfate 35 000 I.U., Polymyxin B sulfate 35 000 I.U., Nystatin 100 000 I.U. 35 000 I.U., 35 000 I.U., 100 000 I.U. Vaginal capsules 6 capsules PVC/PVDC/Aluminium blister, in a carton box 24 Months INNOTHERA CHOUZY, Rue René Chantereau, Chouzy-sur-Cisse 41150, Valloire-sur-Cisse, France FRANCE LABORATOIRE INNOTECH INTERNATIONAL DEPOT PHARMACEUTIQUE LE MEDICAL 2024-01-05 2029-01-04

683 Rwanda FDA-HMP-MA-0768 FECK Aceclofenac Tablets 100 mg 100 mg Film coated tablets 3x10’s Tablets Alu/Alu blister pack. Such 3 blisters are packed in a printed outer carton along with a pack insert 36 Months ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar, Nagpur 441 501, Maharashtra State, India INDIA ZIM LABORATORIES LIMITED, INDIA SUN ENTERPRISES LTD 2024-01-05 2029-01-04

684 Rwanda FDA-HMP-MA-0769 FARIN- 5 Warfarin Tablets BP 5 mg 5 mg Uncoated tablets 28’s tablets HDPE Jar. Such Jars packed in export worthy shipper 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-01-05 2029-01-04

685 Rwanda FDA-HMP-MA-0771 TRAMADIS 100MG/2ML Tramadol hydrochloride 100mg/2ml 100mg/2ml Liquid Injectable Solution 5 Ampoules Type I white neutral drawn glass silk-screen ampoules with breaking point (OPC), capacity 2ml; are packed in a carton, with a package insert 48 Months LES LABORATOIRES MEDIS, Km 7 Route De Tunis, BP 206, 8000 Nabeul, Tunisia. TUNISIA LES LABORATOIRES MEDIS, TUNISIA KIPHARMA LTD 2024-01-05 2029-01-04

686 Rwanda FDA-HMP-MA-0772 URYDOS-8 Silodosin Capsules 8 mg 8 mg Hard gelatin capsule 1x10’s capsules Alu/Alu blister pack 24 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-01-05 2029-01-04

687 Rwanda FDA-HMP-MA-0773 FENTANYL TRANSDERMAL PATCHES Fentanyl 100mcg 100mcg Transdermal Patch 5 transdermal patches of fentanyl are Packed in sachets (sachet foil paper/PE/AL/PE) and finally in cardboard cartons 24 Months HEXAL AG, Industriestrasse, 25 D-83607, Holzkirchen, Germany GERMANY SANDOZ GmbH, Kundl SURGIPHARM (RWANDA) LTD 2024-01-05 2029-01-04

688 Rwanda FDA-HMP-MA-0774 RELCER GEL Aluminium Hydroxide Gel USP 365 mg Magnesium Hydroxide Paste USP 80 mg; Simethicone USP 100 mg and Deglycyrrhizinated Liquoride 400 mg 365 mg, 80 mg, 100 mg and 400 mg Oral Suspension 100/180ml Bottles Amber coloured labelled sealed PET bottle with 10 ml measuring cup, in a printed carton 48 Months GLENMARK PHARMACEUTICALS LTD, Plot No. E-37, 39, D-Road, MIDC, Satpur, Nashik – 422007, Maharashtra, India INDIA GLENMARK PHARMACEUTICALS LTD WESSEX PHARMACEUTICAL (RWANDA) LTD 2024-01-05 2029-01-04

689 Rwanda FDA-HMP-MA-0794 HELMINTOX 250MG Pyrantel embonate 250mg 250mg Film-coated tablets 3 tablets PVC/Aluminium Blister 36 Months INNOTHERA CHOUZY, Rue Rene Chantereau, Chouzy-surCisse, 41150 Valloire-sur-Cisse, France FRANCE LABORATOIRE INNOTECH INTERNATIONAL DEPOT PHARMACEUTIQUE LE MEDICAL 2024-01-05 2029-01-04

690 Rwanda FDA-HMP-MA-0795 PROFEN 200MG Ibuprofen BP 200mg 200mg Film-coated tablets 10 x10’s Tablets PVC/Aluminium blister packs, in a carton 36 Months LABORATORY & ALLIED LTD, Plot No: 209/10349 off Mombasa Road, P.O Box 42875, Code 00100 Nairobi, Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-01-05 2029-01-04

691 Rwanda FDA-HMP-MA-0809 CLARIWIN 500 Clarithromycin 500mg 500mg Film coated tablets 10 Tablets Alu/Alu blister pack 36 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-01-05 2029-01-04

692 Rwanda FDA-HMP-MA-0731 XERIN Levocetirizine Hydrochloride 5mg and Montelukast Sodium USP 10 mg 5mg and 10 mg Film coated tablets 10 x 10 Tablets Alu-Alu Blister pack with printed carton along with pack insert 36 Months AKUMS DRUGS & PHARMACEUTICALS LTD, 19,20 & 21 Sector 6A, IIE, SIDCUL, Ranipur, Haridwar-249403, Uttarakhand, India INDIA UNOSOURCE PHARMA LTD, INDIA ABACUS PHARMA(A) LTD 2024-01-08 2029-01-07

693 Rwanda FDA-HMP-MA-0739 BIOMOL Paracetamol BP 500mg 500mg Tablets 10 x 10 Tablets Blister pack of 10 x 10`s in unit boxes 36 Months BIODEAL LABORATORIES LTD, Plot No. 123, Lunga Lunga Road, P.O. Box 32040- 00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICAL SUPPLIES LTD 2024-01-08 2029-01-07

694 Rwanda FDA-HMP-MA-0740 AMLODIPINE 10MG TABLETS Amlodipine besylate 10mg 10mg Tablets 10 x 10 Tablets 10 Alu-Alu blisters of 10 tablets (10 x 10) packed in a carton box 36 Months LEK PHARMACEUTICALS D.D., Verovškova 57 SI-1526 Ljubljana, Slovenia SLOVENIA SANDOZ GmbH, KUNDL SURGIPHARM (RWANDA) LTD 2024-01-08 2029-01-07

695 Rwanda FDA-HMP-MA-0745 AGOMOL TABLET Paracetamol BP 500 mg 500 mg Uncoated tablet 10 x 10 Tablets Blister Pack 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-01-08 2029-01-07

696 Rwanda FDA-HMP-MA-0749 PACLITAXEL Paclitaxel 6mg per 1ml (300mg per 50ml) 300mg/50ml Solution for infusion 1 glass vial of 50ml 1 glass vial of 50ml in volume (300mg in 50ml) 36 Months FAREVA UNTERACH GmbH, Mondseestraße 11 4866 Unterach, Austria Austria SANDOZ GmbH, KUNDL SURGIPHARM (RWANDA) LTD 2024-01-08 2029-01-07

697 Rwanda FDA-HMP-MA-0750 CIPRO-500 Ciprofloxacin Tablets BP 500 mg 500 mg Film coated tablets 10 Tablets Printed Aluminium foil/PVC foil Blister pack 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-01-08 2029-01-07

698 Rwanda FDA-HMP-MA-0781 POLYGYNAX Neomycin sulphate, Polymyxin B sulphate, Nystatin, 35 000/ 35 000/ 100 000 IU 35 000/ 35 000/ 100 000 IU Vaginal capsules 6 or 12’s Capsules PVC/PVDC/Alu blister. Such blister is packed in cardboard box 24 Months INNOTHERA CHOUZY, Rue René Chantereau, Chouzy-Sur-Cisse 41150 Valloire-Sur-Cisse, France FRANCE LABORATOIRE INNOTECH INTERNATIONAL DEPOT PHARMACEUTIQUE LE MEDICAL 2024-01-08 2029-01-07

699 Rwanda FDA-HMP-MA-0782 NYSTATIN VAGINAL TABLETS USP 1,00,000 IU Nystatin 100,000 IU 100,000 IU Vaginal Tablets 1 x 14 tablets Packed in aluminium strip, in a carton 36 Months AURA LIFECARE PVT. LTD, Survey No 254/ 14/1, Jarod, Savli Road, P.O. Karachiya, Tal-Savli, Dist: Vadodara-391520. Gujarat State, India INDIA AURA LIFECARE PVT. LTD SUN ENTERPRISES LTD 2024-01-08 2029-01-07

700 Rwanda FDA-HMP-MA-0783 ARPREL 5 Prasugrel 5mg 5mg Film coated tablets 3x10’s tablets Alu/ Alu blisters. Such 3 blisters are packed in a printed carton along with a package insert 24 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-01-08 2029-01-07

701 Rwanda FDA-HMP-MA-0784 ARPREL 10 Prasugrel 10mg 10mg Film coated tablets 3x10’s Tablets Alu/ Alu blisters. Such 3 blisters are packed in a printed carton along with a package insert 24 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-01-08 2029-01-07

702 Rwanda FDA-HMP-MA-0786 EFFERALGAN 150 MG POWDER Paracetamol 150 mg 150 mg Crystalline Powder 10 Sachets Sachets per box are made of paper/aluminium/polyethylene complex 36 months UPSA SAS 979, Avenue des Pyrénées 47520 Le Passage, France FRANCE PROPHARMED INTERNATIONAL UBIPHARM RWANDA LTD 2024-01-08 2029-01-07

703 Rwanda FDA-HMP-MA-0787 EFFERALGAN 250 MG POWDER Paracetamol 250 mg 250 mg Crystalline Powder 10 Sachets Sachets per box are made of paper/aluminium/polyethylene complex 36 months UPSA SAS 979, Avenue des Pyrénées 47520 Le Passage, France FRANCE UPSA, FRANCE UBIPHARM RWANDA LTD 2024-01-08 2029-01-07

704 Rwanda FDA-HMP-MA-0789 OLIGOCARE TABLETS L-Carnitine Tartrate 50mg, L-Arginine USP 10mg, L- Glutathione BP 2.5mg, Zinc Sulphate Monohydrate USP 7.5mg, Sodium Selenate Anhydrous 100 mcg, Ferrous Fumarate BP 5 mg, Copper Sulphate Pentahydrate USP 3.929 mg, Copper Sulphate (In House Dried) 2.795 mg, Manganese Sulphate Monohydrate USP 2 mg, Folic Acid BP 250 mcg, Thiamine Nitrate BP 5 mg, Pyridoxine Hydrochloride BP 5 mg, Siberian Ginseng Extract 10 mg, Vitamin E Acetate 12.5 mg, Vitamin C, 75 mg eq.78.125 mg, Vitamin A Acetate BP 1250 IU, Methylcobalamin 750 mcg, and Lycopene 6% Beadlets 2 mg 50mg, 10mg, 2.5mg, 7.5mg, 100 mcg, 5 mg, 3.929 mg, 2.795 mg, 2 mg, 250 mcg, 5 mg, 5 mg, 10 mg, 12.5 mg, 75 mg, 1250 IU, 750 mcg, 6% and 2 mg Film coated tablets 30 Tablets Printed Polylaminated, Aluminium foil for strip Packing 24 Months MEYER ORGANICS PVT. LTD., Plot 10 D, Phase II, Peenya Industrial Area, Bangalore 560058, India. INDIA MEYER ORGANICS PVT. LTD SUN ENTERPRISES LTD 2024-01-08 2029-01-07

705 Rwanda FDA-HMP-MA-0790 AIRTAL-100 Aceclofenac 100mg 100mg Film coated tablets 2x10 Tablets or 4x10 Tablets 10’s tablets are packed in Alu/Alu blister. Such 2 or 4 blisters are packed in cardboard box with the patient information leaflet 48 Months INDUSTRIAS FARMACÉUTICAS ALMIRALL, S.A. Ctra. de Martorell 41-61, E-08740 Sant Andreu de la Barca Barcelone, Spain SPAIN ALMIRALL, S.A, SPAIN UBIPHARM-RWANDA LTD 2024-01-08 2029-01-07

706 Rwanda FDA-HMP-MA-0804 GELOFUSINE 40MG/ML SOLUTION FOR INFUSION Succinylated Gelatin 40mg/ml and Sodium Chloride 7.01mg/ml 40mg/ml SOLUTION FOR INFUSION 10 x 500ml Bottle Ecoflac Plus LDPE bottle 24 Months B. BRAUN MEDICAL SA, Route de Sorge 9 CH-1023 Crissier, Switzerland SWITZERLAND B. BRAUN MELSUNGEN AG, GERMANY KIPHARMA LTD 2024-01-08 2029-01-07

707 Rwanda FDA-HMP-MA-0387 Zalain 300 mg ovule Each ovule contains 300mg of sertaconazole nitrate 300mg Ovule One ovule Carton box with one ovule in thermo PVC/PE 60 months, FERRER INTERNACIONAL, S.A., Gran Vía Carlos III, 94, 08028 Barcelona, Spain SPAIN FERRER INTERNACIONAL, S.A., SPAIN GOMHS LIMITED 2024-01-08 2029-01-07

708 Rwanda FDA-HMP-MA-0688 CANDID V3 Clotrimazole USP, 200 mg 200 mg Uncoated tablet 3 Tablets Printed aluminium strips 48 Months GLENMARK PHARMACEUTICALS LTD, Plot No. E-37, 39, D-Road, MIDC, Satpur, Nashik – 422007, Maharashtra, India INDIA GLENMARK PHARMACEUTICALS LTD WESSEX PHARMACEUTICAL (RWANDA) LTD 2024-01-08 2029-01-07

709 Rwanda FDA-HMP-MA-0701 DOXY 200 Doxycycline monohydrate 200mg 200mg Tablets 8 Tablets Blister (PVC-Aluminium) of 8 tablets in a cardboard box 36 Months GRACURE PHARMACEUTICALS LIMITED, E- 1105, Industrial Area, Phase-III BHIWADI, PIN-301019 Dist. Alwar, Rajasthan, India INDIA EXPHAR S.A, BELGIUM H&H PHARMA LTD 2024-01-08 2029-01-07

710 Rwanda FDA-HMP-MA-0734 GLIBENCLAMIDE TABLETS Glibenclamide BP 5 mg 5 mg Uncoated tablets 10 x 10 Tablets Blister Packs 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-01-08 2029-01-07

711 Rwanda FDA-HMP-MA-0748 ZEPIN-200 Carbamazepine BP 200 mg 200 mg Uncoated tablets 10 x 10 Tablets Blister Packs 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-01-08 2029-01-07

712 Rwanda FDA-HMP-MA-0753 AGOCARB TABLET Activated Charcoal tablets 0.25 g 0.25 g Uncoated tablets 100 tablets Jar pack 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-01-08 2029-01-07

713 Rwanda FDA-HMP-MA-0755 FLUOXETINE TABLETS USP 20MG Fluoxetine Hydrochloride equivalent USP to Fluoxetine 20mg 20mg Film coated tablets 100 Tablets Jar Pack 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-01-08 2029-01-07

714 Rwanda FDA-HMP-MA-0756 AGOHAL-5 Haloperidol BP 5 mg 5 mg Uncoated tablets 1000 Tablets Jar Pack 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-01-08 2029-01-07

715 Rwanda FDA-HMP-MA-0759 METRONIDAZOLE VAGINAL TABLETS 500 MG Metronidazole BP 500 mg 500 mg Uncoated tablets 100 Tablets Jar Pack 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-01-08 2029-01-07

716 Rwanda FDA-HMP-MA- 0760 AGOCAL TABLETS Calcium Lactate BP 300mg 300mg Uncoated tablets 1000 Tablets Jar Pack 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-01-08 2029-01-07

717 Rwanda FDA-HMP-MA-0785 ASPIRINE UPSA- 1000 Acetylsalicylic Acid 1000 mg 1000 mg Effervescent tablets 1x10’s effervescent tablets Polypropylene tube with a polyethylene stopper containing a desiccant (molecular sieve) 24 Months UPSA, 979, Avenue des Pyrénées, 47520 Le Passage – France FRANCE UPSA, FRANCE UBIPHARM RWANDA LTD 2024-01-08 2029-01-07

718 Rwanda FDA-HMP-MA-0788 NEBIMAC 10 Nebivolol Hydrochloride 10 mg 10 mg Uncoated tablets 4x7’s tablets Alu/clear PVC/ PVDC blister pack. Such 4 blisters are packed in a carton along with a pack insert 36 month MACLEODS PHARMACEUTICALS LIMITED, Block N-2, Village: Theda, PO: Lodhimajra, Tehsil Baddi, Dist: Solan, Himachal Pradesh – 174 101, India INDIA MACLEODS PHARMACEUTICALS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-01-08 2029-01-07

719 Rwanda FDA-HMP-MA-0796 FLUDITEC® 20 MG/ML Carbocisteine 2% Syrup (20mg/ml) 20mg/ml Syrup 125 ml Bottle Type III white glass bottle of 125 ml, closed with a polyethylene cap. Bottles are packed in a cardboard box along with a leaflet 24 Months UNITHER LIQUID MANUFACTURING, 1-3 Allee de la Neste- ZI d’En Sigal-31770 Colomiers, France FRANCE LABORATOIRE INNOTECH INTERNATIONAL DEPOT PHARMACEUTIQUE LE MEDICAL 2024-01-08 2029-01-07

720 Rwanda FDA-HMP-MA-0797 FLUDITEC® 50 MG/ML Carbocisteine 5% Syrup (50mg/ml) 50mg/ml Syrup 125 ml and 300ml Bottles White type III glass bottle of 125 ml and bottle of 300ml closed with a Polyethylene cap 24 Months UNITHER LIQUID MANUFACTURING, 1-3 Allee de la Neste- ZI d’En Sigal-31770 Colomiers, France FRANCE LABORATOIRE INNOTECH INTERNATIONAL DEPOT PHARMACEUTIQUE LE MEDICAL 2024-01-08 2029-01-07

721 Rwanda FDA-HMP-MA-0798 FLUDITEC 750MG/10ML ADULTS, ORAL SOLUTION Carbocisteine, 750 mg/ 10 ml. 750 mg/ 10 ml Syrup 10ml packet 10ml packet in sachet of complex laminated foil made of PET/aluminium/polyethylene. Sachets are collected in a conventional paper carton box, with a patient information sheet 24 Months UNITHER LIQUID MANUFACTURING, 1-3 Allee de la Neste- ZI d’En Sigal-31770 Colomiers, France FRANCE LABORATOIRE INNOTECH INTERNATIONAL DEPOT PHARMACEUTIQUE LE MEDICAL 2024-01-08 2029-01-07

722 Rwanda FDA-HMP-MA-0799 PROPANE TABLETS Propranolol Hydrochloride BP 40 mg 40 mg Film coated tablets 10x10 tablets printed aluminum foil/PVC foil blisters. Blisters are packed in a unit printed duplex board carton along with a package insert 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-01-08 2029-01-07

723 Rwanda FDA-HMP-MA-0800 ANAWIN HEAVY Bupivacaine Hydrochloride equivalent to anhydrous Bupivacaine Hydrochloride 20mg/4mL 20mg/4mL Solution for injection 5×1 ampoules 5×1 ampoule of 4mL flint with black dotted ‘snap off’ OPC 18 Months NEON LABORATORIES LIMITED, Plot No. 29, 30, 31, 32, 57 & 60, The Palghar Taluka-Co-Op Estate Ltd, Boisar Road, Palghar, Thane 401404, Maharashtra, India INDIA NEON LABORATORIES LIMITED SUN ENTERPRISES LTD 2024-01-08 2029-01-07

724 Rwanda FDA-HMP-MA-0801 YASMIN, FILM-COATED TABLETS, 0.03MG/3MG Each film-coated tablet contains 0.030 mg ethinylestradiol and 3 mg drospirenone 0.030 mg and 3 mg Film coated tablets 21 Tablets Packed in Foil PVC/PE.EVOH.PE/PCTFE colorless transparent sealed with Foil Al sealable to PVC/PVDC 36 Months BAYER AG, Berlin Müllerstrasse 178 13353 Berlin, Germany GERMANY BAYER EAST AFRICA LIMITED SURGIPHARM (RWANDA) LTD 2024-01-08 2029-01-07

725 Rwanda FDA-HMP-MA-0802 MUCOLEX Each 5ml contains: Ambroxol Hydrochloride BP 30 mg; Salbutamol Sulfate BP Equivalent to Salbutamol 1 mg; Guaifenesin BP 50 mg; Levomenthol BP 0.5 mg 30 mg, 1 mg, 50 mg, 0.5 mg/5ml Clear liquid 100 ml Bottle Amber coloured glass bottle 24 Months S KANT HEALTHCARE LTD, Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195, Gujarat. India INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2024-01-08 2029-01-07

726 Rwanda FDA-HMP-MA-0803 TRAMAPA FORT 75MG/650MG Tramadol hydrochloride 75mg and Paracetamol 650mg 75mg and 650mg Tablets Box of 20 tablets Aluminium/polyethylene strips or aluminium/PVC-PVDC blister packs 36 months FERRER INTERNACIONAL, S.A. C/Joan Buscallà, 1-9. 08173 Sant Cugat del Vallès, Barcelona, Spain SPAIN FERRER INTERNATIONAL, S.A. GOMHS LTD 2024-01-08 2029-01-07

727 Rwanda FDA-HMP-MA-0693 AGOFEN-200 TABLET Ibuprofen 200 mg tablet 200 mg Film coated tablets 1000’s Tablets HDPE Jar pack 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-01-08 2029-01-07

728 Rwanda FDA-HMP-MA-0694 AGOBEX TABLETS Mebendazole USP 100mg 100mg Uncoated tablets 1000’s Tablets HDPE Jar pack 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-01-08 2029-01-07

729 Rwanda FDA-HMP-MA-0727 ANAWIN Bupivacaine Hydrochloride BP 2.5mg/mL 2.5mg/mL Solution for Injection 20mL Vial 1 glass vial packed in Unit Carton 24 Months NEON LABORATORIES LIMITED; Plot No.29, 30, 31, 32, 57&60. The Palghar Taluka-Co-op Estate Ltd., Boisar Road, Palghar, Dist: Thane 401404, Maharashtra, India INDIA NEON LABORATORIES LIMITED SUN ENTERPRISE LTD 2024-01-08 2029-01-07

730 Rwanda FDA-HMP-MA-0728 ESOZIM-20 Esomeprazole Magnesium DelayedRelease Capsules USP 20 mg 20 mg Hard Gelatin Capsule 10 × 10 Hard Gelatin Capsules Alu-Alu blister pack 30 Months ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar, Nagpur 441 501, Maharashtra State, India INDIA ZIM LABORATORIES LIMITED SUN ENTERPRISE LTD 2024-01-08 2029-01-07

731 Rwanda FDA-HMP-MA-0729 SUPER WELGRA Sildenafil citrate USP 100 mg and Dapoxetine Hydrochloride 60 mg 100 mg and 60 mg Film coated tablets 4 Tablets Printed Aluminium foil blister pack of 4 tablets, packed in a carton along with a leaflet. 36 Months AKUMS DRUGS & PHARMACEUTICALS LTD, 19,20 & 21 Sector 6A, IIE, SIDCUL, Ranipur, Haridwar-249403, Uttarakhand, India INDIA UNOSOURCE PHARMA LTD, INDIA ABACUS PHARMA(A) LTD 2024-01-08 2029-01-07

732 Rwanda FDA-HMP-MA-0732 XYLOCAINE SPRAY 10% Lidocaine 10mg 10mg Solution spray 1 bottle of 50ml Vials made of type I molded glass 50ml, packed with short bent spray nozzle 36 Months AstraZeneca AB, Forskargatan 18, SE-151 85 Södertälje, Sweden SWEDEN BETA HEALTHCARE INTERNATIONAL LTD SURGIPHARM (RWANDA) LTD 2024-01-15 2029-01-14

733 Rwanda FDA-HMP-MA-0733 INDICONTIN 1.5 MG TABLETS Indicontin controlled release Tablets 1.5mg 1.5mg Film coated tablets 10 x 10 Tablets Tablets are packed in a blister of printed aluminum foil backed with PVC rigid film.10 such blisters are packed in a box 24 Months MODI-MUNDIPHARMA PVT. LTD, Modipuram - 250 110, U.P., India INDIA MODI-MUNDIPHARMA PRIVATE LIMITED SURGIPHARM (RWANDA) LTD 2024-01-15 2029-01-14

734 Rwanda FDA-HMP-MA-0744 VIGAMOX 0.5% EYE DROP 1 ml of solution contains 5.45 mg moxifloxacin hydrochloride equivalent to 5 mg moxifloxacin base 0.005 Eye drops, solution 1 Bottle Round natural low density polyethylene (LDPE) bottle 24 Months ALCON COUVREUR NV, Rijksweg 14Puurs, 2870, Belgium BELGIUM NOVARTIS PHARMA, BASEL, SWITZERLAND SURGIPHARM (RWANDA) LTD 2024-01-15 2029-01-14

735 Rwanda FDA-HMP-MA-0746 KETO PLUS SHAMPOO Ketoconazole BP 2% w/v and Zinc Pyrithione (ZPTO 1% w/v) 2% w/v and 1% w/v Viscous shampoo 60ml Bottle Printed sleeved HDPE bottle with white PP flip off cap 24 Months GLENMARK PHARMACEUTICALS LTD, Plot No. E-37, 39, DRoad, MIDC, Satpur, Nashik – 422007, Maharashtra, INDIA INDIA GLENMARK PHARMACEUTICALS LTD WESSEX PHARMACEUTICAL (RWANDA) LTD 2024-01-15 2029-01-14

736 Rwanda FDA-HMP-MA-0747 XARELTO-20 TABLETS Rivaroxaban 20mg 20mg Film Coated tablets 1x14’s tablets PP/Alu Blister 36 Months BAYER AG, Kaiser-Wilhelm-Allee 51368 Leverkusen, Germany GERMANY BAYER EAST AFRICA LIMITED WESSEX PHARMACEUTICAL (RWANDA) LTD 2024-01-15 2029-01-14

737 Rwanda FDA-HMP-MA-0792 AGO SCRUB PLUS Chlorhexidine Gluconate 1.5% w/v, and Cetrimide 15% w/v 1.5% w/v, and 15% w/v Topical Liquid 1 Litre Bottle HDPE Bottle 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-01-15 2029-01-14

738 Rwanda FDA-HMP-MA-0793 FARIN-1 Warfarin Tablets BP 1 mg 1 mg Uncoated tablets 28’s Tablets HDPE JAR 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-01-15 2029-01-14

739 Rwanda FDA-HMP-MA-0805 HEPARIN MEDIS Heparin Sodium, 25000 UI 25000 UI Injectable solution Box of 10 vials of 5ml Transparent glass vial type I of 8 ml, gray chlorobutyl flat cap, blue aluminium /PVC capsule 36 Months LES LABORATOIRES MEDIS, Km 7 route de Tunis, BP 206, 8000 Nabeul, Tunisia TUNISIA LES LABORATOIRES MÉDIS KIPHARMA LTD 2024-01-15 2029-01-14

740 Rwanda FDA-HMP-MA-0806 DESLOR 5 MG Desloratadine 5mg 5mg Film coated tablets 15 tablets Box, placed in PVC-Aluminum blisters of 15 tablets each. 36 Months LES LABORATOIRES MÉDIS, BP 206 Km 7-Nabeul, 8000 Nabeul, Tunisia. TUNISIA LES LABORATOIRES MÉDIS KIPHARMA LTD 2024-01-15 2029-01-14

741 Rwanda FDA-HMP-MA-0807 ANTHEL Albendazole USP 200mg/5ml 200mg/5ml Oral suspension 20 ml Amber PET Bottle Amber PET Bottle with 25 mm “LPL” logo Printed Aluminium P.P. Cap & 10 ml Measuring Plastic Cup. Such Labelled Bottle is packed in a Printed Carton with Packing Insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, Gandhinagar Gujarat District, India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LIMITED 2024-01-15 2029-01-14

742 Rwanda FDA-HMP-MA-0808 PIROXEN DISPERSIBLE 20MG TABLETS Piroxicam, 20mg 20mg Dispersible tablets 12 Tablets PVC-Aluminum blister packs 36 Months LES LABORATOIRES MÉDIS, BP 206 Km 7 - Nabeul, 8000 Nabeul. TUNISIA TUNISIA LES LABORATOIRES MÉDIS KIPHARMA LTD 2024-01-15 2029-01-14

743 Rwanda FDA-HMP-MA-0810 AGOLITHO TABLET Lithium Carbonate Tablets BP 400mg 400mg Film coated tablets 100 tablets Jar pack 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-01-15 2029-01-14

744 Rwanda FDA-HBP-MA-0105 BINOCRIT 10,000 IU/1 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE Epoetin alfa where it is 10000 IU per 1ml corresponding to 84.0 micrograms per 1mL 10000 IU per 1ml Solution for injection 1 or 6 in pre-filled syringes Pre-filled syringes 24 Months IDT BIOLOGIKA GmbH, Am Pharmapark 06861 DessauRosslau, Germany GERMANY SANDOZ PHARMACEUTICALS D.D., SLOVENIA SURGIPHARM (RWANDA) LTD 2024-01-15 2029-01-14

745 Rwanda FDA-HBP-MA-0106 PAGENAX SOLUTION FOR INJECTION 120MG/ML Brolucizumab, Solution for injection 120mg/ml 120mg/ml Solution for injection 1 vial and 1 filter needle 1 vial and 1 filter needle 24 Months NOVARTIS PHARMA STEIN AG, Schaffhauserstrasse, 4332 Stein, Switzerland SWITZERLAND NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2024-01-15 2029-01-14

746 Rwanda FDA-HBP-MA-0109 BINOCRIT 2000IU/1ML Epoetin alfa 2000IU per 1ml 2000IU/1ml Sterile solution for injection f 1 and 6 pre-filled syringes, re-filled syringes, glass type I 24 Months IDT BIOLOGIKA GmbH, Am Pharmapark 06861 Dessau-Rosslau, Germany GERMANY SANDOZ PHARMACEUTICALS D.D., SLOVENIA SURGIPHARM (RWANDA) LTD 2024-01-15 2029-01-14

747 Rwanda FDA-HMP-MA-0561 SUPIROCIN OINTMENT Mupirocin Ointment USP 2% w/w 2% w/w Ointment 15 g tube Printed carton containing a leaflet and a printed Aluminium collapsible tube 18 Months GLENMARK PHARMACEUTICALS LTD, Plot No. E-37, 39, DRoad, MIDC, Satpur, Nashik – 422007, Maharashtra, India INDIA GLENMARK PHARMACEUTICALS LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-01-15 2029-01-14

748 Rwanda FDA-HMP-MA-0715 AGYCIN-500 Azithromycin Dihydrate USP 500mg 500mg Film coated tablets 3 Tablets Blisters (Alu-PVC foil) of 3 tablets packed in a mono carton along with a pack insert 36 Months BLISS GVS PHARMA Ltd, Plot No. 10, 11A, 12, Survey No. 38/1, Dewan Udyog Nagar, Aliyali Village, Palghar, Thane – 401404, Maharashtra State, India INDIA BLISS GVS PHARMA LTD, INDIA SURYA DEPOT PHARMACY LTD 2024-01-15 2029-01-14

749 Rwanda FDA-HMP-MA-0716 LASTAVIN 160 Valsartan Tablets USP 160 mg 160 mg Film coated tablets 3x10 Tablets Alu-Alu blister of 10 tablets, such 3 three blisters of 10 tablets each along with package insert in carton 30 Months AJANTA PHARMA LIMITED, B-4-5-6, MIDC Industrial Area Paithan, Aurangabad, 431148, Dist: Aurangabad, Maharashtra, India INDIA AJANTA PHARMA LIMITED, INDIA. ABACUS PHARMA (A) LTD 2024-01-15 2029-01-14

750 Rwanda FDA-HMP-MA-0717 DOCETAXEL Docetaxel, 80mg/8ml 80mg/8ml Solution for infusion Vial of 8ml Clear type I glass vial of 8ml with rubber stopper and Aluminum crimp cap, with or without a protective plastic overwrap (OnkoSafe) 24 Months FAREVA UNTERACH GmbH, Mondseestrasse 11 4866 Unterach, AUSTRIA AUSTRIA SANDOZ PHARMACEUTICALS D.D., SLOVENIA SURGIPHARM (RWANDA) LTD 2024-01-15 2029-01-14

751 Rwanda FDA-HMP-MA-0718 Docetaxel Docetaxel, 20mg/2ml 20mg/2ml Solution for infusion Vial of 8ml Clear type I glass vial of 8ml with rubber stopper and Aluminum crimp cap, with or without a protective plastic overwrap (OnkoSafe) 24 Months FAREVA UNTERACH GmbH, Mondseestrasse 11 4866 Unterach, AUSTRIA AUSTRIA SANDOZ PHARMACEUTICALS D.D., SLOVENIA SURGIPHARM (RWANDA) LTD 2024-01-15 2029-01-14

752 Rwanda FDA-HMP-MA-0719 TRAMADIS 50 MG Tramadol hydrochloride, 50mg 50mg Capsules 10 capsules PVC-Aluminium blisters 36 Months LES LABORATOIRES MÉDIS, BP 206 Km 7 Nabeul, 8000 Nabeul, Tunisia TUNISIA LES LABORATOIRES MÉDIS KIPHARMA LTD 2024-01-15 2029-01-14

753 Rwanda FDA-HMP-MA-0720 LOSAR 50 MG Losartan potassium, 50mg 50mg Film-coated tablets 30 film-coated tablets White PVC Aluminium blister packs 36 Months LES LABORATOIRES MÉDIS, BP 206 Km 7 Nabeul, 8000 Nabeul, Tunisia TUNISIA LES LABORATOIRES MÉDIS KIPHARMA LTD 2024-01-15 2029-01-14

754 Rwanda FDA-HMP-MA-0722 ARBITEL-H Telmisartan 40 mg and Hydrochlorothiazide 12.5 mg 40 mg and 12.5 mg Uncoated tablets 3 x 10's Tablets Alu/Alu blister pack of 3 x 10's tablets Packed in outer carton 24 Months MICRO LABS LIMITED, 92 SIPCOT Industrial Complex Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-01-15 2029-01-14

755 Rwanda FDA-HMP-MA-0723 NEBILONG 5 Nebivolol Hydrochloride 5mg 5mg Uncoated tablets 3 x 10's Tablets Alu/Alu blister pack of 3 x 10's tablets Packed in outer carton 24 Months MICRO LABS LIMITED, 92 SIPCOT Industrial Complex Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-01-15 2029-01-14

756 Rwanda FDA-HMP-MA-0724 EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE FILM COATED TABLETS 200 MG/300 MG Emtricitabine/Tenofovir Disoproxil Fumarate, 200 mg/300 mg 200 mg/300 mg Film-coated tablets 30’s Tablets HDPE bottles packed in outer carton 36 Months MYLAN LABORATORIES LIMITED, F-4 & F-12, Malegaon MIDC, Sinnar, Nashik - 422 113, Maharashtra State, India INDIA MYLAN LABORATORIES LIMITED, INDIA PYRAMID PHARMA LIMITED 2024-01-15 2029-01-14

757 Rwanda FDA-HMP-MA-0725 CIPRO 0.3%, EYE DROPS SOLUTION Ciprofloxacin hydrochloride 0.3% 0.003 Eye drops Solution 1 vial of 5ml Unit Pack containing 1 vial of 5ml 24 Months LES LABORATOIRES MÉDIS, Km 7 route de Tunis, BP 206 8000 Nabeul, Tunisia TUNISIA LES LABORATOIRES MÉDIS, TUNISIA KIPHARMA LTD 2024-01-15 2029-01-14

758 Rwanda FDA-HMP-MA-0726 AGOCARB-500 TABLETS Activated Charcoal Tablets 500 mg 500 mg Uncoated tablets 100 tablets Jar Pack 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-01-15 2029-01-14

759 Rwanda FDA-HMP-MA-0775 DESLORASTAL Desloratadine syrup 2.5mg/5ml 2.5mg/5ml Oral Liquid Syrup 60 ml Bottle Amber-coloured PET Bottle 24 Months STALLION LABORATORIES PRIVATE LIMITED. Unit-1Plot No. C-1B, 305/2,3,4&5, G.I.D.C. Kerala (Bavla), Dist. Ahmedabad-382 220, Gujarat, India INDIA STALLION LABORATORIES PVT. LTD SUN ENTERPRISES LTD 2024-01-30 2029-01-29

760 Rwanda FDA-HMP-MA-0811 SIMVASTATIN 20 MG FILM COATED TABLETS Simvastatin 20 mg 20 mg Film coated tablets 7,10,14,20,21,28,30,35,40,42,49,50,56,63,70,77,84,91 and 100 tablets Aluminum/PVC blister 36 Months SANDOZ GRUP, Saglik unreli ilaclari sanayive ticaret A.S GOSB ihsan dede cad.900.sok TR-41480 Gebze-Kocaeli, Turkey TURKEY SANDOZ GmbH, KUNDL SURGIPHARM (RWANDA) LTD 2024-01-30 2029-01-29

761 Rwanda FDA-HMP-MA-0812 SIMVASTATIN 40 MG FILM COATED TABLETS Simvastatin 40 mg 40 mg Film coated tablets 7,10,14,20,21,28,30,35,40,42,49,50,56,63,70,77,84,91 and 100 tablets Aluminum/PVC blister 36 Months SANDOZ GRUP, Saglik unreli ilaclari sanayive ticaret A.S GOSB ihsan dede cad.900.sok TR-41480 Gebze-Kocaeli, Turkey TURKEY SANDOZ GmbH, KUNDL SURGIPHARM (RWANDA) LTD 2024-01-30 2029-01-29

762 Rwanda FDA-HMP-MA-0813 AMOXICLAV-DENK 500/62.5 One film-coated tablet contains 574 mg amoxicillin trihydrate, equivalent to 500 mg amoxicillin and 74.45 mg potassium clavulanate, equivalent to 62.5 mg clavulanic acid 500mg/62.5mg Film coated tablets 16 film-coated tablets Aluminium/Aluminium blister 24 Months PENCEF PHARMA GmbH, Breitenbachstrasse 13 – 14 D-13509 Berlin, Germany GERMANY DENK PHARMA GmbH & Co. KG HERILY – AGENCE DE MARKETING LTD 2024-01-30 2029-01-29

763 Rwanda FDA-HMP-MA-0814 SOLUDOL Diclofenac Sodium BP 50 mg 50 mg Dispersible tablets 10x10 Tablets Printed aluminum foil blister 36 Months WIN-MEDICARE PVT. LTD. Modipuram – 250 110, Country: U.P., India INDIA WIN-MEDICARE PVT. LTD SURGIPHARM (RWANDA) LTD 2024-01-30 2029-01-29

764 Rwanda FDA-HMP-MA-0815 DICLOMOL PLUS Diclofenac Sodium BP 50 mg and Paracetamol BP 500 mg 50 mg and 500 mg Tablets 10x10 Tablets PVC/Aluminium foil blister 36 Months WIN-MEDICARE PVT. LTD. Modipuram – 250 110, Country: U.P., India INDIA WIN-MEDICARE PVT. LTD SURGIPHARM (RWANDA) LTD 2024-01-30 2029-01-29

765 Rwanda FDA-HMP-MA-0816 DICLOMOL EC 50 Diclofenac Sodium BP 50 mg 50 mg Enteric-coated tablets 10x10 Tablets PVC/Aluminium foil blister 36 Months WIN-MEDICARE PVT. LTD. Modipuram – 250 110, Country: U.P., India INDIA WIN-MEDICARE PVT. LTD SURGIPHARM (RWANDA) LTD 2024-01-30 2029-01-29

766 Rwanda FDA-HMP-MA-0817 DICLOMOL SR Sustained release tablets of Diclofenac Sodium 100 mg 100 mg Film coated tablets 10x10 Tablets Clear PVC rigid film and Aluminum foil 0.25mm 36 Months WIN-MEDICARE PVT. LTD. Modipuram – 250 110, Country: U.P., India INDIA WIN-MEDICARE PVT. LTD SURGIPHARM (RWANDA) LTD 2024-01-30 2029-01-29

767 Rwanda FDA-HMP-MA-0818 NATRILIX SR Indapamide 1.5 mg 1.5 mg Film coated tablets 30 Sustained Release Tablets Aluminium/polyamide aluminium polyvinyl chloride blister packs 24 Months SERVIER EGYPT INDUSTRIES LTD (SEI), 61h October City, 151 Industrial zone, Giza A.R.E, EGYPT and LES LABORATOIRES SERVIER LNDUSTRIE (LSI), 905 route de Saran, 45520 Gidy, France EGYPT AND FRANCE LES LABORATOIRES SERVIER, FRANCE KIPHARMA LTD 2024-01-30 2029-01-29

768 Rwanda FDA-HMP-MA- 0823 HEDEX CAPLETS Aspirin 400mg, Paracetamol 200mg and Caffeine 50mg 400mg, 200mg and 50mg Caplets 10x10 Caplets PVC/Aluminium foil blister 24 Months BETA HEALTHCARE INTERNATIONAL LIMITED, Plot No.L.R 209/6554 Mogadishu Road, Industrial Area, Nairobi, Kenya KENYA BETA HEALTHCARE INTERNATIONAL LIMITED SURGIPHARM (RWANDA) LTD 2024-01-30 2029-01-29

769 Rwanda FDA-HMP-MA-0702 MEBENDAZOLE TABLETS USP 100MG Mebendazole 100mg 100mg Uncoated Tablets 1000 Tablets and 10x6 tablets HDPE Jar of 1000 Tablets and, 10x6 tablets blister pack in a carton with pack insert 36 Months LINCOLN PHARMACEUTICALS LTD, Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LTD, INDIA ABACUS PHARMA (A) LTD 2024-01-30 2029-01-29

770 Rwanda FDA-HMP-MA-0721 ASOMEX LT S (-) Amlodipine Besilate 2.5mg & Losartan Potassium 50 mg USP 2.5mg & 50 mg Uncoated tablets 3×10 tablets 2 composite blister strips of PVC/PVDC 24 Months EMCURE PHARMACEUTICALS LTD, SIDCO Industrial complex, Lane No. 03Phase-II, Bari-Brahmana, Jammu (J & K)- 181133, India INDIA EMCURE PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2024-02-09 2029-02-08

771 Rwanda FDA-HMP-MA-0736 AMPICILLIN FOR INJECTION Ampicillin Sodium, 1000mg 1000mg Powder for injection 50 Vials 7ml Type II glass vial, sealed with aluminum cap 36 Months REYOUNG PHARMACEUTICAL CO., LTD, Workshop 301, No. 1, Ruiyang Road, Yiyuan County, Shandong Province, China CHINA REYOUNG PHARMACEUTICAL CO, LTD SUN ENTERPRISES LTD 2024-02-09 2029-02-08

772 Rwanda FDA-HMP-MA-0819 MICORT CREAM Miconazole nitrate 2% w/w; Hydrocortisone acetate equivalent to hydrocortisone 1% w/w 2% w/w; 1% w/w Cream Tube of 15 g Packed in internally lacquered aluminium tube with a polypropylene screw cap. The tube is then placed in a paper carton 24 Months VARICHEM PHARMACEUTICALS (PVT) LTD, 194 Gleneagles Road, Willlowvale, Harare, Zimbabwe ZIMBABWE VARICHEM PHARMACEUTICALS (PVT) LTD ACTIVIS PHARMA 2024-02-09 2029-02-08

773 Rwanda FDA-HMP-MA-0820 UPERIO 50 MG Sacubitril/Valsartan 50 mg film-coated tablets 50 mg Film-coated tablets 28 tablets PA/AL/PVC (Alu-Alu) blister packs 36 Months NOVARTIS PHARMA STEIN AG, Schaffhauserstrasse 4332 Stein, Switzerland. SWITZERLAND NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2024-02-09 2029-02-08

774 Rwanda FDA-HMP-MA-0821 UPERIO 200 MG Sacubitril/Valsartan 200 mg film-coated tablets 200 mg Film-coated tablets 28 tablets PA/AL/PVC (Alu-Alu) blister packs 36 Months NOVARTIS PHARMA STEIN AG, Schaffhauserstrasse 4332 Stein, Switzerland. SWITZERLAND NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2024-02-09 2029-02-08

775 Rwanda FDA-HMP-MA-0822 UPERIO 100 MG Sacubitril/Valsartan 100 mg film-coated tablets. 100 mg Film-coated tablets 28 tablets PA/AL/PVC (Alu-Alu) blister packs 36 Months NOVARTIS PHARMA STEIN AG, Schaffhauserstrasse 4332 Stein, Switzerland SWITZERLAND NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2024-02-09 2029-02-08

776 Rwanda FDA-HMP-MA-0828 PIVAC Bupivacaine Hydrochloride in Dextrose Injection USP 5mg/ml 5mg/ml Liquid Injection 10 Ampoules of 4ml Glass ampoule USP Type I. 10 such ampoules are placed in plastic tray and such a tray is packed in a mono carton along with insert 36 Months KILITCH DRUGS INDIA LTD, Plot no. C-301/2, M.I.D.C T.T.C, Industrial Area Pawane, Navi Mumbai - 400 705, Maharashtra, India INDIA KILITCH DRUGS (INDIA) LTD SUN ENTERPRISES LTD 2024-02-09 2029-02-08

777 Rwanda FDA-HMP-MA-0829 MEDI-KEEL® A HONEY AND LEMON THROAT LOZENGES Cetylpyridinium chloride 1.5 mg and Benzocaine 12.0 mg 1.5 mg and 12.0 mg Lozenges 16’s (2x8’s) Lozenges Blister pack of aluminium foil and PVC/PVDC complex 24 Months UNIQUE PHARMACEUTICALS LABORATORIES, Survey No. 101/2 and 102/1, Daman Industrial Estate, Airport Road, Village Kadaiya, Daman- 396 210, India INDIA ADCOCK INGRAM LIMITED SURGIPHARM (RWANDA) LTD 2024-02-09 2029-02-08

778 Rwanda FDA-HMP-MA-0830 EMETON SYRUP Metoclopramide Hydrochloride BP 5.0mg/ml 5.0mg/ml Syrup 60 ml Bottles Amber coloured (Glass/PET) bottles, 25 mm Aluminium caps, Emeton Syrup 60ml unit boxes 36 Months BIODEAL LABORATORIES LTD, 123, Lunga Lunga road, Industrial area, P.O BOX 32040-00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICAL SUPPLIES LIMITED 2024-02-09 2029-02-08

779 Rwanda FDA-HMP-MA-0831 THEOMOX-250 Amoxicillin Trihydrate USP equivalent to Amoxicillin 250 mg 250 mg Hard gelatin capsules 10 x 10 Capsules Alu-PVC blisters packed in carton with pack insert 36 Months THEON PHARMACEUTICALS LIMITED, Address: Village Saini Majra, Tehsil Nalagarh, Distt. Solan Himachal Pradesh - 174 101, India INDIA THEON PHARMACEUTICALS LIMITED AIVEEN RWANDA LTD 2024-02-09 2029-02-08

780 Rwanda FDA-HMP-MA-0832 AMYN DT 125 Amoxicillin Trihydrate USP 125 mg 125 mg Tablets 10x10 Tablets Alu/Alu blister 24 Months KOPRAN LIMITED, Village Savroli, Taluka Khalapur, District Raigad – 410202, India INDIA KOPRAN LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LIMITED 2024-02-09 2029-02-08

781 Rwanda FDA-HMP-MA-0833 BACTOCLAV-625 Amoxicillin 500mg and Potassium clavulanate tablets 125mg 500mg and 125mg Capsules 2 × 10’s Capsules Alu/Alu blister pack 36 Months MICRO LABS LIMITED; Plot no.16&24, veerasandra industrial area. Bangalore-560100, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-09 2029-02-08

782 Rwanda FDA-HMP-MA-0834 ORNILOX Ornidazole 500mg/ Ofloxacine 200mg 500mg and 200mg Film coated tablets 1x10 Tablets Alu/Alu blister pack 36 Months MICRO LABS LIMITED, No. 31, Race Course Road, Bengaluru 560 001, Karnataka, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-09 2029-02-08

783 Rwanda FDA-HMP-MA-0835 COROLOR-90 Ticagrelor 90mg 90mg Film coated tablets 3x10 Tablets Alu/Alu blister pack. Such 3 blisters are packed in carton along with pack insert 36 Months MICRO LABS LIMITED, 92, SIPCOT, Hosur-635 126, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-09 2029-02-08

784 Rwanda FDA-HMP-MA- 0836 DELASED CHESTY COUGHS SYRUP Diphenidramine HCL BP 14.0 mg, Ammonium chloride BP 135.0 mg, Sodium Citrate BP 57.0 mg, Menthol BP 1.1mg 14.0 mg, 135.0 mg, 57.0 mg, 1.1mg Syrup 100 ml Bottle Amber Glass bottle packed in a corrugated box/carton 36 Months REGAL PHARMACEUTICALS LTD, Plot No. 7879/18, Off Baba Dogo Road, Ruaraka; Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LIMITED 2024-02-09 2029-02-08

785 Rwanda FDA-HMP-MA-0837 LACTULIN SOLUTION Lactulose 10g/15ml 10g/15ml Viscous liquid 100 ml Bottle PET bottle packed in a printed Carton 36 Months MEYER ORGANICS PVT. LTD., 10 D, 2nd Phase, Peenya Ind. Area, Bangalore- 560058, India INDIA MEYER ORGANICS PVT. LTD SUN ENTERPRISES LTD 2024-02-09 2029-02-08

786 Rwanda FDA-HMP-MA-0839 LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE TABLETS FOR SUSPENSION 30MG/50MG/60MG Lamivudine USP 30 mg, Nevirapine USP 50 mg and Zidovudine USP 60 mg 30mg/50mg/60mg Uncoated tablets 60 Tablets HDPE container 24 Months CIPLA LIMITED, Goa (Unit VII) Plot No. S- 103 to S- 105, S-107 to S-112 & L-147, L-147/1 to L- 147/3, L-147/A & L-138 Verna Industrial Estate, Verna, Salcette, Goa – 403 722, India INDIA CIPLA LTD PHILLIPS PHARMACEUTICALS (RWANDA) LIMITED 2024-02-09 2029-02-08

787 Rwanda FDA-HMP-MA-0840 C-ZID INJECTION Ceftazidime USP, 1.0 g 1.0 g Powder for Injection 1.0 g glass vial Sterilized and siliconized flint glass vial. The vial is sealed using Rubber Stopper and Aluminium seal 24 Months SAMRUDH PHARMACEUTICALS LIMITED, Plot No. J-174, J-168 & J-168/1, MIDC, Tarapur, Boisar, Dist Thane-401506, Maharashtra, India INDIA EMCURE PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LIMITED 2024-02-09 2029-02-08

788 Rwanda FDA-HMP-MA-0841 CENTACID SUSPENSION Aluminium Hydroxide Gel USP 250 mg, Magnesium Hydroxide Paste equivalent to Magnesium Hydroxide BP 200 mg, Simethicone USP 40mg 250 mg, 200 mg, 40mg Suspension 170 ml Amber bottle Amber coloured PET bottle with calibrated measuring cup. blue coloured HDPE bag 36 Months CENTAUR PHARMACEUTICAL PVT. LTD., Plant-I, Plot No.3,5B,2C, Tivim Industrial Estate, Karaswada, Mapusa, Goa-403 526, India. INDIA CENTAUR PHARMACEUTICALS PVT. LTD, INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LIMITED 2024-02-09 2029-02-08

789 Rwanda FDA-HMP-MA-0842 COLDAREST TABLETS Paracetamol BP 500mg, Phenylephrine Hydrochloride BP 5mg, Chloropheniramine Maleate BP 2 mg, Caffeine (Anydrous) BP 30mg 500mg, 5mg, 2 mg, 30mg Uncoated tablets 4x10x50 tablets 4 Tablets packed in Alu-Alu Blister pack and 10 such Blister packs are packed in one carton and 50 Such cartons are packed in a one corrugated box along with printed pack insert 36 Months CENTAUR PHARMACEUTICAL PVT. LTD. Centaur house, Near Grand Hyatt, Vakola, santacruz(east), Mumbai – 400055, India INDIA CENTAUR PHARMACEUTICALS PVT. LTD, INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LIMITED 2024-02-09 2029-02-08

790 Rwanda FDA-HMP-MA-0843 FENTANYL MEDIS Fentanyl citrate 0.5mg/10ml 0.5mg/10ml Liquid Injectable solution Box of 10 ampoules of 10ml Type I transparent stretch glass serigraphy ampoules with break point (OPC) of capacity: 10ml 24 Months LES LABORATOIRES MEDIS. Km 7 route de Tunis, BP 206, 8000 Nabeul, Tunisia TUNISIA LES LABORATOIRES MEDIS, TUNISIA KIPHARMA LTD 2024-02-09 2029-02-08

791 Rwanda FDA-HMP-MA-0844 GLUCOSE 5% INJECTION Anhydrous Glucose, 25g/500ml 25g/500ml Solution for Injection 25 bottles of 500ml per carton PP (polypropylene) bottle, each carton contains 25 bottles 36 Months SHIJIAZHUANG NO.4 PHARMACEUTICAL CO., LTD. No. 288, Zhujiang Road, High-Tech Industrial Development Zone, Shijiazhuang City, Hebei Province, China CHINA SHIJIAZHUANG NO.4 PHARMACEUTICAL CO., LTD, CHINA DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-09 2029-02-08

792 Rwanda FDA-HMP-MA-0845 AUROPENT Cyclopentolate Hydrochloride BP 1% w/v 1% w/v Ophthalmic Eye Drops 5 ml Bottle 10 ml LDPE container with HDPE cap and Nozzle. Such LDPE container is packed in a monocarton with package insert 24 Months AUROLAB, No.1, Sivagangai Main Road, Veerapanjan, Madurai – 625 020, India INDIA AUROLAB DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-09 2029-02-08

793 Rwanda FDA-HMP-MA-0846 AUROPRED Prednisolone sodium Phosphate BP 0.5%w/v. 0.5%w/v Ophthalmic Eye Drops 5 ml Bottle 10 ml LDPE container with HDPE cap and Nozzle. Such LDPE container is packed in a monocarton with package insert 24 Months AUROLAB, No.1, Sivagangai Main Road, Veerapanjan, Madurai – 625 020, India INDIA AUROLAB DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-09 2029-02-08

794 Rwanda FDA-HMP-MA-0847 AUROFORT Prednisolone acetate Ophthalmic suspension 1%w/v. 1%w/v Ophthalmic Eye Drops 5 ml Bottle 10 ml LDPE container with HDPE cap and Nozzle. Such LDPE container is packed in a monocarton with package insert 24 Months AUROLAB, No.1, Sivagangai Main Road, Veerapanjan, Madurai – 625 020, India INDIA AUROLAB DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-09 2029-02-08

795 Rwanda FDA-HMP-MA-0848 TOB-DEX Tobramycin: 0.3%w/v USP and Dexemethasone Sodium phosphate: 0.1%w/v BP 0.3%w/v and 0.1%w/v Ophthalmic Eye Drops 5 ml Bottle 10 ml LDPE container with HDPE cap and Nozzle. Such LDPE container is packed in a monocarton with package insert 24 Months AUROLAB, No.1, Sivagangai Main Road, Veerapanjan, Madurai – 625 020, India INDIA AUROLAB DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-09 2029-02-08

796 Rwanda FDA-HMP-MA-0849 AUROPROST RT Latanoprost USP 0.005% w/v 0.005% w/v Ophthalmic Eye Drops 2.5 ml Bottle 5 ml LDPE container with HDPE cap and Nozzle. Such LDPE container is packed in a monocarton with package insert 24 Months AUROLAB, No.1, Sivagangai Main Road, Veerapanjan, Madurai – 625 020, India INDIA AUROLAB DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-09 2029-02-08

797 Rwanda FDA-HMP-MA-0850 IMAZOLE-V Clotrimazole 100mg 100mg Pessaries Box/ 7 Pessaries Alu/PVC/PE strip 36 Months BLISS GVS PHARMA LIMITED, Plot No. 10, 11 A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Palghar, - 401404, India. INDIA BLISS GVS PHARMA LIMITED SURYA DEPOT PHARMACY LTD 2024-02-09 2029-02-08

798 Rwanda FDA-HMP-MA-0851 MEFTAL-SPAS TABLETS Mefenamic Acid 250 mg and Dicyclomine Hydrochloride 10 mg 250 mg and 10 mg Uncoated Tablets 3x 10 tablets Aluminium foil and amber colored PVC blister strip. 36 Months BLUE CROSS LABORATORIES PVT LTD, L-17, verna industrial estate, verna, Goa-403722, India. INDIA BLUE CROSS LABORATORIES PVT LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-09 2029-02-08

799 Rwanda FDA-HMP-MA-0852 CARDINOL 50MG FILM COATED TABLETS Atenolol 50 mg 50 mg Film Coated Tablet 2x14 Tablets PVC blister film and aluminium foil in carton 36 Months COSMOS LIMITED, Rangwe Close, Off Lunga Lunga road; industrial area, Nairobi, Kenya. KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-02-09 2029-02-08

800 Rwanda FDA-HMP-MA-0853 CARDINOL 100MG FILM COATED TABLETS Atenolol 100mg 100mg Film Coated Tablets 2x14 Tablets PVC blister film and Aluminium foil in carton 36 Months COSMOS LIMITED, Rangwe Close, Off Lunga Lunga road; industrial area, Nairobi, Kenya. KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-02-09 2029-02-08

801 Rwanda FDA-HMP-MA-0854 SOMECID Omeprazole Sodium BP, 40mg 40mg Dry Powder for injection or infusion 10 ml vial Amber coloured glass vial. Such 1 vial is packed in printed carton along with pack insert 24 Months STALLION LABORATORIES PVT. LTD, C-1B, 305/2, 3, 4 & 5, G.I.D.C. Kerala (Bavla), Dist. Ahmedabad, Gujarat, India. INDIA STALLION LABORATORIES PVT. LTD. SUN ENTERPRISES LTD 2024-02-09 2029-02-08

802 Rwanda FDA-HMP-MA-0855 ZAHA ORAL SUSPENSION Azithromycin Dihydrate USP, 200 mg/5 mL 200 mg/5 mL Suspension 15 ml Bottle Amber colored glass bottle along with a pack insert 24 Months AJANTA PHARMA LIMITED, 31-O, M.I.D.C, Area Chikalthana-431 210, Aurangabad, Maharashtra, India. INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-02-09 2029-02-08

803 Rwanda FDA-HMP-MA-0856 EFLARON 125MG ORAL SUSPENSION Metronidazole (as Benzoate) BP 125mg/5ml 125mg/5ml Oral Suspension 60ml and 100ml bottles Amber Colored PET Bottles in unit box 36 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Rd, Ruaraka, Kenya. KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-02-09 2029-02-08

804 Rwanda FDA-HMP-MA-0857 5% GLUCOSE INJECTION 500ML PP Anhydrous Glucose 5% 0.05 Solution for intravenous Injection 500ml bottle, Box/ 30 bottles Polypropylene bottles 36 Months SHIJIAZHUANG NO.4 PHARMACEUTICAL CO., LTD; No.518 East Huaian Road, High-tech Industrial Development Zone, Shijiazhuang, China Yangzi Road, Economic & Technological Development Zone, Shijiazhuang, China. CHINA SHIJIAZHUANG NO.4 PHARMACEUTICAL CO., LTD. DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-09 2029-02-08

805 Rwanda FDA-HMP-MA-0858 LEVETIRACETAM UCB 500 MG FILM-COATED TABLETS Levetiracetam 500 mg 500 mg Film-Coated Tablets 10x10 Tablets PVC/Aluminium blister 36 Months UCB PHARMA SA, Chemin du Foriest, Braine-l’Alleud, 1420, Belgium. BELGIUM UCB PHARMA SA. VINE PHARMA LTD. 2024-02-09 2029-02-08

806 Rwanda FDA-HMP-MA-0859 CODIOVAN 160/12.5MG FILM-COATED TABLETS Valsartan 160mg & Hydrochlorothiazide 12.5mg. 160mg and 12.5mg Film Coated Tablets Box/ 28 PVC/PVDC blisters, PVC/PE/PVDC blisters and PA/AL/PVC blisters 36 Months NOVARTIS FARMA S.p.A., Via Provinciale Schito131 IT-80058 Torre Annunziata, Italy. ITALY NOVARTIS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2024-02-09 2029-02-08

807 Rwanda FDA-HMP-MA-0860 ENCIFER INJECTION Iron Sucrose 100mg/5ml (20mg/ml) 100mg/5ml (20mg/ml) Solution for Injection 5 Ampoules of 5ml Alu/PVC blister. One such blister packed in carton 24 Months EMCURE PHARMACEUTICALS LIMITED, Plot No. J-174, J-168 & J-168/1, MIDC, Tarapur, Boisar, Dist Thane-401506, Maharashtra, India. INDIA EMCURE PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2024-02-09 2029-02-08

808 Rwanda FDA-HMP-MA-0861 ASOMEX 5 S (-) Amlodipine besilate equivalent to S (-) Amlodipine 5mg 5mg Uncoated tablets 3x10 Tablets PVDC coated PVC/ Aluminium Foil. Such blisters of 10 tablets each are packed in a carton along with pack insert 36 Months EMCURE PHARMACEUTICALS LIMITED, Lane No.3, Phase-II, SIDCO Industrial Complex, Bari-Brahmana, Jammu – 181 133, India. INDIA EMCURE PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2024-02-09 2029-02-08

809 Rwanda FDA-HMP-MA-0973-R1 PROSTALEN Alfuzosin Hydrochloride 10mg 10mg Film Coated Tablets 3x10 Tablets ALU/PVC FILM BLISTER PACK/CARTON 36 Months GRACURE PHARMACEUTICALS LIMITED 1105, RIICO Industrial Area, Phase-III, Bhiwadi, Alwar (Raj.), India INDIA EXPHAR SA, BELGIUM H&H PHARMA LTD 2024-02-14 2029-02-13

810 Rwanda FDA-HMP-MA-0712 MORPHINE SULFATE KALCEKS Morphine sulphate 10 mg/mL 10 mg/mL Solution for injection 10 ampoules of 1mL TYPE I colourless glass ampoules 36 Months HBM PHARMA S.R.O. Sklabinska 30, 036 80 Martin, Slovakia Republic SLOVAKIA REPUBLIC AS KALCEKS, LATVIA ACTIVIS PHARMA 2024-02-17 2029-02-16

811 Rwanda FDA-HMP-MA-0824 TOT’HEMA® Ferrous gluconate 50mg, Manganese gluconate 1.33mg and Copper gluconate 0.7mg 50mg, 1.33mg and 0.7mg Oral solution 20 ampoules of 10ml Ampoule (Brown Glass) 24 Months INNOTHERA CHOUZY, Rue René Chantereau Chouzy-sur-Cisse 41150 VALLOIRE-SUR-CISSE France FRANCE LABORATOIRE INNOTECH INTERNATIONAL MEDIASOL PHARMACEUTICAL DEPOT LTD 2024-02-17 2029-02-16

812 Rwanda FDA-HMP-MA-0825 IBUGO-400 TABLETS Ibuprofen 400mg 400mg Film coated tablets 500 Tablets JAR PACK 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-02-17 2029-02-16

813 Rwanda FDA-HMP-MA-0826 BYANNLI® 700 Paliperidone Palmitate 700mg 700mg Prolonged-release suspension for injection 1 Prefilled 5 mL syringe and one thin walled 20-gauge (G)x 1½ inch safety needle one assembled prefilled 5 mL syringe and one thin walled 20-gauge (G)x 1½ inch safety needle a carton 24 Months JANSSEN PHARMACEUTICA NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. BELGIUM JANSSEN-CILAG INTERNATIONAL NV KIPHARMA LIMITED 2024-02-17 2029-02-16

814 Rwanda FDA-HMP-MA-0827 BYANNLI® 1000 Paliperidone Palmitate 1000mg 1000mg Prolonged-release suspension for injection 1 Prefilled 5 mL syringe and one thin walled 20-gauge (G)x 1½ inch safety needle one assembled prefilled 5 mL syringe and one thin walled 20-gauge (G)x 1½ inch safety needle a carton 24 Months JANSSEN PHARMACEUTICA NV, Turnhoutseweg 30, B-2340 Beerse, Belgium BELGIUM JANSSEN-CILAG INTERNATIONAL NV KIPHARMA LIMITED 2024-02-17 2029-02-16

815 Rwanda FDA-HBP-MA-0111 HEPATITIS B VACCINE (rDNA) (ADULT) 1 DOSE Hepatitis B Surface Antigen (Aqueous), 20mcg/1ml 20mcg/1ml Suspension for injection Box of 50 vials of 4ml Tubular Flint Vial (Type I Glass) with a gray plain bromobutyl rubber stopper and aluminium flip off cap 36 Months SERUM INSTITUTE OF INDIA PVT. LTD 2122, Hadapsar, Pune411028, India INDIA SERUM INSTITUTE OF INDIA PVT. LTD SUN ENTERPRISES LTD 2024-02-17 2029-02-16

816 Rwanda FDA-HMP-MA-0838 TRIMEX PAEDIATRIC COUGH EXPECTORANT Chlorpheniramine Maleate BP 1mg, Pseudoephedrine Hcl 15mg, Guaifenesin BP 50mg 1mg, 15mg, 50mg Oral syrup 100 ml Bottle Amber colored glass bottle, with a 25mm neck, ROPP cap and 10ml measuring cap 36 Months REGAL PHARMACEUTICALS LTD, Plot No. 7879/18, Off Baba Dogo Road, Ruaraka; P.O Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LIMITED 2024-02-17 2029-02-16

817 Rwanda FDA-HMP-MA-0862 RANEXA 500 MG Ranolazine 500 mg 500 mg Film coated prolonged-release tablets 3x 20 Tablets PVC/PVDC/Aluminium Blisters. Each carton contains 3 blister cards 24 Months MENARINI-VON HEYDEN GMBH, Lei ziger Strasse 7-13, 01097 – Dresden, Germany GERMANY MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. PRAFIN RWANDA LTD 2024-02-17 2029-02-16

818 Rwanda FDA-HMP-MA-0864 PANTO-DENK 20 Pantoprazole 20mg 20mg Tablets 28 Tablets Alu/Alu blister strips which are also in packed cardboard boxes together with a leaflet 36 Months ALLPHAMED PHARBIL ARZNEIMITTEL GMBH, Hildebrandstr. 10–12, Göttingen, Lower Saxony, 37081 Germany GERMANY DENK PHARMA GMBH & CO. KG ETS CONTINENTAL LTD 2024-02-17 2029-02-16

819 Rwanda FDA-HMP-MA-0865 PANTO-DENK 40 Pantoprazole 40mg 40mg Tablets 28 Tablets Alu/Alu blister strips which are also in packed cardboard boxes together with a leaflet 36 Months ALLPHAMED PHARBIL ARZNEIMITTEL GMBH, Hildebrandstr. 10–12, Göttingen, Lower Saxony, 37081 Germany GERMANY DENK PHARMA GMBH & CO. KG ETS CONTINENTAL LTD 2024-02-17 2029-02-16

820 Rwanda FDA-HMP-MA-0866 PACLITAXEL 6MG PER 1ML Paclitaxel 100mg per 16.7ml 100mg per 16.7ml Solution for infusion 20ml Vial Colourless vial of glass type I Ph. Eur. 36 Months FAREVA UNTERACH GMBH, Mondseestraße 11 4866 Unterach, am Attersee Austria AUSTRIA SANDOZ GMBH, KUNDL SURGIPHARM (RWANDA) LIMITED 2024-02-17 2029-02-16

821 Rwanda FDA-HMP-MA-0867 PICAMAR 80 Gliclazide BP 80 mg 80 mg Uncoated Tablets 3 x10 Tablets Alu/Alu Blister Pack 24 Months BAROQUE PHARMACEUTICALS PRIVATE LIMITED, 192/2&3, 190/1 & 202/9, Sokhada-388 620 Tal: Khambhat, Dist. Anand, Gujarat, India INDIA BEKRA PHARMA UK LTD UBIPHARM RWANDA LTD 2024-02-17 2029-02-16

822 Rwanda FDA-HMP-MA-0868 AMATRIX PLUS Glibenclamide BP 5 mg and Metformin Hydrochloride BP 500mg 5mg and 500mg Uncoated Tablets 3 x10 Tablets Alu/Alu Blister Pack 36 Months BAROQUE PHARMACEUTICALS PVT. LTD, Address: Sokhada-388 620, Ta-Khambhat, Dist-Anand (Gujarat), India INDIA BEKRA PHARMA UK LTD UBIPHARM RWANDA LTD 2024-02-17 2029-02-16

823 Rwanda FDA-HMP-MA-0870 MOXACIL 250MG CAPSULES Amoxicillin Trihydrate BP 250mg 250mg Hard Gelatin Capsules 10x10 Capsules PVC/Aluminium foils blister pack in a unit box along with a literature insert 36 Months DAWA LIMITED, Physical Address: Plot No.7879/8, Baba Dogo Road, Ruaraka. Postal Address: 16633-00620 Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISE LTD 2024-02-17 2029-02-16

824 Rwanda FDA-HMP-MA-0871 KAREXONE 1G Ceftriaxone Sodium 1G 1G Powder for Solution for injection 10 x 10mL and 50 x 10mL Type II Glass Mould Vial 36 Months REYOUNG PHARMACEUTICAL CO., Ltd. No.1 Ruiyang Road Yiyuan county, Shandong Province, P. R. China CHINA KAREMAX INDUSTRIAL LTD SUN ENTERPRISES LTD 2024-02-17 2029-02-16

825 Rwanda FDA-HMP-MA-0872 VINGRAF-0.5 Tacrolimus Capsules USP 0.5 mg 0.5 mg Hard Gelatin Capsules 6 x 10 Capsules Alu-Alu Blister. Such blister is packed in a carton along with a leaflet 24 Months EMCURE PHARMACEUTICALS LIMITED, Lane No. 3, Phase-II, SIDCO Industrial Complex, Bari-Brahmana, Jammu-181 133, India. INDIA EMCURE PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LIMITED 2024-02-17 2029-02-16

826 Rwanda FDA-HMP-MA-0873 AUROCAINE Proparacaine Hydrochloride Ophthalmic solution USP 0.5% w/v 0.5% w/v Ophthalmic Eye Drops 10 ml Bottle Low Density Polyethylene Container with HDPE cap and nozzle packed in a monocarton with pack insert 12 Months AUROLAB, No.1 Sivagangai Main Road, Veerapanjan, Madurai, India. INDIA AUROLAB DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-17 2029-02-16

827 Rwanda FDA-HMP-MA-0874 BENYLIN DRY COUGH. Dextromethorphan Hydrobromide 15mg/5ml. 15mg/5ml Syrup 100ml and 200ml Bottles Amber Glass Bottles closed with a white polypropylene cap with expanded polyethylene liner 24 Months JOHNSON & JOHNSON (PTY) LTD, 241 Main Road, Retreat, 7945, Cape Town, South Africa. SOUTH AFRICA JOHNSON & JOHNSON (PTY) LTD, SOUTH AFRICA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-17 2029-02-16

828 Rwanda FDA-HMP-MA-0875 ERYTHROMYCIN TABLETS BP 250 MG Erythromycin stearate 250mg 250mg Film Coated Caplet 10x10 Tablets and 1000 Tablets Blisters and P.P. Bag packed in a HDPE Container (for 1000 tablets) 36 Months MILAN LABORATORIES (INDIA) PVT LTD, Plot no. 35/36/63/64/65/67/87, J.C.I.E. Ltd., Kamothe, Panvel, Navi Mumbai, India INDIA MILAN LABORATORIES (INDIA) PVT LTD, INDIA. SIGMA PHARMA RWANDA LIMITED 2024-02-17 2029-02-16

829 Rwanda FDA-HMP-MA-0876 MFLOX Moxifloxacin BP 0.5%w/v 0.5%w/v Eye drops solution 5ml Bottle Low Density Polyethylene container with HDPE cap and nozzle. Such 5ml is packed in a monocarton with package insert 24 Months AUROLAB, NO.1, Sivagangai Main Road, Veerapanjan, Madurai 625 020, India INDIA AUROLAB, INDIA DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-17 2029-02-16

830 Rwanda FDA-HMP-MA-0877 KLAMADOL Tramadol Hydrochloride Injection 50mg/ml 50mg/ml Liquid Injection 10 Ampoules of 2ml Flint USP Type 1 glass ampoule. 10 such labeled ampoules are to be placed in a transparent tray; inserted along with a leaflet in printed carton 30 Months KILITCH DRUGS LTD, C- 301/2, T.T.C. Industrial area, M.I.D.C, Pawane, Navi Mumbai- 400 705, Maharashtra, India INDIA KILITCH DRUGS (INDIA) LTD SUN ENTERPRISES LTD 2024-02-17 2029-02-16

831 Rwanda FDA-HMP-MA-0878 CAPECITABINE 150 MG FILM-COATED TABLETS Capecitabine 150 mg film-coated tablet 150 mg Film-coated tablet 60 Tablets PVC/PVDC– Al Foil Blisters Or Alternatively in Al-Al Blisters placed into cardboard boxes 24 Months HETERO LABS LTD, Unit VI, TSIIC, Formulation SEZ, Sy. No. 410 & 411, Polepally Village, Jadcherla (Mandal), Mahaboobnagar-(District), Pin-509301, Telangana, India INDIA SANDOZ GMBH, KUNDL AUSTRIA SURGIPHARM (RWANDA) LIMITED 2024-02-17 2029-02-16

832 Rwanda FDA-HMP-MA-0879 ITACARE Itraconazole Capsules 100 mg 100 mg Capsules 3 x 10 capules Alu/ Alu Blisters. Such 3 Blisters are packed in a printed outer carton along with a pack insert 24 Months MICRO LABS LIMITED, 92, SIPCOT Industrial Complex, HOSUR-635 126. (T.N), India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LIMITED 2024-02-17 2029-02-16

833 Rwanda FDA-HMP-MA-0880 PIRICLOR TABLETS Chlorpheniramine Maleate BP 4mg 4mg Tablets 10x10 Tablets BLISTER FILMS (PVC)-Aluminium Foil. Such blisters are packed in printed carton 36 Months BIODEAL LABORATORIES LTD, 123, lunga lunga P.O BOX 32040-00600, Nairobi Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-02-17 2029-02-16

834 Rwanda FDA-HMP-MA-0882 PARACETAMOL 250MG SUPPOSITORIES Paracetamol 250 mg 250 mg Suppositories 100 suppositories PVC-Blister Pack 48 Months FULTON MEDICINALI S.P.A, Via Marconi, 28/9 20020 – Arese (Milan) Italy. ITALY FULTON MEDICINALI S.P. A UBIPHARM-RWANDA LTD 2024-02-17 2029-02-16

835 Rwanda FDA-HMP-MA-0884 UDIHEP TABLET Ursodeoxycholic acid 150mg 150mg Uncoated tablets 3x10 Tablets Aluminium blister strips made up of printed aluminium foil (width 80mm ´ thickness 0.025 mm) and clear PVC rigid film (width 84mm thickness 0.30 mm). 24 Months WIN-MEDICARE PVT. LTD, 1311 Modi Tower, 98 Nehru Place, Delhi-110019, India. INDIA WIN-MEDICARE PVT. LTD SURGIPHARM (RWANDA) LTD 2024-02-17 2029-02-16

836 Rwanda FDA-HMP-MA-0885 KARECLOX 500MG Cloxacillin Sodium 500mg 500mg Crystalline Powder for solution for injection 50 Vials of 7ml Mould vials glass containers, Non flip off cap, butyl rubber stopper, with adhesive label in box alongside with leaflet 36 Months REYOUNG PHARMACEUTICAL CO., LTD, No.1 Ruiyang Road, Yiyuan County, Shandong Province, P. R. China. CHINA KAREMAX INDUSTRIAL LTD SUN ENTERPRISES LTD 2024-02-17 2029-02-16

837 Rwanda FDA-HMP-MA-0886 MEBUX 40 Febuxostat 40 mg 40 mg Film Coated Tablets 3x10 Tablets Alu-Alu Blisters. Such 3 blisters are packed in a printed outer carton along with a pack insert. 36 Months MICRO LABS LIMITED, 92 Sipcot, Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-17 2029-02-16

838 Rwanda FDA-HMP-MA-0887 MEBUX 80 Febuxostat 80 mg 80 mg Film Coated Tablets 3x10 Tablets Alu-Alu Blisters. Such 3 blisters are packed in a printed outer carton along with a pack insert. 36 Months MICRO LABS LIMITED, 92 Sipcot, Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-17 2029-02-16

839 Rwanda FDA-HMP-MA-0888 OLEPTISS 90 MG FILM-COATED TABLETS Deferasirox 90mg 90mg Film-Coated Tablets 90 Tablets PVC/PVDC/Aluminium blisters 36 Months NOVARTIS PHARMA STEIN AG, Schaffhauserstrasse, 4332 Stein AG, Switzerland. SWITZERLAND NVS KENYA LIMITED SURGIPHARM (RWANDA) LIMITED 2024-02-17 2029-02-16

840 Rwanda FDA-HMP-MA-0889 SANTRIAX 1000 Ceftriaxone Sodium USP 1000 mg 1000 mg Powder for Injection 10ml Vial Flint glass vial USP type III with 20mm grey bromo butyl rubber stopper and sealed with 20 mm blue coloured flip-off aluminium seal 24 Months INJECT CARE PARENTERAL PVT LTD, Plot No. 130, Silvassa Road, GIDC, Vapi – 396 195, Dist – Valsad, India. INDIA BLISS GVS PHARMA LTD, INDIA SURYA DEPOT PHARMACY LTD 2024-02-17 2029-02-16

841 Rwanda FDA-HMP-MA-0890 NIRCIP Ciprofloxacin Intravenous Infusion BP 200mg/100ml (0.2% w/v) 200mg/100ml (0.2% w/v) Intravenous Infusion 100 ml Bottle Nipple Head FFS Plastic Bottle 36 Months ACULIFE HEALTHCARE PVT. LTD, Village: Sachana, Taluka: Viramgam, District: Ahmedabad - 382 150, Gujarat, India. INDIA ACULIFE HEALTHCARE PVT. LTD, INDIA SUN ENTERPRISES LTD 2024-02-17 2029-02-16

842 Rwanda FDA-HMP-MA-0891 PIRICET SYRUP Cetirizine Hydrochloride BP 5.0mg. 5.0mg/60 ml Syrup 60ml Bottle Amber Coloured Glass Bottle, with 25 mm Aluminium caps, packed in a carton with the package insert 36 Months BIODEAL LABORATORIES LTD, Plot No.123, Lunga, Lunga P.O. Box 32040-00600, Nairobi, Kenya. KENYA BIODEAL LABORATORIES LIMITED CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-02-17 2029-02-16

843 Rwanda FDA-HMP-MA- 0892 ERO-125 DRY SYRUP Erythromycin Estolate USP 125 mg / 5ml 125 mg / 5ml Powder for suspension 100 ml Bottle Amber Coloured PET Bottle with PP Cap packed in a unit printed duplex board carton along with its package insert 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India. INDIA AGOG PHARMA LTD SUN ENTERPRISE LTD 2024-02-17 2029-02-16

844 Rwanda FDA-HMP-MA- 0893 CHLOZINE-25 TABLETS Chlorpromazine BP 25 mg 25 mg Film coated tablets 1000 tablets Transparent polypropylene bag, in a white HDPE round jar with white cap 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India. INDIA AGOG PHARMA LTD SUN ENTERPRISE LTD 2024-02-17 2029-02-16

845 Rwanda FDA-HMP-MA-0894 VOLUVEN Poly (O-2-hydroxyethyl) starch 130/0.4 60g per 1000 ml 130/0.4 60g per 1000 ml Solution for infusion 1 bag of 500ml 1 bag of 500ml, made of Free Flex (Polyolefin) 36 Months FRESENIUS KABI MANUFACTURING SA (PTY) LTD, 6 Gibaud Road Korsten, 6020, Port Elizabeth, South Africa SOUTH AFRICA FRESENIUS KABI SOUTH AFRICA (PTY) LTD SURGIPHARM (RWANDA) LTD 2024-02-17 2029-02-16

846 Rwanda FDA-HMP-MA- 0895 SILDENAFIL TABLETS BP 50MG Sildenafil Citrate 50mg 50mg Film coated tablets 4 Tablets ALU/PVC blister. Such 1 blister are packed in a carton along with insert 36 Months MERIT ORGANICS LTD, Plot No. 2104/2/A, G.I.D.C., Sarigam, Bhilad, Dist. Valsad - 396 155, Gujarat India. INDIA MERIT ORGANICS LTD SUN ENTERPRISES LTD 2024-02-17 2029-02-16

847 Rwanda FDA-HMP-MA-0896 KARECIPRO 500 MG Ciprofloxacin Hydrochloride 500 mg 500 mg Film coated tablets 10x10 Tablets PVC/Aluminium Blisters packed in unit box along with leaflet insert 36 Months REYOUNG PHARMACEUTICAL CO., LTD, No.1 Ruiyang Road, Yiyuan County, Shandong Province, P.R. China. CHINA KAREMAX INDUSTRIAL LTD, CHINA SUN ENTERPRISES LTD 2024-02-17 2029-02-16

848 Rwanda FDA-HMP-MA-0881 PEDIAVIT SYRUP Vitamin A 3000 IU, Vitamin D3 400 IU, Vitamin B1 1.5 mg, Vitamin B2 1.2 mg, Vitamin C 50 mg, Nicotina 10 mg, Vitamin B6 1mg, Vitamin B12 3 mcg, Dexpanthenol 5 mg, Potassium Iodide: 98 mcg equivalent to elemental iodine 75 mcg, Calcium Lactate Pentahydrate 158 mg, Calcium Hypophosphite 82 mg, Magnesium Gluconate 55 mg, Manganese Gluconate 4.5 mg, Zinc Gluconate 3.9 mg. 3000IU/400IU/1.5mg/1.2mg/50mg/10mg/1mg/3mcg/5mg/98mcg/75mcg/158mg/82mg/82mg/55mg/4.5mg/3.9mg Syrup 100 ml Bottles Glass bottle of rounded shape, light amber color, hermetically sealed with a n25mm PP cap and a 10ml measuring cup 24 Months MADRAS PHARMACEUTICAL PVT. LTD. 137-Boldmahabalipuram Road, Karapakkam City: Bangalore, India. INDIA B&O PHARM KIPHARMA LTD 2024-02-21 2029-02-20

849 Rwanda FDA-HMP-MA-0883 LOFNAC-P Paracetamol 500 mg and Diclofenac 50mg 500mg/50mg Uncoated tablets 10 Tablets Aluminium Foil/PVC Film Amber Blister Pack in a carton along with leaflet 36 Months BLISS GVS PHARMA LTD, Plot No.10, Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. & Dist. Palghar – 401 404, India INDIA IMEX PHARMA MEDIASOL PHARMACEUTICAL DEPOT LTD 2024-02-21 2029-02-20

850 Rwanda FDA-HMP-MA-0898 FORTIFIED PROCAINE PENICILLIN INJECTION 4MIU Procaine Penicillin 3000000IU and Benzyl Penicillin sodium 1000000IU 3000000IU/1000000IU Sterile Powder for Injection 20ml glass vial, Packs of 50 vials/tray/middle box, TYPE II (SODA LIME) Glass Vial, Sealed With Al-Cap 36 Months REYOUNG PHARMACEUTICAL CO., LTD No,1, Ruiyang Road, Yiyuan County, Shandong Province, P.R. China. CHINA REYOUNG PHARMACEUTICAL CO., LTD. SUN ENTERPRISES LIMITED 2024-02-21 2029-02-20

851 Rwanda FDA-HMP-MA-0919 KAREFOTAX Cefotaxime Sodium 1.0 g 1.0 g Powder for Solution for Injection 50 Vials of 10ml Mould Vials Glass containers 36 Months REYOUNG PHARMACEUTICAL CO., LTD, No.1 Ruiyang Road, Yiyuan County, Shandong Province, P. R. China CHINA KAREMAX INDUSTRIAL LTD SUN ENTERPRISES LTD 2024-02-21 2029-02-20

852 Rwanda FDA-HMP-MA-0920 PHYTOMENADIONE INJECTION Phytomenadione BP 10 mg/ml 10 mg/ml Solution for injection 10 Ampules of 1ml Amber Ampoules packed in a mono carton with Insert 36 Months MERIT ORGANICS LTD, Plot No. 2104/2/A, G.I.D.C., Sarigam, Bhilad, Dist. Valsad - 396 155, Gujarat, India INDIA MERIT ORGANICS LTD. SUN ENTERPRISES LTD 2024-02-21 2029-02-20

853 Rwanda FDA-HMP-MA-0921 ELMOX CAPSULES Amoxicillin trihydrate BP 500 mg 500 mg Hard Gelatin Capsules 10x10 Capsules Alu-PVC blister pack 36 Months YELURI FORMULATIONS PVT. LTD, Sy. No. 296 / 7 / 6, IDA Bollaram, Sangareddy Dist. – 502 325, Telangana, India INDIA YELURI FORMULATIONS PVT. LTD SUN ENTERPRISES LTD 2024-02-21 2029-02-20

854 Rwanda FDA-HMP-MA-0922 BETADINE SURGICAL SCRUB Povidone-Iodine USP 7.5% w/v (available Iodine 0.75% w/v) 0.75% w/v Viscous liquid for Topical 1 Bottle of 50 ml and 500 ml Amber PET bottle and HDPE Bottle 18 Months G.S. PHARMBUTOR PVT. LTD., B-172, Industrial Area, Behror – 301 701, Rajasthan, India INDIA MODI-MUNDIPHARMA PRIVATE LIMITED SURGIPHARM (RWANDA) LTD 2024-02-21 2029-02-20

855 Rwanda FDA-HMP-MA-0923 IBUPROFEN TABLETS Ibuprofen BP 400mg 400mg Film Coated Tablets 10x10 Tablets Alu-PVC blister packed in a carton along with insert 36 Months MERIT ORGANICS LTD, Plot No. 2104/2/A, G.I.D.C., Sarigam, Bhilad, Dist. Valsad - 396 155, Gujarat, India INDIA MERIT ORGANICS LTD SUN ENTERPRISES LTD 2024-02-21 2029-02-20

856 Rwanda FDA-HMP-MA-0924 BENZATHINE BENZYL PENICILLIN Benzathine Benzyl penicillin 2.4 MIU 2.4 MIU Powder for solution for injection Packs of 50 vials of 12ml Type II Glass Vial, Sealed with Aluminium Cap 36 Months REYOUNG PHARMACEUTICAL CO., Ltd, Workshop 301, No. 1, Ruiyang Road, Yiyuan County, Shandong Province, China CHINA REYOUNG PHARMACEUTICAL CO., LTD SUN ENTERPRISES LTD 2024-02-21 2029-02-20

857 Rwanda FDA-HMP-MA-0925 CEFTRIAXONE FOR INJECTION Ceftriaxone sodium 1g 1g Powder for injection 10ml Vial Type II Glass Vial 36 Months. REYOUNG PHARMACEUTICAL CO., LTD, No.1, Ruiyang Road, Yiyuan County, Shandong Province, P.R. Country: China CHINA REYOUNG PHARMACEUTICAL CO., LTD SUN ENTREPRISES LIMITED 2024-02-21 2029-02-20

858 Rwanda FDA-HMP-MA-0926 AZBACT SUSPENSION AZITHROMYCIN 200mg/5ml Oral Suspension 30 ml Bottle HDPE Bottles with a PP/ PE 36 Months GLOBELA PHARMA PVT. LTD. 357-358, G.I.D.C, Sachin, Surat – 394 230, Gujarat, India INDIA GLOBELA PHARMA PVT. LIMITED AFRIPHARM LTD 2024-02-21 2029-02-20

859 Rwanda FDA-HMP-MA-0927 FLURIFEN Flurbiprofen 100 mg 100 mg Film coated tablet 15 Tablets ALU/PVC Blister, in cardboard Box with insert 36 Months BILIM ILAÇ SANAYII VE TICARET A.?, Kocaeli/Gebze, Gebze Organize, Sanayi Bölgesi 1900 Sokak N° 1904, Gebze – Kocaeli, Turkey. TURKEY DAFRA PHARMA GmbH UBIPHARM RWANDA 2024-02-21 2029-02-20

860 Rwanda FDA-HMP-MA-0928 MORPHINE SULPHATE- FRESENIUS PF Morphine Sulphate 10 mg/1 ml 10 mg/1 ml Solution For Injection/Infusion 10x1ml Ampoules Amber Glass Ampoules Ph Eur. Type I glass ampoules packaged in a carton box 36 Months FRESENIUS KABI MANUFACTURING SA (PTY) LIMITED, 6 Gibaud Road, Korsten, Port Elizabeth, 6020, South Africa. SOUTH AFRICA FRESENIUS KABI MANUFACTURING SA (PTY) LIMITED. SURGIPHARM (RWANDA) LIMITED 2024-02-21 2029-02-20

861 Rwanda FDA-HMP-MA-0929 MORPHINE SULPHATE- FRESENIUS PF Morphine Sulphate 15 mg/1 ml 15 mg/1 ml Solution for injection/infusion 10 x 1 ml Ampoules Amber Glass Ampoules Ph Eur. Type I glass ampoules packaged in a carton box 36 Months FRESENIUS KABI MANUFACTURING SA (PTY) LIMITED, 6 Gibaud Road, Korsten, Port Elizabeth, 6020, South Africa. SOUTH AFRICA FRESENIUS KABI MANUFACTURING SA (PTY) LIMITED SURGIPHARM (RWANDA) LIMITED 2024-02-21 2029-02-20

862 Rwanda FDA-HMP-MA-0930 LOFNAC-100 Diclofenac Sodium USP 100mg 100mg Enteric coated tablet 10 Tables Alu/ PVC foil blister. Such 1 blister packed in carton containing pack insert. 36 Months BLISS GVS PHARMA LIMITED; Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Palghar, District Thane – 401404, India INDIA BLISS GVS PHARMA LTD SURYA DEPOT PHARMACY LTD 2024-02-21 2029-02-20

863 Rwanda FDA-HMP-MA-0931 NEBILET-5 Nebivolol (as Nebivolol hydrochloride) 5 mg 5 mg Tablets 28 Tablets and 14 Tablets PVC/Alu blister pack 36 Months BERLIN CHEMIE AG, Glicnicker Weg 125, D-12489 Berlin, Germany GERMANY MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A PRAFIN RWANDA LTD 2024-02-21 2029-02-20

864 Rwanda FDA-HMP-MA-0932 ZYLORIC TABLETS Allopurinol 100mg 100 mg Tablets 28 Tablets PVC/aluminium foil blister pack 60 Months ASPEN BAD OLDESLOE GmbH, Industriestrasse 32-36, D-23843 bad oldesloe, Germany GERMANY BETA HEALTHCARE INTERNATIONAL LTD SURGIPHARM (RWANDA) LIMITED 2024-02-21 2029-02-20

865 Rwanda FDA-HMP-MA-0933 SODIUM CHLORIDE INJECTION Sodium chloride 0.9%, 500mL: 4.5g 0.9%, (500mL: 4.5g) Solution for infusion 500 ml Bottle Polypropylene Infusion Bottle 36 Months SHIJIAZHUANG NO.4 PHARMACEUTICAL CO., LTD. Yangzi Road, Economic & Technological Development Zone, Shijiazhuang City, Hebei Province, China CHINA SHIJIAZHUANG NO.4 PHARMACEUTICAL CO., LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-21 2029-02-20

866 Rwanda FDA-HMP-MA-0938 CEFOTAXIME FOR INJECTION Cefotaxime Sodium 1.0g 1.0g Powder for injection 10ml vial, 50vial/tray/box, and 20 boxes/carton. MOLDED VIAL WITH FLIP-OFF CAPS, RUBBER STOPPER 36 Months REYOUNG PHARMACEUTICAL CO, LTD, No.1, Ruiyang Road, Yiyuan country, Shandong province, China CHINA REYOUNG PHARMACEUTICAL CO., LTD, CHINA SUN ENTERPRISES LTD 2024-02-21 2029-02-20

867 Rwanda FDA-HMP-MA-0939 CAPRIN® Heparin Injection 5000IU/5ml 5000IU/5ml Injection solution 10x5ml in a clear vial USP Type I glass of 5ml, with a dark green our flip off aluminium seal, then packed in a carton box 24 Months SAMARTH LIFE SCIENCES PVT. LTD, Unit–II, Plot No.2, Industrial Area, Lodhimajra, Baddi, Himachal Pradesh -173 205, India. INDIA SAMARTH LIFE SCIENCES PVT. LTD, INDIA SUN ENTERPRISES LTD 2024-02-21 2029-02-20

868 Rwanda FDA-HMP-MA-0940 ZITHROX DRY POWDER FOR SUSPENSION Azithromycin 200mg/5ml 200mg/5ml Granular powder 60mL Bottle Amber Glass Bottle, with a 15ml plastic measuring cup, in a carton box 48 Months COSMOS LIMITED, Rangwe Road, Off Lunga Lunga Road, Industrial Area, P. O. Box 41433, GPO 00100 Nairobi, Kenya KENYA COSMOS LIMITED, KENYA SUN ENTERPRISES LTD 2024-02-21 2029-02-20

869 Rwanda FDA-HMP-MA-0941 TADAFORCE Tadalafil USP 20mg 20mg Film coated tablets 1× 4 Tablets PVC/ALU Blister 36 Months AKUMS DRUGS AND PHARMACEUTICALS LTD, Plot no. 19,20 & 21, Sector-6A, IIE., SIDCUL, Ranipur, Haridwar-249403, Uttarakhand, India INDIA UNOSOURCE PHARMA LIMITED, INDIA. AIVEEN RWANDA LTD 2024-02-21 2029-02-20

870 Rwanda FDA-HMP-MA-0942 ATROP OPHTHALMIC SOLUTION Atropine Sulfate 1.0 % w/v 1.0 % w/v Ophthalmic Solution 10 ml Bottle Low Density Polyethylene (LDPE) container with HDPE cap and noozle 24 Months AUROLAB, No.1 Sivagangai Main Road, Veerapanjan, Madurai, 625020, India INDIA AUROLAB, INDIA DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-21 2029-02-20

871 Rwanda FDA-HMP-MA- 0863 UDIHEP FORTE Ursodeoxychobic acid 300mg 300mg Uncoated tablets 5x10 Tablets Blisters of 10 tablets 36 Months WIN-MEDICARE PVT. LTD. Address: Modipuram – 250 110, Country: U.P., India INDIA WIN-MEDICARE PVT. LTD SURGIPHARM (RWANDA) LTD 2024-02-22 2029-02-21

872 Rwanda FDA-HMP-MA-0897 TEGRETOL ORAL SUSPENSION Carbamazepine 100mg/5ml Oral Suspension 100mg/5ml Oral suspension 100 ml Bottle Brown glass bottles with a child-resistant closure with tamper-proof ring packed in carton 36 Months DELPHARM HUNINGUE S.A.S, 26, rue de la Chapelle 68330 Huningue, France FRANCE NVS KENYA LIMITED, KENYA SURGIPHARM (RWANDA) LTD 2024-02-22 2029-02-21

873 Rwanda FDA-HMP-MA-0899 AUROMIDE PLUS Tropicamide 0.8% w/v and Phenylephrine HCl 5% w/v 0.8% w/v and 5% w/v Ophthalmic Eye Drop 5ml Bottle Packed in 10ml LDPE container with HDPE cap and Nozzle. Such LDPE container is packed in a monocarton with package insert 24 Months AUROLAB, No.1 Sivagangai Main Road, Veerapanjan, Madurai, India INDIA AUROLAB, INDIA DEPOT PHARMACEUTICAL LE MEDICAL 2024-02-22 2029-02-21

874 Rwanda FDA-HMP-MA-0900 AUROCROME Cromolyn sodium ophthalmic solution 2%w/v 2%w/v Ophthalmic Eye Drop 5ml Bottle 10ml LDPE container with HDPE cap and Nozzle. Such LDPE container is packed in a monocarton with package insert 24 Months AUROLAB, No.1 Sivagangai Main Road, Veerapanjan, Madurai, India INDIA AUROLAB, INDIA DEPOT PHARMACEUTICAL LE MEDICAL 2024-02-22 2029-02-21

875 Rwanda FDA-HMP-MA-0901 COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP Sodium lactate as lactate 0.32gms, Sodium chloride 0.6gms, Potassium chloride 0.04gms, Calcium chloride Dihydrate 0.027gms 0.32gms, 0.6gms, 0.04gms, 0.027gms Solution for infusion 500 ml bottle Closed System Container (CSC) which is a plastic collapsible container fabricated from LDPE. The container is formed with euro head where a twin-port cap is welded. The Twin Cap has injected thermoplastic elastomers (TPE) closure 24 Months B. BRAUN PHARMACEUTICALS EPZ LTD, L.R. No 18474/84 Athi River, P.O. Box 51200 – 00100, Nairobi, Kenya KENYA B. BRAUN PHARMACEUTICALS EPZ LTD, KENYA KIPHARMA LTD 2024-02-22 2029-02-21

876 Rwanda FDA-HMP-MA-0902 SODIUM CHLORIDE INTRAVENOUS INFUSION BP 0.9% W/V Sodium Chloride 0.9 gms/100ml 0.9 gms/100ml Solution for infusion 500 ml bottle Closed System Container (CSC) which is a plastic collapsible container fabricated from LDPE. The container is formed with euro head where a twin-port cap is welded. The Twin Cap has injected thermoplastic elastomers (TPE) closure 24 Months B. BRAUN PHARMACEUTICALS EPZ LTD, L.R. No 18474/84 Athi River, P.O. Box 51200 – 00100, Nairobi, Kenya KENYA B. BRAUN PHARMACEUTICALS EPZ LTD, KENYA KIPHARMA LTD 2024-02-22 2029-02-21

877 Rwanda FDA-HMP-MA-0903 P-ALAXIN DISPERSIBLE 40/320 Dihydroartemisinin Ph.int. 40mg, Piperaquine Phosphate 320 mg 40mg, 320 mg Tablets 1x3 tablets or 2x3 ablets Alu/Alu blister pack. Such 1 or 2 blister(s) is packed in a carton along with pack insert 24 Months BLISS GVS PHARMA LIMITED, Plot 11, Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Palghar, District-Thane – 401404, India INDIA BLISS GVS PHARMA LTD, INDIA SURYA DEPOT PHARMACY LTD 2024-02-22 2029-02-21

878 Rwanda FDA-HMP-MA-0904 ARBITEL –AM Telmisartan BP 40mg and Amlodipine Besilate 5mg 40mg and 5mg Film coated tablets 3x10 tablets Alu/Alu blisters. Such 3 blisters are packed in a printed outer carton along with a pack insert 36 Months MICRO LABS LIMITED, 92 SIPCOT Industrial Complex, Hosur-635 126, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-22 2029-02-21

879 Rwanda FDA-HMP-MA-0905 NEURO-FORTE TABLETS Vitamin B1 USP 200 mg, Vitamin B6 USP 50 mg, Vitamin B12 USP 1000 mcg, and Color Erythrosine 200 mg, 50 mg, 1000 mcg, Film coated tablets 2 x 10 Tablets Alu-PVDC white Opaque strip pack, packed in a carton 36 Months CENTAUR PHARMACEUTICALS PVT. LTD, Plant: I Plot No: 3. Tivim Industrial Estate. Karaswada, Mapusa Goa-403526, India INDIA CENTAUR PHARMACEUTICALS PVT. LTD, INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LIMITED 2024-02-22 2029-02-21

880 Rwanda FDA-HMP-MA-0906 ZIMAGRA 100 Sildenafil Tablet USP 100mg 100mg Film coated tablets 1 x 4 Tablets Alu-PVC Blister packed in carton along with pack insert 36 Months ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar, Nagpur 441501, Maharashtra State, India INDIA ZIM LABORATORIES LIMITED, INDIA SUN ENTERPRISES LTD 2024-02-22 2029-02-21

881 Rwanda FDA-HMP-MA-0907 MICROGYNON FE Ethinylestradiol 0.03 mg, Levonorgestrel 0.15 mg 0.03 mg, 0.15 mg Tablets 1x28 Tablets Pvc/Aclar blister strip 36 Months BAYER WEIMAR GmbH UND Co. KG, Doebereinerstr. 20, 99427 Weimar, Germany GERMANY BAYER EAST AFRICA LIMITED, KENYA SURGIPHARM (RWANDA) LTD 2024-02-22 2029-02-21

882 Rwanda FDA-HMP-MA-0908 STOPKOF SYRUP Diphenhydramine HCL 13.5mg/5ml, Ammonium Chloride 131.5mg/5ml 13.5mg/5ml,131.5mg/5ml Syrup 60 ml & 100 ml Bottles Amber glass bottles 24 Months NATIONAL PHARMACEUTICAL INDUSTRIES CO. (SAOC), P.O Box 120, Rusayl, Postal code 124, Sultanate of Oman SULTANATE OF OMAN NATIONAL PHARMACEUTICAL INDUSTRIES CO. (SAOC), SULTANATE OF OMAN SUN ENTERPRISES LTD 2024-02-22 2029-02-21

883 Rwanda FDA-HMP-MA-0909 MYOSPAZ TABLETS Chlorzoxazone 250 mg and Paracetamol 500 mg tablets 250 mg and 500 mg Uncoated Tablets 10x10 tablets Blisters of 10 tablets packed in a carton 36 Months WIN-MEDICARE PVT. LTD. Address: Modipuram – 250 110, Country: U.P., India INDIA WIN-MEDICARE PVT. LTD SURGIPHARM (RWANDA) LTD 2024-02-22 2029-02-21

884 Rwanda FDA-HMP-MA-0910 KAREFENAC INJECTION Diclofenac Sodium BP injection 75mg/3mL 75mg/3mL Powder for solution for injection 10x10 Ampoules of 3ml in box Packed in 3ml USP type I glass ampoule, then 10 amps are packed in a tray, the 10 trays are in turn packed in a box. The boxes are then 200 boxes contained in a carton 36 Months REYOUNG PHARMACEUTICAL CO., LTD. No.1 Ruiyang Road Yiyuan county, Shandong Province, P. R. China P. R. CHINA KAREMAX INDUSTRIAL LTD SUN ENTERPRISES LTD 2024-02-22 2029-02-21

885 Rwanda FDA-HMP-MA-0911 KAREMYCIN Gentamicin Sulfate, 80mg/2ml 80mg/2ml Solution for injection 10x10 Ampoules of 2ml in box 2mL USP type I glass amber ampoules, 10 amps/tray, 10 trays/box, 200 boxes/ carton along with literature insert 36 Months REYOUNG PHARMACEUTICAL CO., LTD. No.1 Ruiyang Road Yiyuan county, Shandong Province, P. R. China CHINA KAREMAX INDUSTRIAL LTD SUN ENTERPRISES LTD 2024-02-22 2029-02-21

886 Rwanda FDA-HMP-MA-0912 CLAMOXIN -1000 TABLETS Amoxicillin Trihydrate 875 mg & Potassium Clavulanate 125 mg 875 mg & 125 mg Film coated tablets 1x10 Tablets, 2x10 Tablets, 1x6 Tablets 10’s Tropical Blister pack. Such 1 blister is packed in a printed carton with leaflet, 10’s Tropical Blister pack. Such 2 blister are packed in a printed carton with leaflet and 6’s Tropical Blister pack. Such 1 blister is packed in a printed carton with leaflet 24 Months MEDOPHARM PRIVATE LIMITED, Guduvanchery No.50, Kayarambedu village, Guduvanchery -603 202, Chengalpattu District, Tamil Nadu, India INDIA BLISS GVS PHARMA LTD SURYA DEPOT PHARMACY LTD 2024-02-22 2029-02-21

887 Rwanda FDA-HMP-MA-0913 AGYCIN-250 Azithromycin Dihydrate USP 250 mg 250 mg Film coated tablets 6 tablets Blister of Aluminium/PVC foil in monocarton along with insert 36 Months BLISS GVS PHARMA LIMITED. Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal- Palghar, District-Thane 401404 INDIA BLISS GVS PHARMA LTD SURYA DEPOT PHARMACY LTD 2024-02-22 2029-02-21

888 Rwanda FDA-HMP-MA-0914 DIOCLAV 625 MG Amoxicillin trihydrate 500mg and Clavulante Potassium 125mg 500mg and 125mg Film coated tablets 7x2 Tablets Alu-Alu foil laminated with LDPE. These strips in a carton 36 Months NATIONAL PHARMACEUTICAL INDUSTRIES CO. (SAOC), P.O Box 120, Rusayl, Postal code 124, Sultanate of Oman SULTANATE OF OMAN NATIONAL PHARMACEUTICAL INDUSTRIES CO. (SAOC), SULTANATE OF OMAN SUN ENTERPRISES LTD 2024-02-22 2029-02-21

889 Rwanda FDA-HMP-MA-0915 LOPINAVIR AND RITONAVIR TABLETS USP 100 MG/ 25 MG Lopinavir and Ritonavir Tablets USP 100 mg/ 25 mg 100 mg/ 25 mg Film coated tablets 60 Tablets White opaque 85cc HDPE container closed with 33 mm ARGUS CR closure with TEKNIPLEX HS 123 induction sealing wad 24 Months LAURUS LABS LIMITED, (Unit-II), Plot No:19, 20 & 21, Western Sector, APSEZ, Atchutapuram Mandal, Visakhapatnam-District-531011, Andhra Pradesh, India INDIA LAURUS LABS LIMITED CAPITAL PHARMACEUTICAL SUPPLIES LIMITED 2024-02-22 2029-02-21

890 Rwanda FDA-HMP-MA-0916 OLEPTISS 360 MG FILM-COATED TABLETS Deferasirox 360mg 360mg Film coated tablets 90 Tablets PVC/PVDC/Aluminium blisters 36 Months NOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE, 4332 Stein AG, Switzerland SWITZERLAND NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2024-02-22 2029-02-21

891 Rwanda FDA-HMP-MA-0917 OLEPTISS 180 MG FILM-COATED TABLETS Deferasirox 180mg 180mg Film coated tablets 90 Tablets PVC/PVDC/Aluminium blisters 36 Months NOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE, 4332 Stein AG, Switzerland SWITZERLAND NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2024-02-22 2029-02-21

892 Rwanda FDA-HMP-MA-0918 SIRTURO™ 20MG Bedaquiline fumarate 20mg 20mg Film coated tablets 60 Tablets Opaque white high-density polyethylene (HDPE) bottle with child-resistant polypropylene (PP) closure with induction seal liner. 36 Months RECIPHARM PHARMASERVICES PRIVATE LIMITED, 34th KM, Tumkur Road Teppada Begur Nelamangala Taluk Bangalore – 562 123 India INDIA JANSSEN-CILAG INTERNATIONAL NV, BELGIUM KIPHARMA LTD 2024-02-22 2029-02-21

893 Rwanda FDA-HBP-MA-0117 TETANUS ANTITOXIN Tetanus Antitoxin BP 1500 IU 1500 IU Liquid for injection 1 ml Ampoule 1 ml white USP type I One Point Cut (OPC) ampoule with liquid injection 24 Months SERUM INSTITUTE OF INDIA PVT. LTD. 212/2 Hadapsar, Pune- 411 0028, India INDIA SERUM INSTITUTE OF INDIA PVT. LTD, INDIA SUN ENTERPRISES LTD 2024-02-23 2029-02-22

894 Rwanda FDA-HMP-MA-1004 EFFERALGAN CODEINE 500 MG Paracetamol 500 mg and Codeine phosphate hemihydrate 30 mg 500 mg+30 mg Effervescent tablets 8 Effervescent tablets Opaque Polypropylene Tube closed with a polyethylene stopper containing molecular sieve as desiccant packed in a carton 36 Months UPSA, 979, Avenue des Pyrenees, 47520 Le Passage– France. FRANCE UPSA SAS UBIPHARM RWANDA LIMITED 2024-02-23 2029-02-22

895 Rwanda FDA-HMP-MA-1005 DEPAKINE 200 MG Sodium Valproate 200mg 200mg Film Coated Tablets 40 Tablets Polypropylene tubes 36 Months SANOFI WINTHROP INDUSTRIES, Sanofi Winthrop Industrie– Ambare-1, rue de la Vierge ambares et Lagrave 33565 carbon blanc Cedex, France. FRANCE SANOFI AVENTIS KENYA LIMITED KIPHARMA LIMITED 2024-02-23 2029-02-22

896 Rwanda FDA-HMP-MA-1006 DEPAKINE 500 MG Depakine 500 mg 500 mg Film Coated Tablets 30 Tablets Polypropylene tubes 36 Months SANOFI WINTHROP INDUSTRIES, Sanofi Winthrop Industrie Ambare-1, rue de la Vierge ambares et Lagrave 33565 carbon blanc Cedex, France. FRANCE SANOFI AVENTIS KENYA LIMITED KIPHARMA LIMITED 2024-02-23 2029-02-22

897 Rwanda FDA-HMP-MA-1007 DEPAKINE 200 MG/ML Sodium Valproate 200 mg/ml 200 mg/ml Oral Solution Syrup 40 ml Bottle Amber Glass Type III Brown Bottles closed with a polypropylene child-proof cap 36 Months SANOFI WINTHROP INDUSTRIES, Sanofi Winthrop Industrie Ambare-1, rue de la Vierge ambares et Lagrave 33565 carbon blanc Cedex, France. FRANCE SANOFI AVENTIS KENYA LIMITED KIPHARMA LIMITED 2024-02-23 2029-02-22

898 Rwanda FDA-HMP-MA-1008 SINAREST NASAL DROPS Oxymetazoline Hydrochloride USP 0.5 mg 0.5 mg Nasal Solution 10 ml solution Botttle White LDPE Flat Bottle 36 Months CENTAUR PHARMACEUTICAL PVT. LTD., Plant-I, Plot No.3, 5B, 2C, Tivim Industrial Estate, Karaswada, Mapusa, Goa-403 526, India. INDIA CENTAUR PHARMACEUTICALS PVT. LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-23 2029-02-22

899 Rwanda FDA-HMP-MA-1009 WOXHEAL Diperoxochloric Acid Concentrate 1.16 mg 1.16 mg Topical Solution 7.5 ml Bottle HDPE Bottles 24 Months CENTAUR PHARMACEUTICAL PVT.LTD, Plant-I, Plot No.3,5B,2C, Tivim Industrial Estate, Karaswada, Mapusa, Goa-403 526, India. INDIA CENTAUR PHARMACEUTICAL PVT. LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-23 2029-02-22

900 Rwanda FDA-HMP-MA-1010 POVID Povidone Iodine 200mg 200mg Pessaries 7 Pessaries Polyvinyl Chloride/Polyethylene foil packed in a carton along with pack insert 36 Months BLISS GVS PHARMA LIMITED, Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Palghar, District-Thane – 401404. India. INDIA BLISS GVS PHARMA LIMITED SURYA DEPOT PHARMACY LTD 2024-02-23 2029-02-22

901 Rwanda FDA-HMP-MA-1011 DACOF MUCOLYTIC SYRUP Each 5ml contains: Salbutamol (as sulphate) BP 2.0mg, Guaifenesin BP 100.0mg and Bromhexine HCl BP 4.0mg 2.0mg, 100.0mg & 4.0mg/5ml Syrup 100 ml Bottle PET bottle in a unit box along with a literature insert 36 Months DAWA LIMITED, Plot No.7879/8, Baba Dogo Road, Ruaraka, P.O Box 16633-00620, Nairobi-Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-02-23 2029-02-22

902 Rwanda FDA-HMP-MA-1012 CURAMOL 500MG TABLETS Paracetamol 500mg 500mg Tablets 10 x10 Tablets and 1000 Tablets Blister packs and HDPE container 60 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. BOX 16633-00620. Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-02-23 2029-02-22

903 Rwanda FDA-HMP-MA-1013 CALCIVITA FORTE Calcium Carbonate 1500mg containing Calcium 600mg and Vitamin D3 200 IU 1500mg, 600mg & 200 IU Soft gelatin Capsules 30 Capsules HDPVC bottle with HDPVC cap 24 Months MEGA LIFESCIENCES PUBLIC COMPANY LIMITED, 384 Moo 4, Soi 6, Bangpoo Industrial Estate, Pattana 3 Road.Phraeksa, Mueang, Samutprakarn 10280, Thailand THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2024-02-23 2029-02-22

904 Rwanda FDA-HMP-MA-1019 CARDISPRIN® 75MG Aspirin 75mg 75mg Enteric Coated Tablet 14x2 Tablets Alu-Alu blisters in printed carton 24 Months COSMOS LIMITED, Rangwe Road, Off Lunga Lunga Road, Industrial Area, P. O. Box 41433, GPO 00100 Nairobi, Kenya. KENYA COSMOS LIMITED, KENYA SUN ENTERPRISES LTD 2024-02-23 2029-02-22

905 Rwanda FDA-HMP-MA-1058 ESOFAG- 40 Esomeprazole magnesium trihydrate BP 40 mg 40 mg Enteric Coated Tablet 3X10 Tablets Alu/ Alu Blisters in a carton along with pack insert 36 Months MICRO LABS LIMITED, 92, SIPCOT Industrial Complex, Hosur – 635 126, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-23 2029-02-22

906 Rwanda FDA-HMP-MA-1059 ZITHROCARE-200 SUSPENSION Azithromycin USP 200 mg 200 mg Suspension 15 ml Bottle Amber Coloured Glass Bottle with pilfer proof cap and EPE liner packed with a printed carton 36 Months MEYER ORGANICS PVT. LTD, 10 D, IInd Phase, Peenya Industrial Area, Bangalore, 560 058, A-303, Road No.32, Wagle Estate, Thane 400604 (Mumbai), India. INDIA MEYER ORGANICS PVT. LTD SUN ENTERPRISES LTD 2024-02-23 2029-02-22

907 Rwanda FDA-HMP-MA-1060 M-FORLIN-850 Metformin Hydrochloride BP 850 mg 850 mg Film Coated Tablets 10x10 Tablets Alu-PVC Blister. Such 10 blisters are packed in a printed carton along with packaging insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2024-02-23 2029-02-22

908 Rwanda FDA-HMP-MA-1061 HYTAN-40 Termisartan USP 40mg 40mg Uncoated Tablets 3x10 Tablets Alu/Alu Pack (Alu/Alu Printed Aluminium foil with Alu/Alu Base Foil) 24 Months BAFNA PHARMACEUTICALS LTD., No.147, Madhavaram Redhills High Road, Grantlyon, Vadakarai Post, Chennai – 600 052, India. INDIA PRISMA PHARMA FZE PRAFIN RWANDA LTD 2024-02-23 2029-02-22

909 Rwanda FDA-HMP-MA-1062 AUGMENTIN PDR 112.5 MG/5 ML 100 mg of Amoxycillin (as trihydrate) and 12.5mg Potassium Clavulanate 100 mg + 12.5mg Powder for Oral Suspension 30 ml & 60 ml Bottles Glass Bottles 24 Months GLAXO WELLCOME PRODUCTION, ZI de la Peyenniere 53100 Mayenn, France FRANCE GLAXOSMITHKLINE PHARMACEUTICAL KENYA LIMITED KIPHARMA LTD 2024-02-23 2029-02-22

910 Rwanda FDA-HMP-MA-1063 0.9% SODIUM CHLORIDE INJECTION Sodium chloride 500ml: 4.5g. 500ml: 4.5g Solution for Intravenous Infusion 30 bottles of 500ml in a carton Polyethylene Bottles packed in a carton 36 Months SHIJIAZHUANG NO.4 PHARMACEUTICAL CO., LTD, No.518 East Huaian Road, High-tech Industrial Development Zone, Shijiazhuang, China Yangzi Road, Economic & Technological Development Zone, Shijiazhuang, China. CHINA SHIJIAZHUANG NO.4 PHARMACEUTICAL CO., LTD. DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-23 2029-02-22

911 Rwanda FDA-HMP-MA-1064 PARACETAMOL Paracetamol 125 mg 125 mg Suppositories 10x10 Suppositories PVC/PE Blister strip packed in outer carton 48 Months FULTON MEDICINALI S.P.A, Via Marconi, 28/9 20020 –Arese (Milan), Italy ITALY FULTON MEDICINALI S.P.A, ITALY UBIPHARM RWANDA LTD 2024-02-23 2029-02-22

912 Rwanda FDA-HMP-MA-1065 ZITHROX 500MG Azithromycin 500mg 500mg Film Coated Tablet 3 Tablets PVDC/Aluminium Blister packed in a carton 48 Months COSMOS LIMITED, Rangwe Road; Off Lunga Lunga Road, Industrial Area, Nairobi, Kenya KENYA COSMOS LIMITED, KENYA SUN ENTERPRISES LTD 2024-02-23 2029-02-22

913 Rwanda FDA-HMP-MA-1072-R1 DOLOWIN Aceclofenac 100mg 100mg Tablets 3x10 Tablets Alu/Alu Blister Pack. Such 3 blisters are in a carton along with a package insert 36 Months MICRO LABS LIMITED No 92, Sipcot, Industrial Complex, Hosur-635 126, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-26 2029-02-25

914 Rwanda FDA-HBP-MA-0112 FOLISURGE 1200 Follitropin Alpha 1200 IU/1.92 mL 1200 IU/1.92 mL Solution for Injection. 1 Vial of 2ml Type I Glass Vial 24 Months INTAS PHARMACEUTICALS LIMITED, Plot No. 423/P/A Sarkhej - Bavla Highway. Moraiya, Taluka: Sanand Ahmedabad – 382 213 Gujarat, India INDIA INTAS PHARMACEUTICALS LIMITED VINE PHARMA LTD 2024-02-26 2029-02-25

915 Rwanda FDA-HBP-MA-0113 GLARITUS 100 IU/ML Insulin glargine Injection USP, 100 IU/mL (r-DNA origin) 100 IU/mL Solution for Injection. 10 ml vial, 3ml Cartridge Type I Glass Vial, Cartridge and Dispopen 36 Months WOCKHARDT LIMITED, Biotech Park, H-14/2, MIDC, Waluj, Aurangabad-431136, India INDIA WOCKHARDT LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-02-26 2029-02-25

916 Rwanda FDA-HBP-MA-0115 ACURIN 5000I.U/ML Heparin sodium BP 5000I.U/ml 5000I.U/ml Solution for injection 5 ml vial Amber Glass Vial USP Type I closed with grey bromobutyl rubber stopper sealed with flip off seal 24 Months ACULIFE HEALTHCARE PRIVATE LTD, Village- Sachana, Tal-Viramgam, City: Sachana–382 150, Dist: Ahmedabad Gujarat State, India INDIA ACULIFE HEALTHCARE PRIVATE LTD, INDIA SUN ENTERPRISES LTD 2024-02-26 2029-02-25

917 Rwanda FDA-HMP-MA-0934 CLOXACILLIN SODIUM FOR INJECTION Cloxacillin Sodium 546mg equivalent to Cloxacillin 500mg 500mg Powder for Injection. 10 ml Vials, 50vials/Box, 20vials/ Box Molded Vials, rubber stopper, non-flip-off cap 36 Months REYOUNG PHARMACEUTICAL CO., LTD., Ruiyang Road Yiyuan, Shandong, P.R. China. CHINA REYOUNG PHARMACEUTICAL CO., LTD SUN ENTREPRISES LTD 2024-02-26 2029-02-25

918 Rwanda FDA-HMP-MA-0935 DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR ALAFENAMIDE TABLETS Dolutegravir Sodium, Lamivudine and Tenofovir Alafenamide Fumarate 50 mg/300 mg/25 mg 50 mg/300 mg/25 mg Film Coated Tablets 30 Tablets, 90 Tablets and 180 Tablets HDPE Bottles 30 Months LAURUS LABS LIMITED, (Unit-II), Plot No: 19, 20 & 21, Western Sector, APSEZ, Atchutapuram Mandal, Visakhapatnam District, Andhra Pradesh, 531011-India INDIA LAURUS LABS LIMITED CAPITAL PHARMACEUTICAL SUPPLIES LIMITED 2024-02-26 2029-02-25

919 Rwanda FDA-HMP-MA-0936 ABACAVIR AND LAMIVUDINE TABLETS 600MG/300MG Abacavir Sulphate and Lamivudine USP 600mg/300mg 600mg/300mg Film-Coated Tablets 30 Tablets, 90 Tablets and 180 Tablets HDPE Bottles 24 Months LAURUS LABS LIMITED, (Unit-II), Plot No: 19, 20 & 21, Western Sector, APSEZ, Atchutapuram Mandal, Visakhapatnam District, Andhra Pradesh, 531011 India. INDIA LAURUS LABS LIMITED CAPITAL PHARMACEUTICAL SUPPLIES LIMITED 2024-02-26 2029-02-25

920 Rwanda FDA-HMP-MA-0937 DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE Dolutegravir sodium 50 mg, Lamivudine 300 mg and Tenofovir Disoproxil Fumarate 300 mg 50mg/300mg/300mg Film coated tablets 30 Tablets and 90 Tablets 30 tablets in white opaque 100 cc HDPE bottles filled with 1gm silica gel canister closed with 38 mm child resistant closures. 90 Tablets: white opaque 250 cc hdpe bottles filled with 1gm silica gel canister closed with 53 mm child resistant closures 24 Months LAURUS LABS LIMITED, (Unit-Il), Plot No: 19, 20 & 21, Western Sector, APSEZ, Atchutapuram Mandal, Visakhapatnam District, and Andra Pradesh, India. 531011-India. INDIA LAURUS LABS LIMITED, INDIA CAPITAL PHARMACEUTICAL SUPPLIES LIMITED 2024-02-26 2029-02-25

921 Rwanda FDA-HMP-MA-0943 HYDROXYCARBAMIDE 500MG CAPSULES, HARD Hydroxycarbamide 500mg 500mg Hard capsules 100 Capsules PVC/PVDC/Aluminium-Blisters packed in a carton box 24 Months HAUPT PHARMA AMAREG GMBH, Donaustaufer Strasse 378 D-93055 Regensburg, Germany GERMANY SANDOZ GmbH KUNDL SURGIPHARM (RWANDA) LTD 2024-02-26 2029-02-25

922 Rwanda FDA-HMP-MA-0944 AUROCORT Triamcinolone Acetonide 40mg/ml 40mg/ml Intraocular injection 5 vials of 1 mL of a 40 mg/Ml glass vial, are packed in a carton Flint type I single use glass vial with a grey rubber stopper and an open target seal 24 Months AUROLAB, No.1 Sivagangai Main Road, Veerapanjan, Madurai, India INDIA AUROLAB DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-26 2029-02-25

923 Rwanda FDA-HMP-MA-0945 DARUNAVIR TABLETS 600 MG Darunavir amorphous 600mg 600mg Film coated tablets 60 Tablets HDPE container in child resistant plastic caps with pulp liners 38 mm and high-density polyethylene container 160cc with 38 mm neck 24 Months HETERO LABS LIMITED, Unit-III, Industrial Development Area (IDA) 22-110, IDA, Jeedimetla, Hyderabad-500 055, Telangana, India. INDIA HETERO LABS LTD SUN ENTERPRISES LTD 2024-02-26 2029-02-25

924 Rwanda FDA-HMP-MA-0946 CLARITHROMYCIN TABLET 250 MG Clarithromycin BP 250 mg 250 mg Film coated tablet 1 x 14 Tablets Aluminium Foil/PVC Blister 36 Months AGOG PHARMA LTD; Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISE LTD 2024-02-26 2029-02-25

925 Rwanda FDA-HMP-MA-0947 TRADMIN Tramadol Hydrochloride 50 mg 50 mg Capsules 10x10 Capsules ALU-PVC Blister. 10 such blisters packed in a printed carton with pack insert 24 Months AKUMS DRUGS AND PHARMACEUTICALS LTD, Plot no. 19,20 & 21, Sector-6A, IIE., SIDCUL, Ranipur, Haridwar-249403, Uttarakhand, India INDIA UNOSOURCE PHARMA LTD ABACUS PHARMA (A) LTD. 2024-02-26 2029-02-25

926 Rwanda FDA-HMP-MA-0948 HELMINTOX® ORAL SUSPENSION Pyrantel Embonate 125 mg/2.5 ml 125 mg/2.5 ml Oral suspension 15ml Bottle Type III glass bottle, crimped with a varnished aluminium (al) cap including a watertight polyethylene (PE) packed in a printed carton along with packing insert 36 Months INNOTHERA CHOUZY, Rue Rene Chantereau, Chouzy-sur-Cisse, 41150 Valloire-sur-Cisse, France FRANCE LABORATOIRE INNOTECH INTERNATIONAL DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-26 2029-02-25

927 Rwanda FDA-HMP-MA-0949 SENSOCAIN SPINAL 0.5% INJECTION Bupivacaine Hydrochloride 5mg, Dextrose Anhydrous 80mg 5mg /80mg Solution for Injection 5 Ampoules of 4ml 5ml Amber Glass Usp Type-I Ampoule 24 Months BROOKES PHARMA (PRIVATE) LIMITED, 58-59, Sector No. 15, Korangi Industrial Area, Karachi-74900, Pakistan PAKISTAN BROOKES PHARMA (PRIVATE) LIMITED AFRI HEALTH CARE LTD 2024-02-26 2029-02-25

928 Rwanda FDA-HMP-MA-0950 VOLTAREN 1% EMULGEL Diclofenac Diethylamine 11.6mg/gm 11.6mg/gm Cream 20gm and 50gm Tubes Aluminium and laminated aluminium tube closed with a white screw cap (polypropylene) packed in Cardboard folding box 36 Months GSK CONSUMER HEALTH SA, Route De l’Etraz, CH-1260 Nyon 1, Switzerland SWITZERLAND GLAXOSMITHKLINE LIMITED SURGIPHARM (RWANDA) LIMITED 2024-02-26 2029-02-25

929 Rwanda FDA-HMP-MA-0951 DIAZAC 5 Dapagliflozin 5 mg 5 mg Film Coated Tablets 3x10 Tablets Alu-PVC/PVDC Blister. 3 such blisters packed in a printed carton along with pack insert. 24 Months AJANTA PHARMA LIMITED, Z/103/A, Dahej SEZ II, Bharuch-392 130, Dist. Bharuch, Gujarat State, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA(A) LTD 2024-02-26 2029-02-25

930 Rwanda FDA-HMP-MA-0952 DIAZAC 10 Dapagliflozin IH 10mg 10 mg Film Coated Tablets 3x10 Tablets Alu-PVC/PVDC Blister. 3 such blisters packed in a printed carton along with pack insert 24 Months AJANTA PHARMA LIMITED, Mirza-Palashbari Road, Village Kokjhar, Kamrup (R), Guwahati, Assam - 781128, India. INDIA AJANTA PHARMA LIMITED ABACUS PHARMA(A) LTD 2024-02-26 2029-02-25

931 Rwanda FDA-HMP-MA-0953 TELMICLAR 80 Telmisartan Tablets USP 80 mg 80 mg Uncoated Tablets 3x10 Tablets Alu-Alu Blister. 3 such blisters packed in a printed carton along with pack insert 24 Months AJANTA PHARMA LIMITED, Mirza-Palashbari Road, Village Kokjhar, Kamrup (R), Guwahati, Assam - 781128, India. INDIA AJANTA PHARMA LIMITED ABACUS PHARMA(A) LTD 2024-02-26 2029-02-25

932 Rwanda FDA-HMP-MA-0955 OFUSIDIC Fusidic acid 10mg/g 10mg/g Eye Drops 5 ml Bottle LDPE white plastic dropper bottle 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES, Al Obour City-Industrial zone, Area 14,15, Block no. 12011 Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICAL INDUSTRIES, EGYPT ETS CONTINENTAL LTD 2024-02-26 2029-02-25

933 Rwanda FDA-HMP-MA-0956 SPIRIVA RESPIMAT Tiotropium bromide monohydrate 2.5 microgram 2.5 microgram Solution for Inhalation Cartridge/ 60 puffs and 1 Respimat inhaler 1 cartridge (60 puffs) & 1 Respimat inhaler (starter pack) 36 Months BOEHERINGER INGELHEIM PHARMA GmBH & Co.KG. Binger Strasse 173,55216 Ingelheim am Rhein, Germany GERMANY BOEHERINGER INGELHEIM INTERNATIONAL GMBH SURGIPHARM (RWANDA) LTD 2024-02-26 2029-02-25

934 Rwanda FDA-HMP-MA-0957 AUROFLOX Ofloxacin,0.3% w/v 0.3% w/v Ophthalmic eye drop 10 ml Bottle Low density polyethylene container with HDPE cap and Nozzle 24 Months AUROLAB, No.1.Sivagangai Main Road, Veerapanjan, Madurai 625020, India INDIA AUROLAB DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-26 2029-02-25

935 Rwanda FDA-HMP-MA-0958 NOTIUM Diazepam Injection BP 10mg/2mL 10mg/2mL Solution for Injection. 10 Ampoules of 2 ml Amber ampoule is filled, sealed and labelled. 10 such ampoules are to be placed in a transparent tray then placed in a carton 36 Months KILITCH DRUGS INDIA LTD, Plot no- C-301/2, M.I.D.C T.T.C, Industrial Area, Pawane Village, Navi Mumbai - 400 705, Maharashtra, India INDIA KILITCH DRUGS (I) LTD SUN ENTERPRISES LTD 2024-02-26 2029-02-25

936 Rwanda FDA-HMP-MA-0959 KAREMOL TABLETS Paracetamol 500mg 500mg Uncoated Tablets 1x10 Tablets Alu/Alu blister s packed in outer carton 36 Months HEBEI JIHENG (GROUP) PHARMACEUTICAL CO., LTD, No.368Jianshe Street, Hengshui City, Hebei Province 053000 P.R. China CHINA KAREMAX INDUSTRIAL LIMITED SUN ENTERPRISES LTD 2024-02-26 2029-02-25

937 Rwanda FDA-HMP-MA-0960 LEVO-72 TABLETS Levonorgestrel Tablets BP 0.75 mg 0.75 mg Film Coated Tablets 2 Tablets Alu-PVC Blister pack, packed in printed and laminated carton 36 Months WEST-COAST PHARMACEUTICAL WORKS LTD, F. P. No 17 & 16/5, Meldi Estate/s Meldi Mata Temple, Nr. Gota Railway Crossing, AT & POST Gota, Ahmedabad-382481, Gujarat, India INDIA RAY PHARMACEUTICALS LIMITED CAPITAL PHARMACEUTICAL SUPPLIES LTD 2024-02-26 2029-02-25

938 Rwanda FDA-HMP-MA-0961 EMBRACOTRIM 960 Sulphamethoxazole BP 800mg and Trimethoprim BP 160mg 800mg, 160mg Uncoated Tablets 10x10 Tablets Blister pack 36 Months MERIT ORGANICS LTD, Plot No. 2104/2/A, G.I.D.C., Sarigam, Bhilad, Dist. Valsad - 396 155, Gujarat, India INDIA MERIT ORGANICS LTD SUN ENTERPRISES LTD 2024-02-26 2029-02-25

939 Rwanda FDA-HMP-MA-0962 NOOTROPYL 800MG TABLETS Piracetam 800mg 800mg Film-coated tablets 45 Tablets PVC/Aluminium foil blister packs 48 Months UCB PHARMA SA, Chemin du foriest 1420 Braine-1’Alleud, Belgium BELGIUM GLAXOSMITHKLINE PHARMACEUTICAL LTD KIPHARMA LTD 2024-02-26 2029-02-25

940 Rwanda FDA-HMP-MA-0963 NEBILONG-10 Nebivolol Hydrochloride 10mg 10mg Uncoated Tablets 3x10 Tablets Alu/Alu Blister. 3 such blisters are placed in carton along with pack insert 36 Months MICRO LABS LIMITED, 92, SIPCOT, Hosur-635 126, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-26 2029-02-25

941 Rwanda FDA-HMP-MA-0964 SODIUM LACTATE RINGER'S INJECTION Sodium Lactate 0.320g, Sodium chloride 0.600g, Potassium chloride 0.040g and Calcium chloride (CaCl2·dihydrate) 0.027g. 0.320g+0.600g+0.040g +0.027g Solution for intravenous infusion 30 bottles of 500ml Polypropylene Bottles in a carton 36 Months SHIJIAZHUANG NO.4 PHARMACEUTICAL CO., LTD, Yangzi Road, Economic & Technological Development Zone, Shijiazhuang City, Hebei Province, China. CHINA SHIJIAZHUANG NO.4 PHARMACEUTICAL CO., LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-26 2029-02-25

942 Rwanda FDA-HMP-MA- 0965 POLYFRESH EXTRA SDU OPHTHALMIC SOLUTION Sodium Hyaluronate 1mg/ml/, Carboxymethylcellulose sodium 5mg/ml 1mg/ml/, 5mg/ml Eye Drops 30 units Bottles conatining 0.4ml solution Low Density Polyethylene Plastic Bottle in carton box and inner leaflet 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES, El?obour city, Industrial zone, Area 15, Block no. 12011, Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICALS INDUSTRIES ETS CONTINENTAL LTD 2024-02-26 2029-02-25

943 Rwanda FDA-HMP-MA- 0966 CIPROFLOXACIN TABLETS USP 500MG Ciprofloxacin Hydrochloride 500 mg 500 mg Film coated tablets 10x10 Tablets PVC AND AL foil blister. Such 10 blisters are packed in a box 36 Months REYOUNG PHARMACEUTICAL CO, Ltd, No.1, Ruiyang Road, Yiyuan County, Shandong Province, P.R. China CHINA REYOUNG PHARMACEUTICAL CO., LTD SUN ENTERPRISES LTD 2024-02-26 2029-02-25

944 Rwanda FDA-HMP-MA-0967 ASOMEX 2.5 S (-) Amlodipine Besilate 2.5 mg 2.5 mg Uncoated Tablets 3x10 tablets, or 5x10 tablets, PVDC Coated PVC Film and Aluminium Foil. 3 or 5 such blister strips are packed in a carton along with a package insert 36 Months EMCURE PHARMACEUTICALS LIMITED, Lane no. 03, Phase II, SIDCO industrial Complex, Bari-Brahmana, Jammu (J&K) – 181133, India INDIA EMCURE PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2024-02-26 2029-02-25

945 Rwanda FDA-HMP-MA- 0968 DOLUTEGRAVIR SODIUM TABLETS 50MG Dolutegravir Sodium 50 mg 50 mg Film coated tablets 30 Tablets HDPE container packed in a carton along with pack Insert 24 Months MACLEODS PHARMACEUTICALS LIMITED, Plot No. 25 – 27, Survey No. 366, Premier Industrial Estate, Kachigam. Daman, PIN – 396210 India INDIA MACLEODS PHARMACEUTICALS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-26 2029-02-25

946 Rwanda FDA-HMP-MA-0969 NEVXAL Nepafenac, 1mg/ml 1mg/ml Ophthalmic Suspension 5 ml Bottle Low Density Polyethylene Bottle 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES, Al Obour City-Industrial zone, Area 14, 15, Block no. 12011 Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICAL INDUSTRIES, EGYPT ETS CONTINENTAL LTD 2024-02-26 2029-02-25

947 Rwanda FDA-HMP-MA-0970 BRAIPORIN SYRUP Sodium Valproate BP, 200mg/ml 200mg/ml Syrup Liquid 100 ml Bottle Amber Coloured PET Bottle 24 Months AKUMS DRUGS & PHARMACEUTICALS PLANT II, Plot No. 22, Sector 6-A, IIE, Sidcul, Ranipur, District: Haridwar, Uttarakhand, India INDIA UNOSOURCE PHARMA LIMITED, INDIA AIVEEN RWANDA LTD. 2024-02-26 2029-02-25

948 Rwanda FDA-HMP-MA-0971 ORCHAPRED Prednisolone phosphate, 5 mg/1g 5 mg/1g Sterile Ophthalmic Gel 5 ml Bottle LDPE White Plastic Bottle 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES, Al Obour City-Industrial zone, Area 14, 15, Block no. 12011 Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICAL INDUSTRIES, EGYPT ETS CONTINENTAL LTD 2024-02-26 2029-02-25

949 Rwanda FDA-HMP-MA-0972 NIRFOL 1% Propofol BP 10mg/ml 10mg/ml Emulsion for Intravenous Injection Vial of 20 ml and 50 ml Type II glass vial closed with bromobutyl rubber stopper and flip off seal 24 Months ACULIFE HEALTHCARE PVT. LTD, Sachana, Taluka: Viramgam, District: Ahmedabad - 382 150. Gujarat, India INDIA ACULIFE HEALTHCARE PVT. LTD, INDIA SUN ENTERPRISES LTD 2024-02-26 2029-02-25

950 Rwanda FDA-HMP-MA-0974 DAFRAZOL® IV 42.6 mg of omeprazole sodium, corresponding to 40 mg of omeprazole 40 mg Powder for Solution for Injection 12 ml Vial and 10 ml Ampoule Transparent Glass powder vial Type I and Colourless Glass Solvent Ampoule Hydrolytic Class I 36 Months ANFARM HELLAS S.A, 61st km. Nat. Rd. Athens, Lamia, Schimatari Viotias, 32009, Greece GREECE DAFRA PHARMA GMbH SUN ENTERPRISES LTD 2024-02-26 2029-02-25

951 Rwanda FDA-HMP-MA-0975 ARBITEL-40 Telmisartan BP 40 mg 40 mg Tablets 3x10 Tablets Alu/ Alu Blister. Such 10 blisters are packed in a carton along with a pack insert 36 Months MICRO LABS LIMITED, 92 SIPCOT Industrial Complex, Hosur-635 126, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-26 2029-02-25

952 Rwanda FDA-HMP-MA-0976 NIFLURIL 400MG Morniflumate 400 mg 400 mg Suppository 8 Suppositories Polyvinylchloride film of 100 mm thickness, polyurethane adhesive, a low-density polyethylene film of 30 mm thickness 36 Months UPSA, 979, Avenue des Pyrenees, 47520 Le Passage –France FRANCE UPSA UBIPHARMA RWANDA LTD 2024-02-26 2029-02-25

953 Rwanda FDA-HMP-MA-0977 ERO-250 TABLETS Erythromycin Stearate Tablets BP 250 mg 250 mg Film Coated tablets 1000 Tablets and 10x10 tablets Jar pack for 1000 tablets and Blister Pack for 10x10 tablets 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial, Co-Op, Estate Ltd, Gauraipada, Vasai (E), Dist. Thane-401208, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-02-26 2029-02-25

954 Rwanda FDA-HMP-MA-0979 TINI-500 Tinidazole Tablets 500 mg 500 mg Film Coated Tablets 10x10 Tablets Blister Pack, such a 10 Blisters Packed in Printed Carton with Packing Insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-02-26 2029-02-25

955 Rwanda FDA-HMP-MA-0980 ARTEFAN 20MG/120MG Artemether/Lumefantrine 20mg/120mg 20mg/120mg Uncoated Tablets 1x 6’s, 1x12’s, 1x18’s, 1x24’s, 30x6’s, 30x12’s, 30x18’s, 30x24’s, 30x8’s Tablets PVC-PVdC/Aluminium Blister packs, packed in a carton along with pack insert 24 Months AJANTA PHARMA LIMITED, B-4/5/6, M.I.D.C. Area, Paithan, Dist. Aurangabad,431148 Maharashtra, India INDIA AJANTA PHARMA LTD, INDIA ABACUS PHARMA (A) LTD 2024-02-26 2029-02-25

956 Rwanda FDA-HMP-MA-0981 PULMOCEF -250 Cefuroxime Axetil USP 250mg 250mg Film coated tablets 1x10 Tablets Alu/Alu Blister Pack 36 Months MICRO LABS LIMITED, No.121-124, 4th phase, K.I.A.D.B, Bommasandra Industrial Area, Anekal Taluk, Bangalore-560099, India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICAL (RWANDA) LTD 2024-02-26 2029-02-25

957 Rwanda FDA-HMP-MA-0982 KETAM. Ketamine Hydrochloride Injection BP 50mg/ml 50mg/ml Solution for Injection 10 ml Bottle USP type I 10 ml amber glass vial plugged with grey butyl rubber plugs and sealed with yellow colour flip off aluminium seal. 24 Months KILITCH DRUGS (INDIA) LTD, C-301/2, M.I.D.C T.T.C, Industrial Area, Pawane Village, Navi Mumbai - 400 705, India. INDIA KILITCH DRUGS (INDIA) LTD, INDIA. SUN ENTERPRISES LTD 2024-02-26 2029-02-25

958 Rwanda FDA-HMP-MA-0983 GALAXYS NEUROCARE PLUS CAPSULES Methylcobalamin 750mcg, Pregabalin 75mg, Folic acid BP 1.5mg, Pyridoxine hydrochloride BP 3mg, Alpha Lipoic acid USP 100mg 750mcg, 75mg, 1.5mg, 3mg, 100mg Soft Gelatin Capsules 3 X 10 Capsules Blister aluminium foil/plain PVDC foil pack of capsules packed in a primary carton along with the pack insert. 24 Months SOFTGEL HEALTHCARE PRIVATE LIMITED, Survey no. 20/1, Vandalur Kelambakkam road, Pudupakkam village, Kancheepuram district– 603 103, Tamilnadu. Country: India. INDIA GALAXY PHARMACEUTICALS, INDIA STAR BIOTECH LIMITED 2024-02-26 2029-02-25

959 Rwanda FDA-HMP-MA-0984 GALAXY NEUROCARE CAPSULES Methylcobalamin 1500mcg, Gamma Linoleic Acid (From Borage oil BP) 60 mg, Alpha Lipoic Acid USP 100 mg, Folic Acid BP 1.5 mg, Pyridoxine Hydrochloride BP 3 mg, Biotin USP 3mg, Elemental Chromium (as Chromium Picolinate USP) 100 mcg, Elemental Zinc (as Zinc Sulfate USP) 10 mg 1500mcg,60 mg, 100 mg, 1.5 mg,3 mg, 3mg, 100 mcg,10 mg Soft Gelatin Capsules 3 X 10 Capsules Blister aluminium foil/plain PVDC foil pack of capsules packed in a primary carton along with the pack insert 24 Months SOFTGEL HEALTHCARE PRIVATE LIMITED, Survey no. 20/1, Vandalur Kelambakkam road, Pudupakkam village, Kancheepuram district– 603 103, Tamilnadu. India. INDIA GALAXY PHARMACEUTICALS, INDIA STAR BIOTECH LIMITED 2024-02-26 2029-02-25

960 Rwanda FDA-HMP-MA-0985 METAGO-250 MG Metronidazole BP 250 mg 250 mg Uncoated Tablets 1000 Tablets and 10x10 tablets Jar pack for 1000 tablets and Aluminum foil/PVC foil for 10x10 tablets 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-02-26 2029-02-25

961 Rwanda FDA-HMP-MA-0986 FERLIX B12 Each 5 ml syrup contain: Ferric ammonium citrate 200mg equivalent to 41 mg of elemental iron, 500 micrograms of Folic acid BP and 5 micrograms of Vitamin B12 as cyanocobalamin 200mg/500cmg/5cmg Syrup 200 ml Bottle Amber bottle colour and sealed with 28 mm pp cap with latex wad. The bottle is packed in a printed carton with one patient information leaflet and a measuring cup 36 Months MADRAS PHARMACEUTICAL LTD, Pot/building number: 137-boldmahabalipuram road. Street/area name: karapakkam. city: Chennai. Postal/pin code: 600097.state: Tamil Nadu, India INDIA B&O PHARM KIPHARMA LTD 2024-02-26 2029-02-25

962 Rwanda FDA-HMP-MA-0987 TRAVONORM PLUS Each mL of solution contains Travoprost 0.04 mg/ml, Timolol maleate 6.83 mg equivalent to Timolol 5 mg/ml 0.04 mg/ml, 5 mg/ml Eye drops 5ml Bottle LDPE plastic bottle with white plastic dropper covered with blue polypropylene plastic cap 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES, Al Obour City-Industrial zone, Area 14, 15 Block No. 12011 Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICAL INDUSTRIES, EGYPT ETS CONTINENTAL LTD 2024-02-26 2029-02-25

963 Rwanda FDA-HMP-MA-0988 DARUNAVIR AND RITONAVIR TABLETS Darunavir Ethanolate 400mg, Ritonavir 50mg 400mg/50mg Film coated tablets 30’s, 60’s, 120 Tablets HDPE Containers 24 Months HETERO LABS LIMITED, 22-110, IDA, Jeedimetla, Hyderabad-500 055, Telangana, India INDIA HETERO LABS LIMITED, INDIA SUN ENTERPRISES LTD 2024-02-26 2029-02-25

964 Rwanda FDA-HMP-MA-0989 SPECTROMAX-250 Clarithromycin 250mg 250 mg Film coated tablets 7 Tablets Blister of PVC film with printed laminated aluminum backing foil 36 Months NATIONAL PHARMACEUTICAL INDUSTRIES CO. (SAOG), P.O. Box 120, Rusal, Postal Code 124, Sultanate of Oman SULTANATE OF OMAN NATIONAL PHARMACEUTICAL INDUSTRIES CO. (SAOG) SUN ENTERPRISES LTD 2024-02-26 2029-02-25

965 Rwanda FDA-HMP-MA-0991 METCARE 500 Metformin Hydrochloride 500mg 500mg Tablets 10 x 10 Tablets ALU-PVC blisters packed in a carton 36 Months MERIT ORGANICS LTD, Plot No. 2104/2/A, G.I.D.C., Sarigam, Bhilad, Dist. Valsad - 396 155, Gujarat, India INDIA MERIT ORGANICS LTD SUN ENTERPRISES LTD 2024-02-26 2029-02-25

966 Rwanda FDA-HMP-MA-0992 TRICOLAM. Tinidazole BP 500mg 500mg Film coated tablets 25 x 4 Tablets Printed Aluminium foil, clear PVC film, in cartons with leaflet 36 Months MERIT ORGANICS LTD, Plot No. 2104/2/A, G.I.D.C., Sarigam, Bhilad, Dist. Valsad - 396 155, Gujarat, India INDIA MERIT ORGANICS LIMITED, INDIA. SUN ENTERPRISES LTD 2024-02-26 2029-02-25

967 Rwanda FDA-HMP-MA-0993 CLARITAB- 500 Clarithromycin BP 500mg 500 mg Film coated tablet 4 x 10 tablets Printed aluminium foil, clear PVC film, in cartons with leaflet 36 Months MERIT ORGANICS LTD. Plot No. 2104/2/A, G.I.D.C., Sarigam, Bhilad, Dist. Valsad - 396 155, Gujarat, India INDIA MERIT ORGANICS LIMITED, INDIA SUN ENTERPRISES LTD 2024-02-26 2029-02-25

968 Rwanda FDA-HMP-MA-0994 METCARE 850 Metformin Hydrochloride 850mg 850mg Tablet 10 x 10 Tablets ALU-PVC blisters packed in a carton 36 Months MERIT ORGANICS LTD. Plot No. 2104/2/A, G.I.D.C., Sarigam, Bhilad, Dist. Valsad - 396 155, Gujarat, India INDIA MERIT ORGANICS LIMITED, INDIA. 2024-02-26 2029-02-25

969 Rwanda FDA-HMP-MA-0995 ZYRTEC TABLETS Cetirizine dihydrochloride 10 mg 10 mg Film coated tablet 10 tablets PVC/Aluminium blister packs 60 Months UCB FARCHIM SA, Z.I. de Planchy, 10, Chemin de Croix Blanche, 1630 Bulle Switzerland. SWITZERLAND GLAXOSMITHKLINE PHARMACEUTICAL KENYA LIMITED KIPHARMA LTD 2024-02-26 2029-02-25

970 Rwanda FDA-HMP-MA-0996 AUROCARPINE Pilocarpine Nitrate USP 0.5%w/v 0.5%w/v Eye drops solution 1ml Bottle Amber glass vial with grey bromo butyl rubber wad and flip off seals 24 Months AUROLAB, No.1, Sivagangai Main Road, Veerapanjan, Madurai – 625 020, India INDIA AUROLAB, INDIA DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-26 2029-02-25

971 Rwanda FDA-HMP-MA-0997 KLAVMOX LB 625 Amoxicillin Trihydrate USP 500MG, Clavulanate potassium USP 125mg and Lactic acid bacillus 500mg/125mg Tablets 1×10 tablets ALU-ALU FOIL 24 Months KILITCH DRUGS (INDIA) LTD, T.T.C Industrial Area, M.I.D.C Turbh, Navi Mumbai, Maharashtra, India INDIA KILITCH DRUGS (INDIA) LTD, INDIA SUN ENTERPRISE LTD 2024-02-26 2029-02-25

972 Rwanda FDA-HMP-MA-0998 ENTEZMA OINTMENT Betamethasone (as Dipropionate BP) 0.5 mg and salicylic acid BP 30mg 0.5 mg and 30mg Ointment 1 Tube Aluminum collapsible tubes, which are packed in well labeled cartons 36 Months CENTAUR PHARMACEUTICAL PVT. LTD., Plant-I, Plot No.3,5B,2C, Tivim Industrial Estate, Karaswada, Mapusa, Goa-403 526, India INDIA CENTAUR PHARMACEUTICALS PVT. LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-26 2029-02-25

973 Rwanda FDA-HMP-MA-0999 OPELAN ODT 5 Olanzapine Orodispersible 5mg 5mg Tablets 3 x 10 Tablets Alu/Alu Blisters. 3 such Blisters packed in a carton 36 Months MICRO LABS LIMITED, No 27, Race Course Road, Bangalore - 560 001, India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-26 2029-02-25

974 Rwanda FDA-HMP-MA-1000 CANAZOL TABLETS Clotrimazole 100mg 100mg Tablets 6 Tablets Blisters strips made of printed aluminum foils, the pessaries and applicator are enclosed in a carboard carton 36 Months BIODEAL LABORATORIES LTD, Plot No.123, Lunga Lunga Road, P.O Box 32040-00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LTD, KENYA SUN ENTERPRISES LTD 2024-02-26 2029-02-25

975 Rwanda FDA-HMP-MA-1001 DYNACORT-6 TABLETS Deflazacort 6 mg tablets 6mg Tablets 3 X 10 Tablets Alu-Alu blister and such blisters packed in a carton along with product insert 36 Months SKY BIOTECH LIFE SCIENCES PVT. LTD, Gut no.5, Gevrai Tanda, Paithan road, Aurangabad (M.S) India INDIA GALAXY PHARMACEUTICALS LTD, INDIA STAR BIOTECH LIMITED 2024-02-26 2029-02-25

976 Rwanda FDA-HMP-MA-1002 KLAVMOX LB 1000 Amoxicillin Trihydrate USP 875mg, Clavulanate Potassium USP 125mg, With Lactic Acid Bacillus 60millions Spores 875mg/125mg Film coated tablets 10 tablets Alu-Alu printed foil blister and one blister parked in box along with leaflet and silica gel bag 24months KILITCH DRUGS (INDIA) LTD, 37/39, Ujagar Industrial estate, W.T.Patil marg, Deonar, Mumbai-400 088, Maharashtra, India INDIA KILITCH DRUGS (INDIA) SUN ENTERPRISE LTD 2024-02-26 2029-02-25

977 Rwanda FDA-HMP-MA-1003 TRIMEX ADULT COUGH EXPECTORANT Chlorpheniramine Maleate PB 2.0 mg, Pseudoephedrine HCl 30.0 mg; Guafenesin BP 100.0 mg 2.0 mg, 30.0 mg, 100.0 mg Syrup 100 ml Bottle Glass Amber Bottle round with threaded head packed in unit carton 36 Months LABORATORY AND ALLIED LIMITED, Plot No. 209/10349, Opposite Sameer Business Park, next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY AND ALLIED LIMITED, KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-26 2029-02-25

978 Rwanda FDA-HMP-MA-1032 COMBIART 20&120MG Artemether 20mg and Lumefantrine 120 mg 20mg/120mg Tablets 1x6’s,1x12’s,1x18’s,1x24’s and 4x6’s tablets PVC/PE/PVDC-ALU Blisters 24 Months STRIDES SHASUN LIMITED, 36/7, KRSG Garden Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore –562106, India INDIA STRIDES SHASUN LIMITED SUN ENTERPRISES LTD 2024-02-28 2029-02-27

979 Rwanda FDA-HMP-MA-1033 OMILOK-20 CAPSULES Omeprazole BP 20 mg 20 mg Hard gelatin capsules 10x10 Capsules Alu-PVC blisters. Such 10 blisters are packed in an outer carton along with the pack insert 36 Months MERIT ORGANICS LTD, Plot No. 2104/2/A, G.I.D.C., Sarigam, Bhilad, Dist. Valsad - 396 155, Gujarat, India INDIA MERIT ORGANICS LTD, INDIA SUN ENTERPRISES LTD 2024-02-28 2029-02-27

980 Rwanda FDA-HMP-MA-1034 SAMVEC-4 Vecuronium Bromide 4mg 4mg Lyophilised Powder for Injection 5 Vials Glass vials with five 2 ml ampoules of sterile water for injection packed in PVC tray such one tray along with packing insert is packed in a carton 24 Months SAMARTH LIFE SCIENCES PVT. LTD, Unit – II, Plot No: 2, Industrial Area, Lodhimajra, Baddi, Himachal Pradesh - 173 205, India INDIA SAMARTH LIFE SCIENCES PVT. LTD, INDIA SUN ENTERPRISES LTD 2024-02-28 2029-02-27

981 Rwanda FDA-HMP-MA-1035 RABEPRIDE CAPSULES Rabeprazole Sodium 20mg and Itropride Hydrochloride 150mg 20mg/150mg Hard Gelatin Capsules 3 x 10’s Capsules ALU-ALU Blisters packed in a carton 24 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Road, Ruaraka. P.O. Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED. KENYA SUN ENTERPRISE LTD 2024-02-28 2029-02-27

982 Rwanda FDA-HMP-MA-1036 ACEPAR MR CAPLETS Paracetamol 500 mg, Aceclofenac 100 mg and Chlorzoxazone 375 mg 500mg/100mg/375mg Film Coated Caplets 1x10 Caplets Alu–Alu Blister Pack 36 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Road, Ruaraka. P.O. Box 16633-00620, Nairobi, Kenya. KENYA DAWA LIMITED, KENYA SUN ENTERPRISE LTD 2024-02-28 2029-02-27

983 Rwanda FDA-HMP-MA-1037 ACEPAR CAPLETS Paracetamol BP 500mg and Aceclofenac BP 100mg 500mg/100mg Tablets 1x10s Tablets ALU–ALU Blister Pack and Carton 36 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Road, Ruaraka. P.O. Box 16633-00620, Nairobi, Kenya. KENYA DAWA LIMITED, KENYA. SUN ENTERPRISE LTD 2024-02-28 2029-02-27

984 Rwanda FDA-HMP-MA-1038 TRANGEL GEL Diclofenac Diethylammonium Gel Salt B.P. 1.16% w/w 1.16% w/w Gel for Topical administration 20mg Tube Aluminium Tubes 36 Months NEM LABORATORIES PVT. LTD, 133, Krishna Ind. Estate, Navghar Rd., Vasai (E), Dist. Thane- 401210, India. INDIA NEM LABORATORIES PVT. LTD, INDIA. RENE PHARMACY (R) LTD 2024-02-28 2029-02-27

985 Rwanda FDA-HMP-MA-1039 LIVOLUK Lactulose Solution USP 10 g 10 g Syrup 100 ml Bottle Amber PET Bottle 36 Months PANACEA BIOTEC PHARMA LIMITED, B-1 Ext. / A27, MCIE, Mathura Road, New Delhi-110044, India. INDIA PANACEA BIOTEC PHARMA LIMITED, INDIA AIVEEN RWANDA LIMITED 2024-02-28 2029-02-27

986 Rwanda FDA-HMP-MA-1040 SPASCOL® TABLETS Drotaverine Hydrochloride 80mg and Paracetamol 500mg 80mg, 500mg Film coated tablet 10 Tablets Alu-Alu Pack. Such 1 pack is packed in printed and laminated carton along with pack insert. 36 Months WEST-COSAT PHARMACEUTICAL WORK LTD, EP No.17&16/5, Meldi Estate, B/s Meldi Mata Temple, Near Gota Railway Crossing, At& Post Gota, Ahmedabad-382481. Gujarat, India INDIA BEKRA PHARMA UK LTD UBIPHARMA-RWANDA LTD 2024-02-28 2029-02-27

987 Rwanda FDA-HMP-MA-1041 WHITFIELD’S OINTMENT Benzoic Acid BP 6% w/w and Salicylic Acid BP 3% w/w 6% w/w- 3% w/w Ointment 25mg Aluminium tubes in unit carton with leaflet 36 Months REGAL PHARMACEUTICALS LIMITED, Plot No.: 7879/18, off Baba Dogo Road, Ruaraka, Postal address: P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2024-02-28 2029-02-27

988 Rwanda FDA-HMP-MA-1042 COMIT-100 TABLETS Sildenafil Citrate 100mg 100mg Film coated tablet 4 Tablets ALU/PVC BLISTER 36 Months BLISS GVS PHARMA LIMITED, Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Palghar, District- Thane 401404, India INDIA BLISS GVS PHARMA LTD SURYA DEPOT PHARMACY LTD 2024-02-28 2029-02-27

989 Rwanda FDA-HMP-MA-1043 IMPLANON NXT Etonogestrel 68 mg 68 mg Implant for subdermal use One implant The blister pack contains one implant which is preloaded in the stainless steel needle of a ready-for-use, disposable, sterile applicator 60 Months NV ORGANON, Kloosterstraat 6 5349 AB Oss. The Netherlands THE NETHERLANDS N.V. ORGANON UBIPHARM-RWANDA LTD 2024-02-28 2029-02-27

990 Rwanda FDA-HMP-MA-1044 EFFERALGAN 80 MG SUPPOSITORY Acetaminophen, 80mg 80mg Suppository 2x5’s suppositories Heat-Sealed Sachets, consisting of a Paper/Aluminium/Polyethylene Complex. 36 Months UPSA 304, Avenue du Docteur Jean Bru 47000 Agen – France FRANCE UPSA SAS, FRANCE UBIPHARMA RWANDA LTD 2024-02-28 2029-02-27

991 Rwanda FDA-HMP-MA-1045 SPASMOMEN TABLETS Otilonium Bromide 40mg 40mg Film-coated tablet 10 tablets or 30 tablets PVC/PVDC/AL blister, in a box 36 Months BERLIN CHEMIE AG, Glienicker Weg 125, D-12489 Berlin, Germany GERMANY GERMANY A. MENARINI INDUSTRIE FARMACEUTICHE RIUNITE S.R.L. FLORENCE-ITALY PRAFFIN RWANDA LTD 2024-02-28 2029-02-27

992 Rwanda FDA-HMP-MA-1046 MISO-FEM TABLETS Misoprostol HPMC 1% Dispersion USP 1% Dispersion Tablets 4 tablets in One or three aluminium/aluminium blister pack ALUMINIUM/ALUMINIUM BLISTER PACK 24 Months NAARI PHARMA PRIVATE LTD, Plot No, 14-16, 55-57, Sector -5, IIE, Pantnagar, Rudrapur-263153, Dis Udham singh Nagar Uttarakhand, India. INDIA NAARI PTE LIMITED, SINGAPORE CROWN HEALTHCARE ® LTD 2024-02-28 2029-02-27

993 Rwanda FDA-HMP-MA-1047 APEXIME® 200MG/5ML Azithromycin 200mg/5ml 200mg/5ml Suspension 15ml Bottle PET Bottle, packed in a carton 24 Months THE MADRAS PHARMACEUTICALS, 137-B Old Mahabalipuram Road, Karappakkam, Chennai, Tamilnadu – 603 103, India. INDIA CROSS PHARM SA, SUISSE. GOMHS LTD 2024-02-28 2029-02-27

994 Rwanda FDA-HMP-MA-1048 APEXIME® 500 MG TABLETS Azithromycin 500mg 500mg Film-coated tablet 3 Tablets ALU/PVC blister, and in a printed carton 36 Months THE MADRAS PHARMACEUTICALS, 137-B Old Mahabalipuram Road, Karappakkam, Chennai, Tamilnadu – 603 103, India. INDIA CROSS PHARM SA, SUISSE GOMHS LTD 2024-02-28 2029-02-27

995 Rwanda FDA-HMP-MA-1049 SILDENAFIL-100 TABLETS Sildenafil Citrate BP 100mg 100mg Film coated tablet 4 Tablets ALU-PVC blister is packed in a carton along with insert 36 Months MERIT ORGANICS LTD, Plot No. 2104/2/A, G.I.D.C., Sarigam, Bhilad, Dist. Valsad - 396 155, Gujarat, India INDIA MERIT ORGANICS LTD SUN ENTERPRISES LTD 2024-02-28 2029-02-27

996 Rwanda FDA-HMP-MA-1050 ARIMIDEX® 1 MG TABLETS Anastrozole 1mg 1mg Film Coated Tablet 14*2 (28) Tablets PVC/Aluminium Blister 60 Months ASTRAZENECA UK LTD, Silk Road Business Park, Macclesfield, SK10 2NA, United Kingdom UNITED KINGDOM ASTRAZENECA UK LIMITED SURGIPHARM (RWANDA) LTD 2024-02-28 2029-02-27

997 Rwanda FDA-HMP-MA-1051 LOPINAVIR 200 MG & RITONAVIR 50 MG TABLETS Lopinavir 200 mg & Ritonavir 50 mg 200 mg, 50 mg Film Coated Tablet 60 Tablets White HDPE Container &Silica gel bag 24 Months CIPLA LIMITED, Patalganga Unit II MIDC Patalganga 410 220, District Raigad, Maharashtra, India INDIA CIPLA LTD PHILLIPS PHARMACEUTICALS RWANDA LTD 2024-02-28 2029-02-27

998 Rwanda FDA-HMP-MA- 1052 ALLERBAN SYRUP Chlorpheniramine Maleate 2mg/5ml 2mg/5ml Syrup 100ml Bottle HDPE round bottle with polypropylene screw cap 24 Months VARICHEM PHARMACEUTICALS (PVT.) LTD, 194 Gleneagles road, Willow vale, Harare, Zimbabwe ZIMBABWE VARICHEM PHARMACEUTICALS (PVT.) LTD ACTIVIS PHARMA 2024-02-28 2029-02-27

999 Rwanda FDA-HMP-MA-1053 CORILIEF DRY COUGH SYRUP Dextromethorphan Hydrobromide 15mg/5ml 15mg/5ml Syrup 100ml Bottle Amber Glass Bottle with a Polypropylene screw cap/ HDPE bottlewith LDPE cap 24 Months VARICHEM PHARMACEUTICALS (PVT) LTD, 194 Gleneagles Road, Willow vale, Harare, Zimbabwe ZIMBABWE VARICHEM PHARMACEUTICALS (PVT) LTD ACTIVIS PHARMA 2024-02-28 2029-02-27

1000 Rwanda FDA-HMP-MA-1054 MYLOVASC–2.5 TABLETS. S-Amlodipine Besilate 2.5mg 2.5mg Tablet 3x10 Tablets Aluminium Foil & Amber Color PVC Film Blister Pack, packed in a carton with a package insert 36 Months BAFNA PHARMACEUTICALS LTD No.147, Madhavaram Redhills High Road, Grantlyon, Vadakarai Post, India. INDIA PRISMA PHARMA FZE PRAFIN (RWANDA) LTD 2024-02-28 2029-02-27

1001 Rwanda FDA-HMP-MA-1055 MYLOVASC 5 TABLETS S-Amlodipine besilate 5mg 5mg Tablet 3x10 Tablets Aluminium Foil & Amber Color PVC Film Blister Pack, packed in a carton with a package insert 36 Months BAFNA PHARMACEUTICALS LTD No.147, Madhavaram Redhills High Road, Grantlyon, Vadakarai Post, India. INDIA PRISMA PHARMA FZE PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-02-28 2029-02-27

1002 Rwanda FDA-HMP-MA-1056 LYSOFLAM TABLETS Paracetamol, Diclofenac Potassium and Serratiopeptidase, 500 mg&50 mg&15mg, Tablets 500 mg&50 mg&15mg Film-Coated Tablets 1x10 Tablets Alu-PVC Blister 24 Months CACHET PHARMACEUTICAL PVT. LTD. Thana, Baddi, Himachal Pradesh-173 205, India INDIA CACHET PHARMACEUTICALS PVT. LTD SURGIPHARM (RWANDA) LIMITED 2024-02-28 2029-02-27

1003 Rwanda FDA-HMP-MA-1057 HYTAN-80 TABLETS Telmisartan USP 80mg 80mg Uncoated Tablets 3x10 Tablets Alu/Alu Blister. Such Blister packed in a carton along with product insert 24 Months BAFNA PHARMACEUTICALS LTD., No.147, Madhavaram Redhills High Road, Grantlyon, Vadakarai Post, Chennai – 600 052, India INDIA PRISMA PHARMA FZE, DUBAI, U.A.E. PRAFIN RWANDA LTD 2024-02-28 2029-02-27

1004 Rwanda FDA-HBP-MA-0114 REPOITIN 4000 IU Erythropoietin Concentrated Solution B.P. (Epoetin Alfa), 4000 IU/0.4 mL 4000 IU/0.4 mL Solution for injection 1 Vial Type -I glass vial with bromobutyl rubber and aluminium seal having flip off cap 24 Months SERUM INSTITUTE OF INDIA PVT. LTD. 212/2, Hadapsar, Off Soli-Poonawalla Road, Pune - 411028, Maharashtra, India INDIA SERUM INSTITUTE OF INDIA PVT. LTD, INDIA SUN ENTERPRISES LTD 2024-02-28 2029-02-27

1005 Rwanda FDA-HBP-MA-0116 FOLIGRAF 150 I.U INJECTION Recombinant-Human Follicle Stimulating Hormone for Injection 150 IU 150 IU Sterile Solution 0.5 ml in pre-filled syringes Pre-filled syringes containing 0.5ml of sterile colourless liquid having FOLIGRAF (r-hFSH) activity of 150 I.U. USP Type 1 glass Barrel along with Plunger stopper nested 24 Months BHARAT SERUMS & VACCINES LTD, Plot No. K-27, K-27 part and K-27/1, Anand Nagar, Jambivili Village, Additional MIDC, Ambernath (East), Thane 421501 Maharashtra State, India INDIA BHARAT SERUMS & VACCINES LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-28 2029-02-27

1006 Rwanda FDA-HMP-MA-0990 MICOVAR ORAL GEL Miconazole 20 mg 20 mg Gel 40g Tube Collapsible Aluminium tube 24 Months VARICHEM PHARMACEUTICALS (PVT) LTD, 194 Gleneagles Road, Willlowvale, Harare, Zimbabwe ZIMBABWE VARICHEM PHARMACEUTICALS (PVT) LTD ACTIVIS PHARMA 2024-02-28 2029-02-27

1007 Rwanda FDA-HMP-MA-1014 TWINZOL SDU Dorzolamide Hydrochloride 20mg/ml and Timolol Maleate 5mg/ml 20mg/ml-5mg/ml Solution 0.2 ml strips Carton box containing strips, each containing 5 LDPE plastic single dose units each of 0.2 ml + insert leaflet 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES, Al Obour City-Industrial zone, Area 14, 15 Block no. 12011 Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICAL INDUSTRIES, EGYPT ETS CONTINENTAL LTD 2024-02-28 2029-02-27

1008 Rwanda FDA-HMP-MA-1015 ORCHAZID SDU Ketotifen fumarate 0.25mg/ml 0.25mg/ml Solution 30x0.4ml strips LDPE white plastic single dose unit 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES, Al Obour city, Industrial zone, Area15, Block no. 12011, Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICAL INDUSTRIES, EGYPT ETS CONTINENTAL LTD 2024-02-28 2029-02-27

1009 Rwanda FDA-HMP-MA-1016 MOXACIL 500 MG Amoxicillin Trihydrate BP 500mg 500 mg Hard Gelatin Capsules 10x10 capsules, 500’s & 1000 capsules PVC blister pack in a unit box and bulk packs of 1000’s or 500’s in HDPE jars 36 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Rd, Ruaraka, P.O. Box 16633-00620, Kenya KENYA DAWA LIMITED, KENYA SUN ENTERPRISES LIMITED 2024-02-28 2029-02-27

1010 Rwanda FDA-HMP-MA-1017 AKEROL SYRUP 2.5MG/5ML Desloratadine 2.5mg/5ml 2.5mg/5ml Syrup 60 ml Bottle Amber PET bottle, in printed and laminated carton 36 Months WEST-COAST PHARMACEUTICAL WORKS LTD F.P. No. 17 & 16/5, Meldi Estate, B/s Meldi Mata Temple, Near Gota Railway Crossing, At & Post Gota, Ahmedabad – 382481. Gujarat State, India INDIA BEKRA PHARMA UK LTD UBIPHARM RWANDA LTD 2024-02-28 2029-02-27

1011 Rwanda FDA-HMP-MA-1018 NEUROGIL®75 Pregabalin 75mg 75mg Hard gelatin Capsule 2 x 10 capsules ALU/ALU Pack 36 Months WEST-COAST PHARMACEUTICAL WORKS LTD, F.P. No. 17 & 16/5, Meldi Estate, B/S Meldi Mata Temple, Near Gota Railway Crossing, At & Post Gota, Ahmedabad- 382481 Gujarat State, India INDIA BEKRA PHARMA UK LTD UBIPHARM RWANDA LTD 2024-02-28 2029-02-27

1012 Rwanda FDA-HMP-MA-1020 ZEPIN-400 Carbamazepine BP 400mg 400 mg Film-coated tablets 100 Tablets Jar Pack 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LIMITED, INDIA SUN ENTERPRISES LTD 2024-02-28 2029-02-27

1013 Rwanda FDA-HMP-MA-1021 CIT-20 TABLETS Citalopram Hydrobromide BP equivalent to Citalopram 20mg 20mg Film-coated tablets 100 tablets Jar packed in the export-worthy shipper. Shippers are sealed with bopp tape 36 Months AGOG PHARMA LIMITED, Plot No. 33, Sector II, The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LIMITED, INDIA SUN ENTERPRISES LTD 2024-02-28 2029-02-27

1014 Rwanda FDA-HMP-MA-1022 ZEPIN SYRUP Carbamazepine BP 100mg 100 mg Syrup 250 ml Bottle PET amber-coloured bottle packed in a carton box 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LIMITED, INDIA SUN ENTERPRISES LTD 2024-02-28 2029-02-27

1015 Rwanda FDA-HMP-MA-1023 ALUCID TABLETS Aluminium hydroxide BP 500mg 500mg Tablets 1000’s Tablets JAR PACK 36 Months AGOG PHARMA LIMITED, Plot No. 33, Sector II, The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LIMITED, INDIA SUN ENTERPRISES LTD 2024-02-28 2029-02-27

1016 Rwanda FDA-HMP-MA-1024 INBEC TABLETS Dolutegravir 50mg, Lamivudine 300mg and Abacavir 600mg 50mg/300mg/600mg Tablets 30 Tablets 100CC HDPE CONTAINER 24 Months EMCURE PHARMACEUTICALS LTD, Plot No P-2 I.T.B park, phase II, M.I.D.C, Hinjwadi, Pune-411057, India INDIA EMCURE PHARMACEUTICALS LTD; INDIA ABACUS PHARMA (A) LTD 2024-02-28 2029-02-27

1017 Rwanda FDA-HMP-MA-1025 FERVEX ADULT Paracetamol 500mg, Ascorbic acid (Vitamin C) 200mg and Pheniramine 25mg 500mg/200mg/25mg Granulated oral powder 8 sachets Paper/Aluminium/Polyethylene complex enclosed in a carton box 24 Months UPSA SAS, 979, Avenue des Pyrénées 47520 Le Passage – France FRANCE UPSA SAS UBIPHARM-RWANDA LTD 2024-02-28 2029-02-27

1018 Rwanda FDA-HMP-MA-1026 LORHISTINA 10MG TABLETS Loratadine 10mg tablets 10mg Tablets 30 tablets Blister packing with PVDC coated PVC and 20 microns’ aluminum foil pharma grade packed in 300 gm cartons with literature insert 36 Months COSMOS LIMITED, Rangwe Road; Off Lunga Lunga Road, Industrial Area, P.O. Box 41433, Gpo 00100-Nairobi, Kenya KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-02-28 2029-02-27

1019 Rwanda FDA-HMP-MA-1027 PROFEN 400MG TABLETS Ibuprofen BP 400mg 400mg Film-coated tablets 10x10’s Tablets and 500 Tablets Blisters of 10x10’s in a unit box with literature insert and 500’s in HDPE containers with literature insert 36 Months LABORATORY AND ALLIED LIMITED, Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY AND ALLIED LIMITED DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-28 2029-02-27

1020 Rwanda FDA-HMP-MA-1028 DEPAKINE CHRONO 500MG Sodium Valproate + Valproic Acid 500mg 500mg Tablets 30 tablets Polypropylene tube secured by a Polyethylene stopper containing a desiccant 36 Months SANOFI WINTHROP INDUSTRIE-AMBARES, 1, Rue de la Vierge Ambares et Lagrave 33565 Carbon Blanc Cedex, France FRANCE SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2024-02-28 2029-02-27

1021 Rwanda FDA-HMP-MA-1029 SPECTROMAX 500 Clarithromycin 500mg 500mg Tablets 2x7 Tablets Blister of PVC/PE/PVDC film with printed laminated aluminum backing foil. Two such blisters are packed in a carton 36 Months NATIONAL PHARMACEUTICAL INDUSTRIES CO. (SAOC), P. O Box 120, Rusayl, Postal code 124, Sultanate of Oman SULTANATE OF OMAN NATIONAL PHARMACEUTICAL INDUSTRIES CO. (SAOC) SUN ENTERPRISES LTD 2024-02-28 2029-02-27

1022 Rwanda FDA-HMP-MA-1030 CIDINE Cinitapride, 1mg 1mg Tablets 5x10 Tablets PVC/ Aluminium blister pack. Such five blisters are packed in a carton along with pack insert 60 Months INDUSTRIAS FARMACEUTICAS ALMIRALL, S.A., Ctra. Nacional II, Km 593 E-08740 Sant Andreu de la Barca Barcelona, Spain SPAIN ALMIRALL, S.A. ETS CONTINENTAL LTD 2024-02-28 2029-02-27

1023 Rwanda FDA-HMP-MA-1031 TRIMEX DIABETIC COUGH SYRUP Chlorpheniramine Maleate 2mg, Pseudoephedrine HCl 30mg and Guaifenesin BP 100mg 2mg/30mg/100mg Syrup 100 ml Bottle 100 ml Amber glass bottle and in a unit carton pack 36 Months REGAL PHARMACEUTICALS LTD, P.O Box 44421-00100 GPO, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2024-02-28 2029-02-27

1024 Rwanda FDA-HMP-MA-1539 D5 GLUCOSE INTRAVENOUS INFUSION BP Solution for Infusion 500ml 60 Amanta Healthcare Limited India Amanta Healthcare Limited SUN ENTERPRISES LTD 2024-02-29 2029-02-26

1025 Rwanda FDA-HMP-MA-1066 CORILIEF ® 5 FLU Paracetamol 500mg, Diphenhydramine Hydrochloride 12.5mg, Pseudoephedrine Hydrochloride 22.5mg 500mg, 12.5mg, 22.5mg Tablet 20’s tablets or 24’s tablets HDPE round bottles with aluminium waded HDPE screw caps or PVC-Aluminium blister packs 24 Months VARICHEM PHARMACEUTICALS (PVT) LTD, 194 Gleneagles Road, Willowvale, Harare, Zimbabwe ZIMBABWE VARICHEM PHARMACEUTICALS (PVT) LTD ACTIVIS PHARMA. 2024-04-20 2029-04-19

1026 Rwanda FDA-HMP-MA-1067 CORILIEF® SINUS PAIN & ALLERGY RELIEF TABLETS Paracetamol 500mg, Pseudoephedrine Hydrochloride 30mg, Chlorpheniramine Maleate 2mg 500mg, 30mg, 2mg Tablet 20 tablets PVC/Aluminium foil blister 24 Months VARICHEM PHARMACEUTICALS (PVT) LTD, 194 Gleneagles Road, Willowvale, Harare, Zimbabwe ZIMBABWE VARICHEM PHARMACEUTICALS (PVT) LTD ACTIVIS PHARMA 2024-04-20 2029-04-19

1027 Rwanda FDA-HMP-MA-1068 FLUMED SYRUP Paracetamol 120mg, Chlorpheniramine Maleate 0.5mg, Phenylephrine Hydrochloride 2.5mg and Dextromethorphan Hydrobromide 2mg 120mg, 0.5mg, 2.5mg, 2mg Syrup 100 ml bottle HDPE bottle packed in a printed carton 24 Months VARICHEM PHARMACEUTICALS (PVT) LTD, 194 Gleneagles Road, Willowvale, Harare, Zimbabwe ZIMBABWE VARICHEM PHARMACEUTICALS (PVT) LTD ACTIVIS PHARMA 2024-04-20 2029-04-19

1028 Rwanda FDA-HMP-MA-1069 GIGAPYN TABLETS Paracetamol 500mg, Codeine Phosphate 8mg 500mg, 8mg Tablets 30’s and 100’s tablets or 3x10 tablets & or 1000 tablets 30’s and 100’s tablets in white round HDPE jar or induction sealing liner PVC/ Aluminium foil blister of 10 tablets in a carton of 30’s and or 1000’s 24 Months VARICHEM PHARMACEUTICALS (PVT) LTD, 194 Gleneagles Road, Willowvale, Harare, Zimbabwe ZIMBABWE VARICHEM PHARMACEUTICALS (PVT) LTD ACTIVIS PHARMA 2024-04-20 2029-04-19

1029 Rwanda FDA-HMP-MA-1070 ZINCOL TABLETS Zinc (as sulphate), 20mg 20 mg Dispersible Tablets 10 × 10 tablets PVC/Aluminium blisters packed in dispenser carton 24 Months VARICHEM PHARMACEUTICALS (PVT) LTD, 194 Gleneagles Road, Willowvale, Harare, Zimbabwe ZIMBABWE VARICHEM PHARMACEUTICALS (PVT) LTD ACTIVIS PHARMA 2024-04-20 2029-04-19

1030 Rwanda FDA-HMP-MA-1071 KOFLYN RASPBERRY FLAVOUR COUGH EXPECTORANT Chlorpheniramine Maleate 2.2mg, Ammonium Chloride 110mg and Sodium Citrate 40mg per 5ml 2.2mg, 110mg, 40mg per 5ml Syrup 100 ml bottle Amber coloured glass bottles that are sealed with 25mm ROPP aluminium caps and labelled, then packed in unit cartons made of chipboard 36 Months BETA HEALTHCARE INTERNATIONAL LTD, Plot No. LR 209/6554, Mogadishu Road, Industrial Area, Nairobi, Kenya KENYA BETA HEALTHCARE INTERNATIONAL LTD SURGIPHARM (RWANDA) LIMITED 2024-04-20 2029-04-19

1031 Rwanda FDA-HMP-MA-1073 OMOL TABLETS Paracetamol 500mg 500 mg Uncoated Tablet 2×10 tablets PVDC / PE coated PVC blisters, backed up with aluminium foil in a carton box 36 Months NATIONAL PHARMACEUTICAL INDUSTRIES CO. (SAOC), P.O. Box 120, Rusayl, Postal code 124, Sultanate of Oman SULTANATE OF OMAN NATIONAL PHARMACEUTICAL INDUSTRIES CO. (SAOC) SUN ENTERPRISE LTD 2024-04-20 2029-04-19

1032 Rwanda FDA-HMP-MA-1074 PAUSE 500 Tranexamic Acid 500mg 500 mg Film coated tablet 3×10 tablets VMCH coated Alu foil/ PVC blister strips packed in a carton 24 Months EMCURE PHARMACEUTICALS LTD, Lane No. 3. Phase-II, SIDCO, Industrial Complex, Bari – Brahmana, Jammu (J&K) – 181133, India INDIA EMCURE PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

1033 Rwanda FDA-HMP-MA-1075 AMOXICILLIN CAPSULE 250MG Amoxicillin trihydrate 250mg 250 mg Hard Gelatin Capsules 10×10 capsules Aluminum foil and PVC blisters packed in box. Amber PET coloured bottle in a unit carton with a literature insert 36 Months REYOUNG PHARMACEUTICAL CO., LTD, No.1, Ruiyang Road, Yiyuan County, Shandong Province, P.R. China CHINA REYOUNG PHARMACEUTICAL CO., LTD SUN ENTREPRISES LTD 2024-04-20 2029-04-19

1034 Rwanda FDA-HMP-MA-1076 DACOF PAEDIATRIC SYRUP Diphenhydramine hydrochloride BP 7.0mg and Sodium Citrate BP 28.5mg 7.0mg & 28.5mg per 5ml Syrup 100 ml Bottle Amber PET coloured bottle in a unit carton with a literature insert 36 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTREPRISES LTD 2024-04-20 2029-04-19

1035 Rwanda FDA-HMP-MA-1077 ZEFONE-1000 Ceftriaxone Sodium 1000mg 1000 mg Dry powder for injection 10 ml glass vial Moulded clear glass vial, sealed with grey colored butyl rubber plugs with colored flip off seal 24 Months INJECT CARE PARENTERALS PVT. LTD, Plot. No. 130, Silvassa Road, G.I.D.C., Vapi-396195, India INDIA CADILA HEALTHCARE LTD ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

1036 Rwanda FDA-HMP-MA-1079 DACOF DRY COUGH SYRUP Diphenhydramine Hydrochloride BP 12.5mg + Dextromethophan Hybromide 6.5mg 12.5mg + 6.5 mg per 5ml Syrup 100 ml bottle Amber coloured bottle tightly closed with Aluminium cap/ label, unit box and measuring cap 36 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Rd, Ruaraka, P.O. Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-04-20 2029-04-19

1037 Rwanda FDA-HMP-MA-1080 CURAMOL SUSPENSION Paracetamol 125mg/5ml 120mg/5ml Suspension 100mL & 60mL bottles Amber colored PET bottle in printed unit carton 36 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Rd, Ruaraka, P.O. Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-04-20 2029-04-19

1038 Rwanda FDA-HMP-MA-1081 POLYFRESH Sodium Hyaluronate 2mg/ml 2mg/ml Sterile ophthalmic solution 10 ml dropper bottle Low-density polyethyene (LDPE) Dropper bottle with polypropylene cover 36 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES. Al Obour City-Industrial zone, Area 14, 15 Block no. 12011 Cairo, Egypt P.O Box 11341 Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICAL INDUSTRIES ETS CONTINENTAL 2024-04-20 2029-04-19

1039 Rwanda FDA-HMP-MA-1082 NEBTAS 5 Nebivolol Hydrochloride 5mg 5 mg Uncoated Tablet 1x 10 tablets Alu/PVC blister 36 Months INTAS PHARMACEUTICALS LIMITED, Camp Road, Selaqui – 248 197, Dehradun, Uttarakhand, India INDIA INTAS PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

1040 Rwanda FDA-HMP-MA-1083 LEVOC 500 Levofloxacin USP 500mg 500 mg Film Coated Tablets 3 x 10 Film Coated Tablets Alu-Alu Blisters pack 36 Months ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar, Nagpur 441501, Maharashtra State, India INDIA ZIM LABORATORIES LIMITED SUN ENTERPRISES LTD 2024-04-20 2029-04-19

1041 Rwanda FDA-HMP-MA-1084 INVEGA SUSTENNA® 100 MG Paliperidone Palmitate 156mg equivalent to Paliperidone 100mg 100 mg Suspension for injection 1ml Long pre-filled syringe and two needles. Pre-filled syringe (cyclic olefin-copolymer) with a plunger stopper, backstop, and tip cap (bromobutyl rubber) with a 22G 1½-inch safety needle (0.72 mm x 38.1 mm) and a 23G 1-inch safety needle (0.64 mm x 25.4 mm) 24 Months JANSSEN PHARMACEUTICA NV, Tumhoutseweg 30; B2340 Beerse Belgium Tumhoutseweg 30; B2340 Beerse, Belgium BELGIUM JANSSEN-CILAG INTERNATIONAL NV, BELGIUM KIPHARMA LTD 2024-04-20 2029-04-19

1042 Rwanda FDA-HMP-MA-1085 INVEGA SUSTENNA® 25 MG Paliperidone Palmitate 39mg equivalent to Paliperidone 25mg 25 mg Suspension for injection 0.5ml pre-filled syringe and two needles. Pre-filled syringe with needle (cyclic olefin-copolymer) with a plunger stopper, backstop, and tip cap (bromobutyl rubber) with a 22G 1½-inch safety needle (0.72 mm x 38.1 mm) and a 23G 1-inch safety needle (0.64 mm x 25.4 mm). 24 Months JANSSEN PHARMACEUTICA NV, Tumhoutseweg 30; B2340 Beerse, Belgium Tumhoutseweg 30; B2340 Beerse, Belgium BELGIUM JANSSEN-CILAG INTERNATIONAL NV, BELGIUM KIPHARMA LTD 2024-04-20 2029-04-19

1043 Rwanda FDA-HMP-MA-1086 INVEGA SUSTENNA® 50 MG Paliperidone Palmitate 78mg equivalent to Paliperidone 50mg 50 mg Suspension for injection 0.5ml pre-filled syringe and two needles. Pre-filled syringe with needle (cyclic olefin-copolymer) with a plunger stopper, backstop, and tip cap (bromobutyl rubber) with a 22G 1½-inch safety needle (0.72 mm x 38.1 mm) and a 23G 1-inch safety needle (0.64 mm x 25.4 mm). 24 Months JANSSEN PHARMACEUTICA NV, Tumhoutseweg 30; B2340 Beerse, Belgium Tumhoutseweg 30; B2340 Beerse, Belgium BELGIUM JANSSEN-CILAG INTERNATIONAL NV, BELGIUM KIPHARMA LTD 2024-04-20 2029-04-19

1044 Rwanda FDA-HMP-MA-1087 INVEGA SUSTENNA® 75 MG Paliperidone Palmitate 117mg equivalent to Paliperidone 75mg 75mg Suspension for injection 1ml Long pre-filled syringe and two needles. Pre-filled syringe with needle (cyclic olefin-copolymer) with a plunger stopper, backstop, and tip cap (bromobutyl rubber) with a 22G 1½-inch safety needle (0.72 mm x 38.1 mm) and a 23G 1-inch safety needle (0.64 mm x 25.4 mm). 24 Months JANSSEN PHARMACEUTICA NV, Tumhoutseweg 30; B2340 Beerse, Belgium Tumhoutseweg 30; B2340 Beerse, Belgium BELGIUM JANSSEN-CILAG INTERNATIONAL NV, BELGIUM KIPHARMA LTD 2024-04-20 2029-04-19

1045 Rwanda FDA-HMP-MA-1088 INVEGA SUSTENNA® 150 MG Paliperidone Palmitate 234 mg equivalent to Paliperidone 150 mg 150 mg Suspension for injection 2.25ml pre-filled syringe and two needles. Pre-filled syringe with needle (cyclic olefin-copolymer) with a plunger stopper, backstop, and tip cap (bromobutyl rubber) with a 22G 1½-inch safety needle (0.72 mm x 38.1 mm) and a 23G 1-inch safety needle (0.64 mm x 25.4 mm). 24 Months JANSSEN PHARMACEUTICA NV, Tumhoutseweg 30; B2340 Beerse, Belgium Tumhoutseweg 30; B2340 Beerse, Belgium BELGIUM JANSSEN-CILAG INTERNATIONAL NV, BELGIUM KIPHARMA LTD 2024-04-20 2029-04-19

1046 Rwanda FDA-HMP-MA-1089 AMPIKARE 1G INJECTION Ampicillin Sodium 1g 1g Solution for injection 50’s x 7mL glass vials Mould vials glass containers, Non flip off cap, butyl rubber stopper, with adhesive label in box 36 Months REYOUNG PHARMACEUTICAL CO., LTD. No.1 Ruiyang Road, Yiyuan county, Shandong Province, P. R. China CHINA KAREMAX INDUSTRIAL LTD, INDIA SUN ENTERPRISES LTD 2024-04-20 2029-04-19

1047 Rwanda FDA-HMP-MA-1091 CLAMOXYL 1G TABLETS Amoxicillin Trihydrate 1g 1g Dispersible Tablets 2x6 tablets Blisters made of PVC PVdC complex and an aluminium lidding foil coated with a heat-sealing lacquer in a classic blister pack and a supplementary aluminium laminate material covers the PVC/PVdC for the tropicalised blster 24 Months GLAXO WELLCOME PRODUCTION, ZI de la Peyenniere 53100 Mayenne, France FRANCE GLAXOSMITHKLINE PHARMACEUTICAL KENYA LIMITED KIPHARMA LTD 2024-04-20 2029-04-19

1048 Rwanda FDA-HMP-MA-1092 ELMOX- CV 625 Amoxicillin and Clavulanate Potassium Tablets USP 625mg 625 mg Film coated tablets 2x10 tablets Alu-Alu Blisters packed in one Aluminium Pouch, this pouch is kept in one monocarton along with pack insert and silica gel bag 24 Months YELURI FORMULATIONS PVT LTD, Sy. No. 296 / 7 / 6, IDA Bollaram, Sanga reddy Dist. – 502 325, Telangana, India INDIA YELURI FORMULATIONS PVT LTD SUN ENTERPRISES LTD 2024-04-20 2029-04-19

1049 Rwanda FDA-HMP-MA-1093 VALPIN-200MG Valproate Tablets BP 200mg 200 mg Enteric coated tablets 10×10 tablets Alu Strips packed in a printed carton 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, TalKalol, District: Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

1050 Rwanda FDA-HMP-MA-1094 CHALEATE® TABLETS Chlorphenamine Maleate BP 4mg 4 mg Tablets 10x10 tablets and 1000 tablets Blisters in a unit box or HDPE container (1000 tablets) packed in a double layer polyethylene bag of 25kgs and closed in such a manner that it is air tight and then packed in Polythene bag and in HDPE/Poly Coated Fibre Drum 36 Months LABORATORY AND ALLIED LIMITED, Plot No. 209/10349, Opposite, Sameer Business Park, Next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY AND ALLIED LIMITED DEPOT PHARMACEUTIQUE LE MEDICAL 2024-04-20 2029-04-19

1051 Rwanda FDA-HMP-MA-1095 NATOA TABLETS Mebendazole BP 100mg 100 mg Tablets 6 tablets, 100 tablets and 1000 Tablets Packed in blister packs in a unit box and in HDPE Containers for 1000 tablets 36 Months LABORATORY AND ALLIED LIMITED, Plot No. 209/10349, Opposite, Sameer Business Park, Next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY AND ALLIED LIMITED DEPOT PHARMACEUTIQUE LE MEDICAL 2024-04-20 2029-04-19

1052 Rwanda FDA-HMP-MA-1096 KAMAGRA CT 100 Sildenafil Citrate USP 100 mg 100 mg Uncoated chewable Tablets 4 Tablets Alu- PVC/PVdC blister pack. 1 such blister is packed in a carton along with Patient Information Leaflet 24 Months AJANTA PHARMA LIMITED, Plot No. B-4/5/6, MIDC Area Paithan, Aurangabad-431148, Maharashtra State, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

1053 Rwanda FDA-HMP-MA-1097 KAMAGRA CT 50 Sildenafil Citrate USP 50 mg 50 mg Uncoated Chewable Tablets 4 Tablets Alu- PVC/PVdC blister. 1 such blister is packed in a carton along with Patient Information Leaflet 24 Months AJANTA PHARMA LIMITED, Plot No. B-4/5/6, MIDC Area Paithan, Aurangabad-431148, Maharashtra State, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

1054 Rwanda FDA-HMP-MA-1098 INSTACLOP 75 Clopidogrel Bisulfate 75 mg 75 mg Film coated Tablets 3x10 Tablets Aluminium strip foil and such 3 strips are packed into carton along with leaflet 36 Months AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED, INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

1055 Rwanda FDA-HMP-MA-1099 KAMAGRA 100 Sildenafil Citrate USP 100 mg 100 mg Film Coated Tablets 4 Tablets Alu- PVC blister pack. 1 such blister is packed in a carton along with Patient Information Leaflet 36 Months AJANTA PHARMA LIMITED, Plot No. B-4/5/6, MIDC Area Paithan, Aurangabad-431148, Maharashtra State, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

1056 Rwanda FDA-HMP-MA-1101 BOSUTINIB PFIZER 400 MG FILM-COATED TABLETS Bosutinib monohydrate 400 mg 400 mg Film Coated Tablets 28 or 30 Tablets PVC/Polychlorotrifluoroethene/PVC blisters 48 Months Pfizer Manufacturing Deutschland GmbH, Betriebsstätte Freiburg Mooswaldallee 1 79090 Freiburg, Germany GERMANY PFIZER LIMITED, UNITED KINGDOM GILMED LIMITED 2024-04-20 2029-04-19

1057 Rwanda FDA-HMP-MA-1102 TOFACITINIB PFIZER 5 FILM COATED TABLETS Tofacitinib Citrate 5 mg 5 mg Film Coated Tablets 56 Tablets Aluminium foil/PVC Blisters 48 Months Pfizer Manufacturing Deutschland GmbH Betriebsstätte, Freiburg Mooswaldallee 1 79090 Freiburg Germany GERMANY PFIZER LIMITED, UNITED KINGDOM GILMED LIMITED 2024-04-20 2029-04-19

1058 Rwanda FDA-HMP-MA-1103 RALEF 90 Etoricoxib 90mg 90mg Film Coated Tablets 7 Tablets Alu-PVC/PVdC blister, 1 such blister is packed in a carton along with patient information Leaflet. 24 Months AJANTA PHARMA LIMITED, Plot No. B-4/5/6, MIDC Area Paithan, Aurangabad-431148, Maharashtra State, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

1059 Rwanda FDA-HMP-MA-1104 AGODAPS-100 TABLETS Dapsone tablets BP 100mg 100mg Uncoated Tablets 10x10 Tablets Blister Pack 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-04-20 2029-04-19

1060 Rwanda FDA-HMP-MA-1105 ABACAVIR 600 MG AND LAMIVUDINE 300 MG TABLETS Abacavir Sulfate USP 600mg, Lamivudine USP 300mg 600 mg and 300 mg Film-coated tablets 30 tablets HDPE container 24 Months MACLEODS PHARMACEUTICALS LTD. Block N-2, Village Theda, Post Office Lodhimajra, Tehsil Baddi, Dist. Solan, Himachal Pradesh – 174101 India INDIA MACLEODS PHARMACEUTICALS LTD AIVEEN RWANDA LIMITED 2024-04-20 2029-04-19

1061 Rwanda FDA-HMP-MA-1106 LOKIT HP Clarithromycin USP 250mg, Omeprazole BP 20mg and Tinidazole BP 500mg 250 mg, 20 mg, 500 mg Combipack of Tablets & Capsules 7 x 1 x 6 Tablets & Capsules Alu/Alu strip of Tablets & Capsules packed in a paperboard carton 36 Months KOPRAN LIMITED, Village Savroli, Tal. Khalapur, Dist. Raigad – 410 202 Maharashtra, India INDIA KOPRAN LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-04-20 2029-04-19

1062 Rwanda FDA-HMP-MA-1107 AMADAY PL 5/4 Amlodipine 5mg and Perindopril Erbumine BP 4mg 5mg, 4mg Uncoated tablets 3x 10 tablets Alu-PVC/Alu blisters packed in a carton box 24 Months AJANTA PHARMA LIMITED, Mirza-Palashbari Road, Village Kokjhar, Kamrup (R), Guwahati, Assam - 781128, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

1063 Rwanda FDA-HMP-MA-1108 TELMICLAR 40 Telmisartan USP 40mg 40 mg Uncoated tablet 3x 10 tablets Alu-PVC/Alu blisters packed in a carton box along with pack insert 24 Months AJANTA PHARMA LIMITED, Mirza-Palashbari Road, Village Kokjhar, Kamrup (R), 1085Guwahati, Assam - 781128, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

1064 Rwanda FDA-HMP-MA-1109 NEBUNTA 5 Nebivolol Hydrochloride IH 5mg 5 mg Uncoated tablet 3x 10 tablets Alu-PVC/Alu blisters packed in a carton box along with pack insert 24 Months AJANTA PHARMA LIMITED, Mirza-Palashbari Road, Village Kokjhar, Kamrup (R), Guwahati, Assam - 781128, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

1065 Rwanda FDA-HMP-MA-1110 BESICOR 10 Bisoprolol Fumarate Ph.Eur 10mg 10 mg Film-coated tablets 3x 10 tablets Alu-PVC/Alu blisters packed in a carton box along with pack insert 24 Months AJANTA PHARMA LIMITED, Mirza-Palashbari Road, Village Kokjhar, Kamrup (R), Guwahati, Assam - 781128, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

1066 Rwanda FDA-HMP-MA-1112 TALIMUS 0.1% Tacrolimus Ointment 0.1% w/w 0.1% w/w Ointment 10 g tube Laminated tube along with Pack Insert 36 Months AJANTA PHARMA LIMITED, Mirza, Palashbari Road, Vill-Kokjhar, Kamrup(R), Guwahati, Assam-781128, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

1067 Rwanda FDA-HMP-MA-1113 XELTIN Tofacitinib citrate equivalent to Tofacitinib 5 mg 5 mg Film Coated Tablets 3x10 Tablets Alu-PVC/PVdC blister, 3 such blisters are packed in a carton along with Patient Information Leaflet 24 Months AJANTA PHARMA LIMITED, Plot No. B-4/5/6, Midc Area Paithan, Aurangabad-431148, Maharashtra State, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

1068 Rwanda FDA-HMP-MA-1114 CLONEM-G CREAM Clotrimazole USP 1% w/w, Beclomethasone Dipropionate BP 0.025%w/w and Gentamicin Sulphate BP Eq. to Gentamicin 0.1% w/w 1% w/w, 0.025%w/w and 0.1% w/w Cream 30 gm tube Aluminum collapsible Tube 36 Months NEM LABORATORIES PVT. LTD, 133, Krishna Ind. Estate, Navghar, Vasai (E), Dist. Palghar- 401210, India INDIA NEM LABORATORIES PVT. LTD, INDIA RENE PHARMACY (R) LTD 2024-04-20 2029-04-19

1069 Rwanda FDA-HMP-MA-1115 BURNEM CREAM Acriflavine BPC 1.32mg 1.32 mg Cream 20 gm tube Aluminium collapsible tube 36 Months NEM LABORATORIES PRIVATE LTD. 133, Krishna indl. estate, navghar, vasai road (e), dist. palghar - 401 210. India INDIA NEM LABORATORIES PRIVATE LTD. RENE PHARMACY (R) LTD 2024-04-20 2029-04-19

1070 Rwanda FDA-HMP-MA-1116 SODIUM CHLORIDE INTRAVENOUS INFUSION BP (0.9% W/V) Sodium Chloride Intravenous Infusion BP (0.9% w/v) (0.9% w/v) Intravenous Infusion 500ml & 1000 ml Bottles LDPE Plastic Bottles 36 Months ACULIFE HEALTHCARE PVT. LTD. Sachana. Taluka: Viramgam, District: Ahmedabad - 382 I50, Gujarat, India INDIA ACULIFE HEALTHCARE PVT. LTD, INDIA SUN ENTERPRISES LTD 2024-04-20 2029-04-19

1071 Rwanda FDA-HMP-MA-1117 FECONTIN-Z Ferrous GlycineSulphate: 100 mg, Zinc Sulphate Monohydrate USP: 61.8mg, Folic Acid BP: 0.5 mg 100 mg, 61.8 mg, 0.5 mg Film coated tablet 10×10 tablets Aluminium blister strips made up of printed aluminium foil and PVC rigid film-coated with PVDC 24 Months MODI-MUNDIPHARMA PVT. LTD. Modipuram - 250 110, Uttar, Pradesh, India INDIA MODI-MUNDIPHARMA PVT. LTD. SURGIPHARM (RWANDA) LTD 2024-04-20 2029-04-19

1072 Rwanda FDA-HMP-MA-1118 CARYLCOUGH EXPECTORANT Bromhexine HCl 4.0mg, Guaiphenesin 50mg and salbutamol sulphate 1.0mg 4.0mg, 50mg and 1.0mg Syrup 100 ml Bottle Glass Bottle inserted in unit cartons 36 Months BIODEAL LABORATORIES LTD, Plot no.123 Lunga Lunga Road, Industrial area.32040-00600, Nairobi Kenya KENYA BIODEAL LABORATORIES LTD, KENYA CAPITAL PHARMACEUTICAL SUPPLIES LTD 2024-04-20 2029-04-19

1073 Rwanda FDA-HMP-MA-1119 AMPICLO-DAWA Ampicillin trihydrate BP 125mg/5ml and Cloxacillin Sodium BP 125mg/5mL 125mg/5ml and 125mg/5mL Powder for suspension 60 ml and 100 ml Bottles High Density Polyethylene (HDPE) bottles 36 Months DAWA LIMITED. Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620. Nairobi. Kenya KENYA DAWA LIMITED, KENYA SUN ENTERPRISES LTD 2024-04-20 2029-04-19

1074 Rwanda FDA-HMP-MA-1120 PEDSOL TABLETS Prednisolone BP 5mg 5mg Tablets 10x10’s, 100x10’s, 1000 tablets PVC/ Aluminium foil blisters and HDPE container for 1000 tablets 36 Months LABORATORY & ALLIED LIMITED. Plot No:209/10349, Opposite Sameer Business Park, Mombasa road, Kenya KENYA LABORATORY & ALLIED LIMITED, KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2024-04-20 2029-04-19

1075 Rwanda FDA-HMP-MA-1121 MEROSAN® 0.5 Meropenem for Injection 0.5g 0.5 mg Sterile powder for injection 20ml lass vial Glass vial. The vial is labeled and inserted to folding box 24 Months PT. SANBE FARMA. Jalan Mahar Martanegara. No. 162 (Jl. Leuwigajah No. 162) RT.01 RW.12, Kelurahan Baros, Kecamatan Cimahi Tengah, Kota Cimahi. Indonesia INDONESIA PT. SANBE FARMA, INDONESIA AFRI HEALTHCARE LTD 2024-04-20 2029-04-19

1076 Rwanda FDA-HMP-MA-1122 RAYZIUM Esomeprazole Magnesium Trihydrate USP 40mg 40 mg Enteric coated tablet 3 x 10 tablets PVC/ALU blister pack in a carton 36 Months BIODEAL LABORATORIES LTD, Plot no.123, Lunga Lunga P.O. Box 32040-00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-04-20 2029-04-19

1077 Rwanda FDA-HMP-MA-1123 LECOTRIM SUSPENSION Trimethoprim BP 40mg and sulfamethoxazole BP 200mg 40mg and 200mg Suspension 50mL/100mL Bottles Amber PET/glass bottles contained in unit box along with a literature insert 24 Months LABORATORY & ALLIED LIMITED, Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road. 42875 GPO 00100, Kenya. KENYA LABORATORY & ALLIED LIMITED, KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2024-04-20 2029-04-19

1078 Rwanda FDA-HMP-MA-1161 GATISTAR Gatifloxacin 3mg/ml 3 mg/ml Eye Drops 5 ml Bottle LDPE white plastic bottle 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES, Al Obour city, Industrial zone, Area 15, Block no. 12011, Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICAL INDUSTRIES ETS CONTINENTAL 2024-04-20 2029-04-19

1079 Rwanda FDA-HMP-MA-1162 BUTO-ASMA INHALER Salbutamol 100 micrograms 100 micrograms Pressurised inhalation 1 Container with 200 inhalations Aluminium container 36 Months LABORATORIO ALDO-UNIÓN, S.L. Baronesa de Malda, 73 08950 Esplugues de Llobregat. Barcelona, Spain SPAIN LABORATORIO ALDO-UNIÓN, S.L. GOMHS LTD 2024-04-20 2029-04-19

1080 Rwanda FDA-HMP-MA-1163 PYRIDOXINE TABLETS Pyridoxine Hydrochloride 100 mg 100 mg Uncoated Tablets 10x10’s, 100’s & 1000 Tablets Alu-PVC Blister and jar of 100 & 1000 tablets 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-04-20 2029-04-19

1081 Rwanda FDA-HMP-MA-1164 DOLUTEGRAVIR 50MG TABLETS Dolutegravir Sodium 50 mg 50 mg Film coated Tablets 30 & 90 tablets HDPE Bottles 24 Months LAURUS LABS LIMITED (UNIT II), Plot No.19,20 & 21, Western sector, APSEZ, Atchutapuram Mandal, Vasakhapatnam district, Andhra Pradesh, 531011, India INDIA LAURUS LABS LIMITED CAPITAL PHARMACEUTICAL SUPPLIES LTD 2024-04-20 2029-04-19

1082 Rwanda FDA-HMP-MA-1165 CAPECITABINE-500 Capecitabine 500 mg 500 mg Film coated Tablets 120 Tablets PVC/PVDC– Al foil blisters or Al-Al blisters placed into cardboard box 24 Months HETERO LABS LTD, Unit VI, TSIIC, Formulation SEZ, Sy. No. 410&411, Polepally Village, Jadcherla Mandal, Mahaboobnagar-District, Telangana, Pin-509301, India INDIA SANDOZ GmbH, KUNDL, AUSTRIA SURGIPHARM (RWANDA) LIMITED 2024-04-20 2029-04-19

1083 Rwanda FDA-HMP-MA-1166 GYNOFER TABLETS Tinidazole BP 500mg, Miconazole Nitrate BP 100mg, Neomycin Sulphate BP 20mg 500mg, 100mg, and 20mg Uncoated Tablets 2x4 Tablets Strip pack 36 Months CENTAUR PHARMACEUTICALS PVT. LTD, Plant: I. Plot No: 3. Tivim Industrial Estate. Karaswada, Mapusa Goa-403526, India INDIA CENTAUR PHARMACEUTICALS PVT. LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-04-20 2029-04-19

1084 Rwanda FDA-HMP-MA-1167 KENAZOLE CREAM Ketoconazole USP 2% w/w 2% w/w Topical cream 20 gm tube Collapsible Aluminium Tube in a unit carton 36 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Rd, Ruaraka, P.O. Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LIMITED 2024-04-20 2029-04-19

1085 Rwanda FDA-HMP-MA-1168 KLOXY DRY SYRUP Cloxacillin sodium BP 125mg/5ml 125mg/5ml Powder for oral suspension 100 ml bottle Amber Glass/HDPE bottle in a unit box along with literature insert 36 Months LABORATORY & ALLIED LTD, Plot No. 209/10349, Opposite Sameer Business Park, next to Libra, House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-04-20 2029-04-19

1086 Rwanda FDA-HMP-MA-1169 TRAVONORM OPHTALMIC SOLUTION Travoprost 0.04mg/ml 0.04mg/ml Ophtalmic solution 5 ml bottle LDPE white plastic dropper bottle 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES, Al Obour City-Industrial zone, Area 14, 15 Block no. 12011, P.O Box 11341 Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICAL INDUSTRIES ETS CONTINENTAL 2024-04-20 2029-04-19

1087 Rwanda FDA-HMP-MA-1170 TWYNSTA 80MG/5MG Telmisartan 80mg/Amlodipine 5mg 80mg/5mg Tablets 28 Tablets Aluminium/Aluminium blister (PA/Al/PVC/Al) in printed outer carton 36 Months CIPLA LIMITED, Verna Industrial Estate, Goa - 403 722, India INDIA BOEHRINGER INGELHEIM INTERNATIONAL GmbH SURGIPHARM (RWANDA) LIMITED 2024-04-20 2029-04-19

1088 Rwanda FDA-HMP-MA-1171 TUSQ–DX LIQUID Dextromethorphan Hydrobromide BP 15mg, 15mg, Liquid 100 ml Bottle PET bottle Amber packed in a carton with a leaflet 24 Months BLUE CROSS LABORATORIES PVT. LTD A-12, M.I.D.C., Ambad, Nashik- 422010, Maharashtra, India INDIA BLUE CROSS LABORATORIES PVT. LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-04-20 2029-04-19

1089 Rwanda FDA-HBP-MA-0118 POLIOMYELITIS VACCINE (ORAL) BIVALENT TYPE 1 AND 3 - 20 DOSE Monovalent Bulk of Poliomyelitis Type 1 and 3, Type 1 and 3 - 20 Dose Solution for Oral administration 50 vials of 2ml Glass vial 24 Months SERUM INSTITUTE OF INDIA PVT. LTD. 212/2 Hadapsar, Pune- 411 0028, India. INDIA SERUM INSTITUTE OF INDIA PVT. LTD SUN ENTERPRISES LTD 2024-04-21 2029-04-20

1090 Rwanda FDA-HBP-MA-0119 RHOCLONE 300MCG Anti Rho-D Immunoglobulin Injection (Monoclonal) 300mcg Liquid for Injection 2ml Vial USP Type I Glass vial 24 Months BHARAT SERUMS AND VACCINES LIMITED, Plot No. K-27, Anand Nagar, Additional M.I.D.C. Ambernath (East), India INDIA BHARAT SERUMS & VACCINES LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LIMITED 2024-04-21 2029-04-20

1091 Rwanda FDA-HMP-MA-1124 EVA VIT 400 Vitamin E USP 400 IU 400 IU Soft Gelatin Capsules 3× 10’s Blister Pack Alu/Aluminium/Colourless PVDC coated PVC film- Blister pack 24 Months SOFTGEL HEALTHCARE PVT LIMITED, Survey No. 20/1, vandalur kelambakkam road, Pudupakkam, Kancheepuram– 603 103, Tamilnadu.India INDIA SOFTGEL HEALTHCARE PVT LIMITED DOLIPHARM LTD 2024-04-21 2029-04-20

1092 Rwanda FDA-HMP-MA-1125 SOMAZINA 1000MG SOLUTION FOR INJECTION Citicoline Sodium 1000mg 1000mg Solution for injection 5 ampoules Type 1 Eur. Ph. neutral glass colourless ampoules 36 Months FERRER INTERNACIONAL, S.A. Joan Buscallà, 1-9 08173 Sant Cugat del Vallès (Barcelona), Spain SPAIN FERRER INTERNATIONAL, S.A. GOMHS LTD 2024-04-21 2029-04-20

1093 Rwanda FDA-HMP-MA-1127 AGOMETHASONE TABLETS Dexamethasone tablets BP 0.5 mg 0.5 mg Tablets 10x10 tablets and 1000 tablets Alu/PVC Blister Pack and HDPE Jar pack for 1000 tablets 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane-401208, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-04-21 2029-04-20

1094 Rwanda FDA-HMP-MA-1128 RANEXA 375 Ranolazine 375 mg prolonged 375 mg Prolonged-release tablet 2x20 Tablets PVC/PVDC/Aluminium blisters packed in a carton 24 Months MENARINI-VON HEYDEN GmbH, Leipziger Stra?e 7-13,01097 - Dresden, Germany GERMANY MENARINI -VON HEYDEN GmbH PRAFIN RWANDA LTD 2024-04-21 2029-04-20

1095 Rwanda FDA-HMP-MA-1129 MOMADERM Mometasone Furoate Cream USP 0.1% w/w 0.1% w/w Cream 15gr Tube Aluminium Collapsible Tube in a carton along with pack insert 36 Months AJANTA PHARMA LIMITED, Mirza - Palashbhari Road, Vill. – Kokhjar, Kamrup (R), Guwahati, Assam – 781128, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-04-21 2029-04-20

1096 Rwanda FDA-HMP-MA-1130 LOPINAVIR AND RITONAVIR TABLETS USP 200 MG/50 MG Lopinavir 200mg and Ritonavir 50mg 200 mg/50 mg Film Coated Tablets 120 tablets HDPE bottle 24 Months LAURUS LABS LIMITED, Plot No. 19, 20 & 21, Western Sector, APSEZ, Atchutapuram Mandal, Visakhapatnam-District-531011, Andhra Pradesh, India INDIA LAURUS LABS LIMITED CAPITAL PHARMACEUTICAL SUPPLIES LTD 2024-04-21 2029-04-20

1097 Rwanda FDA-HMP-MA-1131 AGOPRED TABLETS Prednisolone BP 5 mg 5 mg Uncoated Tablets 10x10 tablets & 1000 tablets Alu/PVC Blister Pack and jar pack for 1000 tablets 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane-401208, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-04-21 2029-04-20

1098 Rwanda FDA-HMP-MA-1132 X SONE N Neomycin Sulphate 0.35% w/v, Dexamethasone Sodium Phosphate 0.1% w/v and and Benzalkonium chloride 0.01% w/v as preservative 0.35% w/v, 0.1%w/v & 0.01% w/v Eye/Ear drops 5ml filled in a 10ml bottle Low Density Polyethylene (LDPE) container with HDPE cap and Nozzle. 30 Months ABACUS PARENTERAL DRUGS LTD, Block 191, Plot No.114, Kinga Mukono, P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD ABACUS PHARMA (A) LTD 2024-04-21 2029-04-20

1099 Rwanda FDA-HMP-MA-1133 ACTINAC ER 200 Aceclofenac Extended release tablets, 200 mg 200 mg Film Coated Tablets 2x10 Tablets Alu-Alu blister pack, such 2 blisters in a printed carton along with Pack Insert 24 Months AJANTA PHARMA LIMITED, Mirza - Palashbhari Road, Vill. – Kokhjar, Kamrup (R), Guwahati, Assam – 781128, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-04-21 2029-04-20

1100 Rwanda FDA-HMP-MA-1134 ADACIN Adapalene 0.1% w/w and Clindamycin Phosphate 1.0% w/w 0.1% w/w and 1.0% w/w Gel 15 g Tube A laminated tube packed in a unit carton along with the information insert 24 Months AJANTA PHARMA LIMITED, Mirza - Palashbhari Road, Vill. – Kokhjar, Kamrup (R), Guwahati, Assam – 781128, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-04-21 2029-04-20

1101 Rwanda FDA-HMP-MA-1135 AMILINE TABLET Amitriptyline BP 25 mg 25 mg Film Coated Tablets 10x10 tablets and 1000 tablets Jar pack (1000 tablets) & blister pack (10x10 tablets) 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane-401208, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-04-21 2029-04-20

1102 Rwanda FDA-HMP-MA-1136 AUROTIM Timolol Maleate BP 0.5% w/v 0.5% w/v Eye Drops 5ml filled in a 10ml bottle Low Density Polyethylene (LDPE) container with HDPE 24 Months AUROLAB, No.1 Sivagangai Main Road, Veerapanjan, Madurai, India INDIA AUROLAB DEPOT PHARMACEUTIQUE LE MEDICAL 2024-04-21 2029-04-20

1103 Rwanda FDA-HMP-MA-1137 CANDIZOL Clotrimazole Cream BP 1% w/w 1% w/w Topical cream 20 gram Tube Laminated tubes 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane-401208, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-04-21 2029-04-20

1104 Rwanda FDA-HMP-MA-1138 EFLARON 250MG TABLETS Metronidazole 250mg 250mg Tablets 1000 tablets HDPE container along with literature insert 36 Months DAWA LIMITED, Plot No:7879/8, Baba Dogo Road, Ruaraka, P.O. Box 16633-00620, Nairobi- Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-04-21 2029-04-20

1105 Rwanda FDA-HMP-MA-1139 INSTGRA Dolutegravir Tablets 50 mg 50 mg Film Coated Tablets 30, 90 & 180 Tablets HDPE (High Density polyethylene) container 36 Months EMCURE PHARMACEUTICALS LIMITED, Plot No. P-2, I.T.B.T. Park, Phase II, M.I.D.C., Hinjawadi, Pune –411 057, India. INDIA EMCURE PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LIMITED 2024-04-21 2029-04-20

1106 Rwanda FDA-HMP-MA-1140 SOFTDROPS Carboxymethylcellulose Sodium 0.5 % w/v and Glycerin 0.5 % w/v 0.5 % w/v and 0.5 % w/v Eye drops 10 ml Vial LDPE vial packed in a carton along with the pack insert 36 Months AJANTA PHARMA LIMITED, Mirza - Palashbhari Road, Vill. – Kokhjar, Kamrup (R), Guwahati, Assam – 781128, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-04-21 2029-04-20

1107 Rwanda FDA-HMP-MA-1141 DAWACLOX POWDER FOR ORAL SOLUTION Cloxacillin (as sodium) BP 25mg/5ml 125mg/5ml Powder for oral solution 100 ml Bottle HDPE Bottle 24 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620. Nairobi. Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-04-21 2029-04-20

1108 Rwanda FDA-HMP-MA-1172 BGMET 500 Metformin Hydrochloride BP 500mg 500mg Film Coated Tablet 10 tablets Aluminium / PVC foil Blister packed in carton along with the product insert 36 Months BLISS GVS PHARMA LIMITED, Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Palghar, District Thane – 401404, India INDIA BLISS GVS PHARMA LIMITED SURYA DEPOT PHARMACY LTD 2024-04-21 2029-04-20

1109 Rwanda FDA-HBP-MA-0120 WOSULIN-R 100IU/ML Human Recombinant (r-DNA) Insulin Regular (Soluble/Neutral) 100IU/ml 100IU/ml Injectable 10ml Vial Glass vial packed in a printed carton with literature insert, 24 Months WOCKHARDT LIMITED, Biotech Park, H-14/2, M.I.D.C, Waluj, Aurangabad – 431 136, Maharashtra-India INDIA WOCKHARDT LIMITED ABACUS PHARMA (A) LTD 2024-04-27 2029-04-26

1110 Rwanda FDA-HMP-MA-1142 DICLOFENAC 100 Diclofenac sodium 100 mg 100 mg Suppositories 2x 5 suppositories Blister strips of composite foil made of PVC laminated low-density polyethylene (LD-PE) 36 Months FULTON MEDICINALI S.p.A., Via G. Marconi n. 28/9-20044, Arese Milan– Italy ITALY FULTON MEDICINALI S.P.A. UBIPHARM-RWANDA LTD 2024-04-27 2029-04-26

1111 Rwanda FDA-HMP-MA-1143 AGOMYCIN SUSPENSION Erythromycin Estolate 125mg/5ml 125mg/5ml Suspension 100 ml Bottle PET Amber Colour Bottle packed in a carton box 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIAA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-04-27 2029-04-26

1112 Rwanda FDA-HMP-MA-1144 BRINZOX Brinzolamide USP 1.0% w/v 1.0% w/v Eye drops 5 ml Vial LDPE vial packed in a ctorn along with insert 36 Months AJANTA PHARMA LIMITED, Mirza - Palashbhari Road, Vill. – Kokhjar, Kamrup (R), Guwahati, Assam – 781128, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-04-27 2029-04-26

1113 Rwanda FDA-HMP-MA-1145 ANTI-HIST CREAM Mepyramine maleate BP 2% w/w 2% w/w Cream 20 gm Tube Collapsible aluminium tube with extended nozzle and polythene cap 36 Months DAWA LIMITED, Plot No: 7879/8, Baba Dogo Road, Ruaraka, P.O Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-04-27 2029-04-26

1114 Rwanda FDA-HMP-MA-1146 DERMAZINE CREAM Silver Sulfadiazine USP 1.0% w/w 1.0% w/w Cream 15 gm & Collapsible aluminium tube in a unit carton with a literature insert 36 Months DAWA LIMITED, Plot No: 7879/8, Baba Dogo Road, Ruaraka, P.O Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-04-27 2029-04-26

1115 Rwanda FDA-HMP-MA-1147 TOFF PLUS Paracetamol BP 500 mg, Dextromethorphan Hydrobromide BP 15 mg, Chlorpheniramine Maleate BP 2 mg, Phenylephrine Hydrochloride BP 10 mg 500 mg, 15 mg, 2 mg, P 10 mg Hard Gelatin Capsules 2x 10 capsuless­ Blister alu foil/ clear PVdC coated PVC film packed in a carton along with package insert 36 Months PANACEA BIOTEC PHARMA LTD. Village-Malpur, Baddi District Solan- 173205, Himachal Pradesh, India INDIA PANACEA BIOTEC PHARMA LTD, INDIA AIVEEN RWANDA LTD 2024-04-27 2029-04-26

1116 Rwanda FDA-HMP-MA-1148 FERCEFOL TABLETS Ferrous fumarate 308 mg, folic acid 4mg, and ascorbic acid 200mg 308 mg, 4mg, and 200mg Sugar coated tablets 3x 10 Tablets Alu-Alu strip packed in a cardboard box 36 Months GRACURE PHARMACEUTICALS LIMITED, E- 1105, Industrial Area, Phase-III BHIWADI, PIN-301019 Dist. Alwar, Rajasthan, India INDIA EXPHAR S.A, BELGIUM H & H PHARMA LTD 2024-04-27 2029-04-26

1117 Rwanda FDA-HMP-MA-1149 CIPRONAT® 250 Ciprofloxacin hydrochloride 250 mg 250 mg Film coated Tablets 14 Tablets PVC/Alu blister 36 Months ATABAY ILAC FABRIKASI A.S.; Acibadem, Kóftuncu Sok., No:1, 34718, Kadlkóy / Istanbul; Turkey TURKEY DAFRA PHARMA GmBH, SWITZERLAND SUN ENTERPRISES LTD 2024-04-27 2029-04-26

1118 Rwanda FDA-HMP-MA-1150 AGOFULVIN-500 TABLETS Griseofulvin BP 500 mg 500 mg Uncoated Tablets 10x10 Tablets Aluminum foil/PVC foil blisters packed in a unit printed duplex board carton 36 Months AGOG PHARMA LTD. Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-04-27 2029-04-26

1119 Rwanda FDA-HMP-MA-1151 AGOBURN CREAM Silver Sulfadiazine USP 1%w/w 1%w/w Cream 15 gram tube and 100gm Laminated tube and flower pot type white HDPE cap 36 Months AGOG PHARMA LTD. Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-04-27 2029-04-26

1120 Rwanda FDA-HMP-MA-1152 AGOBEN SUSPENSION Mebendazole Oral Suspension 100 mg/5 ml 100 mg/5 ml Suspension 30 ml Bottle Amber coloured round plastic bottles 36 Months AGOG PHARMA LTD. Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-04-27 2029-04-26

1121 Rwanda FDA-HMP-MA-1153 OFLOZOLE TABLETS Ofloxacin BP 200 mg and Ornidazole 500 mg 200 mg and 500 mg Film coated Tablets 10 Tablets Alu/ Alu Blister packed in a carton 36 Months AUROCHEM LABORATORIES (INDIA) PVT. LTD. Plot 8, Palghar Taluka, Industrial Co.-Op. Estate Ltd INDIA AUROCHEM LABORATORIES (INDIA) PVT. LTD UBIPHARM-RWANDA LTD 2024-04-27 2029-04-26

1122 Rwanda FDA-HMP-MA-1154 AMADAY PL 10/4 Amlodipine 10 mg and Perindopril Erbumine BP 4 mg 10 mg and 4 mg Uncoated Tablets 3x 10 Tablets Alu/Alu Blisters packed in a carton. 24 Months AJANTA PHARMA LIMITED, Mirza-Palashbari Road, Village Kokjhar, Kamrup (R), Guwahati, Assam - 781128, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-27 2029-04-26

1123 Rwanda FDA-HMP-MA-1155 AMADAY PL 10/8 Amlodipine 10 mg and Perindopril Erbumine BP 8 mg 10 mg and 8 mg Uncoated Tablets 3x 10 Tablets Alu/Alu Blisters packed in a carton. 24 Months AJANTA PHARMA LIMITED, Mirza-Palashbari Road, Village Kokjhar, Kamrup (R), Guwahati, Assam - 781128, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-27 2029-04-26

1124 Rwanda FDA-HMP-MA-1156 AMADAY PL 5/8 Amlodipine 5mg and Perindopril Erbumine BP 8mg 5mg and 8mg Uncoated Tablets 3x 10 Tablets Alu/Alu Blisters packed in a carton. 24 Months AJANTA PHARMA LIMITED, Mirza-Palashbari Road, Village Kokjhar, Kamrup (R), Guwahati, Assam - 781128, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-27 2029-04-26

1125 Rwanda FDA-HMP-MA-1157 BESICOR 5 Bisoprolol Fumarate 5mg 5mg Film coated Tablets 3x 10 Tablets Alu-PVC/PVDC blisters packed in a carton 24 Months AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED, INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-27 2029-04-26

1126 Rwanda FDA-HMP-MA-1158 CLOBIT CREAM Clobetasol Propionate B.P.0.05% w/w 0.05% w/w Cream 10 gm tube Aluminum collapsible tube packed in a carton 36 Months NEM LABORATORIES (PVT) LTD. 133, Krishna Indl. Estate, Navghar, Vasai Road (E), Palghar - 401 210. Maharashtra, India INDIA NEM LABORATORIES PVT. LTD, INDIA RENE PHARMACY (R) LTD 2024-04-27 2029-04-26

1127 Rwanda FDA-HMP-MA-1159 CELMAC 400 Celecoxib USP, 400mg 400mg Hard Gelatin Capsules 3x10 capsules Alu-Alu blister packed in a carton alog with patient information leaflet 24 Months AJANTA PHARMA LIMITED, B-4-5-6, MIDC Industrial Area Paithan, Aurangabad, 431148 Dist: Aurangabad Maharashtra, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-27 2029-04-26

1128 Rwanda FDA-HMP-MA-1160 RALEF 120 Etoricoxib 120mg 120mg Film coated Tablet 7 Tablets Alu-PVC/PVdC blister, packed in a carton alog with patient information leaflet 24 Months AJANTA PHARMA LIMITED, B-4-5-6, MIDC Industrial Area Paithan, Aurangabad, 431148 Dist: Aurangabad Maharashtra, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-27 2029-04-26

1129 Rwanda FDA-HBP-MA-0121 CAPRIN Heparin Sodium Injection BP 25000IU/5ml 25000IU/5ml Injection 5ml x 10 vials 5ml clear glass vial, labeled, stoppered and sealed with green coloured flip-off seal, in a carton. 24 months SAMARTH LIFE SCIENCES PVT. LTD, Unit – II, Plot No.2, Industrial Area, Lodhimajra, Baddi, Himachal Pradesh -173 205, India INDIA SAMARTH LIFE SCIENCES PVT. LTD SUN ENTERPRISES LTD 2024-05-06 2029-05-05

1130 Rwanda FDA-HBP-MA-0122 INSULIN GLARGINE, Insulin Glargine Impact 100 Units/ml 100 Units/ml Solution for injection 3 mL cartridge Type I glass, sealed with a flanged cap with inserted laminated sealing disk made of synthetic isoprene rubber (non-product contact side) and Bromo butyl rubber (product contact side) at the top and with a plunger stopper made of Bromo butyl rubber at the bottom. 36 Months SANOFI-AVENTIS DEUTSCHLAND GmbH, Industriepark Höchst Brüningstraße 50 H500, H590, H600, 65926 Frankfurt am Main-Germany GERMANY SANOFI-AVENTIS SOUTH AFRICA (PTY) LTD KIPHARMA LTD 2024-05-06 2029-05-05

1131 Rwanda FDA-HBP-MA-0126 WOSULIN 30/70 100 IU/ML Biphasic Isophane Insulin Injection BP-100IU/ml 100IU/ml Suspension for Injection 3ml and 10ml Vials Cartridge and Dispopen in Type-I glass vials and carton. 36 Months WOCKHARDT LIMITED, Biotech Park, H-14/2, M.I.D.C, Waluj, Aurangabad – 431 136, Maharashtra, India. INDIA WOCKHARDT LIMITED SURGIPHARM (RWANDA) LIMITED 2024-05-06 2029-05-05

1132 Rwanda FDA-HBP-MA-0123 PALBOCICLIB PFIZER 75 FILM COATED TABLETS Palbociclib 75mg 75mg Film Coated Tablets 3 x 7 tablets PVC/OPA/Al/PVC/Al blister card 36 Months Pfizer Manufacturing Deutschland GmbH, Betriebsstätte Freiburg, Mooswaldallee 1,79090 Freiburg, Germany GERMANY PFIZER LIMITED GILMED LIMITED 2024-05-06 2029-05-05

1133 Rwanda FDA-HBP-MA-0124 PALBOCICLIB PFIZER 100 FILM COATED TABLETS Palbociclib 100mg 100mg Film Coated Tablets 3 x 7 tablets PVC/OPA/Al/PVC/Al blister card 36 Months Pfizer Manufacturing Deutschland GmbH, Betriebsstätte Freiburg, Mooswaldallee 1,79090 Freiburg, Germany Betriebsstätte Freiburg, Mooswaldallee 1,79090 Freiburg, Germany GERMANY PFIZER LIMITED GILMED LIMITED 2024-05-06 2029-05-05

1134 Rwanda FDA-HBP-MA-0125 PALBOCICLIB PFIZER 125 FILM COATED TABLETS Palbociclib 125mg 125mg Film Coated Tablets 3 x 7 tablets PVC/OPA/Al/PVC/Al blister card 36 Months Pfizer Manufacturing Deutschland GmbH, Betriebsstätte Freiburg, Mooswaldallee 1,79090 Freiburg, Germany Betriebsstätte Freiburg, Mooswaldallee 1,79090 Freiburg, Germany GERMANY PFIZER LIMITED GILMED LIMITED 2024-05-06 2029-05-05

1135 Rwanda FDA-HMP-MA-1188 AVAZIR Tobramycin 0.3% (3mg/ml) 0.3% (3mg/ml) Ophthalmic Solution 10 ml bottle LDPE white plastic dropper bottle 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES, Al-Obour City, North Industrial zone, Area 14, 15, Block no. 12011 Cairo, Egypt, P.O Box 11341 Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICAL INDUSTRIES ETS CONTINENTAL 2024-05-06 2029-05-05

1136 Rwanda FDA-HMP-MA-1189 CO-AVAZIR Tobramycine, 0.3% (3mg/ml), Dexamethasone 0.1% (1mg/ml) 0.3% (3mg/ml), 0.1% (1mg/ml) Ophthalmic Solution 10 ml bottle LDPE white plastic dropper bottle 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES, Al-Obour City, North Industrial zone, Area 14, 15, Block no. 12011 Cairo, Egypt, P.O Box 11341 Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICAL INDUSTRIES ETS CONTINENTAL 2024-05-06 2029-05-05

1137 Rwanda FDA-HMP-MA-1190 DAPROFEN SUSPENSION Ibuprofen BP 100mg/5ml 100mg/5ml Oral suspension 60ml/ 100ml bottles Amber coloured PET bottles then in unit box 36 Months DAWA LIMITED Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-05-06 2029-05-05

1138 Rwanda FDA-HMP-MA-1191 FEROBSV Ferric Hydroxide in Complex with Sucrose equivalent to Elemental Iron (Iron-Sucrose Complex) 100mg/5ml 100mg/5ml solution for injection or concentrate for solution for infusion 5mL vial Clear ampoule, flat base constricted neck of colorless neutral glass USP Type-I having purple color snap off 24 Months MAIVA PHARMA PVT LTD, Formerly Global Pharmatech 32; SIPCOT industrial complex, Phase I, Hosur-635 126, India INDIA BHARAT SERUMS & VACCINES LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05

1139 Rwanda FDA-HMP-MA-1192 IMMU-C EFFERVESCENT SACHET Echinacea Dry Extract 200mg, Vitamin C 500mg, Zinc Sulphate Monohydrate 38.4 mg 200mg, 500mg, 38.4 mg Deep yellowish free flowing granules 1x 10 sachets Paper, extruded LDPE, aluminum foil, extruded LDPE 36 Months ARAB COMPANY FOR PHARMACEUTICALS & MEDICAL PLANTS (MEPACO-MEDIFOOD), Enshas El Raml, Sharkeiya. P.O Box 324 Heliopolis, Egypt EGYPT ARAB CO. FOR PHARMACEUTICALS & MEDICAL PLANTS (MEPACO-MEDIFOOD) ETS CONTINENTAL 2024-05-06 2029-05-05

1140 Rwanda FDA-HMP-MA-1194 L-CARNITINE PLUS FILM COATED TABLET Levo Carnitine L-Tartrate 1000mg, Zinc gluconate 50mg 1000mg, 50mg Film coated tablets 2x10 blisters Aluminum/Polyvinylchloride blisters in carton box 36 Months ARAB COMPANY FOR PHARMACEUTICALS & MEDICAL PLANTS (MEPACO-MEDIFOOD), Enshas El Raml, Sharkeiya. P.O Box 324 Heliopolis, Egypt EGYPT ARAB CO. FOR PHARMACEUTICALS & MEDICAL PLANTS (MEPACO-MEDIFOOD) ETS CONTINENTAL 2024-05-06 2029-05-05

1141 Rwanda FDA-HMP-MA-1195 OMICAP-20 Omeprazole 20mg 20mg Capsules 3x10 capsules Alu/ Alu strips in carton 24 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur- 635 126, Tamil Nadu- India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05

1142 Rwanda FDA-HMP-MA-1197 PHARMATEX Benzalkonium chloride 50% w/v (37.8 mg) 50% w/v (37.8 mg) Pessary 10 or 20 pessaries Blister pack (PVC/Low-density polyethylene) 36 Months INNOTHERA CHOUZY, Rue René Chantereau, Chouzy-sur-Cisse, 41150 Valloire- Sur-Cisse - France FRANCE LABORATOIRE INNOTECH INTERNATIONAL MEDIASOL PHARMACEUTICAL DEPOT LTD 2024-05-06 2029-05-05

1143 Rwanda FDA-HMP-MA-1198 RABEMAC 20 Rabeprazole Sodium 20 mg 20 mg Delayed Release Tablets 2 x 7 & 4 x 7 tablets Alu / Alu blister pack packed in a carton 36 Months MACLEODS PHARMACEUTICALS LTD. Block N-2, Village Theda, Post Office Lodhimajra, Tehsil Baddi, Distt. Solan, Himachal Pradesh-174 101, India INDIA MACLEODS PHARMACEUTICALS LTD AIVEEN RWANDA LTD 2024-05-06 2029-05-05

1144 Rwanda FDA-HMP-MA-1199 RALTEGRAVIR TABLETS Raltegravir Potassium (Amorphous) 400mg 400mg Film coated tablets 60 tablets HDPE Container 100 cc with 38 mm neck (Medium weight), Closure: Child resistant plastic caps with pulp liner 38mm and Desiccant Canister 2.0-gram silica gel 24 Months HETERO LABS LIMITED, Unit-III, Survey No.: 51, 22-110, Industrial Development Area (IDA), Jeedimetla, Hyderabad-500 055 Telangana, India INDIA HETERO LABS LIMITED SUN ENTERPRISES LIMITED 2024-05-06 2029-05-05

1145 Rwanda FDA-HMP-MA-1200 ERYKO -250 Erythromycin Stearate BP 250mg 250mg Film Coated Tablet 10 x 10 tablets and 1000 Tablets Alu/PVC & HDPE Jar pack for 1000 tablets 36 Months KOPRAN LIMITED, Village Savroli Khalapur, Dist-Raigad, Maharashtra, District Raigad – 410202, India INDIA KOPRAN LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05

1146 Rwanda FDA-HMP-MA-1202 PROFEN SUSPENSION Ibuprofen BP 100mg/5ml 100mg/5ml Suspension 60mL/100mL bottle amber PET/glass bottle and contained in a 36 Months LABORATORY & ALLIED LIMITED. Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road,42875 GPO 00100, Nairobi-Kenya KENYA LABORATORY & ALLIED LIMITED DEPOT PHARMACEUTIQUE LE MEDICAL 2024-05-06 2029-05-05

1147 Rwanda FDA-HMP-MA-1203 VITA-1 TABLETS Thiamine Hydrochloride Tablets BP 50 mg 50 mg Uncoated Tablets 1000 tablets White ribbed Jar pack with a white cap having uniform shape and no deformity 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II. The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-05-06 2029-05-05

1148 Rwanda FDA-HMP-MA-1204 VITAMIN E FORTE SOFT GELATIN CAPSULE dl-Alpha Tocopherol Acetate 400mg (Equivalent to 400 I.U Natural Vitamin E) 400 UI Capsules 2×10 capsules transparent PVC-Aluminium strips 36 Months ARAB COMPANY FOR PHARMACEUTICALS & MEDICAL PLANTS (MEPACO-MEDIFOOD), Enshas El Raml, Sharkeiya. P.O Box 324 Heliopolis, Egypt EGYPT ARAB COMPANY FOR PHARMACEUTICALS & MEDICAL PLANTS (MEPACO-MEDIFOOD) ETS CONTINENTAL 2024-05-06 2029-05-05

1149 Rwanda FDA-HMP-MA-0589 PAUSE Tranexamic acid BP 500 mg/5 ml 500 mg/5 ml Solution for injection 5 ml ampoule USP Type I Flint Glass Ampoule with yellow Snap off 24 Months EMCURE PHARMACEUTICALS LTD. At, J - 174, J-168,J-168/1, MIDC, Tarapur, -401506, Taluka: - MIDC Tarapur Bhoisar, Dist.–Thane- Zone 4, India INDIA EMCURE PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2024-05-06 2029-05-05

1150 Rwanda FDA-HMP-MA-1173 EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE Efavirenz 600 mg, Lamivudine 300 mg, and Tenofovir Disoproxil Fumarate 600 mg 600 mg, 300 mg, 600 mg Film coated tablets 30 tablets and 90 tablets White opaque HDPE bottle 24 Months LAURUS LABS LIMITED, (Unit-2), Plot No. 19, 20 & 21, Western Sector, APSEZ, Atchutapuram Mandal, Visakhapatnam-531011. Andhra Pradesh, India INDIA LAURUS LABS LIMITED CAPITAL PHARMACEUTICAL SUPPLIES LTD 2024-05-06 2029-05-05

1151 Rwanda FDA-HMP-MA-1174 NUSAR 50 Losartan Potassium BP/USP 50 mg 50 mg Film-coated tablet 3×10 capsules Alu-Alu blister (Palin Alu-Alu foil/Printed Blister Aluminium foil) 36 Months EMCURE PHARMACEUTICALS LIMITED, Lane No.3, Phase-II, SIDCO Industrial Complex, Bari-Brahmana, Jammu – 181133, India INDIA EMCURE PHARMACEUTICALS LIMITED ABACUS PHARMA(A) LTD 2024-05-06 2029-05-05

1152 Rwanda FDA-HMP-MA-1175 TUSQ – X LIQUID Terbutaline Sulphate 1.25mg, Bromhexine Hydrochloride 4mg, and Guaifenesin50mg/5ml syrup 1.25mg, 4mg, 50mg/5ml Syrup 100 ml bottle Pet bottle Amber, sealed with 25 mm ROPP cap with EP WAD and 10 ml measuring cup 24 Months BLUE CROSS LABORATORIES PVT. LTD. A-12, M.I.D.C., Ambad, Nashik-422010. Maharashtra. India INDIA BLUE CROSS LABORATORIES PVT. LTD. PHILIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05

1153 Rwanda FDA-HMP-MA-1176 DAWA – PROM TABLETS Promethazine Hydrochloride BP 25 mg 25 mg Film coated tablets 10x10 Tablets Alu-PVC blister pack 36 Months DAWA LIMITED. Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620. Nairobi. Kenya. KENYA DAWA LIMITED SUN ENTERPRISES 2024-05-06 2029-05-05

1154 Rwanda FDA-HMP-MA-1177 CHONDROGEN FILM COATED TABLET Sodium chondroitin sulphate 400mg, and Sodium glucosamine sulphate 500mg 400mg and 500mg Film Coated Tablet 2×10 tablets PVC – aluminium 36 Months THE ARAB CO. FOR PHARMACEUTICALS & MEDICAL PLANTS (MEPACO-MEDIFOOD), Inshas El raml, Sharkeyia, P.O.Box: 324 Heliopolis, Egypt EGYPT THE ARAB CO. FOR PHARMACEUTICALS & MEDICAL PLANTS (MEPACO-MEDIFOOD) ETS CONTINENTAL DEPOT 2024-05-06 2029-05-05

1155 Rwanda FDA-HMP-MA-1178 DNS 500 ML Sodium Chloride (0.9%w/v) & Glucose (5%w/v) (0.9%w/v) & (5%w/v) Intravenous solution 500 ml Bottle Bottle made of Plastic granule and Protective cap. 36 Months ACULIFE HEALTHCARE PRIVATE LIMITED, Sachana, Taluka: Viramgam, District: Ahmedabad, 382150, Gujarat, India INDIA ACULIFE HEALTHCARE PRIVATE LIMITED SUN ENTERPRISES LTD 2024-05-06 2029-05-05

1156 Rwanda FDA-HMP-MA-1179 ALVITE SYRUP Ferrous Sulphate 166.70mg, Thiamine Hydrochloride 0.67mg, Riboflavin 0.67mg, Pyridoxine Hydrochloride 0.50mg, Nicotinamide 7.50mg, Cyanocobalamin 0.5mcg, Dexpanthenol 1.33mg, Flavoured syrup base q.s. 166.70mg, 0.67mg, 0.67mg, 0.50mg, 7.50mg, 0.5mcg, 1.33mg Syrup 200ml Bottle Amber colored brute shaped glass bottle and each bottle is packed in a mono carton 24 Months BLISS GVS PHARMA LIMITED, 10, Dewan Udyog Nagar, Aliyali, Palghar, Maharashtra – 401 404, India INDIA BLISS GVS PHARMA LIMITED SURYA DEPOT PHARMACY LTD 2024-05-06 2029-05-05

1157 Rwanda FDA-HMP-MA-1180 EXTRACEF 200 DT TABLETS Cefixime trihydrate USP 200mg 200mg Dispersible tablets 1×10 Tablets Printed aluminium strip packed in a printed mono carton 30 Months BLUE CROSS LABORATORIES PVT. LTD. A - 12, M.I.D.C., Ambad, Nashik – 422 010.Maharashtra, India INDIA BLUE CROSS LABORATORIES PVT. LTD. WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05

1158 Rwanda FDA-HMP-MA-1181 GRAMOCEF-O-400 Cefixime 400mg 400mg Capsules 1×10 Capsules Alu/Alu blister packed in a printed outer carton along with a pack insert 36 Months MICRO LABS LTD, Plot No.121 to 124, KIADB, Bommasandra Industrial Area, 4th Phase, Bangalore-560 099. Anekal Taluk INDIA MICRO LABS LTD WESSEX PHARMACEUTICALS RWANDA LTD 2024-05-06 2029-05-05

1159 Rwanda FDA-HMP-MA-1182 SONADERM CREAM Clobetasol Propionate BP 0.05% w/w, Miconazole Nitrate BP 2.0% w/w, & Gentamicin Sulphate BP equivalent to Gentamicin 0.1% w/w 0.05% w/w, 2.0% w/w, 0.1% w/w Cream 10g Tube Aluminium collapsible tube is packed in printed carton 24 Months BLUE CROSS LABORATORIES PVT. LTD, L-17, Verna Industrial Estate, Verna, GOA-403-722, India. INDIA BLUE CROSS LABORATORIES PVT. LTD. WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05

1160 Rwanda FDA-HMP-MA-1183 HYOCE Hyoscine Butylbromide 20mg/ml 20mg/ml Solution for injection 1ml×10 ampoules Amber colored glass ampoules with white ring at constriction 24 Months KILITCH DRUGS (INDIA) LIMITED. Plot no. C-301/2, M.I.D.C T.T.C, Industrial Area, Pawane Village, Navi Mumbai - 400 705, Maharashtra, India INDIA KILITCH DRUGS (INDIA) LIMITED SUN ENTERPRISES LTD 2024-05-06 2029-05-05

1161 Rwanda FDA-HMP-MA-1184 OMACILLIN 500 Amoxicillin trihydrate equivalent to Amoxicillin 500 mg 500 mg Capsules 2x10 Capsules PVC/PE/PVDC backed up with printed aluminium foil 36 Months NATIONAL PHARMACEUTICAL INDUSTRIES CO. (SAOC), P. O Box 120, Rusayl, Postal code 124, Sultanate of Oman SULTANATE OF OMAN NATIONAL PHARMACEUTICAL INDUSTRIES CO. (SAOC) SUN ENTERPRISES LTD 2024-05-06 2029-05-05

1162 Rwanda FDA-HMP-MA-1185 RUBEM CREAM Methyl Nicotinate 1%w/w, Capsicum Oleoresin0.1%w/w, Methyl Salicylate 5% w/w 1%w/w, 0.1%w/w, 5% w/w Cream 25g tube Printed aluminum collapsible tube filled with a cap, packed in a unit carton. 36 Months REGAL PHARMACEUTICALS LTD, Plot No:7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi-Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2024-05-06 2029-05-05

1163 Rwanda FDA-HMP-MA-1186 ABBORI EAR DROPS Boric acid B.P equivalent to Boric acid 1.83%w/v Otic Solution 5ml & 10ml ampoules Sealed transparent low density polyethylene plastic ampoules, packed in mono baby cartons ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O.Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2024-05-06 2029-05-05

1164 Rwanda FDA-HMP-MA-1187 AVASTIN Bevacizumab 400mg/16ml 400mg/16ml Concentrate for solution for infusion 16 ml vial (Type I glass) with a stopper (butyl rubber) 36 Months ROCHE PHARMA AG, Emil-Barrell-Str. 1, D-79639 GrenzachWyhlen, Germany GERMANY F. HOFFMANN-LA ROCHE LTD. KIPHARMA LTD 2024-05-06 2029-05-05

1165 Rwanda FDA-HMP-MA-1188 BREN-400 Ibuprofen BP 400 mg 400 mg Film Coated Tablets 10x10 Tablets & 1000 tablets Alu/PVC Blister and HDPE Jar for 1000 tablets 36 Months KOPRAN LIMITED, Village Savroli Khalapur, Dist-Raigad, Maharashtra, India. INDIA KOPRAN LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05

1166 Rwanda FDA-HMP-MA-1193 COLDCAP SYRUP Paracetamol BP 120 mg, Pseudoephedrine Hydrochloride BP 10 mg, Chlorpheniramine Maleate BP 2 mg 120 mg, 10 mg, 2 mg Syrup 100ml bottle Round amber glass bottle 36 Months REGAL PHARMACEUTICALS LTD, Plot No:7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi-Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2024-05-06 2029-05-05

1167 Rwanda FDA-HMP-MA-1201 PULMOCEF – 500 Cefuroxime Axetil USP equivalent to Cefuroxime 500 mg 500 mg Film coated tablets 1x10 Tablets Alu/Alu blister packed in a carton along with a pack insert 36 Months MICRO LABS LTD. No 121 to 124, 4th Phase, K.I.A.D.B, Bommasandra Industrial Area, Bangalore – 560 099. India INDIA MICRO LABS LTD. WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05

1168 Rwanda FDA-HMP-MA-1205 BIOTRIM SUSPENSION Trimethoprim 40 mg, and Sulphamethoxazole 200 mg 40 mg, 200 mg suspension 100 ml and 50 ml PET bottles with caps and in unit boxes. 36 Months BIODEAL LABORATORIES LTD, Lunga Lunga Road, P.O. Box 32040-00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICAL SUPPLIES LTD 2024-05-06 2029-05-05

1169 Rwanda FDA-HMP-MA-1206 PEDIFEN® PEDIATRIC SUSPENSION Ibuprofen 100 mg/ml 100 mg/ml (20 mg/ml) Suspension 100 ml Bottle Amber glass bottle 36 Months. ATABAY K?MYA SAN. Ve T?C. A.?. Dilovas? Organize Sanayi Bölgesi, 4. K?s?m Sakarya Caddesi No:28, Gebze/KOCAEL?, Turkey TURKEY DAFRA PHARMA GMBH SUN ENTREPRISES LTD 2024-05-06 2029-05-05

1170 Rwanda FDA-HMP-MA-1207 PEDIFEN® ADULT Ibuprofen 400 mg 400 mg Film coated Tablets 3x10 tablets PVC / aluminum blister packs 60 Months ATABAY ?LAÇ FABRIKASI A.?., Ac?badem Köftüncü Sokak No: 1, 34718 Kad?köy, Istanbul – Turkey TURKEY DAFRA PHARMA GMBH SUN ENTREPRISES LTD 2024-05-06 2029-05-05

1171 Rwanda FDA-HMP-MA-1208 PAROL® Paracetamol 500 mg 500 mg Tablets 3x10 tablets PVC/Aluminium blister 60 Months ATABAY ?LAÇ FABR?KASI A.?., Ac?badem Köftüncü Sokak No: 1, 34718 Kad?köy, Istanbul – Turkey TURKEY DAFRA PHARMA GMBH SUN ENTREPRISES LTD 2024-05-06 2029-05-05

1172 Rwanda FDA-HMP-MA-1209 TRAJENTA 5 MG Linagliptin 5mg 5 mg Film coated Tablets 1x30’s aluminium unit /PVC/PVAC blister 36 Months WEST-WARD COLUMBUS INC. 1809 Wilson Road. Columbus, Ohio 43228, U.S.A. UNITED STATES OF AMERICA BOEHRINGER INGELHEIM INTERNATIONAL GMBH SURGIPHARM (RWANDA) LIMITED 2024-05-06 2029-05-05

1173 Rwanda FDA-HMP-MA-1210 KIRACLAV® 562.5 Amoxicillin Trihydrate USP Eq. to Anhydrous Amoxicillin 500mg and diluted potassium clavulanate BP Eq. to Clavulanic acid 62.5mg 500mg/62.5 mg Film coated tablets 2x8 tablets Alu-Alu blisters of 8 tablets each packed in a carton along with leaflet 24 Months. BAROQUE PHARMACEUTICALS PVT.LTD., 192/2& 3, 190/1 and 202/9, Sokhada-388 620, Tal: Khambhat, Dist. Anand Gujarat State, India INDIA BEKRA PHARMA UK LTD UBIPHARMA-RWANDA LTD 2024-05-06 2029-05-05

1174 Rwanda FDA-HMP-MA-1211 ARTHRIX CAPSULE 200 MG Celecoxib 200mg 200 mg Hard gelatin capsules 1×10 capsules Alu/Alu Blisters packed in a carton along with a pack insert 36 Months NEOPHARMA. Plot No. A-1, 89-95, Industrial City of Abu Dhabi (ICAD), P.O Box 72900, Mussafah, Abu Dhabi, UAE UNITED ARAB EMIRATES NEOPHARMA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05

1175 Rwanda FDA-HMP-MA-1212 NEOCLAV POWDER FOR ORAL SUSPENSION 228.5 MG/ 5 ML Amoxicillin 200 mg and Clavulanic Acid 28.5 mg 228.5 Mg/ 5 ml Powder for Oral Suspension 70ml Bottle Amber glass bottle 24 Months NEOPHARMA, Plot No. A1, 89-95, Industrial City of Abu Dhabi (ICAD), P.O. Box 72900, Mussafah, Abu Dhabi UAE, United Arab Emirates UNITED ARAB EMIRATES NEOPHARMA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05

1176 Rwanda FDA-HMP-MA-1213 NOVAMENTIN-228.5 Amoxicillin 200mg and Clavulanic Acid 28.5 mg. 228.5 mg/5ml Powder for Oral Suspension 100 ml Amber glass bottle Amber glass bottle 24 Months SCOTT- EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LTD, Hill Top Industrial Area, Bhatoli Kalan, Baddi-173205, Himachal Pradesh, India INDIA SCOTT-EDIL ADVANCE RESEARCH LABORATORIES & ESCORTS PHARMACEUTICALS LIMITED 2024-05-06 2029-05-05

1177 Rwanda FDA-HMP-MA-1214 ARTHRIX CAPSULE 100 MG Colecoxib 100mg 100 mg Hard gelatin capsules 2×10’s blister Alu/Alu Blisters packed in a printed carton along with a pack insert 36 Months NEOPHARMA. Plot No. A1, 89-95, Industrial City of Abu Dhabi (ICAD), P.O. Box 72900, Mussafah, Abu Dhabi UAE, United Arab Emirates UNITED ARAB EMIRATES NEOPHARMA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05

1178 Rwanda FDA-HMP-MA-1215 TRAMAREN CAPSULES Tramadol Hydrochloride 50mg 50 mg Capsules 10x10 capsules Aluminium/PVC blister strip 36 Months RENE INDUSTRIES LIMITED. Plot No 680, P O Box 6034, Kamuli, Kireka, Kampala, Uganda UGANDA RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-05-06 2029-05-05

1179 Rwanda FDA-HMP-MA-1216 DISTEM TABLETS Methocarbamol 380mg & Paracetamol 300mg 380mg /300mg Tablet 50 tablets PVC- Aluminium blister pack 60 Months FAES FARMA, S.A Máximo Aguirre 14-48940 Leioa (Biscay) Spain SPAIN FAES FARMA, S.A., SPAIN GOMHS LTD 2024-05-06 2029-05-05

1180 Rwanda FDA-HMP-MA-1217 DEFAL DROPS Deflazacort 22.75mg/ml 22.75mg/ml Oral drops suspension 13 ml Bottle Amber glass container of 20 ml with a cap with aluminium seal 36 Months FAES FARMA, S.A Máximo Aguirre 14-48940 Leioa (Biscay) Spain SPAIN FAES FARMA, S.A., SPAIN GOMHS LTD 2024-05-06 2029-05-05

1181 Rwanda FDA-HMP-MA-1218 VENOSMIL CAPSULES Hidrosmin 200mg 200 mg Gelatin Capsules 60 or 90 capsules Aluminium/PVC blister packs 60 Months FAES FARMA, S.A FAES FARMA, S.A SPAIN FAES FARMA, S.A GOMHS LTD 2024-05-06 2029-05-05

1182 Rwanda FDA-HMP-MA-1219 VENOSMIL GEL Hidrosmin 20mg per 100 g of gel 20mg per 100 g of gel Gel 60g of 2% tube Aluminium tube 60 Months FAES FARMA, S.A Máximo Aguirre 14-48940 Leioa (Biscay) Spain SPAIN FAES FARMA, S.A. GOMHS LTD 2024-05-06 2029-05-05

1183 Rwanda FDA-HMP-MA-1220 DEFAL 6MG TABLETS Deflazacort 6 mg 6 mg Tablets 20 Tablets Blister made of PVC and aluminium-PVC 60 Months FAES FARMA, S.A Máximo Aguirre 14-48940 Leioa (Biscay) Spain SPAIN FAES FARMA, S.A. GOMHS LTD 2024-05-06 2029-05-05

1184 Rwanda FDA-HMP-MA-1221 SUVITRA-500 Levetiracetam USP 500mg 500mg Film Coated Tablets 3x10 Tablets Alu/Alu Blister Pack 36 Months MICRO LABS LIMITED, 92, SIPCOT, Hosur-635 126, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05

1185 Rwanda FDA-HMP-MA-1222 ASCIPRAM 10 Escitalopram Oxalate, 10mg 10mg Film Coated Tablets 3x10 Tablets Alu/PVC Blisters pack 36 Months MICRO LABS LIMITED, No.92, Sipcot Industrial Complex, Hosur – 635 126, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICAL (RWANDA) LIMITED 2024-05-06 2029-05-05

1186 Rwanda FDA-HMP-MA-1223 ASCIPRAM 20 Escitalopram Oxalate, 20mg 20mg Film Coated Tablets 3x10 Tablets Alu/PVC Blister pack 36 Months MICRO LABS LIMITED, No.92, Sipcot Industrial Complex, Hosur – 635 126, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICAL (RWANDA) LIMITED 2024-05-06 2029-05-05

1187 Rwanda FDA-HMP-MA-1224 BETASALIC OINTMENT Betamethasone dipropionate eq. to betamethasone 0.5mg/gm and Salicylic acid 30 mg/gm 0.5mg/gm and 30 mg/gm Ointment 15 g tube LDPE bottle 24 Months ATCO LABORATORIES LIMITED, B?18, S.I.T.E., Karachi ?75700, Karachi. Sindh, Pakistan PAKISTAN ATCO LABORATORIES LIMITED, PAKISTAN M/S AFRI HEALTH CARE LTD 2024-05-06 2029-05-05

1188 Rwanda FDA-HMP-MA-1225 BAROLE INJECTION Rabeprazole sodium 20mg 20 mg Lyophilized Powder for Injection 1 Vial Type I or Type III and amber colour borosilicate glass 24 Months NAPROD LIFE SCIENCES PVT. LTD. G-17/1, M.I.D.C. Tarapur Industrial Area, Boisar, Dist – Thane – 401506, India INDIA MEGA LIFESCIENCES PUBLIC COMPANY LIMITED, THAILAND ABACUS PHARMA (A) LTD 2024-05-06 2029-05-05

1189 Rwanda FDA-HMP-MA-1226 AZITHROSAFE SUSPENSION Azithromycin Suspension 200 mg/5 ml 200 mg/5 ml Suspension 15 ml Bottle Amber coloured pet bottle 24 Months ENICAR PHARMACEUTICALS PVT. LTD. J-214, 215, 216, M.I.D.C, Tarapur Industrial Area, Boisar, Taluka Palghar, Dist. Palghar401 506, Maharashtra, India INDIA PHARMA LIFE SCIENCE LTD, KENYA STAR BIOTECH LIMITED 2024-05-06 2029-05-05

1190 Rwanda FDA-HMP-MA-1227 ACINET DRY SYRUP 156.25 MG/ML Amoxicillin 125 mg and Clavulanate Potassium 156.25 mg/ml Powder for Oral Suspension 100 ml Bottle Amber glass bottle 24 Months INDCHEMIE HEALTH SPECIALITIES PVT. LTD. Village – Than, Tehsil –Baddi, Dist. – Solan, Himachal Pradesh – 173 205, India INDIA CACHET PHARMACEUTICALS PVT. LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LIMITED 2024-05-06 2029-05-05

1191 Rwanda FDA-HMP-MA-1228 MOXVID - 250 Amoxicillin Trihydrate USP 250 mg 250 mg Hard Gelatin Capsule 10x10 Capsules Alu-PVC Blister Pack 36 Months SCOTT - EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LIMITED, Hill Top Industrial Area, Bhatolikalan, Baddi- 173205, (HP) India INDIA SCOTT - EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LIMITED ESCORTS PHARMACEUTICALS LIMITED 2024-05-06 2029-05-05

1192 Rwanda FDA-HMP-MA-1229 OMEP Omeprazole BP 20mg 20mg Capsules 10x10 Capsules Aluminium Strip 24 Months BAL PHARMA LIMITED, 21 & 22-Bommasandra Industrial Area Bangalore – 560099 Karnataka, India INDIA BAL PHARMA LIMITED SUN ENTERPRISES LIMITED 2024-05-06 2029-05-05

1193 Rwanda FDA-HMP-MA-1230 SPASMODEX-10 Hyoscine Butylbromide 10 mg 10 mg Film Coated Tablets 3×10’s Alu-Alu Blisters 36 Months SKYBIOTECH LIFE SCIENCES PVT. LTD, Factory: Gut No.5, Gevrai Tanda Paithan Road, Aurangabad, 431 002, M.S. India INDIA PHARMA LIFE SCIENCE LTD STAR BIOTECH LIMITED 2024-05-06 2029-05-05

1194 Rwanda FDA-HMP-MA-1231 BALFEN. Ibuprofen BP 400 mg 400 mg Film Coated Tablets 10x10 Tablets Alu-PVC blister pack. 36 Months BAL PHARMA LIMITED, 21 & 22 - Bommasandra Industrial Area, Bangalore - 560099 Karnataka, India. INDIA BAL PHARMA LIMITED. SUN ENTERPRISES LIMITED 2024-05-06 2029-05-05

1195 Rwanda FDA-HMP-MA-1232 DOCETAXEL IMPACT 80MG/4ML Docetaxel 80mg/4ml 80mg/4ml solution for infusion 7 ml Vial Glass vials 36 Months SANOFI-AVENTIS DEUTSCHLAND GmbH, Industriepark Höchst, 65926 Frankfurt am Main, Germany GERMANY SANOFI-AVENTIS SOUTH AFRICA (PVT) LTD. KIPHARMA LTD. 2024-05-06 2029-05-05

1196 Rwanda FDA-HMP-MA-1233 CEFTRIMED Ceftriaxone sodium 1.0g/vial 1.0g/vial Powder for injection 10x100 Vials of 10 ml Colourless Type III glass vial 36 Months CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD; No.88 Yangzi Road, Shijiazhuang City, Hebei Province, China CHINA MEDISEL (K) LTD SUN ENTERPRISES LTD 2024-05-06 2029-05-05

1197 Rwanda FDA-HMP-MA-1234 NEWCOX-60 Etoricoxib Tablets 60 mg 60 mg Film coated tablets 3x10 Tablets Alu-Alu Blisters 36 Months M/S SKYBIOTECH LIFESCIENCES PVT. LTD, Gut no.: 5, Gevrai Tanda, Paithan Road, Aurangabad (M.S.) India INDIA PHARMA LIFE SCIENCE LTD STAR BIOTECH LIMITED 2024-05-06 2029-05-05

1198 Rwanda FDA-HMP-MA-1235 NEWCOX-90 Etoricoxib Tablets 90 mg 90 mg film coated tablets 3x10 Tablets Alu-Alu Blisters 36 Months M/S SKYBIOTECH LIFESCIENCES PVT. LTD, Gut no.: 5, Gevrai Tanda, Paithan Road, Aurangabad (M.S.) India INDIA PHARMA LIFE SCIENCE LTD STAR BIOTECH LIMITED 2024-05-06 2029-05-05

1199 Rwanda FDA-HMP-MA-1236 CIPRONAT® Ciprofloxacin hydrochloride 500 mg 500 mg Film coated tablets 14 tablets PVC/Alu Blister 36 Months ATABAY ILAC FABRIKASI A.S., Acibadem, Kóftiincii sok., No:1, 34718, Kadlkóy / Istanbul, Turkey TURKEY DAFRA PHARMA GMBH SUN ENTREPRISES LTD 2024-05-06 2029-05-05

1200 Rwanda FDA-HMP-MA-1237 CIPRONAT® Ciprofloxacin hydrochloride 750 mg 750 mg Film coated tablets 14 tablets PVC/Alu Blister 36 Months ATABAY ILAC FABRIKASI A.S., Acibadem, Kóftiincii sok., No:1, 34718, Kadlkóy / Istanbul, Turkey TURKEY DAFRA PHARMA GMBH SUN ENTREPRISES LTD 2024-05-06 2029-05-05

1201 Rwanda FDA-HMP-MA-1238 PHARMADEX Paracetamol 325 mg, Aspirin 400 mg and Caffeine 30 mg 325mg/400mg/30mg Tablets 10x10 Tablets Alu-PVC Blisters 36 Months M/S SKYBIOTECH LIFESCIENCES PVT. LTD, Gut no.: 5, Gevrai Tanda, Paithan Road, Aurangabad (M.S.) India INDIA PHARMA LIFE SCIENCE LTD STAR BIOTECH LIMITED 2024-05-06 2029-05-05

1202 Rwanda FDA-HMP-MA-1239 PIRICLOR SYRUP Chlorpheniramine Maleate BP 2.0mg/5ml 2.0mg/5ml Syrup 100 ml and 60 ml Bottles Amber Plastic Bottle 36 Months BIODEAL LABORATORIES LTD, 123, Lunga Lunga P.O Box 32040 00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-05-06 2029-05-05

1203 Rwanda FDA-HMP-MA-1240 DAFLON 1000MG Micronised purified flavonoid fraction 1000 mg 1000 mg Film-coated tablet 30 tablets PVC Aluminium 48 Months SERVIER (IRELAND) INDUSTRIES LTD, Moneylands, Gorey Road, Arklow-Co. Wicklow, Y14 E284, Ireland IRELAND LES LABORATOIRES SERVIER KIPHARMA LTD 2024-05-06 2029-05-05

1204 Rwanda FDA-HMP-MA-1241 ETROBAX 60 Etoricoxib Tablets 60mg 60mg Film Coated Tablets 3x 10 Tablets Alu-Alu blisters 36 Months HETERO LABS LIMITED, (Unit-III), survey No.: 51 22-110, Industrial Development Area (IDA), Jeedimetla, Hyderabad- PIN-500 055, Telangana, India INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-05-06 2029-05-05

1205 Rwanda FDA-HMP-MA-1242 GALAXY’S HEEL CREAM Vitamin A Palmitate BP 1000IU/g, Vitamin D3 BP 30IU/g, Urea BP 5.0% w/w, Aloe vera Extract 5.0% w/w, Magnesium Lactate Dihydrate BP 2.0% w/w and Zinc Oxide BP 2.0% w/w 1000IU/g, 30IU/g, 5.0% w/w, 5.0% w/w, 2.0% w/w and 2.0% w/w Cream 30 gm Tube Laminated Tube 36 Months CURETECH SKINCARE, Plot No. 33 & 34, Phase – IV, Bhatoli Kalan, Baddi, Distt. Solan (HP)-173205, India INDIA GALAXY PHARMACEUTICALS STAR BIOTECH LIMITED 2024-05-06 2029-05-05

1206 Rwanda FDA-HMP-MA-1243 LISOF Ledipasvir and Sofosbuvir 90mg/400mg 90mg/400mg Film Coated Tablets 28 Tablets HDPE container pack 24 Months HETERO LABS LIMITED, (Unit-V), TSIIC Formulation sez, s.no 439, 440, 441 & 458 Polepally village, Jadcherla Mandal, Mahaboob Nagar (Dist) –509301, Telangana, India INDIA HETERO LABS LIMITED VINE PHARMA LIMITED 2024-05-06 2029-05-05

1207 Rwanda FDA-HMP-MA-1244 AGOPHENOL SUSPENSION Chloramphenicol Palmitate BP eq. to 125 mg of Chloramphenicol/5ml 125 mg/5ml Oral suspension 100 ml Bottle Polythene Bags 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II. The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-05-06 2029-05-05

1208 Rwanda FDA-HMP-MA-1245 TENOFOVIR ALAFENAMIDE 25MG Tenofovir alafenamide hemifumarate 25mg 25mg Film Coated Tablets 30 Tablets & 100 Tablets HDPE container 24 Months HETERO LABS LIMITED, (Unit-V), TSIIC Formulation sez, s.no 439, 440, 441 & 458 Polepally village, Jadcherla Mandal, Mahaboob Nagar (Dist) –509301, Telangana, India INDIA HETERO LABS LIMITED VINE PHARMA LIMITED 2024-05-06 2029-05-05

1209 Rwanda FDA-HMP-MA-1246 REVIVE Glucose anhydrous 13.5g, sodium chloride 2.6g, trisodium citrate dihydrate BP 2.9g, Potassium chloride 1.5g 13.5g, 2.6g, 2.9g + 1.5g Crystalline Powder 20.5 g Sachet Aluminum printed foil sachet 24 Months RENE INDUSTRIES LTD, Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda UGANDA RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-05-06 2029-05-05

1210 Rwanda FDA-HMP-MA-1247 RENETRIM DS TABLETS Sulfamethoxazole 800mg and Trimethoprim 160mg 800mg and 160mg Tablets 10 Tablets Aluminium/transparent PVC blister 24 Months RENE INDUSTRIES LTD. Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda UGANDA RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-05-06 2029-05-05

1211 Rwanda FDA-HMP-MA-1248 RENE-CPM TABLETS Chlorpheniramine Maleate 4 mg 4 mg Tablets 10 Tablets Aluminium/transparent PVC blister 24 Months RENE INDUSTRIES LTD, Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda UGANDA RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-05-06 2029-05-05

1212 Rwanda FDA-HMP-MA-1249 CIPROREN TABLETS Ciprofloxacin Hydrochloride 500mg 500mg Film Coated Tablets 10 Tablets Aluminium/ 24 Months RENE INDUSTRIES LTD, Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda UGANDA RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-05-06 2029-05-05

1213 Rwanda FDA-HMP-MA-1250 MYCOREN TABLET Nystatin 500,000 IU 500,000 IU Tablets 10 Tablets Aluminium /amber PVC blister 24 Months RENE INDUSTRIES LTD, Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda UGANDA RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-05-06 2029-05-05

1214 Rwanda FDA-HMP-MA-1251 BALFEN Ibuprofen 200 mg 200 mg Film Coated Tablets 10 Tablets Aluminium/PVC blister 36 Months BAL PHARMA LIMITED, 21 & 22 - Bommasandra Industrial Area Bangalore, India INDIA BAL PHARMA LIMITED, INDIA SUN ENTERPRISES LIMITED 2024-05-06 2029-05-05

1215 Rwanda FDA-HMP-MA-1252 BALTRIM Sulfamethoxazole 400mg and Trimethoprim 80mg 400mg and 80mg Uncoated Tablets 10 Tablets Aluminium/PVC blister 48 Months BAL PHARMA LIMITED, 21 & 22 - Bommasandra Industrial Area Bangalore, India INDIA BAL PHARMA LIMITED, INDIA SUN ENTERPRISES LIMITED 2024-05-06 2029-05-05

1216 Rwanda FDA-HMP-MA-1253 AZIWIN 500 Azithromycin USP 500mg 500mg Film Coated Tablets 3 Tablets Aluminium/PVC blister 36 Months BAL PHARMA LIMITED, 21 & 22 - Bommasandra Industrial Area Bangalore, India INDIA BAL PHARMA LIMITED, INDIA SUN ENTERPRISES LTD 2024-05-06 2029-05-05

1217 Rwanda FDA-HMP-MA-1254 SCOFIX SUSPENSION Cefixime USP as trihydrate 50 mg/5ml 50 mg/5ml Powder for oral suspension 60 ml Bottle HDPE bottle 36 Months SCOTT-EDIL ADVANCE RESEARCH LABORATORY EDUCATION LTD, hill top industrial area, bhatoli Kalan, baddi-173205, (HP), India. INDIA SCOTT-EDIL ADVANCE RESEARCH LABORATORY EDUCATION LTD. ESCORTS PHARMACEUTICALS (RWANDA) LTD. 2024-05-06 2029-05-05

1218 Rwanda FDA-HMP-MA-1255 BOSUTINIB PFIZER 100 FILM COATED TABLETS Bosutinib monohydrate 100 mg 100 mg Film Coated Tablets 14 or 15 Tablets PVC/Polychlorotrifluoroethene/PVC blister 48 Months PFIZER MANUFACTURING DEUTSCHLAND GmbH Betriebsstätte Freiburg, Mooswaldallee 1, 79090 Freiburg, Germany. GERMAY PFIZER LABORATORIES LIMITED GILMED LIMITED 2024-05-06 2029-05-05

1219 Rwanda FDA-HMP-MA-1256 DEFAL 30MG Deflazacort 30mg 30mg Tablets 10 Tablets Blister made of PVC and aluminium-PVC foil 60 Months FAES FARMA, S.A, Máximo Aguirre 14-48940 Leioa (Biscay) Spain SPAIN FAES FARMA, S.A GOMHS LTD 2024-05-06 2029-05-05

1220 Rwanda FDA-HMP-MA-1257 DOM R CAPSULES Rabeprazole Sodium 20 mg & Domperidone 30 mg 20 mg & 30 mg Hard Gelatin Capsules 10 Capsules Alu/Alu Blister 24 Months CORONA REMEDIES PRIVATE LIMITED, Village Jatoli, Post Office - Oachghat, Tehsil Solan, Dist. Solan, Himachal Pradesh – 173223 India INDIA I-CARE PHARMA LIMITED AIVEEN (R) LTD 2024-05-06 2029-05-05

1221 Rwanda FDA-HMP-MA-1258 BEDAQUILINE TABLETS 100MG Bedaquiline Fumarate, 100mg 100mg Tablet 4x14 Tablets Alu-Alu Blister 24 Months LUPIN LTD, A-28/1, M.I.D.C. Industrial Area, Chikalthana, Aurangabad-431 210 Maharashtra State, India INDIA LUPIN LTD AIVEEN (R) LTD 2024-05-06 2029-05-05

1222 Rwanda FDA-HMP-MA-1259 UTROGESTAN VAGINAL 200MG SOFT CAPSULES Progesterone Ph Eur. (Micronized),200mg 200mg Soft Capsules 15 Capsules PVC/Aluminium blister. 36 Months CYNDEA PHARMA, Poligono Industrial Emiliano Revilla Sanz Avenida de Agreda, 31 Olvega 42110 (Soria), Spain SPAIN BESINS HEALTHCARE BENELUX SA. SURGIPHARM RWANDA LTD 2024-05-06 2029-05-05

1223 Rwanda FDA-HMP-MA-1260 ESLOTIN 5MG FILM COATED TABLETS Desloratidine 5mg 5mg Film Coated Tablets 10, 20 & 30 Tablets Alu-PVC/Aclar foil blister 36 Months WORLD MEDICINE ?LAÇ SAN. VE TIC. A.?. 15 Temmuz Mah. Cami Yolu Cad. No:50, Güne?li, Ba?c?lar, Istanbul, Turkey TURKEY WORLD MEDICINE ?LAÇ SAN. VE TIC. ?., TURKEY GOODMAN INTERNATIONAL LTD (R) 2024-05-06 2029-05-05

1224 Rwanda FDA-HMP-MA-1261 METAPIR-100 Topiramate USP, 100mg 100mg Film Coated Tablets 10 Tablets Alu / Alu blister 36 Months MICRO LABS LIMITED, 92, SIPCOT, Industrial Complex, Hosur-635 126, Tamil Nadu, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05

1225 Rwanda FDA-HMP-MA-1301 VERBITAL 30 Phenobarbital BP 30mg 30 mg Un coated Tablets 10x10 tablets Alu/PVC blisters packed in a carton 36 Months VERVE HUMAN CARE LABORATORIES, Plot No-15-A, Pharm city, Selaqui Dehradun-248011, Uttarakhand, India INDIA VERVE HUMAN CARE LABORATORIES ABACUS PHARMA (A) LTD 2024-05-07 2029-05-06

1226 Rwanda FDA-HMP-MA-1302 AGOFORMIN TABLETS Metformin Tablets BP 500mg 500 mg Film coated tablet 10X10 tablets Blister pack 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II. The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-05-07 2029-05-06

1227 Rwanda FDA-HMP-MA-1303 SEKALGIC SUSPENSION Paracetamol 125mg & Ibuprofen 100mg/5ml 125 mg,100 mg/5 ml Suspension Bottle of 100 ml Amber, PET bottle 36 Months BAROQUE PHARMACEUTICALS PVT, LTD, 192/2 & 3, Sokhada-388 620Tal: khambhat, Dist. Anand (Gujarat), India INDIA BEKRA PHARMA UK LTD UBIPHARM-RWANDA LTD 2024-05-07 2029-05-06

1228 Rwanda FDA-HMP-MA-1304 TRIMAGO ORAL SUSPENSION Sulfamethoxazole 200 mg and Trimethoprim 40 mg/ 5ml 200 mg/40 mg/5ml Oral liquid Suspension Bottle pack of 60 ml & 100 ml Amber coloured pet bottles 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II. The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-05-07 2029-05-06

1229 Rwanda FDA-HBP-MA-0127 VINTOR 4000 Erythropoietin Concentrated Solution Ph. Eur, 4000 IU/ml 4000 IU/ml Solution for injection 1 Pre-filled syringe Type I glass with a rubber stopper, and with a stainless steel needle OR in a vial (Type I glass) with a rubber stopper 24 months GENNOVA BIOPHARMACEUTICALS LIMITED, Block 1, Plot No. P-1 & P-2, ITBT Park, Phase II, MIDC, Hinjawadi, Pune-411057, India INDIA GENNOVA BIOPHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2024-05-07 2029-05-06

1230 Rwanda FDA-HMP-MA-1100 KAMAGRA 50 Sildenafil Citrate USP equivalent to Sildenafil 50mg 50mg Film Coated Tablets 4 Tablets Alu- PVC/PVdC blister pack, 1 such blister is packed in a carton along with PIL 36 Months AJANTA PHARMA LIMITED, Plot No. B-4/5/6, MIDC Area Paithan, Aurangabad-431148, Maharashtra State, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-05-07 2029-05-06

1231 Rwanda FDA-HMP-MA-1262 ULTRA-LEVURE 50MG, GÉLULE Saccharomyces boulardii CNCM 1-745, 50mg 50mg Capsules 20 Capsules Type III glass bottles, closed with low density polyethylene (LDPE) caps surrounded with a thermo-retractable polyvinyl chloride security sealing 36 Months BIOCODEX, 1 avenue Blaise Pascal, 60000 Beauvais, France FRANCE BIOCODEX FORTILAB RWANDA 2024-05-07 2029-05-06

1232 Rwanda FDA-HMP-MA-1263 OTIPAX® 15ML SOLUTION, EAR DROPS Phenazone 4g Lidocaine Hydrochloride 1g for 100g of solution 4g & 1g for 100g of solution Solution for ear drops 15 ml Bottle containing 16 g of solution Yellow glass type III, closed by a stopper (LDPE) with a seal (LDPE) and a dropper (PE/vinyl acetate) and a stopper (LDPE). Box of 1 bottle 36 Months BIOCODEX, 1 avenue Blaise Pascal, 60000 Beauvais, France FRANCE BIOCODEX FORTILAB RWANDA 2024-05-07 2029-05-06

1233 Rwanda FDA-HMP-MA-1264 BREN-200 Ibuprofen BP 200 mg 200 mg Film Coated Tablets 10 x 10 tablets & 1000 tablets Alu/PVC & HDPE Jar 36 Months KOPRAN LIMITED, Village Savroli, Taluka Khalapur, District Raigad – 410202, India INDIA KOPRAN LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-07 2029-05-06

1234 Rwanda FDA-HMP-MA-1265 ERYTHROX 500MG Erythromycin Stearate 500mg 500mg Film-coated tablets 10 x 10 tablets & 1000 tablets Alu/PVC & HDPE Jar 36 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Rd, Ruaraka, P.O. BOX 16633-00620. Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-05-07 2029-05-06

1235 Rwanda FDA-HMP-MA-1266 QUININE SULFATE Quinine Sulfate film-coated tablets 300 mg 300 mg Film-coated tablets 10 x 10 tablets Blisters of aluminium foil and PVC packed in a carton 60 Months REMEDICA LIMITED, Aharnon Street, Limassol Industrial Estate, 3056, Limassol, Cyprus CYPRUS REMEDICA LIMITED GOODMAN INTERNATIONAL (R) LTD 2024-05-07 2029-05-06

1236 Rwanda FDA-HMP-MA-1267 AMYN DT 250 Amoxicillin Trihydrate USP 250 mg 250 mg Dispersible tablets 3x 15 tablets, 2x 10 tablets Alu/Alu strips packed in a carton 24 Months KOPRAN LIMITED, Village Savroli, Taluka Khalapur, District Raigad – 410202, India INDIA KOPRAN LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-07 2029-05-06

1237 Rwanda FDA-HMP-MA-1268 ESOCOR 40 Esomeprazole Magnesium Trihydrate 40mg 40mg Tablets 3 x10 Tablets Alu/Alu Blister packed in carton along with insert 24 Months CORONA REMEDIES PRIVATE LIMITED, Village Jatoli, Post Office - Oachghat, Tehsil Solan, Dist. Solan, Himachal Pradesh – 173223, India INDIA CORONA REMEDIES PRIVATE LIMITED SUN ENTERPRISES LTD 2024-05-07 2029-05-06

1238 Rwanda FDA-HMP-MA-1269 GALAXY’S NEUROCARE-25 Methylcobalamin 750mcg, Pregabalin 25mg, Folic acid 1.5mg, Pyridoxine hydrochloride 3mg, Alpha Lipoic acid 100mg 750mcg, 25mg, 1.5mg, 3mg, 100mg Soft gelatin capsules 3x10 Capsules Alu-Alu Blister pack 24 Months SOFTGEL HEALTHCARE PVT LTD, Survey No. 20/1, new survey No. 9/810, Vandalur –Kelambakkam Road, Pudupakkam Village, Kancheepuram District – 603 103, Tamilnadu, India INDIA GALAXY PHARMACEUTICALS, INDIA STAR BIOTECH RWANDA 2024-05-07 2029-05-06

1239 Rwanda FDA-HMP-MA-1270 GLYKA MR TABLETS 60 MG Gliclazide 60 mg 60 mg Modified Release Tablets 3×10 tablets Alu/Alu blister placed in a printed carton along with a pack insert 36 Months NEOPHARMA, Plot No. A-1, 89-95, Industrial City of Abu Dhabi (ICAD), P.O Box 72900, Mussafah, Abu Dhabi, UAE UAE NEOPHARMA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-07 2029-05-06

1240 Rwanda FDA-HMP-MA-1271 KETAMINE HYDROCHLORIDE INJECTION USP 50 MG/ML, 10 ML Ketamine Hydrochloride Injection USP 50 mg/ml 50 mg/ml Solution for injection 10 ml vial Amber Glass vial (USP Type- I) in a carton with insert 36 Months SWISS PARENTERALS LTD, 808,809 & 810 Kerala Industrial Estate, G.I.D.C., Bavla, Dist. Ahmedabad – 382220, Gujarat, India INDIA SWISS PARENTERALS LTD SUN ENTERPRISES LTD 2024-05-07 2029-05-06

1241 Rwanda FDA-HMP-MA-1272 LUMITER 20/120 Artemether 20mg, Lumefantrine 120 mg 20mg, 120 mg Uncoated tablets 17 or 30x6 tablets, 30x12 tablets PVC/PE/PVDC-Alu blister packed in a carton 36 Months MACLEODS PHARMACEUTICALS LIMITED, At, Oxalis Labs G Block, Village Theda, P.O Lodhimajra, Baddi, Distt. Solan, Himachal Pradesh, 174101, India INDIA MACLEODS PHARMACEUTICALS LIMITED AIVEEN RWANDA LIMITED 2024-05-07 2029-05-06

1242 Rwanda FDA-HMP-MA-1273 AGODOX CAPSULES Doxycycline hydrochloride 100 mg 100 mg Hard Gelatin Capsules 10 x 10 capsules 1000 Capsules Printed Aluminum foil/PVC foil Blister in unit printed duplex board carton and HDPE Jar 36 Months AGOG PHARMA LTD. Plot No. 33, Sector II. The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-05-07 2029-05-06

1243 Rwanda FDA-HMP-MA-1274 AGOPRED-10 TABLETS Prednisolone BP 10mg 10mg Uncoated tablets 1000 Tablets and 10x10 tablets Jar pack & Blister pack 36 Months AGOG PHARMA LTD. Plot No. 33, Sector II. The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-05-07 2029-05-06

1244 Rwanda FDA-HMP-MA-1275 AGONAL TABLETS Nalidixic Acid BP 500 mg 500 mg Uncoated tablets 1000 Tablets and 10x10 tablets Jar pack & Blister pack 36 Months AGOG PHARMA LTD. Plot No. 33, Sector II. The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-05-07 2029-05-06

1245 Rwanda FDA-HMP-MA-1276 DOPAMET TABLETS Methyldopa BP 250 mg 250 mg Film Coated Tablets 1000 Tablets and 10x10 tablets Jar pack & Blister pack 36 Months AGOG PHARMA LTD. Plot No. 33, Sector II, The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-05-07 2029-05-06

1246 Rwanda FDA-HMP-MA-1277 VITALIPID NOVUM INFANT Vitamin A 69µg (230IU), Vitamin D2 1.0µg (40IU), Vitamin E 0.64mg (0.7IU), Vitamin K1 20µg 69µg (230 IU), 1.0µg (40IU), 0.64mg (0.7IU), 20µg Concentrate for solution for infusion 10 x 10 ml ampoules Type I glass ampoules 24 Months FRESENIUS KABI AB, Rapsgatan 7 SE-751 74 Uppsala, Sweden SWEDEN FRESENIUS KABI SOUTH AFRICA (PTY) LTD SURGIPHARM (RWANDA) LTD 2024-05-07 2029-05-06

1247 Rwanda FDA-HMP-MA-1278 XPEL SYRUP 15 MG/5 ML Ambroxol Hydrochloride 15mg/5 ml 15mg/5 ml Syrup 100 ml Bottle 125 ml amber glass bottle sealed with child-resistant cap (CRC) and packed in a printed carton 36 Months NEOPHARMA, Plot No. A-1, 89-95, Industrial City of Abu Dhabi (ICAD), P.O Box 72900, Mussafah, Abu Dhabi, UAE UAE NEOPHARMA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-07 2029-05-06

1248 Rwanda FDA-HMP-MA-1279 XPEL SYRUP 30MG/5 ML Ambroxol Hydrochloride 30mg/5 ml 30mg/5 ml Syrup 100 ml Bottle 125 ml amber glass bottle sealed with child-resistant cap and packed in a printed carton 36 Months NEOPHARMA, Plot No. A-1, 89-95, Industrial City of Abu Dhabi (ICAD), P.O Box 72900, Mussafah, Abu Dhabi, UAE UAE NEOPHARMA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-07 2029-05-06

1249 Rwanda FDA-HMP-MA-1285 RIFAPENTINE AND ISONIAZID 300MG/300MG TABLETS Rifapentine 300mg and Isoniazid 300mg 300 mg/300 mg Film coated tablets 10’s, 12’s &14’s Tablets Aluminium Strip/Blister 24 Months LUPIN LIMITED, A-28/1, MIDC Area, Chikalthana, Aurangabad, Aurangabad-431210, India INDIA LUPIN LIMITED AIVEEN RWANDA LIMITED 2024-05-07 2029-05-06

1250 Rwanda FDA-HMP-MA-1286 ABLEVOX Levofloxacin Hemihydrate 0.5 %w/v 0.5 %w/v Solution for infusion 100ml bottles LDPE (Low Density Polyethylene) bottles 24 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL), UGANDA ABACUS PHARMA (A) LTD 2024-05-07 2029-05-06

1251 Rwanda FDA-HMP-MA-1287 PACLITAXEL NEAPOLIS 6 MG/ML (30 MG) 5ml contains 30mg of Paclitaxel 6 mg/ml (30 mg) Solution for infusion 5ml Vial A vial Type I glass 24 Months NEAPOLIS PHARMA, Route de Tunis, Km7-B.P.206, 8000 Nabeul, Tunisia TUNISIA NEAPOLIS PHARMA KIPHARMA LTD 2024-05-07 2029-05-06

1252 Rwanda FDA-HMP-MA-1288 PACLITAXEL NEAPOLIS 6 MG/ML (100 MG) Each vial of 16.7ml contains 100mg of Paclitaxel 6 mg/ml (100 mg) Solution for infusion 16.7ml Vial A vial Type I glass 24 Months NEAPOLIS PHARMA, Route de Tunis, Km7-B.P.206, 8000 Nabeul, Tunisia TUNISIA NEAPOLIS PHARMA KIPHARMA LTD 2024-05-07 2029-05-06

1253 Rwanda FDA-HMP-MA-1289 AGOPRIL TABLETS Captopril Tablets BP 25 mg 25 mg Un coated Tablets 10x10 tablets and 1000 tablets Alu-Alu blister and Jar pack of 1000 tablets 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II. The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-05-07 2029-05-06

1254 Rwanda FDA-HMP-MA-1290 AGOSPIRIN-100 TABLETS Aspirin BP 100 mg 100 mg Un coated Tablets 1000 Tablets Jar pack 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II. The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-05-07 2029-05-06

1255 Rwanda FDA-HMP-MA-1291 AGOSPIRIN-500 TABLETS Aspirin BP 500 mg 500 mg Un coated Tablets 1000 Tablets Jar pack 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II. The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-05-07 2029-05-06

1256 Rwanda FDA-HMP-MA-1292 AGOTHIAZIDE TABLETS Hydrochlorothiazide BP 50 mg 50 mg Un coated Tablets 10x10 tablets and 1000 tablets Alu-Alu blister and Jar pack of 1000 tablets 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane-401208, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-05-07 2029-05-06

1257 Rwanda FDA-HMP-MA-1293 BRAMOL INFUSION Paracetamol, 1000 mg/100ml 1000mg/100 ml Solution for infusion 100ml amber glass USP type II vial Amber glass USP type II vial sealed with rubber stopper 24 Months BROOKES PHARMA (PRIVATE) LIMITED, 58 & 59, Plot 15, Korangi Industrial Area, Karachi, Pakistan PAKISTAN BROOKES PHARMA (PRIVATE) LIMITED SUN ENTERPRISES LTD 2024-05-07 2029-05-06

1258 Rwanda FDA-HMP-MA-1294 EPHEVER Ephedrine hydrochloride injection BP, 50mg/ml 50mg/ml Solution for Injection 10 ml ampoule Amber USP Type-1 glass ampoules 24 Months VERVE HUMAN CARE LABORATORIES, Plot no. 15-A, Pharmacity, Selaqui, Dehradun, Uttarakhand, India INDIA VERVE HUMAN CARE LABORATORIES ABACUS PHARMA (A) LTD 2024-05-07 2029-05-06

1259 Rwanda FDA-HMP-MA-1295 IBICAR-250 Beclometasone Pressurized anhydrous, Inhalation, 250 mcg 250 mcg Pressurized solution filled inhalation 19 ml canister with 200 metered doses 200 Metered Doses. Actuator (19 ml canister) 24 Months GLENMARK PHARMACEUTICALS LIMITED, At: (Unit III), Village Kishanpura, Baddi – Nalagarh Road, Tehsil Baddi, Distt. Solan, Himachal Pradesh 173 205, India INDIA GLENMARK PHARMACEUTICALS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-07 2029-05-06

1260 Rwanda FDA-HMP-MA-1296 PIRETIKOL 250 MG/5 ML SUSPENSION Paracetamol 250 mg/5 ml 250 mg/5 ml Suspension 125 ml bottles Amber type III glass bottles 36 Months WORLD MEDICINE ?LAÇ SAN. VE TIC. A.?., 15 Temmuz Mah. Cami Yolu Cad. No:50, Güne?li, Ba?c?lar, Istanbul, Turkey TURKEY WORLD MEDICINE ?LAÇ SAN. VE TIC. A.? GOODMAN INTERNATIONAL (R) LIMITED 2024-05-07 2029-05-06

1261 Rwanda FDA-HMP-MA-1297 DELASED DRY COUGHS (NON-DROWSY) SYRUP Dextromethorphan HBr 7.5mg/5ml 7.5mg/5ml Syrup 100ml bottles Amber 100ml glass bottles with Roll-On-Pilfer-Proof (ROPP) Caps 36 Months REGAL PHARMACEUTICALS LTD, Plot No:7879/18. Off Baba Dogo Road, Ruaraka P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2024-05-07 2029-05-06

1262 Rwanda FDA-HMP-MA-1298 CINOD 5 Cilnidipine 5mg 5 mg Film coated tablets 3x10 tablets Alu-Alu blister, 3 such blisters in a printed carton 24 Months AJANTA PHARMA LIMITED, Mirza-Palashbari Road, Village Kokjhar, Kamrup (R), Guwahati, Assam - 781128, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-05-07 2029-05-06

1263 Rwanda FDA-HMP-MA-1299 CINOD 10 Cilnidipine 10 mg 10 mg Film coated tablets 3x10 tablets Alu-Alu blister, 3 such blisters in a printed carton 24 Months AJANTA PHARMA LIMITED, Mirza-Palashbari Road, Village Kokjhar, Kamrup (R), Guwahati, Assam - 781128, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-05-07 2029-05-06

1264 Rwanda FDA-HMP-MA-1300 MERONIA® 1000 IV Meropenem Trihydrate, 1000 mg 1000 mg Powder for solution for injection or infusion 20 ml vial Clear glass vial (type III) closed with a rubber stopper and sealed with an aluminium cap with a plastic flip-top cover 48 Months ANFARM HELLAS S.A, 61st km. Nat. Rd. Athens, Lamia, Schimatari Viotias, 32009, Greece GREECE DAFRA PHARMA GMBH, SWITZERLAND SUN ENTERPRISES LTD 2024-05-07 2029-05-06

1265 Rwanda FDA-HMP-MA-1280 UNOSURE-72 Levonorgestrel 1.5mg 1.5mg Film Coated Tablets 1 tablet Alu-PVC blister packed in a carton 36 Months AKUMS DRUGS AND PHARMACEUTICALS LTD, Plot no. 47 & 48, Sector-6A, IIE., Sidcul, Ranipur, Haridwar-249403, Uttarakhand, India INDIA UNOSOURCE PHARMA LTD, INDIA ABACUS PHARMA (A) LTD 2024-05-16 2029-05-15

1266 Rwanda FDA-HMP-MA- 1281 CLOXVID-500 Cloxacillin Sodium USP 500mg 500mg Hard gelatin capsules 10x10 Capsules Alu/PVC Blister foil and packed in carton 36 Months SCOTT- EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LTD. Hill Top Industrial Area, Bhatoli Kalan, Baddi- 173205, (HP), India INDIA SCOTT- EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LTD, INDIA SUN ENTERPRISES LTD 2024-05-16 2029-05-15

1267 Rwanda FDA-HMP-MA-1282 AZITHROMIL -500 Azithromycin 500mg 500 mg Film coated tablet 1 X 3 tablets Alu/Alu Blister pack, in carton 36 Months BAROQUE PHARMACEUTICALS PRIVATE LIMITED, Address: 192/2&3, 190/1 & 202/9, Sokhada-388 620 Tal: Khambhat, Dist. Anand, Gujarat, India INDIA BEKRA PHARMA UK LTD UBIPHARM-RWANDA LTD 2024-05-16 2029-05-15

1268 Rwanda FDA-HMP-MA-1284 GANVIR GEL OPHTHALMIC Ganciclovir 0.15% w/w 0.15% w/w Eye gel 10 gm bottle LDPE white plastic dropper bottle 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES. Al Obour CityIndustrial zone, Area 14, 15 Block no. 12011 Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICAL IND, EGYPT M/S ETS CONTINENTAL 2024-05-16 2029-05-15

1269 Rwanda FDA-HMP-MA-1305 DOLIMEX SUPPOSITORIES 250 MG Paracetamol BP 250mg 250 mg Suppositories 2 Strip of 5 Suppositories Polyvinyl Chloride / Polyethylene (PVC/PE) foil packed in monocarton. 36 Months BLISS GVS PHARMA LTD, Plot 10, 11-A, 12 Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, District-Thane – 401404, INDIA. INDIA IMEX PHARMA, MAURITIUS MEDIASOL PHARMACEUTICAL DEPOT LTD 2024-05-16 2029-05-15

1270 Rwanda FDA-HMP-MA-1306 CARBEN 500 Mebendazole B.P 500mg 500mg Uncoated chewable tablet 1 Tablet Blister packed in a carton along with leaflet 36 Months BLISS GVS PHARMA LTD, Plot 10, 11-A, 12 Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, District-Thane – 401404, INDIA. INDIA IMEX PHARMA, MAURITIUS MEDIASOL PHARMACEUTICAL DEPOT LTD 2024-05-16 2029-05-15

1271 Rwanda FDA-HMP-MA-1307 CARBEN 100 Mebendazole B.P 100mg 100mg Uncoated chewable tablet 6 Tablets Blister packed in a carton along with leaflet 36 Months BLISS GVS PHARMA LTD. Plot 10, 11-A, 12 Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, District-Thane – 401404, INDIA. INDIA IMEX PHARMA, MAURITIUS MEDIASOL PHARMACEUTICAL DEPOT LTD 2024-05-16 2029-05-15

1272 Rwanda FDA-HMP-MA-1308 SPAMOX ORAL SUSPENSION Amoxicillin Trihydrate 125 mg per 5ml 125 mg per 5ml Powder for reconstitution 100 ml Bottle Amber Colored Glass with measuring cup packed in a carton 24 Months SPARSH BIO-TECH PVT. LTD. Plot No. 1; Survey No.242/243/244,Lakhabavad, Jamnagar-361 006, India INDIA SPARSH BIO-TECH PVT. LTD. INDIA ABACUS PHARMA (A) LTD 2024-05-16 2029-05-15

1273 Rwanda FDA-HMP-MA-1309 SPOTCLAV 625 Amoxycillin Trihydrate USP 500mg and Clavulanate Potassium USP 125mg 500mg 125mg Film Coated Tablet 2 ×10 Tablets Alu-Alu blisters packed in aluminium pouch with silica gel, which is further packed in a carton 24 Months SPARSH BIO-TECH PRIVATE LIMITED, Plot no. 1; Survey no. 242/243/244, Lakhabavad, Jamnagar-361 006, India INDIA SPARSH BIO-TECH PRIVATE LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-05-16 2029-05-15

1274 Rwanda FDA-HMP-MA-1310 VERBITAL-100 Phenobarbital BP 100 mg 100 mg Uncoated tablets 10×10 tablets Amber ALU/PVC blisters pack in a printed carton 36 Months VERVE HUMAN CARE LABORATORIES, Plot No-15A, Selaqui, Pharmacity, Dehradun (Uttarkhand), India INDIA VERVE HUMAN CARE LABORATORIES ABACUS PHARMA (A) LTD 2024-05-16 2029-05-15

1275 Rwanda FDA-HMP-MA-1311 DILINCT DRY COUGH SYRUP Dextromethorphan hydrobromide 15 mg / 5 ml 15 mg / 5 ml Syrup 50ml, 100 ml and 200 ml bottles Labelled amber glass bottles with 28 mm Medropp Generic Cap and placed in a printed carton 24 Months ADCOCK INGRAM HEALTHCARE (PTY) LIMITED, Corner Axel Drive and Baksteen Road, Clayville, Olifantsfontein, Johannesburg, 1665, Republic of South Africa SOUTH AFRICA ADCOCK INGRAM HEALTHCARE (PTY) LIMITED, SOUTH AFRICA SURGIPHARM (RWANDA) LIMITED 2024-05-16 2029-05-15

1276 Rwanda FDA-HMP-MA-1312 ESOCOR 20 Esomeprazole Magnesium Trihydrate BP 20mg 20mg Enteric coated tablet 3×10 Tablets Alu/Alu Blisters packed in carton along with insert 24 Months CORONA REMEDIES PRIVATE LIMITED, Village Jatoli,Post Office - Oachghat,Tehsil Solan, Dist. Solan Himachal Pradesh – 173223, India INDIA CORONA REMEDIES PRIVATE LIMITED, INDIA SUN ENTERPRISES LTD 2024-05-16 2029-05-15

1277 Rwanda FDA-HMP-MA-1313 TEMOL 10MG/ML SOLUTION FOR INTRAVENOUS INFUSION Paracetamol 10mg/ml 10mg/ml Solution for intravenous infusion 100 ml vial Colourless type II glass vial, closed with a bromobutyl rubber stopper and sealed with an aluminum flip-off cap, and inserted in the carton 24 Months S.M. FARMACEUTICI SRL, Zona Industrial – 85050 Tito – Potenza Italy ITALY SANDOZ GMBH, KUNDL, AUSTRIA SUN ENTERPRISES LTD 2024-05-16 2029-05-15

1278 Rwanda FDA-HMP-MA-1314 LOPINE-5 Amlodipine Besylate USP 5mg 5mg Tablets 3 x 10 tablets ALU/PVC clear blister pack in carton 36 Months BLISS GVS PHARMA LTD, Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Palghar, District-Thane – 401404, India INDIA IMEX PHARMA, MAURITIUS MEDIASOL PHARMACEUTICAL DEPOT LTD 2024-05-16 2029-05-15

1279 Rwanda FDA-HMP-MA-1315 SURDEX SYRUP Phenylephrine Hydrochloride BP 2.5 mg, Paracetamol BP 125 mg and Chlorphenamine Maleate BP 1 mg 2.5 mg, 125 mg and 1 mg Syrup 60 ml bottle Amber coloured PET bottle packed in a carton 36 Months BLISS GVS PHARMA LTD, Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Palghar, District-Thane – 401404, India INDIA IMEX PHARMA, MAURITIUS MEDIASOL PHARMACEUTICAL DEPOT LTD 2024-05-16 2029-05-15

1280 Rwanda FDA-HMP-MA-1316 EZPAIN TABLETS Paracetamol 450mg, Codeine Phosphate 10mg, Doxylamine Succinate 5mg & Caffeine 50mg 450mg, 10mg, 5mg 50mg Uncoated tablet 2 x 9 tablets Aluminum-PVC strip packed in a carton 36 Months KWALITY PHARMACEUTICALS LTD. Vill. Nag Kalan, Majitha Road, Amritsar– 143601. India INDIA SUN ENTERPRISES LTD SUN ENTERPRISES LTD 2024-05-16 2029-05-15

1281 Rwanda FDA-HMP-MA-1317 EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS 12.5 MG/1000 MG Empagliflozin 12.5mg and Metformin Hydrochloride 1000mg 12.5mg, 1000 mg Extended Release Tablets 60 tablets White HDPE container 24 Months CIPLA LIMITED, Unit III Plot No. L-139 to L-146, Verna Industrial Estate, Verna-Goa 403 722-India INDIA CIPLA LIMITED, INDIA KIPHARMA LTD 2024-05-16 2029-05-15

1282 Rwanda FDA-HMP-MA-1318 ATRACURIUM MÉDIS 25MG, INJECTION SOLUTION Atracurium Besylate 25mg 25mg Solution for injection 2.5ml ×50 vials Type I white neutral stretched vial 2R blow back of diameter 16 mm closed with Grey chlorobutyl flat rubber stopper Ø13 mm and Aluminum plat green Capsule Ø 13 mm 24 Months LES LABORATOIRES MÉDIS, Road of Tunis Km7 BP 206 Nabeul 8000 Tunisia TUNISIA LES LABORATOIRES MÉDIS, TUNISIA KIPHARMA LTD 2024-05-16 2029-05-15

1283 Rwanda FDA-HMP-MA-1319 ATRACURIUM MÉDIS 50MG, INJECTION SOLUTION Atracurium Besylate 50mg 50mg Solution for injection 2.5ml ×50 vials Type I white neutral stretched vial 2R blow back of diameter 16 mm closed with Grey chlorobutyl flat rubber stopper Ø13 mm and Aluminum plat green Capsule Ø 13 mm 24 Months LES LABORATOIRES MÉDIS, Road of Tunis Km7 BP 206 Nabeul 8000 Tunisia TUNISIA LES LABORATOIRES MÉDIS, TUNISIA KIPHARMA LTD 2024-05-16 2029-05-15

1284 Rwanda FDA-HMP-MA-1320 FOLON TABLETS Folic Acid BP 5mg 5 mg Uncoated tablets 10 ×10 Tablets Alu/Alu blister pack in unit printed duplex board carton 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-05-16 2029-05-15

1285 Rwanda FDA-HMP-MA-1283 PYODINE GEL Povidone Iodine USP 5.00g 5.00g Gel 20gm tube Aluminium tube, sealed with plastic cap, further packed in carton 36 Month BROOKES PHARMA (PRIVATE) LIMITED, 58-59, Sector No.15, Korangi Industrial Area, Karachi-74900, Pakistan PAKISTAN BROOKES PHARMA PRIVATE LIMITED, PAKISTAN AFRI HEALTH CARE LTD 2024-05-18 2029-05-17

1286 Rwanda FDA-HMP-MA-1321 BALTRIM FORTE Trimethoprim 160mg and Sulfamethoxazole 800mg 160mg 800mg Uncoated Tablets 10 ×10 tablets Aluminium/PVC blister strip packed in a unit box with pack insert 48 Months BAL PHARMA LIMITED, 21 & 22 - Bommasandra Industrial Area Bangalore - 560099 Karnataka, India INDIA BAL PHARMA LIMITED, INDIA SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1287 Rwanda FDA-HMP-MA-1322 AMIFER SYRUP Ferric ammonium citrate 172.41 mg equivalent to iron 30mg,folic acid (hydrate) 2.5mg and cyanocobalamin 0.02mg per 5ml 172.41 mg equivalent to 30 mg, 2.5mg, 0.02 mg per 5ml Syrup 200ml bottle Amber coloured glass bottle, closed with a white plastic screw-cap, and a plastic graduated measuring cup 24 Months SOFARIMEX - LNDÉSTRIA QUÍMICA E FARMACÊUTICA, S.A., Av. Das lndÍstrias - Alto do Colaride, Cacém, 2735-213, Portugal PORTUGAL DAFRA PHARMA GMBH SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1288 Rwanda FDA-HMP-MA-1323 COLDCAP ORIGINAL CAPSULES Paracetamol BP 400mg, Caffeine Anhydrous BP 30mg, Pseudoephedrine HCl BP 30mg, Chlorpheniramine Maleate BP 4mg 400mg, 30mg, 30mg, 4mg Hard Gelatin Capsules 1x12, 8x12, 10x10 Capsules Blister Packs 36 Months REGAL PHARMACEUTICALS LIMITED, P.O BOX 44421- 00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LIMITED ABACUS PHARMA(A) LTD 2024-05-18 2029-05-17

1289 Rwanda FDA-HMP-MA-1324 PENOFF Tramadol hydrochloride 50mg 50mg Film coated tablets 2x10 tablets Aluminium foil Alu/Alu blister and in a unit carton 36 Months DAWA LIMITED, Plot No.7879/8, Baba Dogo Road, Ruaraka Nairobi, Kenya KENYA DAWA LIMITED, KENYA SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1290 Rwanda FDA-HMP-MA-1325 RINACET Cetirizine hydrochloride 10mg 10mg Film coated tablets 2x5x10 tablets PVC/Aluminium foil blister pack per unit box 36 Months DAWA LIMITED, Plot No.7879/8, Baba Dogo Road, Ruaraka Nairobi, Kenya KENYA DAWA LIMITED, KENYA SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1291 Rwanda FDA-HMP-MA- 1326 VERZEPAM Diazepam injection BP 5mg/ml 5mg/ml Solution for injection 10 x 2 ml Amber red ring ampoule USP type -1 IHS (2 ml) 24 Months VERVE HUMAN CARE LABORATORIES, Plot no. 15-A, Pharmacity, Selaqui, Dehradun, Uttarakhand, India INDIA VERVE HUMAN CARE LABORATORIES, INDIA ABACUS PHARMA (A) LIMITED 2024-05-18 2029-05-17

1292 Rwanda FDA-HMP-MA-1327 AMYN-250 Amoxicillin Trihydrate BP 250mg 250mg Capsules 10x10 Capsules Blister of Alu/PVC 36 Months KOPRAN LIMITED, Village Savroli Khalapur, Dist-Raigad, Maharashtra, India INDIA KOPRAN LIMITED, INDIA PHILIPS PHARMACEUTICALS LTD 2024-05-18 2029-05-17

1293 Rwanda FDA-HMP-MA-1328 SCOFIX Cefixime 200mg 200mg Film coated tablets 10x1x10 Tablets Alu/Alu Blister packed in mono carton 36 Months SCOTT-EDIL ADVANCE RESEARCH LABORATORY EDUCATION LTD, Hill top industrial area, bhatoli Kalan, baddi-173205, (HP), India INDIA SCOTT-EDIL ADVANCE RESEARCH LABORATORY EDUCATION LTD. SUN ENTERPRISE LTD 2024-05-18 2029-05-17

1294 Rwanda FDA-HMP-MA-1329 PARACETAMOL INFUSION Paracetamol B.P 10mg/ml 10mg/ml Solution for intravenous infusion 100 ml bottle FFS LDPE bottle capped by plastic cap 24 Months AMANTA HEALTHCARE LIMITED, Plot no: 876, N.H. No: 8, Hariyala, Kheda-387411, Gujarat, India INDIA AMANTA HEALTHCARE LIMITED, INDIA SUN ENTERPRISE LTD 2024-05-18 2029-05-17

1295 Rwanda FDA-HMP-MA-1330 DIOCLAV 1G Amoxicillin Trihydrate 875mg + Potassium Clavulanate 125mg 875mg, 125mg Film Coated Tablets 5 ×2 tablets Alu-Alu foil laminated with LDPE 24 Months NATIONAL PHARMACEUTICAL INDUSTRIES CO.(SAOC), Street No. 15, Rusayl Industrial Area, Muscal Sultanate of Oman SULTANATE OF OMAN NATIONAL PHARMACEUTICAL INDUSTRIES CO.(SAOG) SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1296 Rwanda FDA-HMP-MA-1331 GEN-LEVO 500 Levofloxacin Hemihydrate USP 500mg 500mg Film Coated Tablets 1x10 tablets 1 blister of PVC with printed aluminium foil and insert 36 Months BROOKES PHARMA (PRIVATE) LIMITED, 58-59, Sector No. 15, Korangi Industrial, Area, Karachi-74900-Pakistan PAKISTAN BROOKES PHARMA (PRIVATE) LIMITED, PAKISTAN AFRI HEALTH CARE LTD 2024-05-18 2029-05-17

1297 Rwanda FDA-HMP-MA- 1332 REGAMOL TABLETS Paracetamol BP 500mg 500mg Uncoated Tablets 10x10 tablets Aluminium/PVC blister strips packed in a unit box 48 Months BAL PHARMA LIMITED, 21 & 22 - Bommasandra Industrial Area Bangalore, India INDIA BAL PHARMA LIMITED, INDIA SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1298 Rwanda FDA-HMP-MA-1333 CLARICOS 125 Clarithromycin USP 125mg/5ml 125mg/5ml Graules for Oral suspension 100ml bottle 25mm Mouth OD round amber clear glass bottle and clear plastic measuring cups which are further packed using 14” single shrink film 150 gauge 36 Months COSMOS LIMITED, Rangwe Road; Off Lunga Lunga Road, Industrial Area, P. O. Box 41433, Gpo 00100 - Nairobi, Kenya KENYA COSMOS LIMITED, KENYA SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1299 Rwanda FDA-HMP-MA-1334 MACROMAX Azithromycin 500mg 500mg Film Coated Tablet 1x3 tablets Aluminum foil 36 Months NATIONAL PHARMACEUTICAL INDUSTRIES CO. (SAOC), P.O Box 120, Rusayl, Postal code 124, Sultanate of Oman SULTANATE OF OMAN NATIONAL PHARMACEUTICAL INDUSTRIES CO. SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1300 Rwanda FDA-HMP-MA-1335 NAT-D Cholecalciferol (Vitamin D3 125µg…5,000I.U) 125µg…5,000I.U Soft Gelatin Capsules 30 & 60 Capsules Polypropylene bottles 24 Months MEGA LIFESCIENCES PUBLIC COMPANY LIMITED. 384 Moo 4, Soi 6, Bangpoo Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280, Thailand THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2024-05-18 2029-05-17

1301 Rwanda FDA-HMP-MA- 1336 VERBITAL Phenobarbital Sodium 100mg 100 mg Solution for Injection 10x2 ml USP Type-I clear glass black ring ampoule loaded on a plastic tray ampoules in an inner printed carton 24 Months VERVE HUMAN CARE LABORATORIES, Plot No-15A, Selaqui, Pharmacity, Dehradun (Uttarkhand), India INDIA VERVE HUMAN CARE LABORATORIES ABACUS PHARMA (A) LTD 2024-05-18 2029-05-17

1302 Rwanda FDA-HMP-MA- 1337 RL-500ML Sodium lactate 0.320% w/v, Sodium chloride 0.600 % w/v, Potassium chloride 0.040 % w/v, Calcium chloride 0.027 % w/v 0.320% w/v, 0.600 % w/v, 0.040 % w/v, 0.027 % w/v Solution for Intravenous Infusion 500 ml bottle LDPE bottle 60 Months AMANTA HEALTHCARE LIMITED Plot no: 876, N.H. No: 8, Hariyala, Kheda-387411, Gujarat, India INDIA AMANTA HEALTHCARE LIMITED, INDIA SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1303 Rwanda FDA-HMP-MA- 1338 VERBITAL-50 Phenobarbital BP 50mg 50 mg Uncoated tablet 10×10 tablets ALU/PVC blister pack in a printed carton 36 Months VERVE HUMAN CARE LABORATORIES, Plot No-15A, Selaqui, Pharmacity, Dehradun (Uttarkhand), India INDIA VERVE HUMAN CARE LABORATORIES ABACUS PHARMA (A) LTD 2024-05-18 2029-05-17

1304 Rwanda FDA-HBP-MA-1356 CRIZOTINIB PFIZER-250 Crizotinib 250mg 250 mg Hard capsule 60 capsules and 10 capsules HDPE bottles with a polypropylene closure and PVC-foil blisters for 10 capsules 48 Months PFIZER MANUFACTURING DEUTSCHLAND GmbH, Betriebsstätte Freiburg, Mooswaldallee 1, 79090 Freiburg, Germany GERMANY PFIZER LABORATORIES LIMITED WESSEX PHARMACEUTICAL (RWANDA) LTD 2024-05-18 2029-05-17

1305 Rwanda FDA-HMP-MA-1339 METALYSE 10,000 IU Tenecteplase 1,000units (5mg) per ml 1,000units (5mg) per ml Powder for injection Vial Pre-filled syringe Type 1 glass Vial with 50 mg powder for solution for injection with bromotyl rubber stopper and flip-off seal. Pre-filled syringe with 10ml water for injection with assembled tip cap 24 Months BOEHRINGER INGELHEIM PHARMA GmbH & Co. KG. Birkendorfer Strasse 65 88397 Biberach (Riss), Germany GERMANY BOEHRINGER INGELHEIM INTERNATIONAL GMBH, GERMANY SURGIPHARM (RWANDA) LIMITED 2024-05-18 2029-05-17

1306 Rwanda FDA-HMP-MA-1340 PIP OFF Clindamycin Phosphate 1 % w/w 1 % w/w topical gel 25 gm Tube Printed Lami Tube packed in a carton 24 Months BLISS GVS PHARMA LIMITED, Gopaldas Visram & Co. Ltd., Plot No. A/590-591, T.T.C. Industrial Area, M.I.D.C, Mahape, Navi Mumbai, Maharashtra, India INDIA BLISS GVS PHARMA LIMITED, INDIA SURYA DEPOT PHARMACY LTD 2024-05-18 2029-05-17

1307 Rwanda FDA-HMP-MA-1341 AMAREL - 1 Glimepiride 1mg 1 mg Tablets 3 x 10 tablets PVC/ALU Blister packed in a carton 36 Months SANOFI S.PA – SCOPPITO, Strada Statale 17, Km 22, 67019 Scoppito (AQ), Italy ITALY SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2024-05-18 2029-05-17

1308 Rwanda FDA-HMP-MA-1342 AMAREL - 2 Glimepiride 2mg 2 mg Tablets 3 x 10 tablets PVC/ALU Blister packed in a carton 36 Months SANOFI S.PA – SCOPPITO, Strada Statale 17, Km 22, 67019 Scoppito (AQ), Italy ITALY SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2024-05-18 2029-05-17

1309 Rwanda FDA-HMP-MA-1343 AMAREL - 3 Glimepiride 3mg 3 mg Tablets 3 x 10 tablets PVC/ALU Blister packed in a carton 36 Months SANOFI S.PA – SCOPPITO, Strada Statale 17, Km 22, 67019 Scoppito (AQ), Italy ITALY SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2024-05-18 2029-05-17

1310 Rwanda FDA-HMP-MA-1344 AMAREL - 4 Glimepiride 4mg 4 mg Tablets 3 x 10 tablets PVC/ALU Blister packed in a carton 36 Months SANOFI S.PA – SCOPPITO, Strada Statale 17, Km 22, 67019 Scoppito (AQ), Italy ITALY SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2024-05-18 2029-05-17

1311 Rwanda FDA-HMP-MA-1345 JITRIT-5 Tofacitinib citrate 8mg equivalent to Tofacitinib 5 mg 5 mg Film Coated Tablets 4 x 15 tablets Alu / PVC blister packed in a printed outer carton 36 Months MICRO LABS LIMITED, 92, SIPCOT, Hosur-635 126, India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-18 2029-05-17

1312 Rwanda FDA-HMP-MA-1346 VIVIAN-SR-100 Diclofenac Sodium BP 100mg 100mg Prolonged release film coated tablets 10 x 10 tablets Strips packed in a printed carton along with insert 24 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khantraj, Taluka: Kalol, Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-05-18 2029-05-17

1313 Rwanda FDA-HMP-MA-1347 LAMIVUDINE 300MG&TENOFOVIR DISOPROXIL FUMARATE 300MG TABLETS Lamivudine 300mg and Tenofovir disoproxil fumarate 300mg 300mg and 300mg Film Coated Tablets 30 tablets and 10 x 10 tablets Round white HDPE bottle placed in a cardboard carton for 30 tablets and Alu/PVC Blister in preprinted carton 24 Months MACLEODS PHARMACEUTICALS LIMITED. Phase II; Plot No. 25 – 27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman – 396210, India INDIA MACLEODS PHARMACEUTICALS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-18 2029-05-17

1314 Rwanda FDA-HMP-MA-1348 LACTIV (VAGINAL WASH) Lactic Acid BP 1.2 % w/v, Liquid Sorbitol (NonCrystallising) BP1.0 % w/v, Tea Tree Oil (Melaleuca Alternifolia)0.05 % w/v, Hippophae Rhamnoides (Sea Buckthorn) fruit oil 0.25 % w/v, Cocamidopropyl Betaine 7.0 % w/v, Polyquaternium-7 0.5 % w/v, D-Panthenol USP 0.5 % w/v 1.2 % w/v, 1.0 % w/v, 0.05% w/v, 0.25% w/v, 7.0 % w/v, 70.5% w/v, 0.5 % w/v Solution 200 ml bottle HDPE bottle packed in carton 36 Months AUROCHEM LABORATORIES (INDIA) PVT. LTD., Plot No.:8, Palghar Taluka, Ind CO-OP. Estate Ltd. Boisar road, Tal-Palghar, Thane – 401 404, Maharashtra State, India INDIA AUROCHEM LABORATORIES (INDIA) PVT. LTD. UBIPHARM-RWANDA LTD 2024-05-18 2029-05-17

1315 Rwanda FDA-HMP-MA-1349 CARDIOTEM 10 Amlodipine Besylate tablets USP 10mg 10 mg Uncoated Tablets 3 X 10 Tablets Alu/Alu Blister pack 36 Months BAROQUE PHARMACEUTICALS PVT. LTD, 192/2 & 3, 190/1 and 202/9, Sokhada-388 620 Tal: Khambhat, Dist. Anand, Gujarat State, India INDIA BEKRA PHARMA UK LTD UBIPHARMA-RWANDA LTD 2024-05-18 2029-05-17

1316 Rwanda FDA-HMP-MA-1350 ESOMAC 40 MUPS Esomeprazole Magnesium Dehydrate 40mg 40 mg Film Coated Tablets 3x 10 tablets & 2x7 tablets Alu-Alu blister strips 24 Months CIPLA LIMITED, Cipla Goa, Unit IV, Plot No. L-139 to L-146, Verna Industrial Estate, Verna Salcette, Goa 403722, India INDIA CIPLA LIMITED, INDIA KIPHARMA LTD 2024-05-18 2029-05-17

1317 Rwanda FDA-HMP-MA-1351 TAMBALGIC Tramadol 37.5mg and Paracetamol 325mg 37.5 mg, 325mg Film Coated Tablets 2 x 10 Tablets Alu-Alu Pack, Packed in Printed and Laminated Carton 48 Months WEST-COAST PHARMACEUTICAL WORKS LTD, F.P. No17 & 16/5, Meldi Estate, B/s Meldi Mata Temple, Near Gota Railway Crossing, At & Post Gota, Ahmedabad- 382481. Gujarat State (India) INDIA WEST-COAST PHARMACEUTICAL WORKS LTD DOLI PHARMA 2024-05-18 2029-05-17

1318 Rwanda FDA-HMP-MA-1352 VERFEN Fentanyl citrate Injection USP 50mcg/ml 50mcg/ml Solution for Injection 10x10x2ml ampoules clear ampoules, glass type I, packed in cardboard cartons 24 Months VERVE HUMAN CARE LABORATORIES, Plot No-15-A, Pharm city, Selaqui Dehradun-248011, Uttarakhand, India INDIA VERVE HUMAN CARE LABORATORIES ABACUS PHARMA (A) LIMITED 2024-05-18 2029-05-17

1319 Rwanda FDA-HMP-MA-1353 VERMOR-10 Morphine sulphate Injection BP 10mg/ml 10mg/ml Solution for Injection 10x1 ml ampoule USP Type- I amber glass Ampoules loading on a plastic Tray 24 Months VERVE HUMAN CARE LABORATORIES, Plot No-15-A, Pharm city, Selaqui Dehradun-248011, Uttarakhand, India INDIA VERVE HUMAN CARE LABORATORIES ABACUS PHARMA (A) LIMITED 2024-05-18 2029-05-17

1320 Rwanda FDA-HMP-MA-1354 VERPAT Pethidine hydrochloride 100mg/2ml 100mg/2ml Solution for Injection 10x10x2ml ampoules Clear ampoules, glass type I, packed in cardboard cartons 24 Months VERVE HUMAN CARE LABORATORIES, Plot No-15-A, Pharm city, Selaqui Dehradun-248011, Uttarakhand, India INDIA VERVE HUMAN CARE LABORATORIES ABACUS PHARMA (A) LIMITED 2024-05-18 2029-05-17

1321 Rwanda FDA-HMP-MA-1355 CRIZOTINIB PFIZER 200 Crizotinib 200mg 200 mg Hard capsules 60 capsules and 10 capsules HDPE bottles with a polypropylene closure & PVC-foil blisters in a carton for 10 capsules 48 Months PFIZER MANUFACTURING DEUTSCHLAND GmbH, Betriebsstatte Freiburg, Mooswaldallee 1, 79090, Freiburg, Germany GERMANY PFIZER LIMITED UNITED KINGDOM WESSEX PHARMACEUTICALS (RWANDA) LIMITED 2024-05-18 2029-05-17

1322 Rwanda FDA-HMP-MA-1090 NAT – B SOFT GELATIN CAPSULES Riboflavin (Vitamin B2) 50.00 Mg, Pyridoxine Hydrochloride (Vitamin B6) 50.00 Mg, Cyanocobalamin (Vitamin B12) 50.00 Mcg, Nicotinamide 50.00 Mg, Calcium Pantothenate 50.00 Mg, Folic Acid 100.00 Mcg, Choline Bitartrate 50.00 Mg, Biotin 50.00 Mcg, Inositol 50.00 Mg 50.00 Mg, 50.00 Mg, 50.00 Mcg, 50.00 Mg, 50.00 Mg, 100.00Mcg 50.00 Mg, 50.00 Mcg, 50.00 Mg Soft Gelatin Capsules 3 ×10 Soft gelatin capsules Alu-PVC/PVDC blister packed in a cardboard carton 24 Months MEGA LIFESCIENCES PUBLIC COMPANY LIMITED, 384 Moo 4, Soi 6, Bangpoo Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280 Thailand THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED, THAILAND ABACUS PHARMA (A) LTD 2024-05-18 2029-05-17

1323 Rwanda FDA-HMP-MA-1357 NUGREL 75MG Clopidogrel Tablets USP 75 mg 75 mg Film-Coated Tablets 3 ×10 tablets Alu/Alu Blisters packed in a carton 36 Months MICRO LABS LIMITED, 92, Sipcot, Hosur-635 126. India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-18 2029-05-17

1324 Rwanda FDA-HMP-MA-1358 AGODIC-50 TABLETS Diclofenac BP 50mg 50 mg Enteric Coated Tablets 10 tablets Printed Aluminum foil/PVC in a carton 36 Months AGOG PHARMA LTD. Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1325 Rwanda FDA-HMP-MA-1359 AGOTOIN TABLETS Nitrofurantoin tablets BP 100mg 100 mg Uncoated Tablets 10 tablets Printed Aluminum foil/PVC in a carton 36 Months AGOG PHARMA LTD. Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1326 Rwanda FDA-HMP-MA-1360 METRONIDAZOLE INTRAVENOUS INFUSION BP 5G/100ML Metranidazole BP 5g/100ml 5g/100ml Solution for infusion 100 ml bottle LDPE bottle by FFS Technology 60 Months AMANTA HEALTHCARE LIMITED, Plot No. 876, N.H.No: 8, Villi: Hariyala, Tal.Mata, Dist:Kheda-387411, Gujarat, India INDIA AMANTA HEALTHCARE LIMITED, INDIA SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1327 Rwanda FDA-HMP-MA-1361 UTROGESTAN 200MG SOFT CAPSULE Progesterone (micronized) 200mg 200 mg Soft capsules 10, 30, 90x100mg and 15 or 45 x 200 mg capsules Blisters packed in boxes 36 Months CYNDEA PHARMA S.L., Polígono Industrial Emiliano Revilla Sanz Avenida de Ágreda, 31, Olvega 42110 (Soria), Spain SPAIN BESINS MANUFACTURING BENELUX, BELGIUM SURGIPHARM (RWANDA) LTD 2024-05-18 2029-05-17

1328 Rwanda FDA-HMP-MA-1362 FUCIDINE 2% CREAM Fusidic acid 2,000g for 100g of Cream 0.02 Cream 15 g or 30 g tube Lacquered aluminum tube 36 Months LEO LABORATORIES, Cashel Road, Dublin12, Ireland IRELAND LABORATOIRES LEO, FRANCE KIPHARMA LTD 2024-05-18 2029-05-17

1329 Rwanda FDA-HMP-MA-1363 FUCIDINE 250 MG Sodium fusidate 250mg 250mg Film-Coated Tablets 10 or 100 tablets Blister packs (PVC-PVDC/Aluminium) 36 Months LABORATOIRES LEO, 39 Route de Chartres – Vernouillet-28500, France FRANCE LABORATOIRES LEO, FRANCE KIPHARMA LTD 2024-05-18 2029-05-17

1330 Rwanda FDA-HMP-MA-1364 BAROLE 20 Rabeprazole Sodium Capsules 20mg 20mg Enteric Coated Capsules 3x10 and 10x10 Capsules Strips packed in a box 24 Months INVENTIA HEALTHCARE LIMITED, F1-F1/1 Additional Ambernath M.I.D.C., Ambernath (East), Thane 421506, Maharashtra state, India INDIA MEGA LIFESCIENCES (AUSTRALIA) PTY LTD ABACUS PHARMA (A) LTD 2024-05-18 2029-05-17

1331 Rwanda FDA-HMP-MA-1365 BETADINE OINTMENT 5% W/W Povidone-Iodine USP 5% w/w 5% w/w Ointment 15 g &125 g Tubes Aluminum Collapsible Tubes 24 Months G.S. PHARMBUTOR PVT. LTD, B-172, Industrial Area, Behror – 301 701, Rajasthan, India INDIA MODI-MUNDIPHARMA PRIVATE LIMITED SURGIPHARM (RWANDA) LTD 2024-05-18 2029-05-17

1332 Rwanda FDA-HMP-MA-1366 ANASICA 2% Lidocaine Hydrochloride BP 21.330mg/ml 21.330mg/ml Solution for Injection 10 x 30 ml glass vials Amber colored glass vials packed in a carton 36 Months BHARAT PARENTERALS LIMITED, Survey No. 144& 146, Jarod Samlaya Rod, Vill. Haripura, Tal. Savli, Dist. Vadodara 391520, India INDIA ASENCE PHARMA PRIVATE LIMITED, INDIA SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1333 Rwanda FDA-HMP-MA-1367 TRISPORIN®, FILM COATED TABLETS Cefdinir 300mg Film Coated Tablets 300mg Film Coated Tablets 10 tablets (AL/PVC/PE/PVDC) Blister 36 Months PHARMAVISION SANAYI VE TICARET A. ?., Davutpa?a Cad. No: 145, 34010 Topkap?/Istanbul, Turkey TURKEY DAFRA PHARMA GMBH, SWITZERLAND SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1334 Rwanda FDA-HMP-MA-1368 VENTOLIN ® 100 MICROGRAMMES/DOSE SUSPENSION FOR INHALATION Salbutamol Sulfate (micronized) 100 mcg 100 mcg Pressurized Inhalation, Suspension 200 actuations per inhaler. Fluoropolymer-coated aluminium alloy can sealed with a metering valve. The resulting canister (can fitted with valve) is fitted into a plastic actuator incorporating an atomising orifice and fitted with a dustcap 24 Months GLAXO WELLCOME PRODUCTION, Zone Industrielle No. 2, 23, rue Lavoisier, 27000 Evreux, France FRANCE GLAXOSMITHKLINE PHARMACEUTICAL KENYA LIMITED KIPHARMA LTD 2024-05-18 2029-05-17

1335 Rwanda FDA-HMP-MA-1369 VANTOX- CP 500MG Vancomycin Hydrochloride 500 mg 500 mg Powder for Injection 10 mL vial Depyrogenated anodized aluminum canister and seal the canister with seal having rubber gasket then cover with tear-off seal and seal the canister with the help of sealer 24 Months SAMARTH LIFE SCIENCES PVT. LTD. Unit-II, Plot No.2. Industrial Area, Lodhimajra, Baddi, and Himachal Pradesh 173 205, India INDIA SAMARTH LIFE SCIENCES PVT. LTD, INDIA SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1336 Rwanda FDA-HMP-MA-1370 ANTI-COUGH SYRUP Ambroxol HCL 50mg, Guaiphenesin 15mg, Terbutaline Sulphate1.5mg, Chlorpheniramine Maleate 2mg, Menthol 1mg 50mg/15mg/1.5mg/2mg/1mg syrup 100 ml Glass bottle Amber Glass Heam up bottle and a primary carton 36 Months SANGEETA PHARMA, Plot No-A-35, MIDC-Malegaon, Sinnar Nashik-422103 Maharashtra., India INDIA SANGEETA PHARMA, INDIA SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1337 Rwanda FDA-HMP-MA- 1371 DICYNONE Etamsylate 500mg 500 mg Hard Gelatin Capsules 20 Capsules Lacquered aluminium and PVC/PVDC foils, housed in cardboard box 36 Months OM PHARMA SA Rue du Bois-du-Lan 221217 Meyrin,Switzerland SWITZERLAND OM PHARMA SA, SWITZERLAND KIPHARMA LTD 2024-05-18 2029-05-17

1338 Rwanda FDA-HMP-MA- 1372 B-TONE Ferric Ammonium Citrate BP 43mg, Cyanocobalamin (Vit. B12) 50mcg, Pyridoxine Hydrochloride BP 1.5 mg, Folic Acid BP 1.5 mg, Zinc Sulphate BP 2.33 mg (Eq. to 43 mg of Elemental Iron), 50mcg , 1.5 mg, 1.5 mg, 2.33 mg Syrup 200 ml Glass bottle Amber Glass Heam up bottle 24 Months SANGEETA PHARMA, Plot No-A-35, MIDC-Malegaon, Sinnar Nashik-422103 Maharashtra., India INDIA SANGEETA PHARMA, INDIA SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1339 Rwanda FDA-HMP-MA- 1373 AMARYL M SR Glimepiride 2mg and Metformin Hydrochloride 500mg 2mg, 500 mg Film Coated Tablets 3x10 Tablets Blisters packed in a carton 36 Months HANDOK INC., 78, Daepungsandan-ro, Daeso-myeon, Eumseong-gun, Chungcheongbuk-do, Korea KOREA SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2024-05-18 2029-05-17

1340 Rwanda FDA-HMP-MA-1374 APFLU Paracetamol 500mg, Pheniramine Maleate 25mg, Ascorbic Acid 200mg 500 mg, 25 mg, 200 mg Granular powder 10 sachets of 13.0g Aluminium sachets in a carton 24 Months AJANTA PHARMA LIMITED. Gut No.11/12/13/14/15, Paithan Road, Chitegaon, Aurangabad 431105 Taluka Paithaan, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-05-18 2029-05-17

1341 Rwanda FDA-HMP-MA- 1375 ASCORIL EXPECTORANT Bromohexine Hydrochloride BP 4mg, Salbutamol sulphate 2mg, Guaifenesin USP 100mg 4mg, 2mg, 100mg Syrup 100mL bottle Amber coloured labelled PET bottle sealed with aluminium PP cap with “G” logo 10 mL HDPE & measuring cup 24 Months GLENMARK PHARMACEUTICALS LTD., Village Kishanpura, Baddi-Nalagarh Road, Teshsil Baddi, Dist. Solan, Himachal Pradesh-173 205 India INDIA GLENMARK PHARMACEUTICALS LTD., INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-18 2029-05-17

1342 Rwanda FDA-HMP-MA-1377 MICROPRIDE-SR Levosulpiride 75 mg 75 mg Film coated tablets 10’s x 3 tablets ALU / PVC blister packed in a carton 24 months MICRO LABS LIMITED, 92, SIPCOT, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-18 2029-05-17

1343 Rwanda FDA-HMP-MA-1378 MERONIA® 500 IV Meropenem Trihydrate equivalent to 500 mg Meropenem 500 mg Powder for solution for injection or infusion 20 ml, clear glass vial Glass vial (type III) closed with a rubber stopper and sealed with an aluminium cap 48 months ANFARM HELLAS S.A, 61st km. Nat. Rd. Athens, Lamia, Schimatari Viotias, 32009, Greece. GREECE DAFRA PHARMA GMBH SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1344 Rwanda FDA-HMP-MA-1379 AGOBIS TABLETS Bisacodyl BP 5 mg 5 mg Enteric coated tablets 10x 10 tablets Blister Pack of 10x10 Tablets 36 months AGOG PHARMA LTD. Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1345 Rwanda FDA-HMP-MA-1381 BETADINE STANDARDISED MICROBICIDAL SOLUTION 10% Povidone-Iodine USP 10% w/v 10% w/v Aqueous Topical Solution. 50 ml & 100 ml Bottles Amber colored PET Bottle of 50 ml & 100 ml, Amber colored HDPE bottle of 500 ml, Amber colored Glass bottle of 50 ml & 100 ml 24 months G.S. PHARMBUTOR PVT. LTD, B-172, Industrial Area, Behror – 301 701, Rajasthan, India. INDIA MODI-MUNDIPHARMA PRIVATE LIMITED SURGIPHARM (RWANDA) LTD 2024-05-18 2029-05-17

1346 Rwanda FDA-HMP-MA-1382 BETADINE GERMICIDE GARGLE 2%-MIN Povidone Iodine 2% 0.02 Solution 50 ml and 100 ml Bottles Amber PET bottles 18 months G.S. PHARMBUTOR PVT. LTD, B-172, Industrial Area, Behror- 301701, Rajasthan, India. INDIA MODI-MUNDIPHARMA PRIVATE LIMITED SURGIPHARM (RWANDA) LTD 2024-05-18 2029-05-17

1347 Rwanda FDA-HMP-MA-1383 OTRIVIN NASAL DROPS SOLUTION 0.05% Xylometazoline Hydrochloride 0.05% 0.0005 Nasal drops 10ml Bottle High density polyethylene bottle 36 months GSK CONSUMER HEALTHCARE S.A., Route de l’Etraz 2, 1260 Nyon, Switzerland. Fondation Polyval, Site de Nyon, Route de Divonne 48, 1260 Nyon, Switzerland. SWITZERLAND GLAXO SMITH KLINE LIMITED KIPHARMA LIMITED 2024-05-18 2029-05-17

1348 Rwanda FDA-HMP-MA-1384 OTRIVIN NASAL DROPS SOLUTION 0.1% Xylometazoline Hydrochloride 0.1% 0.001 Nasal drops 10ml Bottle High density polyethylene bottle 36 months GSK CONSUMER HEALTHCARE S.A., Route de l’Etraz 2, 1260 Nyon, Switzerland. Fondation Polyval, Site de Nyon, Route de Divonne 48, 1260 Nyon, Switzerland SWITZERLAND GLAXO SMITH KLINE LIMITED KIPHARMA LIMITED 2024-05-18 2029-05-17

1349 Rwanda FDA-HMP-MA-1385 SUPIXA-5 Apixaban 5mg 5 mg Film Coated Tablet 3x10 tablets Alu/Alu blisters packed in a carton along with package insert 24 months MICRO LABS LIMITED, 92, SIPCOT, Hosur-635 126, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-18 2029-05-17

1350 Rwanda FDA-HMP-MA-1386 RIVAMAC 10 Rivaroxaban 10 mg 10 mg Film Coated Tablets 4x7 Tablets Alu/white opaque PVC/PE/PVdC blisters packed in a carton along with pack insert 24 months MACLEODS PHARMACEUTICALS LIMITED, Block No.: 2 Village Theda, P.O. Lodhi Majra, Tehsil Baddi, Dist.: Solan, Himachal Pradesh, 174101, India INDIA MACLEODS PHARMACEUTICALS LIMITED AIVEEN RWANDA LIMITED 2024-05-18 2029-05-17

1351 Rwanda FDA-HMP-MA-1387 RIVAMAC 20 Rivaroxaban 20 mg 20 mg Film Coated Tablets 4x7 Tablets Alu/white opaque PVC/PE/PVdC blisters packed in a carton along with pack insert 24 months MACLEODS PHARMACEUTICALS LIMITED, Block No.: 2 Village Theda, P.O. Lodhi Majra, Tehsil Baddi, Dist.: Solan, Himachal Pradesh, 174101, India INDIA MACLEODS PHARMACEUTICALS LIMITED AIVEEN RWANDA LIMITED 2024-05-18 2029-05-17

1352 Rwanda FDA-HMP-MA-1388 AGOVIT-6 TABLETS Pyridoxine Hydrochloride BP 25mg 25mg Uncoated Tablets 1000 Tablets Jar pack 36 months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1353 Rwanda FDA-HMP-MA-1389 SUPIXA-2.5 Apixaban 2.5mg 2.5mg Film Coated Tablets 1x10 Tablets Alu/Alu blisters packed in a carton along with package insert 24 months MICRO LABS LIMITED, 92, SIPCOT, Hosur-635 126, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-18 2029-05-17

1354 Rwanda FDA-HMP-MA-1390 GALVUS® 50MG Vildagliptin 50mg 50mg Tablets 56 Tablets PA/AL/PVC blister foil 36 months NOVARTIS FARMACÉUTICA S.A., Barberá del Vallés, Spain SPAIN NVS KENYA LIMITED, KENYA SURGIPHARM (RWANDA) LIMITED 2024-05-18 2029-05-17

1355 Rwanda FDA-HMP-MA-1391 ZINC OXIDE OINTMENT Zinc Oxide USP 20% w/w 20% w/w Topical ointment 500gm jar Jar pack 36 months AGOG PHARMA LTD, Plot No. 33, Sector II, the Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1356 Rwanda FDA-HMP-MA- 1392 MICLOGEN CREAM Miconazole Nitrate BP 2 %w/w, Clobetasol BP 0.05 % w/w and Gentamicin Sulphate BP Eq. to Gentamicin 0.1 % w/w 2 %w/w, 0.05 % w/w, 0.1 % w/w Cream 30 gm tube Lami tube pack of 30 gm 36 months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane-401208, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1357 Rwanda FDA-HMP-MA- 1393 AGOBATE CREAM Clobetasol Propionate BP 0.05 % w/w 0.05 % w/w Cream 30gm Tube 30gm packed in one tube such tube packed in unit printe carton 36 months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-05-18 2029-05-17

1358 Rwanda FDA-HBP-MA-0129 ROTARIX Human rotavirus, live attenuated vaccine, 1 dose (1.5 ml) contains: Human rotavirus RIX4414 strain (live, attenuated) not less than 106.0 CCID50 1 dose (1.5 ml) contains: Human rotavirus RIX4414 strain (live, attenuated) not less than 106.0 CCID50 Oral suspension 3 ml tube Polyethylene tubes that are assembled with a polypropylene cap to protect the membrane of the tube which has to be perforated, before use, with the help of the spike located on the top of the cap 36 Months GLAXOSMITHKLINE BIOLOGICALS, Parc de la Noire Epine, Rue Fleming, 20, 1300 Wavre-Belgium BELGIUM GLAXOSMITHKLINE PHARMACEUTICAL KENYA LIMITED KIPHARMA LTD 2024-05-18 2029-05-17

1359 Rwanda FDA-HBP-MA-0130 IMMUNOREL® Human immunoglobulin 2.5g and 5g per 100 ml 5% intravenous infusion in packs contain human immunoglobulin 2.5g and 5g per 100 ml Intravenous infusion 100ml bottles Glass bottles stoppered with a rubber bung. The bung is covered with a tamper-evident cap. 36 Months RELIANCE LIFE SCIENCES PVT. LTD. Plant 4A & 4B, Dhirubhai Ambani Life Sciences Centre (DALC) R-282, TTC Area of MIDC, Thane Belapur Road Rabale, Navi Mumbai, 400701 India INDIA RELIANCE LIFE SCIENCES PVT. LTD. STAR BIOTECH LIMITED 2024-05-18 2029-05-17

1360 Rwanda FDA-HBP-MA-0131 MENOTAS HP 75 Menotrophin for Injection BP 75 IU/vial 75 IU/vial Powder for injection; and solvent for parenteral use 1 Vial of 75IU & 1 ampoule Sodium Chloride Injection (0.9% w/v) BP as solvent Vial & ampoule 36 Months INTAS PHARMACEUTICALS LIMITED, Plot No. – 85/87, Kailash Industrial Estate Vill. -Iyava, Tal- Sanand, Dist.- Ahmedabad-382 110, Gujarat, India INDIA INTAS PHARMACEUTICALS LIMITED VINE PHARMA LTD 2024-05-18 2029-05-17

1361 Rwanda FDA-HBP-MA-0132 CORIOSURGE XP 5000 Chorionic Gonadotrophin for injection BP 5000IU/Vial 5000IU/Vial Lyophilized powder for reconstitution for injection 1 Vial containing H.C.G & 1 ampoule Sodium Chloride Injection (0.9% w/v) BP as solvent Vial & ampoule 24 Months INTAS PHARMACEUTICALS LIMITED, Plot No. – 85/87, Kailash Industrial Estate Vill. -Iyava, Tal- Sanand, Dist.- Ahmedabad-382 110, Gujarat, India INDIA INTAS PHARMACEUTICALS LIMITED VINE PHARMA LTD 2024-05-18 2029-05-17

1362 Rwanda FDA-HMP-MA-1394 OZITAS-10 Olanzapine 10 mg tablets 10 mg Film Coated Tablets 3 X 10 Tablets Alu/Alu blister pack which is in a printed carton 24 Months INTAS PHARMACEUTICALS LIMITED, Camp Road, Selaqui-248197 Dehradun Uttarakhand, India INDIA INTAS PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-07-18 2029-07-17

1363 Rwanda FDA-HMP-MA-1395 OZITAS-5 Olanzapine 5 mg tablets 5 mg Film Coated Tablets 3 X 10 Tablets Alu/Alu blister pack where each one is inserted a printed carton 24 Months INTAS PHARMACEUTICALS LIMITED, Camp Road, Selaqui-248197 Dehradun Uttarakhand, India INDIA INTAS PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-07-18 2029-07-17

1364 Rwanda FDA-HMP-MA-1396 VAXATO 15MG Rivaroxaban 15 mg 15 mg Film Coated Tablets 3 X 10 Tablets Alu/Alu Blister Pack 24 Months LIPTIS FOR PHARMACEUTICALS AND MEDICAL PRODUCTS, Plot No. B/2, 6th industrial zone, 6th of October City, Egypt EGYPT LIPTIS FOR PHARMACEUTICAL AND MEDICAL PRODUCTS (S.A.E) GOODMAN INTERNATIONAL LTD (R) 2024-07-18 2029-07-17

1365 Rwanda FDA-HMP-MA-1397 VAXATO 20 MG Rivaroxaban 20 mg 20 mg Film Coated Tablets 3 X 10 Tablets Alu/Alu Blister Pack 24 Months LIPTIS FOR PHARMACEUTICALS AND MEDICAL PRODUCTS, Plot No. B/2, 6th industrial zone, 6th of October City, Egypt EGYPT LIPTIS FOR PHARMACEUTICAL AND MEDICAL PRODUCTS (S.A.E) GOODMAN INTERNATIONAL LTD (R) 2024-07-18 2029-07-17

1366 Rwanda FDA-HMP-MA-1398 VAXATO 10 MG Rivaroxaban 10 mg 10 mg Film Coated Tablets 1 X 10 Tablets Alu/Alu Blister Pack 24 Months LIPTIS FOR PHARMACEUTICALS AND MEDICAL PRODUCTS, Plot No. B/2, 6th industrial zone, 6th of October City, Egypt EGYPT LIPTIS FOR PHARMACEUTICAL AND MEDICAL PRODUCTS (S.A.E) GOODMAN INTERNATIONAL LTD (R) 2024-07-18 2029-07-17

1367 Rwanda FDA-HMP-MA-1399 AGO-CPM Chlorphenamine Maleate BP 2mg/5ml 2mg/5ml Syrup 60ml Bottle PET Amber Bottles 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-07-18 2029-07-17

1368 Rwanda FDA-HMP-MA-1400 CALOSHELL-500 COATED TABLETS Calcium Carbonate from an organic source (Oyster shell)1250mg equivalent to Elemental Calcium 500mg & Colecalciferol BP (Vitamin D 250 IU/mg) 500mg Tablets 10x10 Tablets Alu-PVC blister; such 10 blisters along with the pack insert are Packed in a carton 24 Months EMCURE PHARMACEUTICALS LIMITED, Lane No.3, Phase-II, SIDCO Industrial Complex, Bari-Brahmana, Jammu – 181 133, India INDIA EMCURE PHARMACEUTICALS LIMITED BION PHARMA GROUP LIMITED 2024-07-18 2029-07-17

1369 Rwanda FDA-HMP-MA-1401 CO-MICARDIS 80/12.5MG TABLETS Telmisartan 80 mg + Hydrochlorothiazide 12.5mg 80 mg + 12.5mg Tablets 7 or 10 tablets Aluminium/aluminium blisters (PA/Al/PVC/Al or PA/PA/Al/PVC/Al). 36 Months BOEHRINGER INGELHEIM, Ellas A.E. 5th km Paiania-Markopoulo, Koropi Attiki, 19400, Greece GREECE BOEHRINGER INGELHEIM INTERNATIONAL GMBH, GERMANY SURGIPHARM (RWANDA) LIMITED 2024-07-18 2029-07-17

1370 Rwanda FDA-HMP-MA-1402 LASTAVIN AM 10/160 Amlodipine 10 mg, Valsartan 160 mg 10 mg, 160 mg Film Coated Tablets 3x10 Tablets Alu-Alu blister. Such 3 blisters of 10 tablets along with package insert are packed in a carton 30 Months AJANTA PHARMA LIMITED, Plot No. B-4/5/6, MIDC Area Paithan, Aurangabad-431148, Taluka: Paithan, District: Aurangabad Zone 2, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-07-18 2029-07-17

1371 Rwanda FDA-HMP-MA-1403 LOTEM SUSPENSION Ibuprofen 200mg and Paracetamol 250mg per 10 ml 200mg and 250mg per 10ml Suspension 100ml and 200ml Bottles Amber glass Bottles 24 Months ADCOCK INGRAM HEALTHCARE (PTY) LIMITED, (Clayville) Corner Axle Drive and Baksteen Road, Clayville, Olifantsfontein, Johannesburg, 1665, RSA, South Africa SOUTH AFRICA ADCOCK INGRAM LIMITED (MIDRAND) SURGIPHARM (RWANDA) LIMITED 2024-07-18 2029-07-17

1372 Rwanda FDA-HMP-MA-1404 MARCAINE SPINAL 0.5% HEAVY AMPS Bupivacaine Hydrochloride 5mg/ml 5mg/ml Solution for Injection 4 ml solution filled into 5 ml ampoules Type I glass ampoules with/without blister blister pack 36 Months BETA HEALTHCARE INTERNATIONAL LTD, Plot No. LR 209/6554, Mogadishu Road, Industrial Area, Nairobi, P.O. BOX 42569-00100 GPO Nairobi, Kenya KENYA BETA HEALTHCARE INTERNATIONAL LTD SURGIPHARM (RWANDA) LIMITED 2024-07-18 2029-07-17

1373 Rwanda FDA-HMP-MA-1405 FRESENIUS PROPOVEN 1 % (20ML) Each ml emulsion contains 10 mg propofol 10mg/ml Emulsion for injection or infusion 10 glass ampoules with 20 ml emulsion Glass ampoules 36 Months FRESENIUS KABI AB, Plant Uppsala Rapsgatan 7 S-75174 Uppsala, Sweden SWEDEN FRESENIUS KABI SOUTH AFRICA (PTY) LIMITED, SOUTH AFRICA SURGIPHARM (RWANDA) LIMITED 2024-07-18 2029-07-17

1374 Rwanda FDA-HMP-MA-1406 DAPAVELDACTIN 10MG Dapagliflozin 10 mg 10 mg Film Coated Tablets 4 X 10 Tablets Alu/Alu Blister Pack. Such 4 blisters are packed in a carton along with package inserts. 24 Months LIPTIS FOR PHARMACEUTICALS AND MEDICAL PRODUCTS, Plot No. B/2, 6th industrial zone, 6th of October City, Egypt EGYPT LIPTIS FOR PHARMACEUTICAL AND MEDICAL PRODUCTS (S.A.E) GOODMAN INTERNATIONAL LTD (R) 2024-07-18 2029-07-17

1375 Rwanda FDA-HMP-MA-1407 RECTONAC-100 Diclofenac Sodium 100 mg 100 mg Suppositories 2 x 5 Suppositories Strip pack 36 Months GALEN PHARMACEUTICALS LTD, 334/5, G.I.D.C Estate, Waghodia- 91760, Dist: - Vadodara, Gujarat, India INDIA GALEN PHARMACEUTICALS LIMITED SUN ENTERPRISES LTD 2024-07-18 2029-07-17

1376 Rwanda FDA-HMP-MA-1408 EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG/1000MG Empagliflozin and Metformin Hydrochloride, 10 mg/1000 10mg/1000mg Film coated extendedrelease tablet 30 Tablets HDPE container with a 38mm blue child resistant cap 24 Months CIPLA LTD, Cipla house, Peninsula business park, Ganpatrao kadam marg, Lower parel, Mumbai INDIA CIPLA LTD PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-07-18 2029-07-17

1377 Rwanda FDA-HMP-MA-1409 VANTOX-CP Vancomycin Hydrochloride 1gr 1gr Powder for Injection 1x20ml vial USP Type-III, 20 ml flint moulded vial with red flip-off seal, labeled and packed 24 Months SAMARTH LIFE SCIENCES PVT. LTD., Unit – II, Plot No.2, Industrial Area, Lodhimajra, Baddi, and Himachal Pradesh 173 205, India INDIA SAMARTH LIFE SCIENCES PVT. LTD SUN ENTERPRISES LTD 2024-07-18 2029-07-17

1378 Rwanda FDA-HMP-MA-1410 CANDIVOR Voriconazole Ph, Eur. 200 mg/vial 200 mg/vial Injection 1 x 30 ml single Vail Type I molded glass and sealed with grey bromobutyl lyophilisation rubber stopper and white colored flip off seal 24 Months ASPIRO PHARMA LIMITED, Survey No. 321, Biotech Park, Phase III., Karkapatla, Markook Mandal, Siddipet District, Telangana (S)-502281, India INDIA ASPIRO PHARMA LIMITED SUN ENTERPRISES LTD 2024-07-18 2029-07-17

1379 Rwanda FDA-HMP-MA-1411 PIRONEM Meropenem Injection 1.0 gm 1.0 gm Injection 1000mg/vial Glass vial (Type III) with rubber stopper and aluminium tear seal. Each vial is placed in a carton unit with package insert 24 Months DAMAIRA EXPORTS, Kunjhal, Jharmajri, Distt-Solan, Baddi- 173205 (H.P), India INDIA DAMAIRA EXPORTS AFRIPHARMA LTD 2024-07-18 2029-07-17

1380 Rwanda FDA-HMP-MA-1412 PARACETAMOL KABI 10 MG/ML SOLUTION FOR INFUSION Paracetamol 10 mg/ml. 10 mg/ml SOLUTION FOR INFUSION 10, 12 or 20 bottles of 50 ml or 100 ml Clear, colorless glass bottles with a red rubber stopper and an aluminium cap with either a tear-off tab of aluminium or a plastic lid 24 Months FRESENIUS KABI GERMANY GmbH, Plant Friedberg, Freseniusstrasse 1, D-61169 Friedberg, Germany GERMANY FRESENIUS KABI SOUTH AFRICA (PTY) LIMITED SURGIPHARM (RWANDA) LIMITED 2024-07-18 2029-07-17

1381 Rwanda FDA-HMP-MA-1656 ERLOCIP 25 Erlotinib Hydrochloride, 25 mg 25 mg Film coated tablets 10 Tablets Aluminium blister foil and PVC Film 24 Months CIPLA LIMITED, Goa Unit X, Plot No. S-103 to S-105, S-107 S-112, L-138, L-147 to L-147/1 to L-147/3 & L147/A, Verna Industrial Estate, Verna Goa-403 722, India INDIA CIPLA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-07-18 2029-07-17

1382 Rwanda FDA-HMP-MA-1413 MEFTAL – 500 TABLETS Mefenamic Acid BP 500 mg 500 mg Tablets 10, 20 Tablets per strip Printed aluminium foil and amber colored PVC blister. 5 combi strip in a carton alongwith leaflet. 48 Months BLUE CROSS LABORATORIES PVT LTD, L-17, Verna Industrial Estate, Verna, Goa-403722 INDIA BLUE CROSS LABORATORIES PVT. LTD. WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-07-18 2029-07-17

1383 Rwanda FDA-HMP-MA-1414 PHARMALGAN 100 ML Paracetamol BP 10 mg/ml 10 mg/ml Solution for IV infusion 100 ml bottle LDPE plastic Bottles covered by plastic dust caps. 24 Months AMANTA HEALTHCARE LIMITED. Plot no: 876, N.H-8, Hariyala, Kheda-387411, Gujarat, India. INDIA PHARMACO DISTRIBUTION (PTY) LTD KIPHARMA LTD 2024-07-18 2029-07-17

1384 Rwanda FDA-HMP-MA-1415 KLOVINAL Metronidazole, Clotrimazole and Lactobacillus spores 500 mg/100 mg/150 million spores 500 mg/100 mg/150 million spores Pessaries 6 Pessaries Polyvinyl chloride/polyethylene foil. 1 strip of 6 pessaries is packed in a carton with pack insert 24 Months BLISS GVS PHARMA LIMITED, Plot No. 10, 11a & 12, Survey No.38/1, Dewan Udyog Nagar, Aliyali, Palghar (W), Dist – Thane, Maharashtra-India. INDIA BLISS GVS PHARMA LTD SURYA DEPOT PHARMACY LTD 2024-07-18 2029-07-17

1385 Rwanda FDA-HMP-MA-1416 NIPINE-SR 20 Nifedipine USP, 20 mg 20 mg Sustained Release Tablets 10×10 Tablets Blister pack along with one Insertpacked in a carton 36 Months CENTURION LABORATORIES PVT. LTD, Plot No: P-2, Savli Bio-Tech Park, At – Manjusar, Tal. – Savli, Dist. Vadodara – 391 775, India INDIA ASENCE PHARMA PVT. LTD SUN ENTERPRISES LTD 2024-07-18 2029-07-17

1386 Rwanda FDA-HMP-MA-1417 MOXACIL DS-250 POWDER FOR ORAL SUSPENSION Amoxicillin Trihydrate 250mg/5ml 250mg/5ml Powder for oral Suspension 100ml Bottle HDPE bottle in a unit carton along with a literature insert 36 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-07-18 2029-07-17

1387 Rwanda FDA-HMP-MA-1418 MICROGYNON 0.03 MG/ 0.15 MG COATED TABLETS Ethinylestradiol 0.03mg, Levonorgestrel 0.15mg 0.03mg, 0.15mg Film Coated tablets 3 x 28 tablets PVC/Aclar-Blister and later packed in a carton 36 Months BAYER WEIMAR GmbH UND CO.KG Doebereinerstr.20 99427 Weimar, Germany GERMANY BAYER EAST AFRICA LTD SURGIPHARM (RWANDA) LIMITED 2024-07-18 2029-07-17

1388 Rwanda FDA-HMP-MA-1419 AMOXIMED Amoxicillin 250 mg capsules 250 mg Hard capsules 10x10 capsules PVC/Aluminum blister foil 36 Months CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. No.88, Yangzi Road, Shijiazhuang City, Hebei province, China CHINA MEDISEL (K) LTD SUN ENTERPRISES LTD 2024-07-18 2029-07-17

1389 Rwanda FDA-HMP-MA-1420 BETADINE ANTISEPTIC CREAM 5% Povidone Iodine 5% 0.05 Topical Cream 10 g and 20 g Polyethylene Tubes 24 Months G.S. PHARMBUTOR PVT. LTD, B-172, Industrial Area, Behror- 301701, Rajasthan, India INDIA MODI-MUNDIPHARMA PRIVATE LIMITED SURGIPHARM (RWANDA) LIMITED 2024-07-18 2029-07-17

1390 Rwanda FDA-HMP-MA-1421 BETADINE STANDARDISED MICROBICIDAL SOLUTION 5% Povidone-Iodine USP 5% w/v 5% w/v Aqueous Topical Solution 50 ml & 100 ml and 500 ml bottles Amber PET bottle of 50 ml & 100 ml and Brown HDPE bottle of 500 ml 24 Months G.S. PHARMBUTOR PVT. LTD, B-172, Industrial Area, Behror- 301701, Rajasthan, India INDIA MODI-MUNDIPHARMA PRIVATE LIMITED SURGIPHARM (RWANDA) LIMITED 2024-07-18 2029-07-17

1391 Rwanda FDA-HMP-MA-1422 TROGYL PLUS SUSPENSION Metronidazole Benzoate 200mg and Diloxanide Furoate 250mg 200mg and 250mg Suspension 60ml, 100ml Bottles Amber colored (Glass/PET) bottles and card box 36 Months BIODEAL LABORATORIES LTD, 123, Lunga. P.O Box 32040-00600, Nairobi, Kenya. KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-07-18 2029-07-17

1392 Rwanda FDA-HMP-MA-1424 SPIROMIDE-40 MG TABLETS Spironolactone (BP) 50 mg and furosemide (Ph.Eur.) 40 mg 50 mg and 40 mg Film Coated Tablets 3x10 Tablets PVC/ALU Blisters 24 Months THE SEARLE COMPANY LIMITED, F-319, S.I.T.E. Karachi, Pakistan PAKISTAN THE SEARLE COMPANY LIMITED SURGIPHARM (RWANDA) LIMITED 2024-07-18 2029-07-17

1393 Rwanda FDA-HMP-MA- 1425 PRAZITEL Praziquantel 600mg 600mg Film Coated Tablets 10x10 Tablets PVC/Alu blister packs and in mono carton along with pack insert 36 Months COSMOS LIMITED, Plot. No L/R209/13268, Rangwe Road; Off Lunga Lunga Road, Industrial Area, P. O. Box 41433, GPO 00100 Nairobi, Kenya KENYA COSMOS LIMITED, KENYA SUN ENTERPRISES LTD 2024-07-18 2029-07-17

1394 Rwanda FDA-HMP-MA- 1426 OXYTOCIN 5 I.U HEXAL Oxytocin, 5IU/1ml 5 IU/1ml Solution for Injection 10 ampoules of 1 ml solution Ampoules of 1 ml solution for injection in clear glass bott 36 Months SALUTAS PHARMA GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben Germany GERMANY SANDOZ GmbH, Kundl, Germany SURGIPHARM (RWANDA) LIMITED 2024-07-18 2029-07-17

1395 Rwanda FDA-HMP-MA- 1427 AMLOZAAR-H Amlodipine 50 mg, Losartan Potassium 50 mg, Hydrochlorothiazide 12.5 mg 50 mg, 50 mg, 12.5 mg Film-coated tablets 3x10 Tablets Alu/Alu blister pack. Three of such blisters are packed in a printed outer carton 24 Months MICRO LABS LIMITED, 92 Sipcot Industrial Complex Hosur-635 126 India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-07-18 2029-07-17

1396 Rwanda FDA-HMP-MA- 1428 PRELYNCA-75 Pregabalin capsules 75 mg 75 mg Hard Gelatin Capsules 2x14 Capsules PVC/Aluminium foil blisters and 2 blisters of 14 capsules are packed in carton along with the pack insert 36 Months PHARMATHEN INTERNATIONAL S.A. Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Ellas- Greece GREECE MEGA LIFE SCIENCES (AUSTRALIA) PTY. LTD AUSTRALIA ABACUS PHARMA (A) LTD 2024-07-18 2029-07-17

1397 Rwanda FDA-HMP-MA-1429 PRELYNCA-50 Pregabalin capsules 50 mg 50 mg Hard Gelatin Capsules 3x7 Capsules PVC/Aluminium foil blisters and 3 such blisters are packed in carton along with the pack insert 36 Months PHARMATHEN INTERNATIONAL S.A. Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Ellas- Greece GREECE MEGA LIFE SCIENCES (AUSTRALIA) PTY. LTD AUSTRALIA ABACUS PHARMA (A) LTD 2024-07-18 2029-07-17

1398 Rwanda FDA-HMP-MA-1430 NEURO-STONE Pregabalin BP 75 mg, MecobalaminJP 1500 mcg, Folic acid BP 5mg, Pyridoxine Hydrochloride BP 20mg 75 mg, 1500 mcg, 5mg, 20mg Film-coated tablets 3x10 Tablets Blister Pack 24 Months THE MADRAS PHARMACEUTICALS, No.137 B, Old Mahabalipuram road, Karapakkam, Chennai 600 096, India INDIA THE MADRAS PHARMACEUTICALS DOLIPHARM LTD 2024-07-18 2029-07-17

1399 Rwanda FDA-HMP-MA-1431 LORI Diazepam BP 5mg/ml 5mg/ml Liquid injection 2ml ampoules Amber ampoules with blue band snaps off 36 Months M/S. NEON LABORATORIES LIMITED, Plot No. 29 to 32, 57 & 60, the Palghar Taluka-Co-op- Estate ltd, Boisar Road, Palgher,401404, Maharashtra, India INDIA M/S NEOM LABORATORIES LIMITED, INDIA SUN ENTERPRISES LTD 2024-07-18 2029-07-17

1400 Rwanda FDA-HBP-MA-0133 ALVEOFACT-54 One vial of 54 mg contains 50.76 – 60.00 mg phospholipid fraction from bovine lung (dried mass), equivalent to a content of 66 ?mol or 54 mg total phospholipids as lyophilised powder 54 mg/ml Powder and solvent for suspension 1 glass vial Type I white glass vial with grey rubber stopper and aluminium cuff with a purple (54 mg). Solvent in a pre-filled white glass syringe with rubber plunger containing 1.2 ml 36 Months BAG HEALTH CARE GmbH, Amtsgerichtsstr. 1-5 35423 Lich, Germany GERMANY BHARAT SERUMS & VACCINES LTD, INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-07-18 2029-07-17

1401 Rwanda FDA-HBP-MA-0134 ALVEOFACT-108 108 mg/ml (One vial of 108 mg contains 101.52 – 120.00 mg phospholipid fraction from bovine lung (dried mass), equivalent to a content of 66 ?mol or 108 mg total phospholipids as lyophilized powder 108 mg/ml Powder and solvent for suspension 1 glass vial Type I white glass vial with grey rubber stopper and aluminium cuff with a purple (54 mg) or blue (108 mg) tear-off seal. Solvent in a pre-filled white glass syringe with rubber plunger containing 1.2 ml or 2.4 ml. 36 Months BAG HEALTH CARE GmbH, Amtsgerichtsstr. 1-5 35423 Lich, Germany GERMANY BAG HEALTH CARE GmbH, India PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-07-18 2029-07-17

1402 Rwanda FDA-HMP-MA-1423 LIDOCAINE HYDROCHLORIDE INJECTION Lidocaine Hydrochloride USP 20mg/ml 20mg/ml Solution for injection 1 vial of 20 ml amber colored USP Type I glass vial 36 Months CIRON DRUGS AND PHARMACEUTICALS PVT. LTD, N-118, N-119, N-113, Midc. Tarapur, Boisar, Dist, Thane-401506, Maharashtra, India INDIA CIRON DRUGS & PHARMACEUTICALS PVT. LTD RENE PHARMACY (R) LTD 2024-07-20 2029-07-19

1403 Rwanda FDA-HMP-MA-1432 DIGOXIN INJECTION BP Digoxin BP 0.25 mg/ml 0.25 mg/ml Solution for injection 5 Ampouls of 2 ml Amber USP type I Ampoules 36 Months CIRON DRUGS AND PHARMACEUTICALS PVT. LTD, N-118, N-119, N-113, Midc. Tarapur, Boisar, Dist, Thane-401506, Maharashtra, India INDIA CIRON DRUGS & PHARMACEUTICALS PVT. LTD RENE PHARMACY (R) LTD 2024-07-20 2029-07-19

1404 Rwanda FDA-HMP-MA-1433 ORCHAZID OPHTHALMIC SOLUTION Ketotifen 0.25mg/ml 0.25mg/ml Ophthalmic Solution 5 ml Bottle LDPE white plastic bottles 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES, Al Obour City-Industrial Zone, Area 14, 15 Block No. 12011 Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICALS ETS CONTINENTAL DEPOT 2024-07-20 2029-07-19

1405 Rwanda FDA-HMP-MA-1434 MOXVID-500 Amoxicillin Trihydrate USP 500mg 500mg Hard gelatin capsules l0 x l0 Capsules Alu/PVC blisters 36 Months SCOTT-EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LTD, Hil Top Industrial Area, Bhatori Karan, Baddi-r 73205, (Hp), India INDIA SCOTT- EDIT ADVANCE RESEARCH LABORATORIES & EDUCATION LTD ESCORTS PHARMACEUTICALS (RWANDA) LIMITED 2024-07-20 2029-07-19

1406 Rwanda FDA-HMP-MA-1435 DEEP HEAT SPRAY Methyl salicylate 1% w/w, Ethyl salicylate 5% w/w, 2-hydroxyethylsalicylate 5% w/w and methyl nicotinate 1.6% w/w 1% w/w, 5% w/w, 5% w/w and 1.6% w/w Aerosol topical spray 150 ml (100g) x1 Container Tinplate aerosol container packed in a box 36 Months COLEP LAUPHEIM Gmbh & Co. KG Fockestraße 12, 88471, Laupheim Germany GERMANY THE MENTHOLATUM COMPANY LIMITED SUN ENTERPRISES LTD 2024-07-20 2029-07-19

1407 Rwanda FDA-HMP-MA-1436 NERVILIN-NT Pregabalin 75 mg and Nortriptyline 10 mg 75 mg and 10 mg Film Coated Tablets 3 X 10 Tablets Alu/ Alu blisters packed in a unit box 24 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-07-20 2029-07-19

1408 Rwanda FDA-HMP-MA-1437 EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE Empagliflozin 5mg/ Metformin Hydrochloride 1000mg 5mg/ 1000mg Film Coated Tablets 60 Tablets White HDPE container of 60 tablets each packed in carton unit 24 Months CIPLA LIMITED, Unit III Plot No. L-139 to L-146 Verna Industrial Estate, Verna, Salcette, Goa-403 722. India INDIA CIPLA LTD, INDIA KIPHARMA LTD 2024-07-20 2029-07-19

1409 Rwanda FDA-HMP-MA-1438 EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE Empagliflozin 25mg/ Metformin Hydrochloride 1000mg 25mg/ 1000mg Film Coated Tablets 30 Tablets White HDPE container of 30 tablets each packed in carton unit 24 Months CIPLA LIMITED, Unit III Plot No. L-139 to L-146 Verna Industrial Estate, Verna, Salcette, Goa-403 722. India INDIA CIPLA LTD, INDIA KIPHARMA LTD 2024-07-20 2029-07-19

1410 Rwanda FDA-HMP-MA-1439 SKDERM CREAM Betamethasone Dipropionate USP 0.05% w/w Clotrimazole BP 1.0% w/w and Gentamicin Sulfate BP 0.1% w/w 0.05% w/w 1.0% w/w and 0.1% w/w Cream 15 g Tubes Aluminium Collapsible tubes internally lacquered with epoxy phenol such tube is packed in a carton with a pack insert 36 Months S.KANT HEALTHCARE LIMITED. Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396-195, Gujarat, India INDIA S KANT HEALTHCARE LTD, INDIA ABACUS PHARMA(A) LTD 2024-07-20 2029-07-19

1411 Rwanda FDA-HMP-MA-1440 COTRIZIM-480 Trimethoprim 80mg & Sulfamethoxazole 400mg tablet 80mg & 400mg Uncoated Tablets 1000 Tablets HDPE Jar 36 Months ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar, Nagpur 441501, Maharashtra State, India INDIA ZIM LABORATORIES LIMITED, INDIA SUN ENTERPRISES LTD 2024-07-20 2029-07-19

1412 Rwanda FDA-HMP-MA-1441 DAWACLOX-250 Cloxacillin (as sodium) BP 250mg 250mg Hard gelatin capsules 10X10’s and 1000 capsules Alu-Alu Blister Pack, packed in printed unit carton /bulk pack of 1000’s packed in 1000CC HDPE container 36 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-07-20 2029-07-19

1413 Rwanda FDA-HMP-MA-1442 RAYZIUM-20 Esomeprazole Magnesium Trihydrate USP 20mg 20mg Enteric coated tablets 3x10 Tablets Blister Pack is packed in a carton along with package insert 36 Months BIODEAL LABORATORIES LTD, 123, Lunga. P.O Box 32040-00600, Nairobi, Kenya. KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-07-20 2029-07-19

1414 Rwanda FDA-HMP-MA-1443 PARACETAMOL-500 Paracetamol BP 500mg 500mg Uncoated Tablets 10x10 Tablets Alu-PVCB Blister packed in printed carton along with one insert 36 Months MERIT ORGANICS LTD, Plot No. 2104/2/A, G.I.D.C., Sarigam, Bhilad, Dist. Valsad - 396 155, Gujarat, India INDIA MERIT ORGANICS LTD, INDIA SUN ENTERPRISES LTD 2024-07-20 2029-07-19

1415 Rwanda FDA-HMP-MA-1444 FLUTROX-200 Fluconazole 200mg 200mg Hard Gelatin Capsules 10 Capsules ALU/ALU blister packs in unit boxes 36 Months UNIVERSAL CORPORATION LIMITED. Club Road, Plot Number 13777, P.O Box 1748-00902, Kikuyu, Kenya KENYA UNIVERSAL CORPORATION LIMITED, KENYA SUN ENTERPRISES LTD 2024-07-20 2029-07-19

1416 Rwanda FDA-HMP-MA-1445 FLUTROX-150 Fluconazole 150mg 150mg Hard Gelatin Capsules 1 Capsule ALU/ALU blister packs in unit boxes 36 Months UNIVERSAL CORPORATION LIMITED. Club Road, Plot Number 13777, P.O Box 1748-00902, Kikuyu, Kenya KENYA UNIVERSAL CORPORATION LIMITED, KENYA SUN ENTERPRISES LTD 2024-07-20 2029-07-19

1417 Rwanda FDA-HMP-MA-1446 LEQVIOTM SOLUTION FOR INJECTION Each pre-filled syringe contains 1.5 mL of solution containing 284 mg inclisiran (equivalent to 300 mg inclisiran sodium) 300mg/1.5ml Solution for injection 1 pre-filled syringe contains 1.5 mL Pre-filled syringe 24 Months SANDOZ GmbH, Biochemiestrasse 10, Langkampfen 6336, Austria AUSTRIA NOVARTIS OVERSEES INVESTMENT SURGIPHARM (RWANDA) LIMITED 2024-07-20 2029-07-19

1418 Rwanda FDA-HMP-MA-1447 RIFAPENTINE TABLETS 300 MG Rifapentine 300mg 300mg Film coated Tablets 3x10 Tablets Strip pack of 10 Tablets such 3 Strips in a carton along with pack insert 24 Months MACLEODS PHARMACEUTICALS LIMITED, Oxalis Labs, Village Theda, P.O Lodhimajra, Baddi, Dist. Solan, Himachal Pradesh, 174101, India INDIA MACLEODS PHARMACEUTICALS LIMITED AIVEEN RWANDA LTD 2024-07-20 2029-07-19

1419 Rwanda FDA-HMP-MA-1448 FUNBACT-A CREAM Clotrimazole USP 1.0% w/w, Betamethasone dipropionate USP equivalent to betamethasone 0.05% w/w, Neomycin sulphate USP 0.5%w/w 1.0% w/w, 0.05% w/w, 0.5%w/w Aqueous cream 30gm Tubes Printed Aluminium collapsible Tubes with rubber latex and sealed nozzle with white Piercing cap 36 Months BLISS GVS PHARMA LTD., 102, Hyde Park, Saki Vihar Road, Andheri (East), Mumbai - 400 072, India INDIA BLISS GVS PHARMA LTD, INDIA SURYA DEPOT PHARMACY LTD 2024-07-20 2029-07-19

1420 Rwanda FDA-HMP-MA-1449 POSITON CREAM Triamcinolone acetonide 1 mg/g, Neomycin sulphate 2.5 mg/g, Nystatin 100,000 I.U./g 1 mg/g, 2.5 mg/g, 100,000 I.U./g Cream 30gm Tubes Collapsible aluminium tube with interior epoxy resin coating, closed with a polypropylene cap 36 Months LABORATÓRIOS VITÓRIA, S.A., Rua Elias Garcia, 28 Venda Nova 2700-327 Amadora, Portugal PORTUGAL FAES FARMA, S.A, SPAIN GOMHS LTD 2024-07-20 2029-07-19

1421 Rwanda FDA-HMP-MA-1450 PIRITON EXPECTORANT SYRUP Each 5ml of syrup conatins Chlorpheniramine Maleate 4mg &Ammonium Chloride 200mg 4mg & 200mg/5ml Syrup 100ml Bottle Amber coloured type III glass bottle 36 Months GlaxoSmithKline Ltd, Likoni Road, Industrial Area, P.O. Box: 78392-00507, Nairobi, Kenya KENYA GLAXOSMITHKLINE LIMITED KIPHARMA LTD 2024-07-20 2029-07-19

1422 Rwanda FDA-HMP-MA-1478 SIMBRINZA EYE DROPS, SUSPENSION 1 mL of suspension contains 10 mg of brinzolamide and 2 mg of brimonidine tartrate equivalent to 1.3 mg of brimonidine 10mg and 2mg/ml Eye drops 1 or 3 bottles of 5 mL LDPE bottles with a LDPE dropper tip and white polypropylene screw cap containing 5 mL suspension 24 Months ALCON-COUVREUR NV, Rijksweg 14, A 2870 Puurs, Belgium BELGIUM NVS KENYA LIMITED SURGIPHARM (RWANDA) LIMITED 2024-07-20 2029-07-19

1423 Rwanda FDA-HMP-MA-1479 DAPAVELDACTIN 5MG Dapagliflozin 5mg 5mg Film Coated Tablets 4x7 Tablets Alu-Alu blister pack. Such 4 blisters are packed in a carton along with package inserts 24 Months LIPTIS FOR PHARMACEUTICALS, Plot No. B/2, 6th Industrial Zone, 6th of October City, Egypt EGYPT LIPTIS FOR PHARMACEUTICAL AND MEDICAL PRODUCTS (S.A.E) GOODMAN INTERNATIONAL LTD (R) 2024-07-20 2029-07-19

1424 Rwanda FDA-HMP-MA-1480 BOSUTINIB PFIZER 500 MG Bosutinib monohydrate 516.98 mg equivalent to Bosutinib 500 mg 500 mg Film Coated Tablets 27 Tablets PVC/Polychlorotrifluoroethene/PVC blister 48 Months PFIZER MANUFACTURING DEUTSCHLAND GmbH, Betriebsstätte Freiburg Mooswaldallee 1, 79090 Freiburg, Germany GERMANY PFIZER LIMITED, UNITED KINGDOM WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-07-20 2029-07-19

1425 Rwanda FDA-HMP-MA-1481 CRISABOROLE PFIZER 2% Crisaborole 20mg/g 20mg/g Ointment 30g, 60g or 100g tubes Tube head with a multi-laminate orifice seal, and a multi-laminate tube sleeve. 30g tube has a sealing layer with a small pull handle 24 Months PHARMACIA & UPJOHN COMPANY LLC, 7000 Portage Road Kalamazoo, Michigan 49001, United States (USA) UNITED STATES (USA) PFIZER LABORATORIES LIMITED, KENYA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-07-20 2029-07-19

1426 Rwanda FDA-HMP-MA-1482 ESLOTIN 2.5MG/ML SYRUP Desloratidine 2.5mg/ml 2.5mg/ml Syrup 100ml Bottle Amber colored Type III glass bottle and closed by white PE cap 36 Months WORLD MEDICINE ?LAÇ SAN. VE TIC. A.?. 15 Temmuz Mahallesi, Cami Yolu Caddesi, No:50 k:4 WM Plaza, Güne?li, Ba?c?lar, Istanbul, Turkey TURKEY WORLD MEDICINE ?LAÇ SAN. VE TIC. A.?. GOODMAN INTERNATIONAL LTD (R) 2024-07-20 2029-07-19

1427 Rwanda FDA-HMP-MA-1483 EROSTINE SUSPENSION Ebastine 5mg/5ml 5mg/5ml Suspension 60ml Bottle Amber glass Bottles 24 Months MICRO LABS LIMITED, At KNM Pharma Pvt. Ltd, No 13, Mahagujrat Industrial Estate, Opp. Nova Petrochem, Sanand Bavla Road, Changodar, Dist: Ahmedabad Gujarat, India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-07-20 2029-07-19

1428 Rwanda FDA-HMP-MA-1484 NOVAMENTIN-625 Amoxicillin Trihydrate USP 500 mg & Diluted Clavulanate Potassium BP 125mg 500 mg & 125mg Film Coated Tablets 2x10 Tablets Alu/Alu Blister 24 Months SCOTT-EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LIMITED, Hill Top Industrial Area, Bhatolikalan, Baddi- 173205, (HP) India INDIA SCOTT-EDIL ADVANCE RESEARCH LABORATORIES & EDUCATION LIMITED, INDIA SUN ENTERPRISES LTD 2024-07-20 2029-07-19

1429 Rwanda FDA-HMP-MA-1485 OSMOWIN Each 15 ml contains Lactulose concentrate USP equivalent to lactulose 10 g 10 g/15ml Syrup 100ml and 200ml Bottles Amber coloured PET bottle of 100ml and 200ml with ROPP caps with coextruded polyethylene wads 24 Months G.S. PHARMBUTOR PVT. LTD., B-172, Industrial Area, Behror- 301 701, Rajasthan, India INDIA WIN-MEDICARE PVT. LTD, INDIA SURGIPHARM (RWANDA) LIMITED 2024-07-20 2029-07-19

1430 Rwanda FDA-HMP-MA-1486 IBUFLAM 400MG TABLETS Ibuprofen 400mg 400mg Film Coated Tablets 10 x10 tablets PVC/aluminum foils blisters into a unit box with a package insert 36 Months BIODEAL LABORATORIES LTD, 123, Lunga. P.O Box 32040-00600, Nairobi, Kenya. KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-07-20 2029-07-19

1431 Rwanda FDA-HMP-MA-1487 CETRIREN TABLETS Cetirizine Hydrochloride BP 10mg 10mg Film Coated Tablets 10 x10 tablets Alu/PVC blister strips of 10 tablets and 10 such blister strips are packed in a unit box with a pack insert 24 Months RENE INDUSTRIES LTD, Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda UGANDA RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-07-20 2029-07-19

1432 Rwanda FDA-HMP-MA-1457 XALME SPAS Mephenamic Acid BP 250mg and Dicyclomino Hydrochloride USP 10mg 250mg and 10mg Tablets 10 tablets A blister (Aluminium / PVC foil) of 10 tablets in inner carton along with the product insert 36 Months BLISS GVS PHARMA LTD. Plot No. 10, 11A, 12, Survey no. 38/1 Dewan Udyog Nagar, Aliyali Village, Taluka - Palghar, Thane - 401404 Maharashtra India, India INDIA BLISS GVS PHARMA LTD SUN ENTERPRISES LTD 2024-07-20 2029-07-19

1433 Rwanda FDA-HMP-MA-1458 DNS Sodium Chloride 0.9% w/v and Anhydrous Glucose 5.0% w/v 0.9% w/v and 5.0% w/v Solution for Intravenous (IV) Infusion 250mL and 500 mL Bottles Low Density Polyethylene plastic bottles overwrapped with a protective plastic pouch made of biaxially oriented polyethylene 36 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono. P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2024-07-20 2029-07-19

1434 Rwanda FDA-HMP-MA-1459 ASPIRIN 300MG TABLETS Aspirin BP 300mg 300g Tablets 20x10 tablets and 1000 tablets Alu/PVDC blisters of 20 x 10 tablets packed in a unit carton with a literature insert and in 1000’s in HDPE container 36 Months LABORATORY & ALLIED LIMITED. Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LIMITED DEPOT PHARMACEUTIQUE LE MEDICAL 2024-07-20 2029-07-19

1435 Rwanda FDA-HMP-MA-1460 LAEOTARIN CREAM Miconazole Nitrate IP/BP 2% w/w 2% w/w Cream 15g Aluminium collapsible tube with Lavender blush and green color printed in white and black with a threaded mouth and sealed top and contained in a unit box with literature insert 36 Months LABORATORY & ALLIED LIMITED. Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LIMITED DEPOT PHARMACEUTIQUE LE MEDICAL 2024-07-20 2029-07-19

1436 Rwanda FDA-HMP-MA-1461 CHLORPROMAZINE 100MG TABLETS Chlorpromazine Hydrochloride 100mg 100mg Film Coated Tablets 10x10 Tablets Alu/PVC blisters of 10x10 contained in a unit box with literature insert 24 Months LABORATORY & ALLIED LIMITED. Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LIMITED DEPOT PHARMACEUTIQUE LE MEDICAL 2024-07-20 2029-07-19

1437 Rwanda FDA-HMP-MA-1462 AMOLAB-5 TABLETS Amlodipine Besilate PB equivalent to Amlodipine 5mg 5mg Tablets 3x10 and 10x10 Tablets Aluminum foil/PVC blister packs of 3x10’s and 10x10’s in a unit box along with a literature insert 36 Months LABORATORY & ALLIED LIMITED. Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LIMITED DEPOT PHARMACEUTIQUE LE MEDICAL 2024-07-20 2029-07-19

1438 Rwanda FDA-HMP-MA-1463 IRBESARTAN/HYDROCHLOROTHIAZIDE IMPACT 300 MG/12.5 MG FILM-COATED TABLETS Irbesartan 300 mg and Hydrochlorothiazide 12,5 mg 300 mg and 12,5 mg Film Coated Tablets 28 Tablets PVC/PVDC/Alu Blisters packed in a box 36 Months TROIKAA PHARMACEUTICALS LTD, C-1, Sara Industrial Estate, Selaqui, Dehradun-248197, Uttarakhand, India INDIA TROIKAA PHARMACEUTICALS LTD, INDIA ABACUS PHARMA (A) LTD 2024-07-20 2029-07-19

1439 Rwanda FDA-HMP-MA-1488 BENZOSED, 5ML Midazolam BP 1mg/ml 1mg/ml Solution for injection 1 Vial of 5ml Amber vial USP type I with 20 mm bromo butyl rubber stopper and 20mm brown flip off seal 24 Months TROIKAA PHARMACEUTICALS LTD, C-1, Sara Industrial Estate, Selaqui, Dehradun-248197, Uttarakhand, India INDIA TROIKAA PHARMACEUTICALS LTD, INDIA ABACUS PHARMA (A) LTD 2024-07-20 2029-07-19

1440 Rwanda FDA-HMP-MA-1489 IRBESARTAN IMPACT 150 MG Irbesartan 150mg 150mg Film Coated Tablets 28 Tablets Opaque PVC/PVDC/Aluminium blisters 36 Months SANOFI WINTHROP INDUSTRIE, 30-36, avenue Gustave Eiffel, Z.I. St. Symphorien 37100 Tours, France FRANCE SANOFI-AVENTIS SOUTH AFRICA (PTY) LTD KIPHARMA LTD 2024-07-20 2029-07-19

1441 Rwanda FDA-HMP-MA-1490 SEKALGIC TABLET Ibuprofen 400 mg, Paracetamol 500 mg and Caffeine (Anhydrous) 30 mg 400 mg, 500 mg and 30 mg Uncoated Tablets 1x12 tablets Alu–PVC blister pack, placed in a printed carton along with a pack insert 36 Months BAROQUE PHARMACEUTICALS PVT, LTD, 192/2 & 3, Sokhada-388 620Tal: khambhat, Dist. Anand (Gujarat), India INDIA BEKRA PHARMA UK LTD UBIPHARM-RWANDA LTD 2024-07-20 2029-07-19

1442 Rwanda FDA-HMP-MA-1530 ASPIRIN CARDIO 100MG ACETYLSALICYLIC ACID 10MG Film Coated Tablets 3x10 Tablets Alu/Alu Blister packs 36 Months BAYER AG Leverkusen, Kaiser-Wilhelm-Allee, 51368 Leverkusen, Germany Germany Bayer (Switzerland) AG SURGIPHARM (RWANDA) LTD 2024-07-24 2029-07-26

1443 Rwanda FDA-HMP-MA-1505 RHEUMAC GEL Diclofenac Diethylamine equivalent to 1%w/w Diclofenac Sodium BP 1%w/w Topical Gel 20g Tube Tubes and contained in a unit box with literature insert 36 Months LABORATORY & ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LIMITED Depot Pharmaceutique Le Medical 2024-07-27 2029-07-26

1444 Rwanda FDA-HMP-MA-1506 LABTOL-200 TABLETS Carbamazepine BP 200mg TABLETS 10x10 Tablets and 1000 Tablets Alu/PVC blisters packed in unit box with a literature insert and 1000’s in HDPE containers with literature insert 36 Months LABORATORY & ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road 42875 GPO 00100, Nairobi-Kenya KENYA LABORATORY & ALLIED LIMITED Depot Pharmaceutique Le Medical 2024-07-27 2029-07-26

1445 Rwanda FDA-HMP-MA-1507 PARATAL TABLETS Paracetamol BP 500 mg TABLETS 10x10 Tablets and 1000 Tablets Alu/PVC blister packs of 10x10’s contained in unit box or bulk packs of 1000’s contained in a HDPE container along with a literature insert 36 Months LABORATORY & ALLIED LIMITED Plot No.209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road. Postal Address: 42875 GPO 00100 Nairobi-Kenya KENYA LABORATORY & ALLIED LIMITED Depot Pharmaceutique Le Medical 2024-07-27 2029-07-26

1446 Rwanda FDA-HMP-MA-1508 BIOFULVIN 125MG TABLETS GRISEOFULVIN 125mg TABLETS 10x10 Tablets Alu/PVC blister packed in a unit box with literature insert 36 Months BIODEAL LABORATORIES LTD Plot No.123, Lunga Lunga P.O Box 32040-00600, Nairobi-Kenya. KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-07-27 2029-07-26

1447 Rwanda FDA-HMP-MA-1509 BIOFULVIN 250MG TABLETS GRISEOFULVINE 250MG TABLETS 10x10 Tablets Alu/PVC foil blisters packed in a unit box with a literature insert 36 Months BIODEAL LABORATORIES LTD Plot No.123, Lunga Lunga P.O Box 32040-00600, Nairobi-Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-07-27 2029-07-26

1448 Rwanda FDA-HMP-MA-1510 KETAMAX 50 Ketamine Hydrochloride USP 50 mg/ml Solution for injection 10ml Vial Amber vial USP Type-I with 20 mm bromobutyl rubber stopper and 20 mm Ice blue flip off seal with “Troikaa embossed”. Further such 1 labelled vial packed in a printed carton along with package insert 36 Months TROIKAA PHARMACEUTICALS LTD C-1, Sara Industrial Estate, Selaqui, Dehradun-248197, Uttarakhand, India INDIA TROIKAA PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2024-07-27 2029-07-26

1449 Rwanda FDA-HMP-MA-1491 FLOXSAFE 400 Moxifloxacin Tablets 400 mg 400 mg IMMEDIATE RELEASE TABLETS 48 Months MSN LABORATORIES PVT LTD India MSN Laboratories Private Limited ABACUS PHARMA (A) Ltd 2024-07-27 2029-07-26

1450 Rwanda FDA-HMP-MA-1511 LAMIVUDINE 150 MG, NEVIRAPINE 200 MG, AND ZIDOVUDINE 300 MG TABLETS LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE 150MG+200MG+300MG FILM COATED TABLETS 60 Tablets Round, wide mouth white 120cc HDPE Bottle with 38mm neck and closure: 38mm white opaque screw cap with induction sealing liner wad 60 Months MYLAN LABORATORIES LIMITED F- 4 & F-12, MIDC, Malegaon, Sinnar, Nashik -422 113, Maharashtra, India INDIA MYLAN LABORATORIES LIMITED PYRAMID PHARMA LTD 2024-07-27 2029-07-26

1451 Rwanda FDA-HMP-MA-1512 ATOSAR-H Losartan Potassium BP & Hydrochlorothiazide BP 50MG/12.5MG TABLET 3x10 Tablets Alu/Alu Blister pack, such 3 Blisters are packed in carton along with insert 24 Months CORONA REMEDIES PRIVATE LIMITED Village Jatoli, Post Office– Oachgha, Tehsil Solan, Dist. Solan Himachal Pradesh – 173223, India INDIA CORONA REMEDIES PRIVATE LIMITED SUN ENTERPRIESES LTD 2024-07-27 2029-07-26

1452 Rwanda FDA-HMP-MA-1513 ZEE-1 LEVONORGESTREL BP 1.5MG TABLET 1X1 TABLET Alu/PVC Blister pack 36 Months CORONA REMEDIES PRIVATE LIMITED Village Jatoli, Post Office– Oachgha, Tehsil Solan, Dist. Solan Himachal Pradesh – 173223, India INDIA CORONA REMEDIES PRIVATE LIMITED SUN ENTERPRISES LTD 2024-07-27 2029-07-26

1453 Rwanda FDA-HMP-MA-1514 CALPOL SUSPENSION PARACETAMOL 120MG/5ML SUSPENSION 60ml and 100ml Bottles Type III Glass bottles 36 Months GLAXOSMITHKLINE LTD Likoni Road, Industrial Area, Likoni Road, Industrial Area, P.O. Box: 78392-00507, Nairobi, Kenya KENYA GLAXOSMITHKLINE LTD KIPHARMA LTD 2024-07-27 2029-07-26

1454 Rwanda FDA-HMP-MA-1515 ERYTHROX TABLETS Erythromycin Stearate 250mg 250MG TABLET 10x10 Tablets and 1000 Tablets Blisters packed in a unit box and bulk packs of 1000s in HDPE along with literature insert 36 Months DAWA LIMITED Plot No. 7879/8, Baba Dogo Rd, Ruaraka, P.O. BOX 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-07-27 2029-07-26

1455 Rwanda FDA-HMP-MA-1516 MIRENA® 20 MICROGRAMS Levonorgestrel 52mg Intrauterine delivery system 1 Piece Film 500 µm APET (4433) sealed with Film PE nonwoven white adhesive coated (4435) or Film 500 µm PETG (4434) sealed with Film PE non-woven white adhesive coated (4435) 36 Months BAYER OY Turku Pansiontie 47, 20210 Turku, Finland Finland Bayer East Africa Limited Surgipharm (Rwanda) Ltd 2024-07-27 2029-07-26

1456 Rwanda FDA-HMP-MA-1517 DYNAMOGEN ORAL SOLUTION ARGININE ASPARTATE 2.50% ORAL SOLUTION 20 drinkable ampoules of 10ml PVC/PVDC/PE material in amber colour with printed text in white colour in a carton box with package insert 12 Months FAES PHARMA SA Máximo Aguirre 14-48940 Leioa (Biscay) Spain Spain FAES PHARMA SA, GOMHS Ltd 2024-07-27 2029-07-26

1457 Rwanda FDA-HMP-MA-1518 ETROBAX 90 Etoricoxib Tablets 90 mg Film Coated Tablets 3x10 Tablets Alu/Alu Blisters packed in printed carton 36 Months HETERO LABS LIMITED (Unit-III), Survey No.: 51, 22-110, Industrial Development Area (IDA), Jeedimetla, Hyderabad, PIN-500 055, Telangana. India INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-07-27 2029-07-26

1458 Rwanda FDA-HMP-MA-1519 LUTENYL NOMEGESTROL ACETATE 5MG TABLET 1x10 Tablets Blister pack made of PVC (250µm) and aluminium (20µm) 60 Months LABORATOIRES MACORS rue des caillottes, ZI Plaine des Isles, 89000 Auxerre, France France Laboratoire B&O Pharm, France KIPHARMA LTD 2024-07-27 2029-07-26

1459 Rwanda FDA-HMP-MA-1520 MAXI-500 Amoxicillin Trihydrate BP 500MG CAPSULE 10x10 Capsules Alu-PVC blisters packed in a unit carton 24 Months MAXTAR BIO-GENICS K. No. 705, Nalagarh road, Malku Majra, (Baddi), Tehsil Nalagarh, Distt. Solan, Himachal Pradesh - 173205 India INDIA MAXTAR BIO-GENICS, India SUN ENTERPRISES LTD 2024-07-27 2029-07-26

1460 Rwanda FDA-HMP-MA-1521 PYLOOCAIN OINTMENT (ANTI HAEMORRHOIDAL OINTMENT), Betamethasone Valerate BP, Phenylephrine Hydrochloride BP, Lidocaine Hydrochloride BP 0.5 mg, 1 mg, 25 mg OINTMENT 30g Tubes Aluminium collapsible tube with HDPE long nozzle cap 36 Months GALENTIC PHARMA (INDIA) PVT LTD R-673, TTC M.I.D.C., Rabale, Thane Belapur Road, Navi Mumbai – 400 701, India INDIA GALENTIC PHARMA (INDIA) PVT LTD DOLIPHARM LTD 2024-07-27 2029-07-26

1461 Rwanda FDA-HMP-MA-1522 GACET -250 ACETAMINOPHEN USP 250MG SUPPOSITORIES 2X5 Suppositories A polyvinylchloride foil coated with Polyethylene. (PVC-PE Foil) 2 strips each containing 5 Suppositories are packed in a carton along with pack insert 36 Months BLISS GVS PHARMA LIMITED Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali Village, Taluka Palghar, Thane 401404, India INDIA BLISS GVS PHARMA LIMITED SURYA DEPOT PHARMACY LTD 2024-07-27 2029-07-26

1462 Rwanda FDA-HMP-MA-1523 JUNIOR ZINC TABLETS Zinc Sulfate Monohydrate USP equivalent to Zinc 20mg 20MG TABLETS 10x10 Tablets Blister pack of 10x10’s in a unit carton with a literature insert 36 Months DAWA LIMITED Plot No. 7879/8, Baba Dogo Rd, Ruaraka, P.O. BOX 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTEPRISES LTD 2024-07-27 2029-07-26

1463 Rwanda FDA-HMP-MA-1524 ZENSALBU NEBULES 2.5 SALBUTAMOL SULFATE 2.5MG/2.5ML 2.5MG/2.5ML Solution for inhalation via a nebulizer 10, 20, 50 plastic ampoules of 2.5ml Plastic ampoule in aluminum bag. 36 Months HA NOI CPC1 PHARMACEUTICAL JOINT STOCK COMPANY Ha Binh Phuong Industrial Zone, Thuong Tin District, Hanoi City, Vietnam Vietnam AFRIPHARMA LTD AFRIPHARM LTD 2024-07-27 2029-07-26

1464 Rwanda FDA-HMP-MA-1525 HYOSPAN SYRUP HYOSCINE BUTYL BROMIDE BP 5MG SYRUP 60ml Bottle Amber glass bottle packed in a carton 36 Months BIODEAL LABORATORIES LTD Plot No.123, Lunga Lunga P.O Box 32040-00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LTD BIODEAL LABORATORIES LTD 2024-07-27 2029-07-26

1465 Rwanda FDA-HMP-MA-1526 AGO-C 500 TABLET ASCORBIC ACID BP 500MG TABLET 10x10 Tablets and 100 Tablets in jar Strip Pack of 10 x 10 Tablets or HDPE jar pack of 100 tablets 36 Months AGOG PHARMA LTD Plot No. 33, Sector Ii, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-07-27 2029-07-26

1466 Rwanda FDA-HMP-MA-1527 AGOMIDE TABLET Furosemide BP 40MG TABLETS 28s, 30s, 50s, 56s, 60s, 84s, 90s, 100s and 1000 tablets Alu/PVC blister pack for 28s, 30s, 50s, 56s, 60s, 84s, 90s, 100s and HDPE jar Pack for1000 tablets 36 Months AGOG PHARMA LTD Plot No. 33, Sector Ii,The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-07-27 2029-07-26

1467 Rwanda FDA-HMP-MA-1528 SPAMOX CAPSULES 500 Amoxicillin Capsules B.P 500MG Hard Gelatin Capsules 10x10 Capsules A blister of 10 capsules and such 10 blisters are placed in carton along with a product leaflet 24 Months SPARSH BIO-TECH PVT.LTD Plot No. 1; Survey No.242/243/244, Lakhabavad, Jamnagar 361 006 (India) INDIA SPARSH BIO-TECH PVT.LTD ABACUS PHARMA (A) LTD 2024-07-27 2029-07-26

1468 Rwanda FDA-HMP-MA-1529 SANDIMMUM NEORAL 100MG CICLOSPORIN 100MG SOFT GELATIN CAPSULES 30’s, 50’s and 60 Capsules PA/AL/PVC (aluminium) blister packs, blister packs are packed in a cardboard based pack 24 Months CATALENT GERMANY EBERBACH GmbH, Gammelsbacher Str. 269412 Eberbach Germany Germany NVS Kenya Limited SURGIPHARM (RWANDA) LTD 2024-07-27 2029-07-26

1469 Rwanda FDA-HMP-MA-1531 AZAL- 500MG Azithromycin Dihydrate USP 500MG Film Coated Tablets 3x10 Tablets Alu-Pvc blister pack 36 Months STALLION LABORATORIES PVT. LTD C-1B, 305/2, 3, 4 & 5, G.I.D.C. Kerala (Bavla), Dist. Ahmedabad-382 220, Gujarat, India INDIA STALLION LABORATORIES PVT. LTD SUN ENTERPRISES LTD 2024-07-27 2029-07-26

1470 Rwanda FDA-HMP-MA-1534 ASOMEX-D S (-) Amlodipine 2.5mg and Hydrochlorothiazide 12.5mg 2.5mg/12.5 mg TABLETS 3x10 Tablets Blister pack of 3 x 10 tablets in a carton along with pack insert 36 Months EMCURE PHARMACEUTICALS LIMITED SIDCO Industrial Complex, Lane -3, Phase II, Bari-Brahmana-Jammu 181133, India INDIA EMCURE PHARMACEUTICALS LIMITED BION PHARMA GROUP LTD 2024-07-27 2029-07-26

1471 Rwanda FDA-HMP-MA-1535 INDOREN CAPSULES INDOMETHACIN BP 25 mg Capsules 10x10 Capsules Aluminium/PVC blister strip of 10 capsules and 10 of such blister strips are packed in a unit box with pack insert 24 Months RENE INDUSTRIES LTD Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda Uganda RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-07-27 2029-07-26

1472 Rwanda FDA-HMP-MA-1537 WOMNIL SUSPENSION ALBENDAZOLE BP 200MG/5ML SUSPENSION 10ml Bottle Amber coloured glass bottle contained in a unit box 36 Months DAWA LIMITED Plot No. 7879/8, Baba Dogo Road, Ruaraka. P.O Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTEPRISES LTD 2024-07-27 2029-07-26

1473 Rwanda FDA-HMP-MA-1538 MELANEZ 500 MESALAZINE 500MG SUPPOSITORIES 2X5 Suppositories PVC/PVdC/PE blisters packed in Carton along with leaflet 24 Months BLISS GVS PHARMA LIMITED Plot No:11, Dewan Udyog Nagar, Aliyali Palghar, Maharashtra, 401404, India INDIA BLISS GVS PHARMA LIMITED SURYA DEPOT PHARMACY LTD 2024-07-27 2029-07-26

1474 Rwanda FDA-HMP-MA-1539 D5 Glucose Intravenous Infusion B.P 50G/LITRE Solution for Infusion 500ml Bottle LDPE bottles packed in a printed carton 60 Months AMANTA HEALTHCARE LIMITED Plot no: 876, N.H. No: 8, Hariyala, Kheda-387411, Gujarat, India INDIA AMANTA HEALTHCARE LIMITED SUN ENTERPRISES LTD 2024-07-27 2029-07-26

1475 Rwanda FDA-HMP-MA-1542 AMVA DENK 10/160MG AMLODIPINE/ VALSARTAN 10/160MG FILM COATED TABLET 28 Tablets PVC/PVDC-Aluminium blisters 36 Months BALKAN PHARMA DUPNITSA AD 3 Samokovsko Shosse Str., Dupnitsa, 2600 Bulgaria Bulgaria Denk Pharma Gmbh & CO. KG, Germany ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2024-07-27 2029-07-26

1476 Rwanda FDA-HMP-MA-1543 AMVA DENK 5/160MG AMLODIPINE/ VALSARTAN 5/160MG Film Coated Tablets 28 Tablets PVC/PVDC-Aluminium blisters packed in Printed carton containing package leaflet 36 Months BALKAN PHARMA DUPNITSA AD 3 Samokovsko Shosse Str., Dupnitsa, 2600 Bulgaria Bulgaria Denk Pharma Gmbh & CO. KG, Germany ETS CONTINENTAL 2024-07-27 2029-07-26

1477 Rwanda FDA-HMP-MA-1544 AGONOR NORFLOXACIN BP 400MG FILM COATED TABLETS 10x10 Tablets Alu-Pvc blister pack 36 Months AGOG PHARMA LTD Plot No. 33, Sector II, The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-07-27 2029-07-26

1478 Rwanda FDA-HMP-MA-1540 ULTRAFLOX-500 CIPROFLOXACIN USP 500 mg Film Coated Tablets 10x10 Tablets and 500 Tablets Blister pack, and Jar pack for 500 tablets 36 Months BAL PHARMA LIMITED 21 & 22 - Bommasandra Industrial Area Bangalore-560099, India INDIA BAL PHARMA LIMITED SUN ENTERPRISES LTD 2024-07-27 2029-07-26

1479 Rwanda FDA-HMP-MA-1545 FLAGENTYL SECNIDAZOLE 500MG TABLET 4 Tablets PVC/ALU Blister pack 36 Months DOPPEL FARMACEUTICI S.R.L. Via Volturno, 48-20089 Quinto de’ Stampi Rozzano (Milano), Italy ITALY Sanofi Aventis, France KIPHARMA LTD 2024-07-27 2029-07-26

1480 Rwanda FDA-HMP-MA-1536 LORHISTINA SYRUP LORATADINE 5MG/5ML SYRUP 60ml Bottle 25 mm mouth OD around amber clear glass bottles 36 Months COSMOS LIMITED Rangwe Road, Off Lunga Road Industrial Area P.O. BOX 41433, GPO 00100 – Nairobi, Kenya KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-07-27 2029-07-26

1481 Rwanda FDA-HMP-MA-1546 SOLIVO 10 LEFLUNOMIDE Ph.Eur 10 MG TABLETS 3x10 Tablets Alu-Alu Blister packed in a carton along with leaflet 24 Months EMCURE PHARMACEUTICALS LIMITED Plot No. P-1 & P- 2, I.T.B.T. Park, Phase II, MIDC, Hinjwadi, Pune-411 057, Maharashtra, India INDIA EMCURE PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2024-07-27 2029-07-26

1482 Rwanda FDA-HMP-MA-1547 SOLIVO-20 LEFLUNOMIDE 20 MG TABLETS 3x10 Tablets Alu-Alu Blister packed in a carton along with leaflet 24 Months EMCURE PHARMACEUTICALS LIMITED Plot No. P-1 & P-2, I.T.B.T. Park, Phase II, MIDC, Hinjwadi, Pune-411 057, Maharashtra, India INDIA EMCURE PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2024-07-27 2029-07-26

1483 Rwanda FDA-HMP-MA-1548 ABLOL-5 Timolol maleate 0.5% W/V EYE DROPS 10ml Bottle LDPE bottles packed in a printed carton 36 Months ABACUS PARENTERAL DRUGS LTD (APDL) Block 191, Plot No. 114, Kinga Mukono P. O. Box 31376, Kampala, Uganda Uganda ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2024-07-27 2029-07-26

1484 Rwanda FDA-HMP-MA-1549 CETRIZ SYRUP Cetirizine Dihydrochloride BP 5.0mg/5ml SYRUP 60ml Bottle Amber PET/glass bottles, contained in a unit box along with literature insert 36 Months LABORATORY & ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, next to Libra House, Mombasa Road, Kenya KENYA LABORATORY & ALLIED LIMITED Depot Pharmaceutique Le Medical 2024-07-27 2029-07-26

1485 Rwanda FDA-HMP-MA-0155 COARTEM 80/480MG ARTEMETER & LUMEFANTRINE 40MG& 480MG TABLET 6,180, 216, 360, 540 Tablets Pack of 6’s tablets PVC/PE/PVDC, other side aluminium foil (blister packs public 180,216,360,540 24 Months NOVARTIS SAGLIK, Gida ve Tarim Ürünleri San. Ve Tic. A.?. Yenisehir Mahallesi Ihlara Vadisi Sokak No. 2 Pendik Istanbul TR 34912, Turkey Turkey NVS Kenya Limited SURGIPHARM (RWANDA) LTD 2024-07-27 2029-07-26

1486 Rwanda FDA-HMP-MA-1451 EFFERALGAN-600 Acetaminophen (Paracetamol) 600MG SUPPOSITOR 10 Suppositories Opaque PVC/PE complex 36 months UPSA SAS 304, Avenue du Docteur Jean Bru 47000 Agen – France. France UPSA SAS Ubipharma Rwanda Ltd 2024-07-27 2029-07-26

1487 Rwanda FDA-HMP-MA-1470 NIPINE-10 NIFEDIPINE BP 10MG TABLETS 10x10 Tablets Blister pack of 10x10 tablets placed in carton along with insert 36 Months AMBALAL SARABHAI ENTERPRISES LIMITED Division: Sarabhai Chemicals. Dr. Vikram Sarabhai Marg, Wadi, Vadodara – 390 023, India INDIA ASENCE PHARMA PVT. LTD, INDIA SUN ENTERPRISES LTD 2024-07-27 2029-07-26

1488 Rwanda FDA-HMP-MA-1452 COLDAMOL-P Chlorpheniramine maleate 2.0 mg, Paracetamol 120 mg, Pseudoephedrine HCl 10 mg 2.0 mg, 120 mg, 10 mg SYRUP 100ml Bottle Amber colored glass bottle inserted in unit box with a pack insert 36 Months BIODEAL LABORATORIES LTD 123, Lunga Lunga Road, Industrial Area, Nairobi, Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-07-27 2029-07-26

1489 Rwanda FDA-HMP-MA-1465 PERFALGAN PARACETAMOL 10MG/ML Solution for Infusion 12 Vials of 100ML& 50ML Type II colourless glass vials with a nominal capacity of 100 ml. The vials are stoppered with 32 mm diameter bromobutyl stoppers with a silicon surface coating and then capped with a 32 mm aluminum seal with a blue plastic flip-off cap. 24 Months BRISTOL-MYERS SQUIBB, S.R.L. Contrada Fontana del Ceraso, 03012 Anagni, Italy ITALY BRISTOL-MYERS SQUIBB, S.R.L. KIPHARMA LTD 2024-07-27 2029-07-26

1490 Rwanda FDA-HMP-MA-1466 MONTIKAST 10 MONTELUKAST 10MG TABLET 1x10 Tablets Alu-Alu Blisters pack, packed in carton along with Product insert 36 Months M/S SKYBIOTECH LIFESCIENCES PVT. LTD Gut no.: 5, Gevrai Tanda, Paithan Road, Aurangabad (M.S.) India INDIA PHARMA LIFE SCIENCE LTD, INDIA STAR BIOTECH LIMITED 2024-07-27 2029-07-26

1491 Rwanda FDA-HMP-MA-1453 ABACAVIR,DOLUTEGRAVIR AND LAMUVIDINE ABACAVIR,DOLUTEGRAVIR AND LAMUVIDINE 600MG/50MG/300MG Film Coated Tablets 30 Tablets HDPE Bottle of 30’s count Container (120 CC) ii) 38 mm – 400 CR Closure with Tekniplex HS 123 induction sealing wad iii) 3 numbers of 1g molecular sieve canister 24 Months LAURUS LABS LIMITED (Unit-II), Plot No: 19, 20 & 21, Western Sector, APSEZ, Atchutapuram Mandal, Visakhapatnam District 531011, Andhra Pradesh, India INDIA LAURUS LABS LIMITED CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-07-27 2029-07-26

1492 Rwanda FDA-HMP-MA-1467 ANOMEX Hydrocortisone Acetate BP, Lidocaine USP, Zinc Oxide USP and Allantoin BP 0.25 % w/w, 3.0 % w/w, 5.0 % w/w and 0.5 % w/w SUPPOSITORIES 2 Strips of 5 Suppositories PVC/PE foil packed in a carton along pack insert 24 Months BLISS GVS PHARMA LIMITED Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Palghar, District Thane – 401404, India INDIA BLISS GVS PHARMA LIMITED SURYA DEPOT PHARMACY LTD 2024-07-27 2029-07-26

1493 Rwanda FDA-HMP-MA-1454 CEFAZIM TABLETS Cefixime Trihydrate 200MG Film Coated Tablets 1×10 Tablets Alu-Alu Blister Pack enclosed in a carton 24 Months ZIM LABORATORIES LIMITED B-21/22, MIDC Area, Kalmeshwar, Nagpur 441 501, Maharashtra State, India INDIA ZIM LABORATORIES LIMITED SUN ENTERPRISES LTD 2024-07-27 2029-07-26

1494 Rwanda FDA-HMP-MA-1456 RACYCLINE EYE OINTMENT. Tetracycline Hydrochloride BP Each gram contains: Tetracycline Hydrochloride BP 10mg in sterilized paraffin base. EYE OINTMENT 1 Tube of 3.5gm Collapsible tubes and contained in a unit box with literature insert 36 Months LABORATORY & ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road. 42875 GPO 00100, Nairobi-Kenya KENYA LABORATORY & ALLIED LIMITED Depot Pharmaceutique Le Medical 2024-07-27 2029-07-26

1495 Rwanda FDA-HMP-MA-1464 Biodox capsules DOXYCYCLINE Hyclate 100mg per capsule Capsules 10 x 10 Capsules PVC and aluminium foil blisters packed in a unit box 36 months BIODEAL LABORATORIES LIMITED Plot No.123, Lunga Lunga P.O Box 32040-00600, Nairobi-Kenya KENYA BIODEAL LABORATORIES LIMITED CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-07-27 2029-07-26

1496 Rwanda FDA-HMP-MA-1468 CIPROFLOXACIN CIPROFLOXACIN Injection U.S.P. 200mg INJECTION 1 bottle of 100 ml LDPE plastic bottle 36 months AMANTA HEALTHCARE LIMITED Plot no: 876, N.H. No: 8, Vill: Hariyala, Tal, Matar, Dist. Kheda- 387411, Gujarat, India INDIA AMANTA HEALTHCARE LIMITED SUN ENTERPRISES LTD 2024-07-27 2029-07-26

1497 Rwanda FDA-HMP-MA-1469 STOPKOF- P DIPHENHYDRAMINE HCL 7.0mg SYRUP 100ml Bottle Amber glass bottle sealed with plastic caps having PE wads 36 months NATIONAL PHARMACEUTICAL INDUSTRIES CO.(SAOC) P. O Box 120, Rusayl, Postal code 124. Sultanate of Oman Sultanate of Oman NATIONAL PHARMACEUTICAL INDUSTRIES CO.(SAOC) SUN ENTERPRISES LTD 2024-07-27 2029-07-26

1498 Rwanda FDA-HMP-MA-1472 FLOEZY TAMSULOSIN HYDROCHLORIDE 0.4MG TABLETS 3x10 Tablets Alu Alu blister pack of 3x10’s packed in a carton 36 Months SYNTHON HISPANIA S.L C/Castello, no1, Pol. Las Salinas Sant Bio de Llobregat, Barcelona,08830, Spain Spain MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2024-07-27 2029-07-26

1499 Rwanda FDA-HMP-MA-1473 SANDIMMUM NEORAL 25MG CICLOSPORIN 25MG SOFT GELATIN CAPSULES 30 Capsules PA/AL/PVC (aluminium) blister packs, blister packs are packed in a cardboard based pack 24 Months CATALENT GERMANY EBERBACH GmbH, Gammelsbacher Str. 269412 Eberbach Germany Germany NVS Kenya Limited SURGIPHARM (RWANDA) LTD 2024-07-27 2029-07-26

1500 Rwanda FDA-HMP-MA-1474 MEDI-KEELl® Cetylpyridinium chloride and Benzocaine 1.5MG/12MG LOZENGES 2X8 Lozenges Blister pack of aluminium foil and PVC/PVDC complex packed in Printed carton along with package leaflet 24 Months UNIQUE PHARMACEUTICALS LABORATORIES (a division of J.B. Chemicals & Pharmaceuticals Limited) Survey No. 101/2 and 102/1 , Daman Industrial Estate, Airport Road, Village Kadaiya, Daman- 396 210, India India ADCOCK INGRAM LIMITED, REPUBLIC OF SOUTH AFRICA SURGIPHARM (RWANDA) LTD 2024-07-27 2029-07-26

1501 Rwanda FDA-HMP-MA-1475 ELMOX 250 Amoxicillin trihydrate BP 250MG hHard Gelatin Capsules 10x10 Capsules Alu-Pvc blister pack 36 Months YELURI FORMULATIONS PVT LTD Sy. No 296/7/6, I.D.A Bollaram, Sangareddy District-502 325, Telangana-India INDIA YELURI FORMULATIONS PVT LTD SURGIPHARM (RWANDA) LTD 2024-07-27 2029-07-26

1502 Rwanda FDA-HMP-MA-1476 MYCOREN SUSPENSION NYSTATIN BP 100000UI SUSPENSION 30ml Bottle Amber colored round glass bottles with roll-on pilfer proof neck 24 Months RENE INDUSTRIES LTD plot No.680, P.O. box 6034 Kamuli, Kireka, Kampala, Uganda UGANDA RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-07-27 2029-07-26

1503 Rwanda FDA-HMP-MA-1477 LABESTEN CREAM Clotrimazole BP 1% w/w CREAM 1 Tube Filled in collapsible tubes and packed in a unit box with literature insert 36 Months LABORATORY & ALLIED LIMITED Plot no. 209/10349, Opposite Sameer business Park, next to Libra house, Mombasa Road. P. O. Box 42875, GPO 00100, Nairobi, Kenya Kenya LABORATORY & ALLIED LIMITED Depot Pharmaceutique Le Medical 2024-07-27 2029-07-26

1504 Rwanda FDA-HMP-MA-1492 MULTIREN TABLETS Vitamin A (as acetate) BP, Vitamin D3, Thiamine HCl BP, Riboflavin BP, Ascorbic acid BP, Nicotinamide BP 2500 IU, 300 IU,1 mg, 500 mcg, 15 mg, 7.5 mg TABLETS 10x10 Tablets Aluminium /PVC foil blister strip of 10x10 tablets in a unit box along with pack insert 24 Months RENE INDUSTRIES LTD Plot No.680, P.O. Box 6034 Kamuli, Kireka, Kampala, Uganda Uganda RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-07-27 2029-07-26

1505 Rwanda FDA-HMP-MA-1493 IBUFLAM 100MG/5ML ORAL SUSPENSION IBUPROFEN BP 100mg/5ml SUSPENSION 60ml and 100ml Bottles Amber coloured glass bottles with caps in a unit carton with a pack insert 36 Months BIODEAL LABORATORIES LTD 123 Lunga Lunga road, P.O. Box 32040-00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-07-27 2029-07-26

1506 Rwanda FDA-HMP-MA-1455 OMIREN CAPSULES OMEPRAZOLE BP 20MG Capsules 10x10 Capsules Alu-PVC foil blisters packed in a unit box 24 Months RENE INDUSTRIES LTD Plot No.680, P.O.Box 6034 Kamuli, Kireka, Kampala, Uganda Uganda RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-07-27 2029-07-26

1507 Rwanda FDA-HMP-MA-1471 LANTUS 10ML Insulin Glargine 100 Units/ml Solution for injection 1 vial of 10ml Type I colourless glass vial with a flanged cap (aluminium), a stopper (type 1, laminate of polyisoprene and bromobutyl rubber) and a tear-off cap (polypropylene) containing 10 ml of solution 36 Months SANOFI-AVENTIS DEUTSCHLAND GmbH Industriepark Höchst-Brüningstraße 50 65926 Frankfurt am Main, Germany Germany SANOFI-AVENTIS DEUTSCHLAND GmbH KIPHARMA LTD 2024-07-27 2029-07-26

1508 Rwanda FDA-HMP-MA-1494 KEMOXYL 250 CAPSULES. Amoxicillin Trihydrate BP 250mg Hard Gelatin Capsules 10x10 Tablets and 1000 Tablets Blisters of 10 x 10’s in a unit box and 1000’s in HDPE container with literature insert 36 Months LABORATORY & ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra, House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LIMITED Depot Pharmaceutique Le Medical 2024-07-27 2029-07-26

1509 Rwanda FDA-HMP-MA-1495 LARINATE-60 Artesunate for Injection Ph. Int 60MG Powder for Injection Vial of 5 ml Type I glass vials with grey colored rubber stoppers and flip off seal 36 Months IPCA LABORATORIES LIMITED Village Sejavta, District Ratlam- 457 001, Madhya Pradesh, India INDIA IPCA LABORATORIES LIMITED SUN ENTREPRISE LTD 2024-07-27 2029-07-26

1510 Rwanda FDA-HMP-MA-1496 LEFRUSID TABLETS Furosemide BP 40mg 40mg TABLETS 10x10 Tablets and 1000 Tablets Blisters of 10 x 10’s in a unit box and 1000’s in HDPE container with literature insert 36 Months LABORATORY & ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra, House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LIMITED Depot Pharmaceutique Le Medical 2024-07-27 2029-07-26

1511 Rwanda FDA-HMP-MA-1497 CLOXAREN CAPSULES Cloxacillin 250 mg Capsules 10x10 Capsules Aluminium/ transparent PVC blister of 10 tablet and 10 of such blister is packed in a unit box with pack insert 24 Months RENE INDUSTRIES LTD Plot No.680, P.O. Box 6034 Kamuli, Kireka, Kampala, Uganda Uganda RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-07-27 2029-07-26

1512 Rwanda FDA-HMP-MA-1498 NOZINAN 100 MG Levomepromazine maleate acid 100MG Film Coated Tablets 20 Tablets PVC-Aluminum blisters 24 Months SANOFI S.P.A. Strada Statale 17, Km 22 67019 Scoppito (AQ), Italy Italy Sanofi Aventis Kenya Limited KIPHARMA LTD 2024-07-27 2029-07-26

1513 Rwanda FDA-HMP-MA-1499 TROYPOFOL 20 ML Propofol Injection BP 1% w/v Emulsion for Injection or infusion 20ml Vial Flint vial USP Type I with Bromo butyl rubber closure and blue flip off aluminium seal with Troikaa logo. Such 1 vial packed in printed carton along with package insert 36 Months TROIKAA PHARMACEUTICALS LTD C-1, Sara Industrial Estate, Selaqui, Dehradun-248197, Uttarakhand, India INDIA TROIKAA PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2024-07-27 2029-07-26

1514 Rwanda FDA-HMP-MA-1500 UROKA PLUS Dutasteride and Tamsulosin 0.5mg & 0.4 mg Hard Gelatin Capsules 5x6 Capsules Alu-Alu blister pack of 6 capsules. Such 5 blisters are packed in a Carton 36 Months SAG MANUFACTURING, S.L.U, Carretera Nacional I, Km. 36 28750 San Agustin de Guadalix (Madrid), Spain Spain MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2024-07-27 2029-07-26

1515 Rwanda FDA-HMP-MA-1501 DISLEP 25MG LEVOSULPIRIDE 25MG TABLET 20 Tablets Aluminum/PVC/PVDC blisters packed in a carton box with literature insert 60 Months DOPPEL FARMACEUTICI S.R.L., Via Volturno, 48, Quinto de’ Stampi, 20089 ROZANO (MI), Italy ITALY Ferrer Internacional, S.A. GOMHS Ltd 2024-07-27 2029-07-26

1516 Rwanda FDA-HMP-MA-1502 OXCIN OPHTHALMIC SOLUTION MOXIFLOXACIN HYDROCHLORIDE BP 5MG EYE DROPS 5ml Bottle LDPE bottle packed in a printed carton 24 Months ATCO Laboratories Limited, B?18, S.I.T.E., Karachi ?75700, Karachi. Sindh, Pakistan Pakistan ATCO Laboratories Limited AFRI HEALTH CARE LIMITED 2024-07-27 2029-07-26

1517 Rwanda FDA-HMP-MA-1503 OXCIN-D OPHTHALMIC SOLUTION MOXIFLOXACIN HYDROCHLORIDE BP /DEXAMETHASONE PHOSPHATE 0.5%W/V+0.1%W/V EYE DROPS 5ml Bottle LDPE bottle packed in a printed carton 24 Months ATCO Laboratories Limited, B?18, S.I.T.E., Karachi ?75700, Karachi. Sindh, Pakistan Pakistan ATCO Laboratories Limited AFRI HEALTH CARE LIMITED 2024-07-27 2029-07-26

1518 Rwanda FDA-HMP-MA-1504 APRETUDE PROLONGED RELEASE SUSPENSION FOR INJECTION Cabotegravir Sodium 600MG/3ML Prolonged release suspension for injection 3ml Vial Type I clear glass vial, sealed with bromobutyl rubber stopper and an aluminum Overseal with a removable plastic cap 36 Months GLAXO OPERATIONS UK LIMITED Harmire Road, Barnard Castle, County Durham DL12 8DT, United Kingdom United Kingdom ViiV Healthcare Pty Ltd KIPHARMA LTD 2024-07-27 2029-07-26

1519 Rwanda FDA-HMP-MA-1662 ERLOCIP 100 Erlotinib hydrochloride 100MG TABLETS 10 Tablets Plain Aluminium Foil (Blister) PVC film strip 24 Months CIPLA LTD Unit X. S-103 to S-105, S-107 to S-112, L-138, L-147 to L-147/1, L-147/3 & L147/A, Verna Industrial Estate, Verna, Salcette, Goa 403 722 India India CIPLA LTD KIPHARMA LTD 2024-08-15 2029-08-15

1520 Rwanda FDA-HMP-MA-1945 SINAREST PAEDIATRIC NASAL DROPS OXYMETHAZOLINE HYDROCHLORIDE USP 0.25MG NASAL DROPS 10ml Bottle LDPE FLAT BOTTLE 36 Months CENTAUR PHARMACEUTICALS PVT LTD Plant :1, plot No:3,5B,2C. Tivin industrial Estate, Karaswada, Mapusa Goa-403526, India INDIA CENTAUR PHARMACEUTICALS PVT. LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-08-15 2029-08-15

1521 Rwanda FDA-HMP-MA-2164 ULGICID SUSPENSION (MINT) ALGINIC ACID, MAGNESIUM HYDROXIDE,ALUMINIUM HYDROXIDE,MAGNESIUM TRISILICATE&SIMETICONE SUSPENSION 200mg, 250mg, 250mg, 250mg, 125mg SUSPENSION 200 ML Amber Colour Glass Brute Bottle With 25 Mm Aluminium Pp Cap. 30 Months SAI MIRRA INNOPHARM PVT. LTD. SAI MIRRA INNOPHARM PVT. LTD. 288 & 299, SIDCO Estate Ambattur, Chennai - 600 098, Tamil Nadu. India INDIA PRISMA PHARMA FZE PRAFIN RWANDA LTD 2024-08-16 2029-08-17

1522 Rwanda FDA-HMP-MA-1681 CLOXACILLIN SODIUM CLOXACILLIN SODIUM USP 250MG HARD GELATIN CAPSULE 10 X10 Capsules Alu-PVDC Blister 24 months Milan Laboratories (India) Pvt Ltd. Milan Laboratories (India) Pvt Ltd. Plot no. 35/36/63/64/65/67/87, J.C.I.E. Ltd., Kamothe, Panvel, Navi Mumbai, India INDIA Milan Laboratories (India) Pvt Ltd, 303 & 304, Odyssey IT Park, Road no.9, Opp. MIDC office, Wagle Estate, Thane- 400 604, India, E-Mail: info@milanlabs.com SIGMA PHARMA RWANDA LIMITED 2024-08-17 2029-08-16

1523 20-4359-DGC&PHS-2018-R1 AMEP-5 Amlodipine 5 mg Tablets Box/7, Box/14, Box/28 PVC/ALUMINIUM BLISTER 36 Months LABORATOIRES COOPER PHARMA Route 107km 2,5 Douar Ouled Sidi Abbou Tit Mellil , CASABLANCA-MOROCCO MOROCCO LABORATOIRES COOPER PHARMA MD CONSEIL MEDICAL SUPPLY LTD 2024-08-17 2029-08-16

1524 Rwanda FDA-HMP-MA-1908 CLOFAINS PARACEUTAMOL/ SODIUM DICLOFENAC 500MG/50MG TABLETS 1x 10 tablets PVC-ALUMINIUM BLISTER 36 months Milân Laboratories (India) Private Limited. : Milân Laboratories (India) Private Limited. Address: Plot N° 35, 36, 63, 64, 65, 67 & 87, Jawahar Co-op Ind. Estate Ltd. Kamothe, Raigad – 410209 Maharashtra, India. INDIA EXPHAR SOCIALITESZoning Industriel de Nivelles Sud, zone II – Av. Thomas Edison 105 – 1402 Thines (Belgium)E-mail: pharmacien@exphar.be H&H PHARMA LTD 2024-08-17 2029-08-16

1525 20-4360-DGC&PHS-2018-R1 AMEP-10 Amlodipine 10 mg Tablets Box/7, Box/14, Box/28 PACK/CARTON 24 Months LABORATOIRES COOPER PHARMA Route 107km 2,5 Douar Ouled Sidi Abbou Tit Mellil , CASABLANCA-MOROCCO MOROCCO LABORATOIRES COOPER PHARMA MD CONSEIL MEDICAL SUPPLY LTD 2024-08-17 2029-08-16

1526 Rwanda FDA-HMP-MA-1909 FEVAROL PARACETAMOL, PHENYLEPHRINE,CHLORPHENIRAMINE MALEATE 125MG/2.5MG/1MG SYRUP 1x100 ml Amber PET Bottle 36 months Baroque Pharmaceuticals Limited Baroque Pharmaceuticals Limited, Private Address: 192/2, Sokhada-388 620 Tal: Khambhat, Dist. Anand, Gujarat, India. INDIA BEKRA PHARMA13, Lavington Road, London, United Kingdom UBIPHARM-RWANDA LTD 2024-08-17 2029-08-16

1527 20-4361-DGC&PHS-2018-R1 ANDOL-500 Paracetamol 500 mg Tablets Box/16 PP TUBE WITH PE STOPPER 24 Months LABORATOIRES COOPER PHARMA Route 107km 2,5 Douar Ouled Sidi Abbou Tit Mellil , CASABLANCA-MOROCCO MOROCCO LABORATOIRES COOPER PHARMA MD CONSEIL MEDICAL SUPPLY LTD 2024-08-17 2029-08-16

1528 Rwanda FDA-HMP-MA-1910 Abacavir Sulfate and Lamivudine Tablets 600/300mg Abacavir Sulfate and Lamivudine 600mg/300mg Tablets 30\\\'s HDPE Container 24 months Hetero Labs Limited Hetero Labs Limited Address : TSIIC Formulation SEZ, S.No 439, 440, 441 & 458 Polepally village, Jadcherla Mandal, Mahaboob Nagar (Dist) –509301, Telangana. Country : India Telephone : +91-8542-238400 Telefax: +91-8542 238404 INDIA Hetero Labs Limited Address : Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad – 500 018, Telangana. SUN ENTREPRISE LTD 2024-08-17 2029-08-16

1529 20-4362-DGC&PHS-2018-R1 ANDOL-1000 Paracetamol 1000 mg Tablets Box/8 PVC/ALUMINIUM BLISTER 36 Months LABORATOIRES COOPER PHARMA Route 107km 2,5 Douar Ouled Sidi Abbou Tit Mellil , CASABLANCA-MOROCCO MOROCCO LABORATOIRES COOPER PHARMA MD CONSEIL MEDICAL SUPPLY LTD 2024-08-17 2029-08-16

1530 Rwanda FDA-HMP-MA-1911 ALBUREL HUMAN ALBUMIN SOLUTION BP 20% INTRAVENOUS INFUSION 50ML AND 100ML Glass vial 36 months Reliance Life Sciences Pvt. Ltd Reliance Life Sciences Pvt. Ltd Address: Plant 4B, Dhirubhai Ambani Life Sciences Centre (DALC), Plant 4B, R-282, TTC Area of MIDC, Thane Belapur Road, Rabale, Navi- Mumbai, India INDIA Reliance Life Sciences Pvt. Ltd, Dhirubhai Ambani Life Sciences Centre (DALC), Plant 4B, R-282, TTC Area of MIDC, Thane Belapur Road, Rabale, Navi- Mumbai, India. STAR BIOTECH RWANDA 2024-08-17 2029-08-16

1531 20-4363-DGC&PHS-2018-R1 ZOEGAS-20 Esomeprazole 20 mg Capsules Box/7, Box/14, Box/28 ALU/PVC FILM BLISTER PACK/CARTON 36 Months LABORATOIRES COOPER PHARMA Route 107km 2,5 Douar Ouled Sidi Abbou Tit Mellil , CASABLANCA-MOROCCO -MOROCCO MOROCCO LABORATOIRES COOPER PHARMA MD CONSEIL MEDICAL SUPPLY LTD 2024-08-17 2029-08-16

1532 Rwanda FDA-HMP-MA-1912 AMOXI-DENK 1000 AMOXICILLIN TRIHYDRATE 1000 MG TABLETS 10 tablets PVC/PVDC aluminium blister strips 36 months PenCef Pharma GmbH PenCef Pharma GmbH Breitenbachstr. 13 - 14, 13509 Berlin GERMANY DENK PHARMA GmbH & Co. KG, Prinzregentenstr. 79, 81675 München, Germany, E-Mail: pharma@denkpharma.de ETS CONTINENTAL 2024-08-17 2029-08-16

1533 20-4364-DGC&PHS-2018-R1 ZOEGAS-40 Esomeprazole 40 mg Capsules Box/7, Box/14, Box/28 ALU/PVC/ALU BLISTER 24 Months LABORATOIRES COOPER PHARMA Route 107km 2,5 Douar Ouled Sidi Abbou Tit Mellil , CASABLANCA-MOROCCO MOROCCO LABORATOIRES COOPER PHARMA MD CONSEIL MEDICAL SUPPLY LTD 2024-08-17 2029-08-16

1534 Rwanda FDA-HMP-MA-1913 AMOXI-DENK 500 AMOXICILLIN TRIHYDRATE 500MG TABLETS 20 TABLETS PVC/PVDC aluminium blister strips 36 months Pencef Pharma GmbH PenCef Pharma GmbH Address: Breitenbachstr. 13-14 13509 Berlin, Germany GERMANY DENK PHARMA GmbH & Co. KG, Prinzregentenstr. 79, 81675 München Country: Germany Telephone: +49 89 - 23 00 29 – 0 Telefax: +49 89 - 23 00 29 – 480 E-Mail: pharma@denkpharma.de ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2024-08-17 2029-08-16

1535 20-4365-DGC&PHS-2018-R1 SPECTRUM-250 Ciprofloxacin 250 mg Tablets Box/10 ALU/PVC FILM BLISTER PACK/CARTON 24 Months LABORATOIRES COOPER PHARMA Route 107km 2,5 Douar Ouled Sidi Abbou Tit Mellil , CASABLANCA-MOROCCO MOROCCO LABORATOIRES COOPER PHARMA MD CONSEIL MEDICAL SUPPLY LTD 2024-08-17 2029-08-16

1536 Rwanda FDA-HMP-MA-1914 GRAMOCEF-O-50 DRY SYRUP CEFIXIME 50MG/5ML 50MG/5ML DRY SYRUP 1x100 ml Amber Coloured glass bottle 24 months Micro Labs Limited Micro Labs Limited No. 121-124, 4th Phase, K.I.A.D.B., Bommasandra Industrial Area, Anekal Taluk, Bangalore-560 099, INDIA INDIA MICRO LABS LTD/INDIA Phillips Pharmaceuticals (Rwanda) Ltd. 2024-08-17 2029-08-16

1537 20-4366-DGC&PHS-2018-R1 SPECTRUM-500 Ciprofloxacin 500 mg Tablets Box/10 ALU/PVC FILM BLISTER PACK/CARTON 36 Months LABORATOIRES COOPER PHARMA Route 107km 2,5 Douar Ouled Sidi Abbou Tit Mellil , CASABLANCA-MOROCCO MOROCCO LABORATOIRES COOPER PHARMA MD CONSEIL MEDICAL SUPPLY LTD 2024-08-17 2029-08-16

1538 Rwanda FDA-HMP-MA-1915 MOVFOR MOLNUPIRAVIR 200MG Capsules 4x10 \\\'s Alu-Alu blister 24 months Hetero Labs Limited (Unit -V) Hetero Labs Limited (Unit -V) Address : Survey No. 439, 440, 441 & 458, TSIIC-Formulation SEZ, Polepally (Village), Jadcherla (Mandal), Mahaboob Nagar (Dist) Telangana State, India – 509301 Country : India India Hetero Lab Limited Bion Group Pharma Ltd 2024-08-17 2029-08-16

1539 20-4367-DGC&PHS-2018-R1 SPECTRUM-750 Ciprofloxacin 750 mg Tablets Box/10 ALU/PVC FILM BLISTER PACK/CARTON 36 Months LABORATOIRES COOPER PHARMA Route 107km 2,5 Douar Ouled Sidi Abbou Tit Mellil , CASABLANCA-MOROCCO MOROCCO LABORATOIRES COOPER PHARMA MD CONSEIL MEDICAL SUPPLY LTD 2024-08-17 2029-08-16

1540 Rwanda FDA-HMP-MA-1703 Olopat OD Olopatadine Hydrochloride USP Olopatadine Hydrochloride Ophthalmic Solution USP 0.2% w/v Ophthalmic 5 ml LDPE vial 36 month Ajanta Pharma Limited Mirza-Palashbhari road, vill.- Kokhjar, Kamrup (R), Guwahati, Assam- 781128 India Ajanta Pharma Limited Abacus Pharma (A) Ltd 2024-08-17 2029-08-16

1541 20-4368-DGC&PHS-2018-R1 TREMADOL-50 Tramadol 50 mg Tablets Box/20 ALU/PVC FILM BLISTER PACK/CARTON 36 Months LABORATOIRES COOPER PHARMA Route 107km 2,5 Douar Ouled Sidi Abbou Tit Mellil , CASABLANCA-MOROCCO MOROCCO LABORATOIRES COOPER PHARMA MD CONSEIL MEDICAL SUPPLY LTD 2024-08-17 2029-08-16

1542 Rwanda FDA-HMP-MA-1704 RENECHLOR 250MG CAPS Chloramphenicol BP 250 mg 250mg Capsules 10 capsules Aluminium/PVC blister 36 month Rene Industries Ltd Plot No 680, P.O Box 6034, Kamuli, Kireka, Kamplala Uganda Rene Industries Ltd Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16

1543 20-4369-DGC&PHS-2018-R1 CO-VIZARTAN-50/12.5 Losartan, Hydrochlorothiazide 50mg, 12.5mg Tablets Box/7, Box/14, Box/28 PP TUBE WITH PE STOPPER 36 Months LABORATOIRES COOPER PHARMA Route 107km 2,5 Douar Ouled Sidi Abbou Tit Mellil , CASABLANCA-MOROCCO MOROCCO LABORATOIRES COOPER PHARMA MD CONSEIL MEDICAL SUPPLY LTD 2024-08-17 2029-08-16

1544 Rwanda FDA-HMP-MA-1915 COLDEASE CAPSULES Paracetamol, Caffeine Anhydrous, Chlorpheniramine Maleate, Pseudoephedrine Hydrochloride 400mg/30mg/4mg/30mg Capsules 10x10 Aluminium/ transparent PVC blister 24 month Rene Industries Ltd Plot No 680, P.O Box 6034, Kamuli, Kireka, Kamplala Uganda Rene Industries Ltd Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16

1545 Rwanda FDA-HMP-MA-1701 DICLO-DENK 100 RECTAL DICLOFENAC SODIUM 100MG SUPPOSITORIES 10 suppositories PVC/PVDC/PE foil 36 month Haupt Pharma Wülfing GmbH Bethelner Landstr. 18 31028 Gronau Germany DENK PHARMA GmbH & Co. KG, Prinzregentenstr. 79, 81675 München, Germany ETS CONTINENTAL Depot Pharmaceutique 2024-08-17 2029-08-16

1546 Rwanda FDA-HMP-MA-1702 VILDA DENK 50 MG VILDAGLIPTIN 50MG TABLETS 28 tablets Alu/ Alu blister 30 month Denk Pharma GmbH & Co.KG Gollsstr.1, 84520 Tittmoning Germany DENK PHARMA GmbH & Co. KG, Prinzregentenstr. 79, 81675 München, Germany, E-Mail: pharma@denkpharma.de ETS CONTINENTAL Depot 2024-08-17 2029-08-16

1547 145-Rwanda FDA-2018-R1 FERTILION-M Lycopene, Co-Enzyme Q 10, L-Glutathione, Vitamin E, Vitamin C, L-Carnitine, Korean Ginseng Extract, Zinc (As Zinc Sulphate Monohydrate), Folic Acid, Iron (As Ferrous Fumarate), Vitamin B6,Manganese (As Manganese Sulphate Monohydrate), Selenium (As Selenious Acid), Vitamin D3, Vitamin B1 (Thiamine Nitrate), Methylcobalamin, Retinol (As Vitamin A Palmitate) 10mg, 50mg, 50mg, 12.5mg, 75mg, 50mg, 10mg,7.5mg, 1.5mg, 5mg, 5mg, 2mg, 100mcg, 12.5mcg, 5mg, 750mcg, 375mcg Soft Gelatin B/2*15 Soft Gelatin POUCH/PET/LDPE 2 RODS/POUCH*10/BOX 48 Months SOFTGEL HEALTHCARE PVT LTD Survey N0.20/1, Vandalur Kelambakkam road; Pudupakkam village, Kancheepuram District, Tamil nadu-603 103, INDIA INDIA SOFTGEL HEALTHCARE PVT LTD STAR BIOTECH RWANDA LIMITED 2024-08-17 2029-08-16

1548 Rwanda FDA-HMP-MA-1700 UPRONE-40 OMEPRAZOLE 40MG STERILE POWDER FOR INJECTION 1x10 ml Glass vial 24 month Indasi Lifescience Pvt. Ltd Plot no. 73-76, Silver Industrial Estate, Bhimpore, Daman (UT) India Bliss GVS Pharma Ltd. Address: 102, Hyde Park, Saki-Vihar Road, Andheri (East). Mumbai-400072 Country: India Telephone: +91-22-42160000 Telefax: +91-22-28563930 E-Mail: info@blissgvs.com SURYA DEPOT PHARMACY LTD 2024-08-17 2029-08-16

1549 146-Rwanda FDA-2018-R1 FERTILION-F Myo-Inositol, D-Chiro-Inositol, Vitamin C, Para Amino Benzoic Acid, Folic Acid, L-Arginine, Vitamin B1 (Thiamine Mononitrate), Vitamin B6, Vitamin B2, Methylcobalamin, Retinol (As Vitamin A Palmitate), Vitamin D3, Vitamin E, Magnesium (As Light Magnesium Oxide), Zinc (As Zinc Sulfate Monohydrate), Iron (As Ferrous Fumarate), Copper (As Copper Sulphate Pentahydrate), Manganese (As Manganese Sulphate Monohydrate), Selenium (As Selenious Acid), Iodine (As Potassium Iodide), Chromium (As Chromium Picolinate) 200mg, 10mg, 75mg, 12.5mg, 1.5mg, 10mg, 5mg, 5mg, 2.5mg, 500mcg, 375mcg, 12.5mcg, 12.5mg, 25mg, 10mg, 9mg, 750mcg, 1.5mcg, 100mcg, 50mcg, 50mcg Soft Gelatin B/2*15 Soft Gelatin POUCH/PET/LDPE 2 RODS/POUCH*10/BOX 24 Months SOFTGEL HEALTHCARE PVT LTD Survey N0.20/1, Vandalur Kelambakkam road; Pudupakkam village, Kancheepuram District, Tamil nadu-603 103, INDIA INDIA SOFTGEL HEALTHCARE PVT LTD STAR BIOTECH RWANDA LIMITED 2024-08-17 2029-08-16

1550 Rwanda FDA-HMP-MA-1697 GACET-500 PARACETAMOL EFFERVESCENT 500MG 500MG EFFERVESCENTS TABLETS 4 strips aluminium foil 36 month Vovantis Laboratories Pvt. Ltd Survey No. 546/1/1, Opposite Ranoli Railway Station, Near GACL Plant, City: Ranoli-391 350, Dist.: Vadodara, Gujrat State India BLISS GVS PHARMA LTD Address: 102, Hyde Park, Saki-Vihar Road, Andheri (East). Mumbai-400072Country: IndiaTelephone: +91-22-42160000Telefax: +91-22-28563930E-Mail: info@blissgvs.com SURYA DEPOT PHARMACY LTD 2024-08-17 2029-08-16

1551 Rwanda FDA-HMP-MA-1698 CARDIOZIDE ® HCT LOSARTAN AND HYDROCHLOROTHIAZIDE 50MG, 12.5MG TABLETS 30 tablets Alu/Alu blister 24 month Baroque Pharmaceuticals Pvt.Ltd 192/2&3, Sokhada-388 620 India BEKRA PHARMAAddress: 13,LAVINGTON ROADLONDON, Country: UNITED KINGDOMTel: +44 745 962162e-mail: export@bekrapharma.uk UBIPHARM-RWANDA LTD 2024-08-17 2029-08-16

1552 Rwanda FDA-HMP-MA-1699 LAMADOL TRAMADOL HCI 100MG/2ML INJECTION 2 ml Clear USP type I ampoule 24 month Brookes Pharma Private Limited 58-59, Sector No. 15, Korangi Industrial Area, Karachi-74900 Pakistan Brookes Pharma Private LimitedAddress: 58-59, Sector No. 15, Korangi Industrial Area, Karachi-74900Country: PakistanE-mail: export@brookespharma.com DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

1553 Rwanda FDA-HMP-MA-1683 NEWCOX - P ETORIXOCIB&PARACETAMOL 60MG/325MG TABLETS 3x10\\\'s Alu-Alu blister 36 month M/S Skybiotech Lifesciences Pvt. Ltd Gut no.: 5, Gevrai Tanda, Paithan Road, Aurangabad (M.S.) India Star Biotech LimitedAddress: 1st floor, Prestige House, Rwandex, Kigali-Rwanda STAR BIOTECH RWANDA 2024-08-17 2029-08-16

1554 Rwanda FDA-HMP-MA-1781 PARACETAMOL 500 Paracetamol BP 500mg Tablets 10 Tablets ALU/PVC BLISTER 36 Months AURA LIFECARE PVT. LTD. Survey No 254/ 14/1,Jarod ,Savli Road, P.O. Karachiya, Tal-Savli ,Dist : Vadodara-391520. Gujarat State, INDIA INDIA AURA LIFECARE PVT. LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1555 Rwanda FDA-HMP-MA-1917 FERCEFOL SYRUP IRON (II) HYDROXIDE POLYMALTOSE/FOLIC ACID/ASCORBIC ACID 172.40MG/4MG/20MG SYRUP 150 ml PET bottle 36 month Gracure Pharmaceuticals Limited E- 1105, Industrial Area, Phase-III BHIWADI, PIN-301019. Dist. Alwar, Rajasthan India EXPHAR SOCIALITESZoning Industriel de Nivelles Sud, zone II – Av. Thomas Edison 105 – 1402 Thines (Belgium)E-mail: pharmacien@exphar.be H&H PHARMA LIMITED 2024-08-17 2029-08-16

1556 Rwanda FDA-HMP-MA-1782 ZIROMIN Azithromycin dehydrate 500mg Tablets 3 Tablets ALU-PVC/PVDC BLISTER 36 Months WORLD MEDICINE ILAC SAN. VE TIC.A.S 15 Temmuz Mah. Cami Yolu Cad. No:50, Güne?li, Ba?c?lar Post code: 34212, ?stanbul ,TURKEY TURKEY WORLD MEDICINE ILAC SAN. VE TIC.A.S GOODMAN INTERNATIONAL (R) LTD 2024-08-17 2029-08-16

1557 0302/Rwanda FDA/2019-R1 CIPRO-DENK-750 Ciprofloxacin Hydrochloride 750mg Tablets 1 Blister Of 10 Tablets PVC/PVDC-ALUMINIUM BLISTERS 24 Months ALLPHAMED PHARBIL ARZNEIMITTEL GmbH Hildedrandstr.10-12,37081 Goyyingen GERMANY DENK PHARMA& CO.KG ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2024-08-17 2029-08-16

1558 Rwanda FDA-HMP-MA-1707 RIFAMPIN AND ISONIAZID DISPERSIBLE TABLETS 75/50MG (10X10 TAB, 2BOXES AND 18X5 2 BOXES) RIFAMPIN AND ISONIAZID DISPERSIBLE TABLETS 75/50MG 75/50MG TABLETS 1. 1 x 5 T, 2. 1 x 10 T, 3. 3 x 28 T, 4. 14 x 6 T Alu Alu Blister, Alu Alu Strip 24 month Lupin Ltd A-28/1, MIDC Area, Chikalthana, Aurangabad, Aurangabad-431210 India LUPIN Ltd3rd floor, Kalpataru InspireOff Western Express Highway, Santacruz (East)Mumbai-400 055, India.Telephone:91-22-66402323www.lupinworld.com AIVEEN RWANDA LTD 2024-08-17 2029-08-16

1559 Rwanda FDA-HMP-MA-1783 BRUTAFLAM-90 Etoricoxib 90mg Tablets 10 Tablets ALU/PVC BLISTER 24 Months MANKIND PHARMA LTD Unit-II, Village Kishanpura, P.O. Jamniwala Tehsil- Paonta Sahib, District Sirmour -173025 (Himachal Pradesh), India. INDIA MANKIND PHARMA LTD WESSEX PHARMACEUTICALS RWANDA LTD 2024-08-17 2029-08-16

1560 Rwanda FDA-HMP-MA-1693 TORICOX -120 ETORICOXIB 120MG TABLET 3 x 10’s Alu/ Clear PVDC Blister 24 month Aurochem Pharmaceuticals (I) pvt. Ltd 58, Palghar Taluka, Industrial Co.-op. Estate Ltd. Palghar – 401 404, District Thane India OCHOA LABORATORIESAddress 430, Mzz,F, Gundecha Indl.Complex Akurli Road, Kandivali €, Email: maheshshah@aurochemgroup.com, poonam@aurochemgroup.com, Pallavmshah@aurochemgroup.com; Telephone: +(91) -(22)-28858503/04/05 SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1561 Rwanda FDA-HMP-MA-1784 BRUTAFLAM-60 Etoricoxib 60mg Tablets 10 Tablets ALU/PVC BLISTER 24 Months MANKIND PHARMA LTD Unit-II, Village Kishanpura, P.O. Jamniwala Tehsil- Paonta Sahib, District Sirmour -173025 (Himachal Pradesh), India. INDIA MANKIND PHARMA LTD WESSEX PHARMACEUTICALS RWANDA LTD 2024-08-17 2029-08-16

1562 Rwanda FDA-HMP-MA-1692 TORICOX-90 ETORICOXIB 90MG TABLET 3 x 10 Alu/ Clear PVDC Blister 24 month Aurochem Pharmaceuticals (I) pvt. Ltd 58, Palghar Taluka, Industrial Co.-op. Estate Ltd. Palghar – 401 404, District Thane India OCHOA LABORATORIESAddress 430, Mzz,F, Gundecha Indl.Complex Akurli Road, Kandivali €, Email: maheshshah@aurochemgroup.com, poonam@aurochemgroup.com, Pallavmshah@aurochemgroup.com; Telephone: +(91) -(22)-28858503/04/05 SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1563 Rwanda FDA-HMP-MA-1785 CORILIEF NON-DROWSY TABLETS Paracetamol & Pseudoephedrine Hydrochloride 500mg/30mg Tablets 20 Tablets PVC/Aluminium foil blister packs of & Polypropylene container with LPE container 24 Months VARICHEM PHARMACEUTICALS (PVT) LTD. 194 Gleneagles Road, Willowvale, Harare, Zimbabwe Tel: +263 (04) 620181-7, Fax: +263 (04) 660424, Email: marketing@varipharm.co.zw ZIMBABWE VARICHEM PHARMACEUTICALS (PVT) LTD. ACTIVIS PHARMA LTD 2024-08-17 2029-08-16

1564 Rwanda FDA-HMP-MA-1708 Cabalin 75 Pregabalin 75 mg 75 mg CAPSULES 12 capsules Alu -PVDC blister 24 month Cachet Pharmaceutical Pvt. Ltd Thana, Baddi, Himachal Pradesh-173 205 India CACHET PHARMACEUTICALS PVT.LTD Wessex Pharmaceuticals Ltd. 2024-08-17 2029-08-16

1565 Rwanda FDA-HMP-MA-1786 DICARD Sacubitril and valsartan 24.30 mg/25.70mg Tablets 3x10 Tablets ALU/PVC BLISTER 24 Months COSMOS LIMITED Rangwe Road; Off Lunga Road, Industrial Area, P. O. Box 41433, Gpo 00100 - Nairobi, Kenya. KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1566 Rwanda FDA-HMP-MA-1918 EFFERALGAN PEDIATRIC-3 PARACETAMOL 3G SYRUP 90 ml Polyethylene terephtalate brown bottle 36 month UPSA SAS 304, Avenue du Docteur Jean Bru 47000 Agen France UPSA SAS/FRANCE Address: 304, Avenue du Docteur Jean Bru 47000 Agen –France UBIPHARM-RWANDA LTD 2024-08-17 2029-08-16

1567 Rwanda FDA-HMP-MA-1787 CLARICOS Clarithromycin USP 500mg Tablets 20 Tablets PVC/ALUMINIUM FOIL 24 Months COSMOS LIMITED Rangwe Road; Off Lunga Road, Industrial Area, P. O. Box 41433, Gpo 00100 - Nairobi, Kenya. KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1568 Rwanda FDA-HMP-MA-1694 INFCLAV 228 ORAL SUSP 100 ML AMOXICILLIN/CLAVULANIC ACID 228MG SUSPENSION 100 ml Amber colour glass bottle 24 month Sakar Healthcare Limited Block No. 10-13, Sarkhej-Bavla Highway, Vill: Changodar, Dist: Ahmedabad-382213, Gujarat India (Company) Name: INFINITE HEALTH LIMTEDAddress: P.O BOX 64001-00620, NAIROBICountry: KENYATelephone: +254 733 733341/725 349888E-Mail: info@infinite.com SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1569 Rwanda FDA-HMP-MA-1788 CISATRA Cisatracurium besylate USP 2mg/ml Injection 1x10ml Vial TYPE I AMBER GLASS VIAL 18 Months THEMIS MEDICARE LIMITED. 11/12, Udyog Nagar, S. V. Road, Goregaon (West), Mumbai- 400104, INDIA, , E-Mail: themis@themismedicare.com INDIA THEMIS MEDICARE LIMITED WESSEX PHARMACEUTICALS RWANDA LTD 2024-08-17 2029-08-16

1570 Rwanda FDA-HMP-MA-1919 Combi pack of sildenafil oral jelly (banana & strawberry) COMBIPACK OF SILDENAFIL 100MG ORAL JELLY 2x5 gm sachets LDPE 36 month AURA LIFECARE PVT. LTD Survey No 254/ 14/1,Jarod ,Savli Road, P.O. Karachiya, Tal-Savli ,Dist : Vadodara-391520. Gujarat State India AURA LIFECARE PVT. LTD. Address: Survey No 254/ 14/1,Jarod ,Savli Road, P.O. Karachiya, Tal-Savli ,Dist : Vadodara-391520.Gujarat State.Country: INDIATelephone: + 91-7574000807/ 7574000858Telefax: --E-Mail:info@auralifecare.com SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1571 Rwanda FDA-HMP-MA-1789 GYNOSPAN Phloroglucinol BP , Trimethyl phloroglucinol IH 40.00mg/0.04mg Injection 6 ampoules of 4 ml AMPOULES OF 4 ML INJECTION PLACED ON A TRAY 24 Months BLISS GVS PHARMA LIMITED ( INDASI LIFESCIENCE PVT. LTD) Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane – 401404, India INDIA IMEX PHARMA KIPHARMA LTD 2024-08-17 2029-08-16

1572 Rwanda FDA-HMP-MA-1706 ZINCOS DISPERSIBLE TABLETS Zinc Sulfate Monohydrate 20 MG TABLETS 1X10 PVC/ALU blister 36 month Cosmos Limited Rangwe Road; Off Lunga Lunga Road, Industrial Area, P. O. Box 41433, GPO 00100 - Nairobi Kenya COSMOS LIMITED,Address: RANGWE ROAD; OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA, P. O. BOX 41433, GPO 00100 - NAIROBI,Country: KENYA.Telephone: +(254-20) 8042200/2/3/4/5 +254(0) 709864000Telefax: +(254-20)8096280/1E-Mail: registration@cosmos-pharm.com SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1573 Rwanda FDA-HMP-MA-1790 GYNO BALANCE Lactose monohydrate BP 1200 mg Suppositories 2X5 Suppositories PVC/PE FILM 24 Months BLISS GVS PHARMA LIMITED 10,11-A&12 Dewan Udyog Nagar, Aliyali, Palghar, Maharashtra 401 404 INDIA BLISS GVS PHARMA LTD SURYA DEPOT PHARMA LTD 2024-08-17 2029-08-16

1574 Rwanda FDA-HMP-MA-1647 ACTIMAG MAGNESIUM PIDOLATE 0.4G/ML ORAL SOLUTION 100ml Bottle Glass amber bottle 60 Months Faes Farma, S.A, Máximo Aguirre, 14-48940 Leioa (Vizcaya) Spain SPAIN FAES FARMA/ SPAIN UBIPHARM-RWANDA LTD 2024-08-17 2029-08-16

1575 Rwanda FDA-HMP-MA-1791 ABDOL-500 Paracetamol 500 mg Tablets 10x10 Tablets ALUMINIUM FOIL PVC 36 Months JIANGSU PENGYAO PHARMACEUTICALS Co LTD No.10, Chaquan road, Yixing city, Jiangsu Province, P.R CHINA FARMASINO Co LTD ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1576 Rwanda FDA-HMP-MA-1646 TRIBEES FORTE Thiamine Nitrate (Vit B1), Pyridoxine (Vit B6), Cyanocobalamin (Vit B12) 200MG+50MG+ 1000MCG TABLETS 20 tablets PVDC/ Alu Blisters 24 Months COSMOS LIMITED Rangwe Road, Off Lunga Lunga, Industrial Area, P.O Box 41433, GPO 00100 Nairobi, Kenya KENYA COSMOS LIMITED/KENYA SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1577 Rwanda FDA-HMP-MA-1645 TETRAREN CAPSULES Tetracycline HCl BP 250 mg Capsules 10 Capsules Aluminium/PVC blisters, such ten blisters are packed in a unit carton along with literature insert 24 Months RENE INDUSTRIES LTD PO Box 6034, Plot No.680, Kamuli, Kireka, Kampala, Uganda Uganda RENE INDUSTRIES LTD, UGANDA Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16

1578 Rwanda FDA-HMP-MA-1793 BUSCOREN 10 MG TAB Hyoscine butyl bromide 10 mg Tablets 10x10 Tablets ALUMINIUM/PVC BLISTER 24 Months RENE INDUSTRIES LTD Plot No 680, P.O. BOX 6034, KAMULI, KIREKA, KAMPALA UGANDA RENE INDUSTRIES LTD RENE PHARMACY (R) LTD 2024-08-17 2029-08-16

1579 Rwanda FDA-HMP-MA-1644 SPASMODEX - P PARACETAMOL & HYOSCINE BUTYLBROMIDE 500MG/10MG TABLETS 3×10 Tablets Alu-Alu Blisters pack 36 Months Skybiotech Life Sciences Pvt. Ltd Gut No.5, Gevrai Tanda Paithan Road, Aurangabad, 431 002, M.S., India India Star Biotech Limited Star Biotech Limited 2024-08-17 2029-08-16

1580 Rwanda FDA-HMP-MA-1794 BICATERO 50 Bicalutamide tablets 50 mg Tablets 30’s HDPE Container & 3 x10’s Tablets in blisters High density polyethylene containers / Blister Pack 36 Months HETERO LABS LIMITED UNIT VI SY.No 410-411,TSIIC FORMULATION SEZ,POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOB NAGAR (DIST)-509301, TELENGANA INDIA HETERO DRUGS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1581 Rwanda FDA-HMP-MA-1643 IBUREN TABLETS Ibuprofen BP 200mg Film coated tablets 10x10 Tablets Aluminium/ transparent PVC blister 24 Months RENE INDUSTRIES LTD PO Box 6034, Plot No.680, Kamuli, Kireka, Kampala, Uganda Uganda Rene Industries Ltd Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16

1582 Rwanda FDA-HMP-MA-1795 GEMTERO 200 Gemcitabine inj 200 mg Injection 1x1 pack glass vial 36 Months M/s. HETERO LABS LIMITED UNIT VI, Sy. No 410-411 TSIIC FORMULATION SEZ, POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOBNAGAR DISTRICT, PIN-509301 TELANGANA INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1583 Rwanda FDA-HMP-MA-1642 RECODIN Chlorpheniramine Maleate BP and Codeine phosphate 4mg/10mg SYRUP 100ml Bottle Amber PET bottles and sealed with ROPP caps 24 Months RENE INDUSTRIES LTD Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda Uganda RENE INDUSTRIES LTD, UGANDA Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16

1584 Rwanda FDA-HMP-MA-1796 PREGA 150 Pregabalin 150 mg Capsules 10 Capsules Clear PVC/ALU BLISTER 24 Months HETERO LABS LIMITED UNIT-III IDA,22-110,JEEDIMETLA,HYDERABAD-500055,TELANGANA INDA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1585 Rwanda FDA-HMP-MA-1641 CETAPIR PIRACETAM 800MG TABLETS 45 Tablets HDPE/Jar pack 36 Months AGOG PHARMA LTD Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1586 Rwanda FDA-HMP-MA-1797 SITA TABLET 50 Sitagliptin phosphate monohydrate 50 mg Tablets 4x7 Tablets ALU-ALU BLISTER 24 Months CCL PHARMACEUTICALS (Pvt) Ltd 62-INDUSTRIAL ESTATE,KOT LAKHAPAT,LAHORE-54770 PAKISTAN CCL PHARMACEUTICALS (Pvt) LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

1587 Rwanda FDA-HMP-MA-1640 AGOMOL-100 TABLETS PARACETAMOL BP 100MG TABLETS 10 x 10 Tablets and 1000 tablets Blister Pack and jar pack 36 Months AGOG PHARMA LTD Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd, Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1588 Rwanda FDA-HMP-MA-1798 SITA TABLET 100 Sitagliptin phosphate monohydrate 100 mg Tablets 4x7 Tablets ALU-ALU BLISTER 24 Months CCL PHARMACEUTICALS (Pvt) Ltd 62-INDUSTRIAL ESTATE,KOT LAKHAPAT,LAHORE-54770 PAKISTAN CCL PHARMACEUTICALS (Pvt) LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

1589 1073-Rwanda FDA-2019-R1 ABACAVIR/LAMIVUDINE-600/300 Abacavir, Lamivudine 600, 300mg Tablets 30 Tablets HDPE BOTTLE 36 Months AUROBINDO PHARMA LIMITED Unit-III, Survey No. 313, Bachupally village, Bachupallapur Mandal, Ranga Reddy District (A.P), INDIA INDIA AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16

1590 Rwanda FDA-HMP-MA-1639 Morphine Medis Morphine Hydrochloride 10mg/ml Solution for injection 10 ampoules of 1ml Type I glass vials 24 Months Les Laboratoires Médis Road of Tunis Km7 BP 206 Nabeul 8000 Tunisia Tunisia Les Laboratoires «MédiS », Road of Tunis Km7 BP 206 Nabeul 8000 Tunisia contact@labomedis.com KIPHARMA Ltd 2024-08-17 2029-08-16

1591 Rwanda FDA-HMP-MA-1799 CRESTAT TABLET 10 Rosuvastatin calcium 10 mg Tablets 3x10 Tablets ALU-ALU BLISTER 24 Months CCL PHARMACEUTICALS (Pvt) Ltd 62-INDUSTRIAL ESTATE,KOT LAKHAPAT,LAHORE-54770 PAKISTAN CCL PHARMACEUTICALS (Pvt) LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

1592 1074-Rwanda FDA-2019-R1 DOLUTEGRAVIR SODIUM Dolutegravir Sodium 50mg Tablets 30 Tablets HDPE BOTTLE 36 Months AUROBINDO PHARMA LIMITED Unit-III, Survey No. 313, Bachupally village, Bachupallapur Mandal, Ranga Reddy District (A.P), INDIA INDIA AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16

1593 Rwanda FDA-HMP-MA-1655 BIOFULVIN GRISEOFULVIN USP 500MG TABLETS 10x10 Tablets PVC 188mm clear, Aluminium foil 185mm 36 Months BIODEAL LABORATORIES LTD Plot No.123, Lunga Lunga P.O Box 32040-00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-08-17 2029-08-16

1594 Rwanda FDA-HMP-MA-1800 CRESTAT TABLET 20 Rosuvastatin calcium 20 mg Tablets 3x10 Tablets ALU-ALU BLISTER 24 Months CCL PHARMACEUTICALS (Pvt) Ltd 62-INDUSTRIAL ESTATE,KOT LAKHAPAT,LAHORE-54770 PAKISTAN CCL PHARMACEUTICALS (Pvt) LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

1595 1075-Rwanda FDA-2019-R1 DOLUTEGRAVIR SODIUM/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE-50/ 300/300 Dolutegravir Sodium, Lamivudine, Tenofovir Disoproxil Fumarate 50mg, 300mg, 300mg Tablets 30 Tablets HDPE BOTTLE 36 Months AUROBINDO PHARMA LIMITED Unit-III, Survey No. 313, Bachupally village, Bachupallapur Mandal, Ranga Reddy District (A.P), INDIA INDIA AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16

1596 Rwanda FDA-HMP-MA-1638 LARTEM Artemether and Lumefantrine 20mg +120mg TABLETS 6’s/12’s/18’s & 24 Tablets Alu/PVC-PVDC blister pack 36 Months S KANT HEALTHCARE LTD Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat, India INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1597 Rwanda FDA-HMP-MA-1801 DOCETAXEL IMPACT Docetaxel 100 unit/ml Solution for injection 7 ml Vial CLEAR GLASS (TYPE I) VIAL 24 Months SANOFI-AVENTIS DEUTSCHLAND GmbH INDUSTRIEPARK HOCHST-BRUNINGSTRABE 50,65926 FRANKFURT AM MAIN GERMANY SANOFI-AVENTIS DEUTSCHLAND GmbH KIPHARMA LTD 2024-08-17 2029-08-16

1598 Rwanda FDA-HMP-MA-1654 DEXAMETHASONE MEDIS DEXAMETHASONE PHOSPHATE 4MG/ML INJECTABLE SOLUTION 50 ampoules of 1ml Glass Ampoules 36 Months Les Laboratoires Médis Route de Tunis, Km7-B.P.206, 8000 Nabeul, Tunisia Tunisia Les Laboratoires Médis, Tunisia KIPHARMA LTD 2024-08-17 2029-08-16

1599 Rwanda FDA-HMP-MA-1802 RAMIPRIL IMPACT 2.5 MG TABLET Ramipril 2.5 mg Film Coated Tablets 28 Tablets PVC/ALU BOX 36 Months SANOFI WINTHROP INDUSTRIE-TOUS 30-36 AVENUE GUSTAVE EIFFEL 37100 TOURS FRANCE SANOFI-AVENTIS SOUTH AFRICA (PTY) LTD KIPHARMA LTD 2024-08-17 2029-08-16

1600 Rwanda FDA-HMP-MA-2161 ZYLORIC-200 ALLOPURINOL 200MG TABLET 28 Tablets polyvinyl chloride (PVC)/aluminium foil blister 60 Months Aspen Bad Oldesloe GmbH Industriestrasse 32-36 Physical Address: D-23843 Bad Oldesloe Germany Beta Healthcare International, Plot No. L.R 209/6554 Mogadishu Road, Industrial Area, Nairobi, Kenya SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16

1601 Rwanda FDA-HMP-MA-1653 CIPROCIN Ciprofloxacin USP 0.3%W/V OPHTHALMIC SOLUTION 5 mL and 10 mL Vials LDPE vials 36 Months Abacus Parenteral Drugs Ltd (APDL) Block 191, Plot No.114, Kinga Mukono P.O. Box 31376, Kampala, Uganda Uganda ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1602 Rwanda FDA-HMP-MA-1803 CALCIVITA Vitamin A Palmitate Equivalent to Vitamin A Vitamin D3 Equivalent to Vitamin D Calcium Phosphate Dibasic Anhydrous Calcium Carbonate Heavy 2500.00 IU, 400.00 IU, 150.00 mg, 50.00 mg Soft gelatin Capsule 5 x 10 Capsules PVC/PVDC film blister and seal with Aluminium foil 24 Months MEGA LIFESCIENCES Public Company Limited 384 Moo 4, Soi 6, Bangpoo Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280 THAILAND MEGA LIFESCIENCES Public Company Limited ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1603 Rwanda FDA-HMP-MA-1652 AGODIC GEL DICLOFENAC BP 1% W/W GEL 30 gram Tube Lami tube, flower pot type white HDPE cap 36 Months AGOG PHARMA LTD Plot No. 33, Section II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1604 Rwanda FDA-HMP-MA-1804 ESMA-20 Esomeprazole Magnesium Trihydrate 20 mg Tablets 10 Tablets ALU-ALU blister 30 Months MAXTAR BIO-GENICS K.No.705, Nalagarh road, Malku Majra, (Baddi), Tehsil Nalagarh, Distt. Solan, Himachal Pradesh-173205 INDIA MAXTAR BIO-GENICS SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1605 Rwanda FDA-HMP-MA-2162 MICROPRIDE-25 LEVOSULPIRIDE 25MG TABLET 3 x10’s Tablets ALU / PVC blister 24 months Micro Labs Limited 92, SIPCOT, Hosur-635 126, Tamil Nadu India Micro Labs Ltd.31, Race Course Road, Bangalore 560 001, Karnataka, India. E-mail;anuradhags@microlabs.in WESSEX PHARMACEUTICALS RWANDA LTD 2024-08-17 2029-08-17

1606 Rwanda FDA-HMP-MA-1637 RECIM-200 TABLETS Cimetidine 200 mg Tablets 10x10 Tablets Aluminium/ transparent PVC blister 24 Months RENE INDUSTRIES LTD Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda Uganda RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-08-17 2029-08-16

1607 Rwanda FDA-HMP-MA-1805 MEDICAINE 2% Mepivacaine hydrochloride Adrenaline bitartrate, adrenalinated 36 mg/ml, 0.032 (0.01819) Solution for injection 1.8ml container Low density polyethylene transparent bag 24 Months Les laboratoire Medis Km 7 ROUTE DE TUNIS, BP 206,800Nabeul TUNISIA LES LABORATORIES «MEDIS» KIPHARMA LTD 2024-08-17 2029-08-16

1608 Rwanda FDA-HMP-MA-1636 METROREN-250 TABLETS Metronidazole 250mg Tablets 10x10 tablets and 1000 tablets Aluminium/PVC blister andpacked in polythene bag and contained in HDPE Container 24 Months Rene Industries Ltd Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda Uganda RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-08-17 2029-08-16

1609 Rwanda FDA-HMP-MA-1806 ESMA - 40 Esomeprazole Magnesium Trihydrate 40 mg Tablets 10x10 Tablets alu/alu blister 30 Months MAXTAR BIO-GENICS no. 705, Vill. Malkumajra, Nalagarh Road, Baddi, Distt. Solan (H.P.) INDIA MAXTAR BIO-GENICS SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1610 Rwanda FDA-HMP-MA-1635 PIRICAM-20 PIROXICAM USP 20MG Capsules 10x10 Capsules Alu-Alu Blister 24 Months MMC Healthcare Ltd No 34 –B, SIDCO Industrial Estate, Thiumazhisai, 600124 Chennai-600124, India India SCOTT-EDIL PHARMACIA LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1611 Rwanda FDA-HMP-MA-1807 DOBESIL Calcium Dobesilate Monohydrate Capsules 500 mg Capsules 5 x 10’s Capsules Alu /PVDC Blister 36 Months Aurochem Pharmaceuticals (I) pvt. Ltd 58, Palghar Taluka, Industrial Co.-op. Estate Ltd. Palghar – 401 404, District Thane INDIA OCHOA LABORATORIES SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1612 Rwanda FDA-HMP-MA-2165 CANESTEN 1VT CLOTRIMAZOLE 500 mg Tablets 1 x 1 tablet Alu/PVDC Blister 24 Months HAUPT PHARMA WÜLFING GMBH HAUPT PHARMA WÜLFING GMBH Germany HAUPT PHARMA WÜLFING GMBH/GP GRENZACH PRODUKTIONS GMBH SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16

1613 Rwanda FDA-HMP-MA-1634 Irbesartan Impact 300 mg IRBESARTAN 300mg Film coated tablets 28 Tablets PVC/PVDC/Aluminium blisters 36 Months Sanofi Winthrop Industrie 30-36, avenue Gustave Eiffel, Z.I. St. Symphorien 37100 Tours, France France Sanofi Winthrop Industrie KIPHARMA LTD 2024-08-17 2029-08-16

1614 Rwanda FDA-HMP-MA-1808 FINACE – MR Aceclofenac, Paracetamol and Chlorzoxazone 100 mg/ 500 mg/ 375 mg Film Coated Tablets 2x10 Tablets Alu /PVDC Blister 36 Months Aurochem Pharmaceuticals (I) pvt. Ltd 58, Palghar Taluka, Industrial Co.-op. Estate Ltd. Palghar – 401 404, District Thane INDIA OCHOA LABORATORIES SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1615 Rwanda FDA-HMP-MA-1633 ERLOCIP 150 Erlotinib hydrochloride 150MG TABLETS 10 tablets Plain Aluminium Foil (Blister) PVC film strip 24 Months CIPLA LTD Unit X. S-103 to S-105, S-107 to S-112, L-138, L-147 to L-147/1, L-147/3 & L147/A, Verna Industrial Estate, Verna, Salcette, Goa 403 722 India India CIPLA LTD KIPHARMA LTD 2024-08-17 2029-08-16

1616 Rwanda FDA-HMP-MA-1809 OFLOX-OZ Ofloxacin BP, Ornidazole 200 mg/ 500mg Film Coated Tablets 3x10 Tablets Alu/Alu Blister 36 Months Aurochem Pharmaceuticals (I) pvt. Ltd 58, Palghar Taluka, Industrial Co.-op. Estate Ltd. Palghar – 401 404, District Thane INDIA OCHOA LABORATORIES SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1617 Rwanda FDA-HMP-MA-2166 NIRMET METRONIDAZOLE 500MG/100ML Intravenous Infusion 100ml BFS bottle (using I-DPE plastic granule) 36 months ACULIFE HEALTHCARE PVT. LTD Village: Sachana, Taluka: Viramgam, District: Ahmedabad - 382 150. Gujarat, india India ACULIFE HEALTHCARE PVT. LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1618 Rwanda FDA-HMP-MA-1651 AZUNATE Artesunate Ph. Int. 60MG POWDER FOR INJECTION 1 VIAL A carton containing one vial of artesunate powder for injection, one ampoule of sodium bicarbonate injection, one ampoule of sodium chloride injection placed in a plastic tray along with a package insert. Artesunate powder for injection is filled in a 10ml clear glass vial (USP Type III.) The filled vial is closed with 20mm grey bromobutyl rubber plug and sealed with 20mm chocolate brown flip off aluminum seal. Sodium bicarbonate injection is filled in a 1ml clear glass ampoule (USP Type I) with a green snap off ring. Diluent: Sodium chloride injection is filled in a 5ml clear glass ampoule (USP Type I) 24 Months MACLEODS PHARMACEUTICALS LIMITED Phase I, Unit II Plot No. 25 – 27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman – 396210, India INDIA MACLEODS PHARMACEUTICALS LIMITED AIVEEN RWANDA LTD 2024-08-17 2029-08-16

1619 Rwanda FDA-HMP-MA-1810 INTRAZ Itraconazole Capsules 100 mg Capsules 1×4 Capsules Alu /PVDC Blister 24 Months Aurochem Pharmaceuticals (I) pvt. Ltd 58, Palghar Taluka, Industrial Co.-op. Estate Ltd. Palghar – 401 404, District Thane INDIA OCHOA LABORATORIES SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1620 Rwanda FDA-HMP-MA-1650 UNSIATEM FEBUXOSTAT 80MG Film Coated Tablets 10x10 Tablets PVC/PVDC/ ALU strips 24 Months Liptis for Pharmaceuticals and Medical Products (S.A.E) Plot No. B/2, 6th industrial zone, 6th of October City, Egypt Egypt Liptis for Pharmaceuticals & Medical Products (S.A.E).Plot No. B/2, 6th Industrial zone, 6th of October City, Egypt.mahmoud.elaila@liptispharma.com Goodman International LTD (R) 2024-08-17 2029-08-16

1621 Rwanda FDA-HMP-MA-1811 CYPROL Syrup Cyproheptadine Hydrochloride BP Lysine Hydrochloride BP 2 mg/ 150 mg Syrup 100 ml Bottle Amber Colour PET Bottle and Aluminium P.P CAPS 36 Months Aurochem Laboratories (I) Pvt. Ltd 8, Palghar Taluka, Industrial Co.-op. Estate Ltd. Palghar – 401 404, District Thane INDIA OCHOA LABORATORIES SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1622 Rwanda FDA-HMP-MA-1649 DAPAVELDACTIN PLUS 5/1000MG DAPAGLIFLOZIN/METFORMIN 5MG+1000MG Film Coated Tablets 4x7 tablets Al/ Transparent PVDC Strips 24 Months Liptis for Pharmaceuticals and Medical Products (S.A.E) Plot No. B/2, 6th Industrial Zone, 6th of October City, Egypt Egypt Liptis for Pharmaceuticals & Medical Products (S.A.E).Plot No. B/2, 6th Industrial zone, 6th of October City, Egypt.mahmoud.elaila@liptispharma.com Goodman International LTD (R) 2024-08-17 2029-08-16

1623 Rwanda FDA-HMP-MA-1812 FIDEMYCIN OINTMENT Silver sulfadiazine, Tetracycline hydrochloride BP 3.0% w/w Ointment for topical application 15 g Tbe COLLAPSIBLE TUBE 36 Months DAWA LIMITED PLOT No 7879/8, BABA GOGO ROAD, RUARAKA, P.O BOX 16633-00620, NAIROBI KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1624 Rwanda FDA-HMP-MA-1541 MICARDIS TERMISARTAN 40MG TABLETS 28 Tablets packed in blister cards with 7 individually molded and separate sealed cavities (7 tablets per card) these blisters consists of a printed aluminum lidding foil, and a molded 3 layer forming foil 48 Months Boehringer Ingelheim Ellas A.E 5th km Paiania-Markopoulo Koropi Attiki 19400 Greece Greece Boehringer Ingelheim Ellas A.E SURGIPHARM RWANDA LTD 2024-08-17 2029-08-16

1625 Rwanda FDA-HMP-MA-1813 GVSOFT 1.2 Glycerine USP 1.2 G Suppositories 2X5 Suppositories ALU/PVC FOILS BOXES. 36 Months BLISS GVS PHARMA LIMITED PLOT No 11, SURVEY No 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR 401404, MAHARASHTRA INDIA BLISS GVS PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1626 Rwanda FDA-HMP-MA-1632 ESOPRAZOLE-40 Esomeprazole Magnesium 40mg TABLETS 1x10 Tablets Alu-Alu Blister 36 Months STALLION LABORATORIES PVT Ltd C-1B-305/2, 3, 4 & 5 G.I.D.C. Kerala (Bavla), Dist; Ahmedabad, Gujarat, India India STALLION LABORATORIES PVT Ltd SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1627 Rwanda FDA-HMP-MA-1814 GVSOFT 2 Glycerine USP 2.0 g Suppositories 2X5 Suppositories ALU/PVC FOILS BOXES. 36 Months BLISS GVS PHARMA LIMITED PLOT No 11, SURVEY No 38/1, DEWAN UDYOG NAGAR, ALIYALI VILLAGE, PALGHAR 401404, MAHARASHTRA INDIA BLISS GVS PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1628 Rwanda FDA-HMP-MA-1631 ACUPAN NEFOPAM 20MG/2ML SOLUTION FOR INJECTION 2ml Ampoules Type I colourless glass, bottle-shaped ampoules with a sealed neck 36 Months BIOCODEX 1 avenue Blaise Pascal, 60000 Beauvais, France France BIOCODEX, FRANCE FORTILAB RWANDA 2024-08-17 2029-08-16

1629 Rwanda FDA-HMP-MA-1815 AGOFEN SUSPENSION Ibuprofen BP 100 mg/5ml Suspension 60ml and 100ml Bottle PET AMBER COLOUR BOTTLE 36 Months AGOG PHARMA LTD Plot No. 33, Section II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai(E), Dist.Thane, India. INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1630 Rwanda FDA-HMP-MA-1630 CAPEMAX 500 CAPECITABINE 500MG TABLETS 3x10 tablets or 12x10 tablets Alu-Alu Blister 36 Months INTAS PHARMACEUTICALS LTD Plot No.457 & 458, Village Matoda, Balva Road and Plot No. 191/218 P, Village Chacharwadi, Tal – Sanand. Vill: Matofa & Chacharwadi – 382 210, Dist. Ahmedabad Gujarat State, India India INTAS PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1631 Rwanda FDA-HMP-MA-1816 SACUVAN 49/51 Sacubitril and Valsartan 49 mg/ 51 mg Tablets 3x10 Tablets ALU-ALU BLISTERS 24 Months HETERO LABS LIMITED Unit-III Address: 22-110, IDA, Jeedimetla, Hyderabad, Telangana, India INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1632 Rwanda FDA-HMP-MA-1648 TRAUSAN CITICHOLONE 100MG/ML ORAL SOLUTION 50ML Bottles Type III amber glass bottle 36 Months Faes Farma, S.A, Máximo Aguirre, 14-48940 Leioa (Vizcaya) Spain SPAIN LABORATORIOS VITORIA S.A/ PORTUGAL UBIPHARM-RWANDA LTD 2024-08-17 2029-08-16

1633 Rwanda FDA-HMP-MA-1817 SACUVAN 24/26 Sacubitril Valsartan Sodium on Colloidal Silicon, Dioxide 24 mg/ 26 mg Tablets 3x10 Tablets ALU-ALU BLISTERS 24 Months HETERO LABS LIMITED Unit-III Address: 22-110, IDA, Jeedimetla, Hyderabad, Telangana, India INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1634 Rwanda FDA-HMP-MA-1660 CANDID DUSTING POWDER CLOTRIMAZOLE 1% W/V Powder for topical application 30 g Bottle Plastic bottle 48 Months Glenmark Pharmaceuticals Limited Plot No. E-37, 39, D-Road, MIDC, Satpur, Nashik – 422007, Maharashtra, India India Glenmark Pharmaceuticals Ltd WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16

1635 Rwanda FDA-HMP-MA-1818 ZIQUANTA Praziquantel USP 600mg Tablets 1x6’s and 10x10’s , 6’s, 100’s, 500’s, 1000’s Tablets ALU-ALU BLISTERS, AND HDPE CONTAINER PACK 24 Months HETERO LABS LIMITED (Unit -V) Survey No. 439, 440, 441 & 458, TSIIC-Formulation SEZ, Polepally (Village), Jadcherla (Mandal), Mahaboob Nagar (Dist) Telangana State, India – 509301 Manufacturing location/Block - VA INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1636 Rwanda FDA-HMP-MA-1675 PANTAKIND-40 PANTOPRAZOLE SODIUM 40MG DELAYED RELEASE TABLETS 6x10 tablets Alu/Alu Blister 24 Months Mankind Pharma Ltd Unit-II, Village-Kishanpura, P.O.-Jamniwala, Tehsil- Paonta Sahib, Distt. Sirmour -173025 Himachal Pradesh, India India Mankind Pharma Limited WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16

1637 Rwanda FDA-HMP-MA-1819 SACUVAN 97/103 Sacubitril and Valsartan 97 mg/ 103 mg Tablets 3x10 Tablets ALU-ALU BLISTERS 24 Months HETERO LABS LIMITED Unit-III Address: 22-110, IDA, Jeedimetla, Hyderabad, Telangana, India INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1638 Rwanda FDA-HMP-MA-1674 DT-ZINC ZINC SULPHATE 10 MG DISPERSIBLE TABLETS 10x10 Tablets PVC/PVDC Aluminum foil blister 36 Months AGOG PHARMA LTD Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India India AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1639 Rwanda FDA-HMP-MA-1820 ERLOZ 150 Erlotinib 150mg Tablets 30 Tablets HDPE BOTTLE 24 Months HETERO LABS LIMITED Unit-V, Address: TSIIC Formulation SEZ, No. 439,440,441 & 458, Polepally Village, Jadcherla, Mahaboob Nagar- 509301, Telangana State, India. INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1640 Rwanda FDA-HMP-MA-1677 C-TAX P DRY SYRUP CEFIXIME USP 50MG/5ML SYRUP 100ml Bottle HDPE bottle 24 Months EMCURE PHARMACETICALS LTD T-184, M.I.D.C., Bhosari, Pune-411026 Maharashtra, India India EMCURE PHARMACETICALS LTD ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1641 Rwanda FDA-HMP-MA-1821 NYSTATIN TABLETS Nystatin BP 500000 IU Tablets 10x10 Tablets ALU/PVC BLISTERS 36 Months MERIT ORGANICS LTD Plot No. 2104/2/A, G.I.D.C., Sarigam, Bhilad, Dist. Valsad - 396 155, Gujarat, India. INDIA MERIT ORGANICS LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1642 Rwanda FDA-HMP-MA-1676 MICROGYNON ED LEVONORGESTREL/ETHINYLESTRADIOL 150 ?g and 30 ?g TABLETS 28 tablets PVC/PPE.EVOH.PE/PCTFE/aluminium 36 Months BAYER AG Muellerstr, 178, 13353 Berlin, Germany Germany Bayer East Africa Limited SURGIPHARM RWANDA LTD 2024-08-17 2029-08-16

1643 Rwanda FDA-HMP-MA-1822 GLUNDOWN 500 TABLETS Metformin Hydrochloride 500mg Tablets 2x10’s, 2x14’s, 3x10’s,4x14’s, 6x10’s, 6x14’s, 9x10’s, 10x10s and 8x14’s Tablets ALU/PVC BLISTERS 24 Months LABORATORY & ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road. Postal Address: 42875 GPO 00100, Kenya. KENYA LABORATORY & ALLIED LIMITED DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

1644 Rwanda FDA-HMP-MA-1673 KABIVEN Purified soybean oil, glucose (anhydrous), Alanine, Arginine, Aspartic acid, Glutamic acid, Glycine, Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Proline, Serine, Threonine, Tryptophan, Tyrosine, Valine, Calcium chloride (as dihydrate), Sodium glycerophosphate (as hydrated), Magnesium sulphate (as heptahydrate), Potassium chloride, Sodium acetate (as trihydrate) 40g, 100g, 4.8g, 3.4g, 1.0g, 1.7g, 2.4g, 2.0g, 1.7g, 2.4g, 2.7g, 1.7g, 2.4g, 2.0g, 1.4g, 1.7g, 0.57g, 0.07g, 2.2g, 0.22g, 1.5g, 0.48g, 1.8g, 1.5g EMULSION FOR INFUSION 1 x 1026 ml, 4 x 1026 ml, 1 x 2053 ml, 4 x 2053 ml Three chamber bag in an overpouch. 24 Months FRESENIUS Kabi AB Rapsgatan 7 SE-751 74 Uppsala, Sweden and Fresenius Kabi Austria GmbH Hafnerstrasse 36 8055 Graz, Austria Austria FRESENIUS KABI MANUFACTURING SA (PTY) LIMITED SURGIPHARM RWANDA LTD 2024-08-17 2029-08-16

1645 Rwanda FDA-HMP-MA-1823 ANATERO Anastrozole 1mg Tablets 30 Tablets HDPE CONTAINER PACK 36 Months HETERO LABS LIMITED Unit-V, TSIIC Formulation SEZ, Survey No. 411, 425, 435 & 458, Polepally village, Jadcherla Mandal, Mahaboob Nagar (Dist) – 509301, Telangana. India. INDIA HETERO DRUGS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1646 Rwanda FDA-HMP-MA-1824 DIKON Diclofenac Sodium 75mg/3ml Injection 3x10x10 GLASS VIAL 36 Months REYOUNG PHARMACEUTICALS CO, LTD No.1 Ruiyang Road, Yiyuan Country, Zibo City, Shandong Province, P. R. China CHINA FARMASINO CO, LTD ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1647 Rwanda FDA-HMP-MA-1672 FAST ACT GEL DICLOFENAC DIETHYLAMINE/ METHYL SALICYLATE 1.16%/ 10%W/W GEL 20 g Tube Collapsible aluminium tubes 36 Months Dawa Limited Plot No. 7879/8, Baba Dogo Road, Ruaraka, P.O Box 16633-00620, Nairobi, Kenya Kenya DAWA limited SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1648 Rwanda FDA-HMP-MA-1825 ZOSEC CAPSULES Omeprazole 20mg Capsules 1X10 & 10X10 Capsules ALUMINIUM STRIP 24 Months EMCURE PHARMACEUTICAL LIMITED Lane No. 3, Phase-II, SIDCO Industrial Complex, Bari-Brahmana, Jammu – 181 133, India INDIA EMCURE PHARMACEUTICAL LIMITED ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1649 Rwanda FDA-HMP-MA-1670 DIPARA DICLOFENAC SODIUM BP + PARACETAMOL BP 50MG/500MG TABLETS 10x10 Tablets Alu-PVC Blister Pack 36 Months STALLION LABORATORIES PVT. LTD C-1B, 305/2, 3, 4 & 5, G.I.D.C. Kerala (Bavla), Dist. Ahmedabad-382 220, Gujarat, India India STALLION LABORATORIES PVT Ltd GLAXO PHARMA WHOLESALE LTD 2024-08-17 2029-08-16

1650 Rwanda FDA-HMP-MA-1826 ULPAN-40 ER Pantoprazole 40 mg Capsules 3 x 10 Capsules ALU-ALU BLISTER PACK 24 Months CORONA REMEDIES PVT LTD Village Jatoli, Post Office - Oachghat, Tehsil, Solan, Distt. Solan, Himachal Pradesh – 173223, India INDIA SUN ENTERPRISE LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1651 Rwanda FDA-HMP-MA-1669 DAWAVATE CREAM BETAMETHASONE VALEARATE BP 0.1% W/W CREAM 15 g Tube Collapsable Aluminium tube 36 Months DAWA LIMITED Plot No.7879/8, Baba Dogo Road, Ruaraka P.O.BOX 16633-00620, Nairobi, Kenya Kenya DAWA LIMITED SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1652 Rwanda FDA-HMP-MA-1827 PACLITERO 100. Paclitaxel USP 100 mg/16.7 ml Injection 20 ml Vial GLASS VIAL 36 Months HETERO LABS LIMITED (Unit-VI)Address : APIIC Formulation SEZ, Survey No. 410 & 411, Polepally village, Jadcherla Mandal, Mahaboob Nagar (Dist) 509301,Andhra Pradesh. India. INDIA HETERO DRUGS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1653 Rwanda FDA-HMP-MA-0869 CARDIOTEM 5 AMLODIPINE BESYLATE 5MG TABLET 3x10 tablets Alu-Alu blister 36 Months BAROQUE PHARMACEUTICALS PVT LTD 192/2 & 3, 190/1 and 202/9, Sokhda –388620,Tal –Khambhat, Dist. Anand Gujarat, India INDIA Bekra Pharma UK Ltd UBIPHARM RWANDA LTD 2024-08-17 2029-08-16

1654 Rwanda FDA-HMP-MA-1828 PACLITERO 30 Paclitaxel 30 mg/5 ml. Injection 5ml Vial GLASS VIAL 36 Months HETERO LABS LIMITED Unit V, TSIIC Formulation SEZ, S.No 439, 440,441 & 458, Polepally Village, Jadcherla (Mandal), Mahaboob Nagar (District)-509301, Telangana State, India. INDIA HETERO DRUGS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1655 Rwanda FDA-HMP-MA-1679 ACYCLOVIR DENK ACYCLOVIR 5% CREAM 7 g Tube Aluminium tube 36 Months RubiePharm Arzneimittel GmbH Brüder-Grimm-Str. 62 36396 Steinau an der Straße, Germany Germany DENK PHARMA GmbH & Co. KG, Germany ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2024-08-17 2029-08-16

1656 Rwanda FDA-HMP-MA-1829 BINFIN 5 Finasteride 5mg Tablets 15 Tablets PVC BLISTER PACK 36 Months HETERO LABS LIMITED IDA, #22-110, Jeedimetla, Hyderabad – 500 055, Telangana. India. INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1657 Rwanda FDA-HMP-MA-1657 ALBENDAZOLE 400mg ALBENDAZOLE 400MG CHEWABLE TABLETS 100 tablets HDPE bottle 36 Months Mepro Pharmaceuticals Pvt. Ltd Unit-II, Q Road, Phase-IV, G.I.D.C, Wadhwan City–363 035, Gujarat, India India MEPRO PHARMACEUTICALS PVT. LTD Depot Pharmaceutique Ubumwe Ltd 2024-08-17 2029-08-16

1658 Rwanda FDA-HMP-MA-1830 IRBIS 150 Irbesartan 150mg Tablets 3x10 Tablets AlU-PVC/PVDC BLISTER PACK 36 Months HETERO LABS LIMITED Unit V, TSIIC Formulation SEZ, S.No 439, 440,441 & 458, Polepally Village, Jadcherla (Mandal), Mahaboob Nagar (District)-509301, Telangana State, India. INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1659 Rwanda FDA-HMP-MA-1658 ACINET 625 Amoxicillin Trihydrate USP and Clavulanate Potassium USP 500mg/125mg TABLETS 10 tablets Alu-Alu blister 24 Months INDCHEMIE HEALTH SPECIALITIES PVT. LTD Village -Than, Tehsil – Baddi, Dist. – Solan, Himachal Pradesh – 173 205, India INDIA CACHET PHARMACEUTICALS PVT. LTD Wessex Pharmaceutical (Rwanda) Ltd 2024-08-17 2029-08-16

1660 Rwanda FDA-HMP-MA-1831 FOSAP. Fosaprepitant Dimeglumine 150 mg/vial. Injection 1x1’s Vial CLEAR/AMBER TUBULAR OR MOLDED GLASS VIAL 24 Months ASPIRO PHARMA LIMITED Survey No. 321, Biotech Park, Phase-III, Karkapatla Village, Markook Mandal, Siddipet Dist., Telangana State- 502281, INDIA INDIA HETERO DRUGS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1661 Rwanda FDA-HMP-MA-1659 BECLOMIN 250 HFA INHALER BECLOMETHASONE DIPROPIONATE 250 ?g/ Puff Pressurized inhalation solution 19 ml canister Aluminium Canister sealed with Aluminium Metering Valve 24 Months SQUARE PHARMACEUTICAL Ltd Dhaka Unit Kaliakoir, Gazipur -1750, Bangladesh Bangladesh SQUARE PHARMACEUTICAL Ltd DOLIPHARM Limited 2024-08-17 2029-08-16

1662 Rwanda FDA-HMP-MA-1832 COSMOL SUSPENSION Paracetamol 120MG/5ML Suspension 60ml and 100ml Bottles AMBER GLASS BOTTLE 36 Months COSMOS LIMITED, RANGWE ROAD; OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA, P. O. BOX 41433, GPO 00100 - NAIROBI, KENYA. KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1663 Rwanda FDA-HMP-MA-1661 MOXAFORTE SUSPENSION Flucloxacillin (as Sodium) BP and Amoxicillin (as Trihydrate) BP 12mg+125mg/5ML POWDER FOR SUSPENSION 100ml Bottle HDPE Bottle 36 Months Dawa Limited Plot No. 7879/8, Baba Dogo Road, Ruaraka, P.O Box 16633-00620, Nairobi, Kenya Kenya DAWA LIMITED SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1664 Rwanda FDA-HMP-MA-1833 PALOX Palonosetron Hydrochloride 0.25mg/5mL. Injection 5ml Vial TUBULAR GLASS VIAL 36 Months ASPIRO PHARMA LIMITED Survey No. 321, Biotech Park, Phase III, Karkapatla, Markook Mandal, Siddipet District, Telangana (S)-502281, India. INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1665 Rwanda FDA-HMP-MA-1834 DAWA PROM SYRUP Promethazine hydrochloride 5mg/5ml Syrup 60ml and 100ml Bottles AMBER COLOURED PET BOTTLES 36 Months DAWA LIMITED Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620. Nairobi. Kenya. KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1666 Rwanda FDA-HMP-MA-1663 CLOM TABLETS CLOMIPRAMINE HYDROCHLORIDE BP 25MG TABLETS 10x10 Tablets Aluminum foil/PVC blister 36 Months AGOG PHARMA LTD Plot No. 33, Sector II, The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1667 Rwanda FDA-HMP-MA-1835 PROMETIN-25 Promethazine Hydrochloride 25mg Film Coated Tablets 10x10 Tablets & 1000 Tablets ALUMINIUM FOIL AND PVC FOIL, AND HDPE CONTAINER 36 Months LABORATORY AND ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road. Postal Address: 42875 GPO 00100, Nairobi-Kenya. KENYA LABORATORY AND ALLIED LIMITED DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

1668 Rwanda FDA-HMP-MA-1836 IBUPLUS Ibuprofen and Paracetamol 400 mg/325 mg Tablets 10 Tablets PVC Blister 36 Months SCOTT-EDIL PHARMACIA LTD 56, EPIP, Phase-I, Jharmajri, Baddi-173 205, (HP), India INDIA SCOTT-EDIL PHARMACIA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1669 Rwanda FDA-HMP-MA-1665 DACOLD SYRUP Paracetamol BP, Pseudoephedrine HCl BP and Chlorphenamine Maleate BP 120MG/10MG/2MG SYRUP 100ml Bottle PET bottles in a unit box along with a literature insert 36 Months Dawa Limited Plot No.7879/8, Baba Dogo Road, Ruaraka, P.O.BOX 16633-00620 Nairobi, Kenya Kenya DAWA LIMITED SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1670 Rwanda FDA-HMP-MA-1837 REVOKE -72 Levonorgestrel 750mcg Tablets 1x 2Tablets PVC-PVdC/AUMINIUM BLISTER 36 Months MYLAN LABORATORIES LIMITED Plot No. 20 &.21, Pharmez, Sarkhej - Bavla, National Highway No. 08A, Near Viltage Matoda, TalSanand, Dist.-Ahmedabad,382213. Gujarar State – India INDIA MYLAN LABORATORIES LIMITED PYRAMID PHARMA LTD 2024-08-17 2029-08-16

1671 Rwanda FDA-HMP-MA-1666 DESLORASTAL DESLORATADINE 5MG TABLETS 3x10 Tablets Alu-Pvc blister pack 36 Months STALLION LABORATORIES PVT. LTD C-1B, 305/2, 3, 4 & 5 G.I.D.C. Kerala (Bavla), Dist.: Ahmedabad, Gujarat, India INDIA STALLION LABORATORIES PVT Ltd SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1672 Rwanda FDA-HMP-MA-1838 PHYSIODOSE Sodium Chloride 0.90% Solution 5 ml Bottle POLYETHYLENE LOW DENSITY BOTTLE 36 Months LABORATOIRES GILBERT 928 avenue du General de Gaulle, 14200 Herouville Saint-Clair France FRANCE LABORATOIRES GILBERT GOMHS Ltd 2024-08-17 2029-08-16

1673 Rwanda FDA-HMP-MA-1667 GRAMOCEF-O-100 DRY SYRUP CEFIXIME USP 100MG/5ML SUSPENSION 100ml Bottle Amber coloured bottles 24 Months MICRO LABS LIMITED No. 121-124, 4th Phase, K.I.A.D.B., Bommasandra Industrial Area, Anekal Taluk, Bangalore-560 099, India India MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16

1674 Rwanda FDA-HMP-MA-1839 ETROBAX 90 Etoricoxib 90 mg Tablets 3x10 Tablets ALU-ALU BLISTER PACK 36 Months HETERO LABS LIMITED Unit – III IDA, #22-110, Jeedimetla, Hyderabad – 500 055, Telangana, India. INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1675 Rwanda FDA-HMP-MA-1678 LUMERAX DT 20/120 ARTEMETHER & LUMEFANTRINE 20/120MG TABLETS 6 Tablets or 12 Tablets PVC/PCTFE/PVC-Alu blister 24 Months IPCA LABORATORIES LTD Plot No. 255/1 Village Athal, Silvassa-396230, Union Territory of Dadra and Nagar Haveli and Daman and Diu, India India IPCA LABORATORIES LTD SUN ENTREPRISE LTD 2024-08-17 2029-08-16

1676 Rwanda FDA-HMP-MA-1840 HENKA 30 Duloxetine Hydrochloride 30 mg. Capsules 3 x 10’s Capsules ALU-PVC/PVDC BLISTER PACK 24 Months HETERO LABS LIMITED Unit-I Address: Kalyanpur (Village), Chakkan Road, Baddi (Tehsil), Solan (Dist.), Himachal Pradesh-173205, India INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1677 Rwanda FDA-HMP-MA-1668 ALCOF-C Dextromethorphan Hydrochloride BP, Cetrizine Hydrochloride BP, Phenylepherine Hydrochloride BP, Levomenthol BP 10mg, 5mg, 5mg, 1.5 mg SYRUP 100ml Bottle Amber PET Bottles 36 Months Aurochem Laboratories (India) Pvt. Ltd 8, Palghar Taluka, Industrial Co.-op. Estate Ltd, Palghar-401 404, District Thane, Maharashtra, India India Aurochem Laboratories (India) Pvt. Ltd UBIPHARM RWANDA LTD 2024-08-17 2029-08-16

1678 Rwanda FDA-HMP-MA-1841 FLUOMIZIN Dequalinium chloride 10 mg Vaginal tablet 1x6's Tablets PVC/PE/PVdC -ALUMINIUM BLISTER 36 Months ROTTENDORF PHARMA GMBH ostenfelder str.51-61,59320 ennigerloh Germany GERMANY DAFRA PHARMA GMBH SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1679 Rwanda FDA-HMP-MA-1920 SERETIDE 500mcg/50mcg Diskus Fluticasone propionate and salmeterol 500mcg and 50mcg Powder for inhalation 20s or 60 doses Hermetically sealed blister pockets that are performed in the aluminium foil laminate strip 24 Months Glaxo wellcome Production Zone Industrielle No. 2 23 Rue Lavoisier 27000 Evreux France France GlaxoSmithKline Pharmaceutical Kenya Limited KIPHARMA LTD 2024-08-17 2029-08-16

1680 Rwanda FDA-HMP-MA-1842 ZINC SULPHATE DISPERSIBLE TABLETTS Zinc Sulfate Monohydrate 20mg Tablets 10x10 Tablets PVC/PRINTED ALUMINIUM FOIL 24 Months LABORATORY & ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, KENYA KENYA LABORATORY & ALLIED LIMITED DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

1681 Rwanda FDA-HMP-MA-1921 SERETIDE 100/50MCG DISKUS FLUTICASONE PROPRIONATE MICRONIZED/SALMETEROL XINAFOATE MICRONIZED 100/50MCG Powder for inhalation 28s or 60 Doses Two tone purple MDPI device moulded in plastic containing a blister strip 24 Months Glaxo wellcome Production Zone Industrielle No. 223 Rue Lavoisier27000 Evreux France France GlaxoSmithKline Pharmaceutical Kenya Limited KIPHARMA LTD 2024-08-17 2029-08-16

1682 Rwanda FDA-HMP-MA-1922 RINOGRIP Paracetamol BP, Pheniramine Maleate BP and Ascorbic Acid 0.025g, 0.500g, 0.200g GRANULES 10 Sachets Sachet, printed polyester foil. 24 Months Bliss GVS Pharma Limited Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane – 401404 , India India IMEX PHARMA, Maurice Mediasol Pharmaceutical Depot Ltd 2024-08-17 2029-08-16

1683 Rwanda FDA-HMP-MA-1844 PHENERGAN 2% Promethazine 2% Cream 30g tube ALUMINIUM TUBE (WITH EPOXYPHENOLIC LACQUER) CLOSED WITH A POLYPROPYLEN SCREW CAP 36 Months LABORATORIOS VICTORIA SA Rua Ekias Ganda, 28, Venda Nova, 2700-327,Amadora , Portugal PORTUGAL FRILAB SA UBIPHARM RWANDA LTD 2024-08-17 2029-08-16

1684 Rwanda FDA-HMP-MA-1923 DIAFORMINE 850 METFORMIN BP 850MG TABLETS 3x10 Tablets Aluminium & PVC foil. 24 Months Bliss GVS Pharma Limited Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane – 401404 , India India IMEX PHARMA, Maurice Mediasol Pharmaceutical Depot Ltd 2024-08-17 2029-08-16

1685 Rwanda FDA-HMP-MA-1845 SLEEPGABA 3 Eszopiclone 3mg Film Coated Tablets 10 Tablets ALU- ALU BLISTER PACK 36 Months HETERO LABS LIMITED Unit V. Address: TSIIC Formulation SEZ, S.No 439, 440,441 & 458, Polepally Village, Jadcherla (Mandal), Mahaboob Nagar (District)-509301, Telangana State, India. INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1686 Rwanda FDA-HMP-MA-1962 DIAFORMINE 1000 METFORMIN BP 1000MG TABLETS 3x10 Tablets Aluminium/PVC foil 36 month Bliss GVS Pharma Limited Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane – 401404 India IMEX PHARMA, Maurice Mediasol Pharmaceutical Depot Ltd 2024-08-17 2029-08-16

1687 Rwanda FDA-HMP-MA-1846 DARUNAVIR AND RITONAVIR TABLETS Darunavir and Ritonavir 800mg/100mg Tablets 60 Tablets and 180 Tablets HDPE CONTAINER 24 Months HETERO LABS LIMITED Unit III, 22-110, IDA, Jeedimetla, Hyderabad, Telangana, INDIA. INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1688 Rwanda FDA-HMP-MA-1963 DIAFORMINE 500 METFORMIN BP 500MG TABLETS 3x10 Tablets Aluminium/ PVC foil 36 Months Bliss GVS Pharma Limited Address: Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane – 401404 India IMEX PHARMA, Maurice Mediasol Pharmaceutical Depot Ltd 2024-08-17 2029-08-16

1689 Rwanda FDA-HMP-MA-1847 LACTITOS SOLUTION Lactulose USP 10mg Syrup 100ml AMBER COLOURED PET BOTTLE 24 Months ENICAR PHARMACEUTICALS PVT. LTD Plot No.J-214,215,216, MIDC Tarapur, Boisar, Tal: Palghar Dist Thane, Tarapur - 401506 INDIA GALAXY PHARMACEUTICAL LTD STAR BIOTECH LTD 2024-08-17 2029-08-16

1690 Rwanda FDA-HMP-MA-1924 MEROSAN® 1 Meropenem USP 1GR Powder for Injection 1 VIAL Printed Lami Tube with Red Cap 24 Months PT. SANBE FARMA Jalan Mahar Martanegara No. 162 (JI, Leuwigajah No.162) RT.01 RW.12, Kelurahan Baros, Kecamatan Cimahi Tengah, Kota Cimahi, Indonesia INDONESIA PT SANBE FARMA AFRIHEALTH CARE LIMITED 2024-08-17 2029-08-16

1691 Rwanda FDA-HMP-MA-1848 ABACAVIR AND LAMIVUDINE DISPERSIBLE TABLETS Abacavir sulphate USP , Lamivudine USP 120mg/60mg Tablets 30 Tablets HDPE BOTTLE 24 Months MICRO LABS LIMITED Plot No. S-155 to S-159 & N1, Phase III & IV, Verna. Industrial Estate, Verna Salcette Goa - 403722 INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS RWANDA LTD 2024-08-17 2029-08-16

1692 Rwanda FDA-HMP-MA-1925 KOFLYN PINEAPPLE FLAVOUR COUGH EXPECTORANT CHLORAMPHENIRAMINE MALEATE, AMMONIUM CHLORIDE, SODIUM CITRATE 2.2MG, 110MG, 40MG /5ML SYRUP 100ml Bottle Amber Glass Bottle 36 Months BETA HEALTHCARE INTERNATIONAL LTD P.O. BOX 42569-00100 Physical Address: Plot No. L.R 209/6554 Mogadishu Road, industrial Area, Nairobi Country: Kenya KENYA BETA HEALTHCARE INTERNATIONAL LTD SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16

1693 Rwanda FDA-HMP-MA-1849 SABULIN SYRUP Salbutamol (as sulphate) 2mg/5ml Syrup 60ml and 100ml Bottles AMBER COLOURED PET BOTTLE 36 Months DAWA LIMITED Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620. Nairobi. Kenya. KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1694 Rwanda FDA-HMP-MA-1926 KODOXY DOXYCYCLINE Hyclate BP 100MG CAPSULES 10x10 Capsules ALU/PVC BLISTER 36 Months KOPRAN LIMITED Village Savroli Khalapur, Dist-Raigad, Maharashtra Country: India INDIA Kopran Limited PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16

1695 Rwanda FDA-HMP-MA-1850 ZIROMIN POWDER FOR ORAL SUSPENSION Azithromycin dehydrate 200mg/5ml Powder for oral suspension 60ml Bottle HDPE BOTTLE 36 Months WORLD MEDICINE ILAC SAN. VE TIC.A.S . 15 Temmuz Mah. Cami Yolu Cad. No:50, Güne?li, Ba?c?lar Post code: 34212, ?stanbul ,TURKEY TURKEY WORLD MEDICINE ILAC SAN. VE TIC.A.S . GOODMAN INTERNATIONAL (R) LTD 2024-08-17 2029-08-16

1696 Rwanda FDA-HMP-MA-1927 ACEM-500 CLARITHROMYCIN USP 500MG TABLETS 1x10 Tablets ALU/PVC BLISTER 24 Months EMCURE PHARMACETICALS LTD Lane No. 3. Phase-II, SIDCO Industrial Complex, Bari – Brahmana, Jammu (J&K) – 181133 INDIA INDIA EMCURE PHARMACETICALS LTD ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1697 Rwanda FDA-HMP-MA-1851 AZITHROMYCIN Azithromycin dehydrate USP 500mg Tablets 3 tablets ALU/PVC BLISTER 24 Months AURA LIFECARE PVT. LTD. Survey No 254/ 14/1,Jarod ,Savli Road, P.O. Karachiya, Tal-Savli ,Dist : Vadodara-391520. Gujarat State, INDIA INDIA AURA LIFECARE PVT. LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1698 Rwanda FDA-HMP-MA-1928 PIRICAM 20 PIROXICAM USP 20MG Capsules 10x10 Capsules ALU/PVC BLISTER 24 Months MMC HEALTHCARE LTD No 34 –B, SIDCO INDUSTRIAL ESTATE, THIRUMAZHISAI, 600124 CHENNAI Country: INDIA INDIA CADILA HEALTHCARE LIMITED ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1699 Rwanda FDA-HBP-MA-0138 PENTA LIQUID VACCINE Diphtheria Toxoid, Tetanus Toxoid, B. Pertussis, HBsAg (rDNA) and Purified capsular Hib Polysaccharide (PRP) conjugated to Tetanus Toxoid (carrier protein) ? 25 Lf (? 30 IU), ? 2.5 Lf (? 40 IU), ? 16 OU (? 4 IU), ? 10 mcg, 10 mcg, ? 1.25 mg, 0.005 % Suspension for injection 2 ml clear and 5 clear glass vial 30 Months SERUM INSTITUTE OF INDIA Pvt.Ltd 212/2, Hadapsar, pune-411028 INDIA SERUM INSTITUTE OF INDIA Pvt.Ltd SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1700 Rwanda FDA-HMP-MA-1929 HYORTH injection Sodium Hyaluronate Sterile Solution 10 mg/1mL Injection 1’s x 2 mL USP type I glass syringe 36 Months VIRCHOW BIOTECH PVT LTD Survey No.172 Part, Gagillapur (V), Dundigal Gandimaisamma (M), Medchal-Malkajgiri (D),Telangana (State) - 500 043, India. INDIA VIRCHOW BIOTECH PVT LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1701 Rwanda FDA-HBP-MA-0139 INSULIN GLARGINE IMPACT SOLO STAR ® Insulin glargine 5 Solostar pens each of 3ml Solution for injection 3 ML Cartridge TYPE 1 COLOURLESS GLASS CARTRIDGE WITH A BLACK PLUNGER (BROMOBUTYL RUBBER) AND A FLANGED CAP (ALUMINIUM) 36 Months SANOFI-AVENTIS DEUTSCHLAND GmbH INDUSTRIEPARK HOCHST-BRUNINGSTRABE 50,65926 FRANKFURT AM MAIN GERMANY SANOFI-AVENTIS DEUTSCHLAND GmbH KIPHARMA LTD 2024-08-17 2029-08-16

1702 Rwanda FDA-HMP-MA-1930 MYCOMIN Beclomethasone Dipropionate USP, Neomycin Sulfate BP & Miconazole Nitrate BP 0.025% w/w, 0.5% w/w & 2.0% w/w CREAM 15G Tube Laminated tubes with internal lacquer coating and HDPE screw-on caps 24 Months CURETECH SKINCARE Plot No.33 & 34, Phase –IV, Bhatoli Kalan, Baddi, Dist- Solan (H.P.) India. INDIA GALAXY PHARMACEUTICALS STAR BIOTECH LIMITED 2024-08-17 2029-08-16

1703 Rwanda FDA-HBP-MA-0137 MENACWY VACCINE PFIZER Meningococcal group A, C, W-135 and Y conjugate vaccine 1.Neisseria meningitides group A polysaccharide 1 5 micrograms 2.Neisseria meningitides group C polysaccharide 1 5 micrograms 3.Neisseria meningitides group W-135 polysaccharide 1 5 micrograms 4.Neisseria meningitides group Y polysaccharide 1 5 micrograms 1Conjugated to tetanus toxoid carrier protein 44 micrograms Powder and solvent for solution for injection in pre-filled syringe 50 Vials vial (type I glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe with a stopper (butyl rubber). 48 Months Pfizer Manufacturing Belgium NV Rijksweg 12 2870 Puurs Belgium PFIZER LABORATORIES LIMITED WESSEX PHARMACEUTICALS (RWANDA) LIMITED 2024-08-17 2029-08-16

1704 Rwanda FDA-HMP-MA-1931 AMOXIMED AMOXICILLIN 500MG Capsules 10x10 Capsules and 500 Capsules ALU/PVC BLISTER and HDPE bottle 36 Months CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) Co., Ltd No.88, Yangzi Road, Shijiazhuang City, Hebei province, China.Corporate Office address: Not applicableManufacturing site Address: No.88, Yangzi Road, Shijiazhuang City, Hebei province, China.Country : China CHINA MEDISEL (K) LTD SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1705 Rwanda FDA-HMP-MA-1938 CIDOL-5 Injection HALOPERIDOL BP 5MG/ML Solution for injection 1ml Ampoule Amber USP type I ampoules 24 Months CIRON DRUGS & PHARMACEUTICALS PVT.LTD N-118, N-119, N-113, MIDC, Tarapur, Boisar, Dist: Thane-401 506. Maharashtra, India. INDIA CIRON DRUGS & PHARMACEUTICALS PVT.LT RENE PHARMACY (R) LTD 2024-08-17 2029-08-16

1706 Rwanda FDA-HMP-MA-1932 LIMZER OMEPRAZOLE & DOMPERIDONE 20MG & 30MG Capsules 3x10 Capsules ALU/PVC BLISTER 30 Months INVENTIA HEALTHCARE LIMITED F1-F1/1 Additional Ambernath MIDC, Ambernath (East) – 421506, Dist. Thane, Maharashtra, INDIA INDIA MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1707 Rwanda FDA-HMP-MA-1972 T-Sar Tablet 40mg Telmisartan BP 40mg Tablets 3x10 Tablets Alu-Alu blisters 24 Months CCL Pharmaceuticals (Pvt.) Ltd 62-Industrial Estate, Kot Lakhpat, Lahore-54770, Pakistan Pakistan CCL Pharmaceuticals (Pvt.) Ltd Depot Pharmaceutique Le Medical 2024-08-17 2029-08-16

1708 Rwanda FDA-HMP-MA-1933 AGODINE -TS POVIDONE IODINE USP 10% W/V TOPICAL SOLUTION 120ml Bottle Amber colour PET Bottle 36 Months AGOG PHARMA LTD Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, Country: India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1709 Rwanda FDA-HMP-MA-1973 Dilconeurine Tablet VITAMIN B1 (Thiamine HCl), VITAMIN B6 (Pyridoxine HCl) & VITAMIN B12 (Cyanocobalamine) 100mg, 100mg & 100mcg Tablets 10x10 Tablets ALU-PVDC blister 36 Months CCL Pharmaceuticals (Pvt.) Ltd 62-Industrial Estate, Kot Lakhpat, Lahore-54770 ,Pakistan Pakistan CCL Pharmaceuticals (Pvt.) Ltd Depot Pharmaceutique Le Medical 2024-08-17 2029-08-16

1710 Rwanda FDA-HMP-MA-1969 DOLIMEX 1000 PARACETAMOL BP 1000MG POWDER FOR ORAL SOLUTION 8 Sachets of 4g Glassin paper + Aluminium + LDPE Laminated foil 24 months BLISS GVS PHARMA LIMITED Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane - 401404, India India IMEX PHARMA, Maurice Mediasol Pharmaceutical Depot Ltd 2024-08-17 2029-08-16

1711 Rwanda FDA-HMP-MA-1974 Irbesartan/Amlodipine Besylate Impact Irbesartan/Amlodipine Besylate Impact 300mg/10mg Film Coated Tablets 28 Tablets PVC /ALU Blisters 36 Months Sanofi Winthrop Industrie 30-36 avenue Gustave Eiffel 37100 Tours France Sanofi-Aventis south africa (pty) ltd KIPHARMA LTD 2024-08-17 2029-08-16

1712 Rwanda FDA-HMP-MA-1970 DOLIMEX 500 PARACETAMOL BP 500MG POWDER FOR ORAL SOLUTION 12 Sachet of 4g Glassin paper + Aluminium + LDPE laminated foil 24 months BLISS GVS PHARMA LIMITED Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane - 401404, India India IMEX PHARMA, Maurice KIPHARMA LTD 2024-08-17 2029-08-16

1713 Rwanda FDA-HMP-MA-1975 Epibalin 25 Pregabalin USP 25 mg Capsules 1 x 10 Capsules & 3x10 Capsules Aluminium Blister foil -178 36 Months MSN LABORATORIES PRIVATE LIMITED Plot No.: 42, Anrich Industrial Estate, Bollaram, Sangareddy District, Pin Code - 502 325, Telangana, INDIA India MSN LABORATORIES PRIVATE LIMITED ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1714 Rwanda FDA-HMP-MA-1971 DOLIMEX-200 PARACETAMOL BP 200MG POWDER FOR ORAL SOLUTION 12 Sachets of 4 g Glassin paper + Aluminium + LDPE laminated foil 24 months BLISS GVS PHARMA LIMITED Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane - 401404, India India IMEX PHARMAAdresse : Rose Belle Building, Unit 3 – Rose Belle Business ParkPays : MauriceE-Mail : contact@imex-group.frTéléphone : 00 230 628 0973 KIPHARMA LTD 2024-08-17 2029-08-16

1715 Rwanda FDA-HMP-MA-1981 AGYCIN SUSPENSION AZYTHROMYCIN 40MG/ML SUSPENSION 15 ml HDPE bottle 24 months Bliss GVS Pharma Ltd, Plot No. 10, 11A, 12, Survey No. 38/1, Dewan Udyog Nagar, Aliyali Village, Palghar, Thane – 401404, Maharashtra State, India. India BLISS GVS PHARMA LTD Address: 102, Hyde Park, Saki-Vihar Road, Andheri (East). Mumbai-400072Country: IndiaTelephone: +91-22-42160000Telefax: +91-22-28563930E-Mail: info@blissgvs.com SURYA DEPOT PHARMACY LTD 2024-08-17 2029-08-16

1716 Rwanda FDA-HMP-MA-1976 LOFNAC GEL Diclofenac Sodium 1-3.00 % w/w of Linseed oil BP, -10.00 % w/w of Methyl salicylatEe BP, -5.00 % w/w of Menthol BP. 1%, 3%, 10%, 5%, GEL 30g Tubes Tube sealed with Cap 36 Months Gopaldas Visram & Co. Ltd A-590/591, M.I.D.C., T.T.C. Industrial Estate, Mahape, Navi Mumbai, Maharashtra, INDIA India BLISS GVS PHARMA LTD SURYA DEPOT PHARMACY LTD 2024-08-17 2029-08-16

1717 Rwanda FDA-HMP-MA-1965 GLIPMEVIA 50/850 Sitagliptin phosphate monohydrate, Metformin hydrochloride 50/850MG TABLETS 3x10 Tablets ALU/PVC BLISTER 24 Months FREDUM PHARMACEUTICALS LIMITED 14,15,16, Zorbian Industrial Complex, Veoor, Palghar(E) -401404 INDIA FREDUN PHARMACEUTICALS LTD STAR BIOTECH LIMITED 2024-08-17 2029-08-16

1718 Rwanda FDA-HMP-MA-1982 AZACITIDINE NEAPOLIS AZACITIDINE 100MG/VIAL SOLUTION FOR INJECTION 10 vial Type I glass vial 24 month NEAPOLIS PHARMA Route de Tunis, Km7- B.P. 206, 8000 Nabeul Tunisia Neapolis Pharma, route de Tunis, Km7-B.P.206, 8000 Nabeul, Tunisia. KIPHARMA Ltd 2024-08-17 2029-08-16

1719 Rwanda FDA-HMP-MA-1966 GYNASTATIN BP NYSTATIN BP 100000IU VAGINAL PESSARIES 2x7 Pessaries PVC/PE foil 24 Months BLISS GVS PHARMA LIMITED Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Palghar, District-Thane – 401404, India India BLISS GVS PHARMA LIMITED SURYA DEPOT PHARMACY LTD 2024-08-17 2029-08-16

1720 Rwanda FDA-HMP-MA-1983 ALLERCET M MONTELUKAST/ LEVOCETRIZINE DIHYROCHLORIDE 10MG/5MG TABLET 1x10\\\'s Alu/Alu blister 36 month Micro Labs Limited 92, SIPCOT, Hosur-635 126, Tamil Nadu India MICRO LABS LTD/INDIA WESSEX PHARMACEUTICALS RWANDA LTD 2024-08-17 2029-08-16

1721 Rwanda FDA-HMP-MA-1967 COFANTRINE DISPERSIBLE ARTEMETHER+ LUMEFANTRINE 20MG/120MG DISPERSIBLE TABLETS 6 tablets PVC/Aluminium foil 24 Months BLISS GVS PHARMA LIMITED Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane – 401404 India IMEX PHARMA, Maurice Mediasol Pharmaceutical Depot Ltd 2024-08-17 2029-08-16

1722 Rwanda FDA-HMP-MA-1984 ATROZEMB 10-10MG ATORVASTATIN/EZETIMIBE 10MG+10MG FILM COATED TABLET 10 tablets Alu/Alu blister 24 month Liptis for Pharmaceutical and Medical Products (S.A.E) Plot no. B/2, 6th industrial zone, 6th of October City Egypt Liptis for Pharmaceuticals & Medical Products (S.A.E).Plot No. B/2, 6th Industrial zone, 6th of October City, Egypt.mahmoud.elaila@liptispharma.com GOODMAN INTERNATIONAL ® LTD 2024-08-17 2029-08-16

1723 Rwanda FDA-HMP-MA-1968 COFANTRINE ADULTES ARTEMETHER& LUMEFANTRINE 80MG/480MG TABLETS 6 Tablets PVC/Aluminium foil 36 Months BLISS GVS PHARMA LIMITED Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane – 401404 India IMEX PHARMA, Maurice Mediasol Pharmaceutical Depot Ltd 2024-08-17 2029-08-16

1724 Rwanda FDA-HMP-MA-1985 ATROZEMB 20-10MG ATORVASTATIN/EZETIMIBE 20MG+10MG FILM COATED TABLET 10 tablets Alu/Alu blister 24 month Liptis for Pharmaceutical and Medical Products (S.A.E) Plot no. B/2, 6th industrial zone, 6th of October City Egypt Liptis for Pharmaceuticals & Medical Products (S.A.E).Plot No. B/2, 6th Industrial zone, 6th of October City, Egypt.mahmoud.elaila@liptispharma.com GOODMAN INTERNATIONAL ® LTD 2024-08-17 2029-08-16

1725 Rwanda FDA-HMP-MA-1934 MYOXERIL CYCLOBENZAPRINE HYDROCHLORIDE 10MG Film Coated Tablets 2x10 Tablets ALU/PVC BLISTER 36 Months THE MADRAS PHARMACEUTICALS 137-B Old Mahabalipuram Road Karappakkam, Chennai. Tamilnadu -603 103, India. INDIA CROSS PHARM, S.A. GOMHS LTD 2024-08-17 2029-08-16

1726 Rwanda FDA-HMP-MA-1986 AZITRINE AZITHROMYCIN 40MG SUSPENSION 15ml HDPE bottle 24 month Bliss GVS Pharma Limited Plot 10, 11A, 12, Survey No. 37/1, Dewan Udyog Nagar, Aliyali, Palghar, DistrictThane – 401404, India IMEX PHARMA, Rose Belle building, unit 3- Rose Belle, Business Park, Maurice, Email: audrene.rouxel@imex-sf.com MEDIASOL PHARMACEUTICAL Ltd 2024-08-17 2029-08-16

1727 Rwanda FDA-HMP-MA-1935 LABGENTIL TABLETS SECNIDAZOLE 500MG TABLETS 4 Tablets PVC/ALU blister 36 Months LABORATORY & ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa road, P.O. Box 42875 GPO 00100, Nairobi Kenya LABORATORY & ALLIED LTD Depot Pharmaceutique Le Medical 2024-08-17 2029-08-16

1728 Rwanda FDA-HMP-MA-1977 OMEPRAGLOBE OMEPRAZOLE 20MG CAPSULES 1x10 Capsules Alu-Alu Blister 36 Months GLOBELA PHARMA PVT. LIMITED Plot No. 357-358, G.I.D.C, Sachin, Road no. 3, Surat, Gujarat, India INDIA GLOBELA PHARMA PVT.LTD AFRIPHARM LTD 2024-08-17 2029-08-16

1729 Rwanda FDA-HMP-MA-1936 DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET 50MG,300MG & 300MG DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE 50MG+300MG+300MG TABLETS 30’s,60’s,90’s,180 Tablets 120cc,200cc,300cc and 400cc Round Opaque White HDPE Bottles 24 Months LUPIN Limited Unit 1, Plot No. 6A1, 6A2, Sector-17, Special Economic Zone, MIHAN Notified Area, Nagpur, Maharashtra-4411 08 India LUPIN Limited Aiveen (R) Ltd 2024-08-17 2029-08-16

1730 Rwanda FDA-HMP-MA-1987 POSITON OINTMENT TRIAMCINOLONE 1MG/G,NEOMYCINE 2.5MG/G,NYSTATIN 100000 I.U/G 1MG/G,2.5MG/G,100000IU OINTMENT 30g Aluminium tube 48 month LABORATORIOS VICTORIA, S.A Rua Elias Garcia, 28 Venda Nova 2700-327 Amadora PORTUGAL FAES PHARMA SAMáximo Aguirre 14 – 48940 Leioa (Biscay) SPAINTel. 0034944818300Fax. 0034944818309Email. ihermo@faes.es, ieguidazu@faes.es GOMHS Ltd 2024-08-17 2029-08-16

1731 Rwanda FDA-HMP-MA-1937 METOCLOPRAMIDE METOCLOPRAMIDE HYDROCHLORIDE BP 5MG/ML INJECTION 10 x 10 x 2 mL Ampoules Amber USP Type I ampoules 36 Months CIRON DRUGS & PHARMACEUTICALS PVT.LTD N-118, N-119, N-113, MIDC, Tarapur, Boisar, Dist: Thane-401 506. Maharashtra, India. INDIA CIRON DRUGS & PHARMACEUTICALS PVT.LTD RENE PHARMACY (R) LTD 2024-08-17 2029-08-16

1732 Rwanda FDA-HMP-MA-1988 CLAVUJECT 1.2 INJECTION CO-AMOXICLAV 1.2MG STERILE POWDER FOR INJECTION 15ml HDPE bottle 24 month Bliss GVS Pharma Limited Plot 10, 11A, 12, Survey No. 37/1, Dewan Udyog Nagar, Aliyali, Palghar, DistrictThane – 401404, India India IMEX PHARMAAdresse : Rose Belle Building, Unit 3 – Rose Belle Business ParkPays : MauriceE-Mail : contact@imex-group.frTéléphone : 00 230 628 0973 KIPHARMA Ltd 2024-08-17 2029-08-16

1733 Rwanda FDA-HMP-MA-1939 RIPAXIL 750 Cefuroxime for Injection USP 750MG Powder for Injection 10ml Vial Flint glass vial USP Type III 24 Months Inject Care Parenterals Pvt.Ltd. Plot No. 130, Silvassa Road, G.I.D.C., Vapi, Dist: Valsad, Gujarat State, India INDIA IMEX PHARMA Mediasol Pharmaceutical Depot Ltd 2024-08-17 2029-08-16

1734 Rwanda FDA-HMP-MA-1989 VASTAREL OD 80MG PRL TRIMETAZIDINE HYDROCHLORIDE 80MG HARD CAPSULE 30 hard capsules PVC-Aluminium 36 months Egis Pharmaceuticals Private Limited H-9900 Körmend Mátyás Király u 65. Hungary Hungary LES LABORATOIRES SERVIERH-1165 Budapest, Bokenyfoldi ut 118-120 KIPHARMA Ltd 2024-08-17 2029-08-16

1735 Rwanda FDA-HMP-MA-1940 CLARYL-500 CLARITHROMYCIN USP 500MG TABLETS 10x10 Tablets Blisters 36 Months UMEDICA LABORATORIES PVT. LTD Plot No. 221, G.I.D.C., VAPI - 396 195, DIST. VALSAD, GUJARAT, INDIA. INDIA UMEDICA LABORATORIES LTD SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16

1736 Rwanda FDA-HMP-MA-1978 ASPOCAN Posaconazole 100 mg Tablets 3x10 Tablets PVC/ALU Blister pack 24 Months M/s. Hetero Labs Limited Unit-III Address: 22-110,IDA,Jeedimetla,Hyderaba,Telangana, India India HETERO LABS LIMITED Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

1737 Rwanda FDA-HMP-MA-1941 AMOXIREN Amoxicillin trihydrate BP 250 MG CAPSULES 10x10 Capsules Aluminium/PVC Blister Strip 24 Months RENE INDUSTRIES LTD Plot No 680,Kamuli, Kireka, Kampala, Uganda. Uganda RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-08-17 2029-08-16

1738 Rwanda FDA-HMP-MA-1990 VASTAREL OD 40MG PRL TRIMETAZIDINE HYDROCHLORIDE 40MG HARD CAPSULE 30 hard capsules PVC-Aluminium 36 months Egis Pharmaceuticals Private Limited H-9900 Körmend Mátyás Király u 65. Hungary Hungary LES LABORATOIRES SERVIERH-1165 Budapest, Bokenyfoldi ut 118-120 KIPHARMA Ltd 2024-08-17 2029-08-16

1739 Rwanda FDA-HMP-MA-1942 MELANEZ MESALAZINE Ph.Eur. 1G SUPPOSITORIES 2x5 Suppositories PVC/PVdC/PE Blisters 24 Months BLISS GVS PHARMA LTD Plot 11, Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Palghar, Maharashtra,401404, India India BLISS GVS PHARMA LTD SURYA DEPOT PHARMACY LTD 2024-08-17 2029-08-16

1740 Rwanda FDA-HMP-MA-1979 LETERO LETROZOLE 2.5 MG TABLETS 30’s HDPE Container. 36 months M/S. Hetero Labs Limited (Unit-VI) Survey No. 440 & 441, TSIIC Formulation SEZ, Polepally village, Jadcherla Mandal, Mahaboobnagar (Dist) – 509301 Telangana.India India Hetero Labs Limited, Address: 7-2-A2, Hetero Corporate, Industrial Estate, Sanath Nagar, Hyderabad, Telangana, Pin Code - 500018 Country: INDIA Telephone : +91-40-23704923/24/25 Tele fax : +91-40-23704926/23714250 Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

1741 Rwanda FDA-HMP-MA-1943 TRISPORIN SP CEFDINIR 125MG/5ML SUSPENSION 100ml Bottle Amber coloured Type III glass bottles 36 Months Pharma Vision Sanayi ve Ticaret A. S/Bilim Ilaç San.ve Tic. A.S Davutpa?a Cad. No. 145, 34010 Topkapi, Istanbul/Turkey Turkey DEFRA PHARMA GmbH UBIPHARM RWANDA LTD 2024-08-17 2029-08-16

1742 Rwanda FDA-HMP-MA-1980 GLINSIP 100 Sitagliptin Tablets USP 100 mg Tablets 2x15 Tablets PVC/PE/PVDC-Blister Pack 24 Months M/s Annora Pharma Private Limited Survey No. 261, Annaram village, Gummadidala Mandal, Sangareddy, Telangana-502313. Country: India \" INDIA HETERO LABS LIMITED Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

1743 Rwanda FDA-HMP-MA-1944 PANADOL EXTRA WITH OPTIZORB PARACETAMOL+CAFFEINE 500MG/65MG TABLETS 20 Tablets PVC- Aluminum foil blisters 24 Months Glaxo Smith Kline Dungarvan Limited Knockbrack, Dungarvan, Co. Waterford, Ireland Ireland GLAXOSMITHKLINE LIMITED SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16

1744 Rwanda FDA-HMP-MA-1991 GLINSIP 50 Sitagliptin Tablets USP 50 mg Tablets 2x15 Tablets PVC/PE/PVDC-Blister 24 Months M/s Annora Pharma Private Limited Survey No. 261, Annaram village, Gummadidala Mandal, Sangareddy, Telangana-502313, India INDIA Hetero Labs Limited, Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

1745 Rwanda FDA-HMP-MA-1993 IRBIS-HT 150/12.5 Irbesartan and Hydrochlorothiazide 150 mg/12.5 mg Tablets 3×10Tablets White Opaque PVC/PVDC Blister and Carton 36 months M/S. Hetero Labs Limited (Unit-V) M/S. Hetero Labs Limited (Unit-V) \\ INDIA Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

1746 Rwanda FDA-HMP-MA-1946 TRD-CONTIN 100 TRAMADOL HYDROCHLORIDE 100 mg TABLETS 5x10 Tablets PVDC/ Alu blisters 24 Months MODI-MUNDIPHARMA PVT.LTD Modipuram-25 110, U.P, INDIA India MODI-MUNDIPHARMA PVT.LTD SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16

1747 Rwanda FDA-HMP-MA-1997 LAZINE Levocetrizine Dihydrochloride 5 mg Tablets 10 x10 Tablets 1 x10’s Blister pack 36 months M/s. Hetero Labs Limited Unit-III, Village Kalyanpur, Chakkan Road, Baddi (Tehsil), Solan (Dist.), Himachal Pradesh-173205, India INDIA Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-19

1748 Rwanda FDA-HMP-MA-1947 INTELENCE-100 INTRAVIRINE 100MG TABLETS 120 Tablets HDPE Bottle 36 Months Janssen-Cilag S.P.A. Via C. Janssen Borgo S. Michele 04100 Latina, Italy ITALY JANSSEN-CILAG INTERNATIONAL NV GILMED LIMITED 2024-08-17 2029-08-16

1749 Rwanda FDA-HMP-MA-1994 ZOLDRO Zoledronic Acid monohydrate for Injection 4 mg/vial Injection 1’s Pack: 12 ml tubular vial 4 mg/Vial tubular vial 4 mg/Vial 24 months Aspiro Pharma Limited Aspiro Pharma Limited Address: Survey No.321, Biotech Park, Phase III, Karkapatla, Markook Mandal, Siddipet District, Telangana (S)- 5002281, INDIA INDIA Aspiro Pharma Limited BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1750 Rwanda FDA-HMP-MA-1948 BRINZOX T Brinzolamide USP, Timolol Maleate BP 1% w/v + 0.5%w/v Ophthalmic Suspension 5ml LDPE vial packed with HDPE cap 36 Months Ajanta pharma Limited Mirza-Palashbhari Road, Vill.-Kokhjar, Kamrup (R), Guwahati, Assam-781128 Country: India INDIA Ajanta pharma Limited ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1751 Rwanda FDA-HMP-MA-1949 ZIMAGRA -50 SILDENAFIL CITRATE 50MG TABLETS 1x4 Tablets ALU/PVC BLISTER 36 Months ZIM LABORATORIES LIMITED B-21/22, MIDC Area,Kalmeshwar, Nagpur 441501, Maharashtra State, India INDIA ZIM LABORATORIES LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1752 Rwanda FDA-HMP-MA-1995 GLINSIP 25 Sitagliptin Phosphate anhydrous 25mg 25 mg Tablets 2×15 PVC/PE/PVDC-Blister Pack and Carton 24 months M/s Annora Pharma Private Limited M/s Annora Pharma Private Limited \\ INDIA Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

1753 Rwanda FDA-HMP-MA-1950 DOXIL-100 DOXYCYCLINE BP 100MG TABLETS 10x10 Tablets ALU/PVC BLISTER 36 Months MAXTAR BIO-GENICS K. No. 705, Nalagarh road, Malku Majra, (Baddi), Tehsil Nalagarh, Distt. Solan, Himachal Pradesh - 173205 India INDIA MAXTAR BIO-GENICS SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1754 Rwanda FDA-HMP-MA-1996 TELMILO 80 Telmisartan Tablets 80 mg Tablets 3×10’s Alu-Alu blister pack, 3×10’s Alu-Peel-Push blister pack Alu-Peel-Push blister pack 36 months M/S. Hetero Labs Limited (Unit-V) M/S. Hetero Labs Limited (Unit-V) \\ INDIA Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

1755 Rwanda FDA-HMP-MA-1951 GYNOSPAN Phloroglucinol BP and Trimethylphloroglucinol IH 62.233MG/80MG TABLETS 3x10 Tablets ALU/PVC BLISTER 24 Months BLISS GVS PHARMA LIMITED Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane – 401404 , India INDIA IMEX PHARMA, Maurice KIPHARMA LTD 2024-08-17 2029-08-16

1756 Rwanda FDA-HMP-MA-1998 AMLOSIN 5 Amlodipine Besylate USP 5 mg Tablets 3 × 10 Tablets Alu– Alu Blister 36 months Hetero Labs Ltd Hetero Labs Ltd. Unit- I, Vill. Kalyanpur, Chakkan Road, Baddi, Distt. Solan [H.P.], India INDIA Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

1757 Rwanda FDA-HMP-MA-1952 AGOVIR-400 TABLETS ACICLOVIR BP 400MG TABLETS 100 Tablets Jar Pack 36 Months AGOG PHARMA LTD Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, Country: India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1758 Rwanda FDA-HMP-MA-1999 AMLOSIN 10 Amlodipine Besylate USP 10 mg Tablets 3 × 10 Tablets Alu–Alu PVC Blister 36 months Hetero Labs Ltd Unit- I Vill. Kalyanpur, Chakkan Road, Baddi, Distt. Solan [H.P.], India INDIA Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

1759 Rwanda FDA-HMP-MA-1566 NEWCOX-TH Etoricoxib & Thiocolchicoside 60mg/8mg Film coated Tablets 3x10 Tablets ALU-ALU BLISTER PACK 36 Months SKYBIOTECH LIFESCIENCES PVT LTD Gut no.: 5, Gevrai Tanda, Paithan Road, Aurangabad (M.S.) India INDIA PHARMA LIFE SCIENCE LTD STAR BIOTECH LIMITED 2024-08-17 2029-08-16

1760 Rwanda FDA-HMP-MA-1953 DAWA-CPM SYRUP CHLORPHENIRAMINE MALEATE 2MG/5ML SYRUP 60ml and 100ml Bottles PET Amber bottles 36 Months DAWA LIMITED Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620. Nairobi. Kenya KENYA DAWA LIMITED SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1761 Rwanda FDA-HMP-MA-1992 LUMECOAT Sucralfate Oral Suspension 1g/10mL SUSPENSION 1 Amber PET Bottle Pack 24 months M/s Annora Pharma Private Limited M/s Annora Pharma Private Limited Address: Survey No. 261, Annaram village, Gummadidala Mandal, Sangareddy, Telangana-502313. Country: India INDIA Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

1762 Rwanda FDA-HMP-MA-1565 MOXACIL POWDER FOR ORAL SUSPENSION Amoxicillin Trihydrate 125mg/5ml Powder for oral suspension 100ml and 60ml bottles HDPE Bottles 36 Months DAWA LIMITED Plot No.7879/8, Baba Dogo Road, Ruaraka 16633-00620 Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISE LTD 2024-08-17 2029-08-16

1763 Rwanda FDA-HMP-MA-1954 VERMOUT SUSPENSION MEBENDAZOLE 100MG/5ML SUSPENSION 30ml Bottle Glass Bottle 36 Months DAWA LIMITED Plot No.7879/8, Baba Dogo Road, Ruaraka. Postal Address: 16633-00620 Nairobi. Country: Kenya KENYA DAWA LIMITED SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1764 Rwanda FDA-HMP-MA-2000 GEMTERO 1G Gemcitabine for Injection USP 1 g Injection 1 x 1 pack USP type 1 glass vial 36 months Hetero Labs Limited Unit VI, Sy. No. 410-411TSIIC Formulation SEZ, Polepally Village, Jadcherla Mandal, Mahaboobnagar District, Pin-509301 Telangana.India INDIA Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

1765 Rwanda FDA-HMP-MA-1564 LOSATRUST H TABLETS Losartan Potassium USP and Hydrochlorthiazide BP 50mg/12.5 mg Film coated Tablets 3x10 Tablets ALU-ALU BLISTER PACK 36 Months CENTAUR PHARMACEUTICALS PVT LTD Plant: I, Plot No: 3, Tivim Industrial Estate, Karaswada. Mapusa Goa-403526, India INDIA CENTAUR PHARMACEUTICALS PVT, LTD WESSEX PHARMACEUTICAL (RWANDA)LTD 2024-08-17 2029-08-16

1766 Rwanda FDA-HMP-MA-1955 PZ-4 PIMOZIDE BP 4MG TABLETS 240 Tablets Jar Pack 36 Months AGOG PHARMA LTD Plot No. 33, Sector II, The Vasai Taluka Industrial, Co-op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India. India AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1767 Rwanda FDA-HMP-MA-2001 FLAIROF Roflumilast 250 mcg Tablets 1 x 15 Tablets & 1 x 10 Tablets Clear PVC/PVdC - Alu Blister pack 24 Months M/s. Hetero Labs Limited Unit III Address: 22-110, IDA, Jeedimetla, Hyderabad Telangana, India India Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

1768 Rwanda FDA-HMP-MA-1566 SPIROMIDE TABLETS Spironolactone and Furosemide 50mg/20mg Tablets 2x10 Tablets ALU/PVC BLISTERS 24 Months THE SEARLE COMPANY LIMITED F-319, S.I.T.E. Karachi Pakistan PAKISTAN THE SEARLE COMPANY LIMITED SURGIPHARM RWANDA LTD 2024-08-17 2029-08-16

1769 Rwanda FDA-HMP-MA-1956 PZ-1 PIMOZIDE BP 1MG TABLET 30 Tablets Jar Pack 36 Months AGOG PHARMA LTD Plot No. 33, Sector II, The Vasai Taluka Industrial, Co-op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India. INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1770 Rwanda FDA-HMP-MA-1957 MOXAFORTE 500 Amoxicillin Trihydrate and Flucloxacillin Sodium 250mg and 250mg Capsules 2x10 Capsules Blister pack, Printed Aluminium foil 36 Months DAWA LIMITED Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620. Nairobi. Kenya. KENYA DAWA LIMITED SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1771 Rwanda FDA-HMP-MA-2002 MONAST 10 Montelukast Sodium 10 mg Tablets 3x10 Tablets Alu-Alu blister pack 36 months M/s. Hetero Labs Limited M/s. Hetero Labs Limited, Unit-IIIAddress: 22-110, IDA, Jeedimetla, Hyderabad, Telangana, INDIACountry: INDIA Telephone: +91-40-23096171/172/173/174 INDIA Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

1772 Rwanda FDA-HMP-MA-1568 SALBUCORT Salbutamol Pressurized Inhalation BP 100 mcg/dose Pressurised metered dose inhaler formulation 19 ml Aluminium Cans, 200 Metered doses ALUMINIUM CANISTER 24 Months HETERO LABS LIMITED Unit-VII, Sy.No.50, Plot No. l4, Phase-III, IDA, Jeedimetla, Hyderabad-500 0:55, Telangana State, India INDIA HETERO LABS LIMITED VINE PHARMA LTD 2024-08-17 2029-08-16

1773 Rwanda FDA-HMP-MA-1958 ANDROGEL TESTOSTERONE 16.2MG/G GEL Boxes of 1, 2, 3 or 6 containers Multi-dose polypropylene canister, containing a pouch, with a metered dose airless pump 36 Months Besins Healthcare Benelux Sa. Groot Bijgaardenstraat 128 1620 Drogenbos, Belgium Belgium BESINS HEALTHCARE BENELUX SA SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16

1774 Rwanda FDA-HMP-MA-2003 NIZACARD 500 Ranolazine 500 mg Extended-Release Tablets 3x10 Tablets Alu PVC/PVdc Blister pack 24 months M/s Hetero Labs Limited Unit-IIIAddress: 22-110, IDA, Jeedimetla, Hyderabad, Telangana, INDIACountry: INDIA Telephone: +91-40-23096171/172/173/174 India Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

1775 Rwanda FDA-HMP-MA-1567 OXYTOCIN 10 I.U Oxytocin 10 IU/ 1ml Solution for injection 10 ampoules of 1 ml solution GLASS AMPOULES 36 Months EVER PHARMA GMBH JENA Otto-Schott-Stra?e 15 07745 Jena, Germany GERMANY SANDOZ GMBH KUNDL SURGIPHARM RWANDA LTD 2024-08-17 2029-08-16

1776 Rwanda FDA-HMP-MA-1959 TORSINEX-20 TORSEMIDE 20 MG TABLETS 3x10 Tablets Alu-Alu Blister pack 36 Months MICRO LABS LIMITED 92, SIPCOT Industrial Complex HOSUR-635 126. (T.N) INDIA India MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16

1777 Rwanda FDA-HMP-MA-2004 HETSOLID 75 Dabigatran Etexilate 75 mg Capsules 1 x10 Tablets Alu–Alu PVC Blister 24 months M/s Hetero Labs Limited Unit-IIIAddress: 22-110, IDA, Jeedimetla, Hyderabad, Telangana, INDIACountry: INDIA Telephone: +91-40-23096171/172/173/174 India M/s Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

1778 Rwanda FDA-HMP-MA-1572 XAROBAN TABLETS Rivaroxaban 10mg Tablets 10 Tablets ALU-ALU BLISTER PACK 24 Months THE SEARLE COMPANY LIMITED F-319, S.I.T.E Karachi, Pakistan PAKISTAN THE SEARLE COMPANY LIMITED SURGIPHARM RWANDA LTD 2024-08-17 2029-08-16

1779 Rwanda FDA-HMP-MA-1960 PED ZINC ZINC SULPHATE MONOHYDRATE 20MG TABLET 10x10 Tablets Aluminium foil Blisters 36 Months SHELYS PHARMACEUTICALS LIMITED & BETA HEALTHCARE INTERNATIONAL LTD P.O. BOX 32781, Dar es Salaam Tanzania, Plot No. 696, New Bagamoyo Road, Mwenge, Dar es Salaam and Plot No. LR 209/6554, Mogadishu Road, Industrial area, Nairobi, Kenya Tanzania & Kenya Shelys Pharmaceuticals Limited SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16

1780 Rwanda FDA-HMP-MA-2005 HETSOLID 110 Dabigatran Etexilate 110mg Capsules 1 x10 Tablets Alu–Alu PVC Blister 24 months M/s Hetero Labs Limited Unit-IIIAddress: 22-110, IDA, Jeedimetla, Hyderabad, Telangana, INDIACountry: INDIA India Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

1781 Rwanda FDA-HMP-MA-1961 GYNOSPAN Phloroglucinol BP, Trimethylphloroglucinol IH 116.70MG/150MG SUPPOSITORIES 2X5 Suppositories Polyvinyl chloride/ Polyethyllene foil 24 Months BLISS GVS PHARMA LIMITED Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane – 401404 INDIA IMEX PHARMA, Maurice KIPHARMA LTD 2024-08-17 2029-08-16

1782 Rwanda FDA-HMP-MA-2006 HETSOLID 150 Dabigatran Etexilate 150 mg CAPSULES 1 x10 Tablets Alu-Alu blister pack 24 months M/s Hetero Labs Limited Unit-IIIAddress: 22-110, IDA, Jeedimetla, Hyderabad, Telangana, INDIA India Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

1783 Rwanda FDA-HMP-MA-1563 CLOXAREN ORAL SUSPENSION Cloxacillin sodium 125 mg Dry powder for oral suspension 25mg for 100ml HDPE BOTTLES 24 Months RENE INDUSTRIES LTD Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda UGANDA RENE INDUSTRIES LTD RENE PHARMACY ® LTD 2024-08-17 2029-08-16

1784 Rwanda FDA-HMP-MA-1671 EROCIN-500 ERYTHROMYCINE 500MG TABLET 10x10 Tablets Alu/PVC blister 36 Months MAXTAR BIO-GENICS K. No. 705, Nalagarh road, Malku Majra, (Baddi), Tehsil Nalagarh, Distt. Solan, Himachal Pradesh – 173205, India INDIA MAXTAR BIO-GENICS SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1785 Rwanda FDA-HMP-MA-2007 NIZACARD 1000 mg Ranolazine Extended-release 1000 mg Tablets 3x10 Tablets Alu PVC/PVdc Blister pack 24 months M/s Hetero Labs Limited Unit-IIIAddress: 22-110, IDA, Jeedimetla, Hyderabad, Telangana, INDIA India Hetero Labs Limited, Address: 7-2-A2, Hetero Corporate, Industrial Estate, Sanath Nagar, Hyderabad, Telangana, Pin Code - 500018 Country: INDIA Telephone : +91-40-23704923/24/25 Tele fax : +91-40-23704926/23714250 Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

1786 Rwanda FDA-HMP-MA-1553 FOLIGRAF 450 IU MULTIDOSE PRE FILLED PEN Follitropin Concentrated Solution 450 IU 33.0?g)/0.75 ml Solution for Injection 3ML Cartridges SILICONIZED GLASS CARTRIDGE 24 Months BHARAT SERUMS & VACCINES LTD Plot No. K-27, K-27 Part and K-2711, Jambivili Village, Anand Nagar, Additional M Ambernath (East), Thane 421506, Maharashtra India INDIA BHARAT SERUMS & VACCINES LTD PHILLIPS PHARMACEUTICALS RWANDA LTD 2024-08-17 2029-08-16

1787 Rwanda FDA-HMP-MA-1710 CLOXACILLIN CAPSULE Cloxacillin Sodium 250mg Capsules 10x10 Capsules ALUMINIUM FOIL and HDPE JAR 36 Months REYOUNG PHARMACEUTICAL CO. LIMITED No.1 Ruiyang Road, Yiyuan County, Zibo City, CHINA FARMASINO CO., LTD ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1788 Rwanda FDA-HMP-MA-2008 Dolutegravir, Emtricitabine and Tenofovir Alafenamide Tablets 50 mg / 200 mg / 25 mg Dolutegravir, Emtricitabine and Tenofovir Alafenamide 50 mg / 200 mg / 25 mg Tablets 30’s HDPE container, 100’s HDPE container HDPE container 24 months M/s. Hetero Labs Limited Unit-III, 22-110, IDA, Jeedimetla, Hyderabad - 500055, Telangana India Hetero Labs Limited Sun Enterprises Limited 2024-08-17 2029-08-16

1789 Rwanda FDA-HBP-MA-0135 MENOTAS HP 150 Menotrophin BP 150 IU/vial Powder for injection 1 VIAL VIAL 24 Months INTAS PHARMACEUTICALS LIMITED Plot No. – 85/87, Kailash Industrial Estate, Village -Iyawa, Tal: Sanand, Dist. Ahmedabad-382 110, Gujarat, India INDIA INTAS PHARMACEUTICALS LIMITED VINE PHARMA LTD 2024-08-17 2029-08-16

1790 Rwanda FDA-HMP-MA-1711 ALTOA TABLETS Albendazole 400mg Tablets 1 x 1 Tablets PVC/ALUMINIUM FOIL 36 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

1791 Rwanda FDA-HMP-MA-2009 JARDIANCE-10 EMPAGLIFLOZINE 10MG TABLETS 3×10 Tablets Alu–Alu PVC Blister 36 months Boehringer Ingelheim International GmbH KGBinger Straße 17355216 Ingelheim am Rhein GERMANY Germany BOEHRINGER INGELHEIM SURGIPHARM RWANDA LTD 2024-08-17 2029-08-16

1792 Rwanda FDA-HMP-MA-1561 NORIGYNON Estradiol valerate Norethisterone enantate 5mg/50mg Solution for Injection 100 x1ml Ampoules GLASS AMPOULES 60 Months BAYER DE MEXICO, S.A DE C.V Ixtaczoquitlán Ojo de Agua S/N 94450 Ixtaczoquitlán, Veracruz México MEXICO BAYER EAST AFRICA LIMITED SURGIPHARM RWANDA LTD 2024-08-17 2029-08-16

1793 Rwanda FDA-HMP-MA-1712 MINOLINE-100 TABLETS Aminophylline 100mg Film Coated Tablets 10x10 Tablets PVC/ALUMINIUM FOIL 36 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

1794 Rwanda FDA-HMP-MA-2010 VALPAGEN-200 SODIUM VALPROATE 200MG TABLET 10 x 10 Tablets ALU/PVC blister 36 months ANGEL BIOGENICS PVT LTD RELAX BIOTECH PVT LTD 862/1,GIDC MAKARPURA ,VADODARA -390010 GUJARAT INDIA India ANGEL BIOGENICS PVT LTD FRAGEM LIMITED 2024-08-17 2029-08-16

1795 Rwanda FDA-HMP-MA-1557 CHLORAMPHENICOL Chloramphenicol 250 mg Capsules 10x10 Capsules ALU/PVC BLISTERS 36 Months AURA LIFE CARE PVT LTD Survey No. 254/14/1, Jarod-Savli Road, Karachiya, India INDIA AURA LIFE CARE PVT LTD SUN ENTERPRISE LTD 2024-08-17 2029-08-16

1796 Rwanda FDA-HMP-MA-1713 LABESTEN VAGINAL TABLETS Clotrimazole BP 100mg Tablets 6x1 Tablets ALUMINIUM FOIL BLISTERS 36 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

1797 Rwanda FDA-HMP-MA-2011 ADDAVEN FERRIC CHLORIDE/ ZINC CHLORIDE/ MANGANESE CHLORIDE TETRAHYDRATE/ COPPER CHLORIDE DIHYDRATE/ SODIUM SELENITE ANHYDROUS/ POTASSIUM IODIDE/ CHROMIC CHLORIDE HEXAHYDRATE/ SODIUM FLUORIDE/ SODIUM MONHYDRATE DEHYDRATE 53.3 mcg,1.02 mg, 5.40 mg, 198 mcg, 166 mcg, 2.10 mg, 48.5 mcg, 173 mcg, 10.5 mg in 10 ml Concentrate for solution for infusion 20 x 10 ml ampoules Ampoule (polypropylene) 36 months Fresenius Kabi Norge AS NORWAYS vinesundsveien 80NO - 1788 Halden Norway Norway FRESENIUS KABI SOUTH AFRICA PTY SURGIPHARM RWANDA LTD 2024-08-17 2029-08-15

1798 Rwanda FDA-HMP-MA-1554 SUPRIDOL Tramadol Hydrochloride 50mg Solution for injection 1ml Ampoules FLINT AMPOULE WITH DOUBLE BLACK BAND S/O 12 Months M/s. NEON LABORATORIES LIMITED Plot no. 29 to 32 & 57, 60, The Palghar Taluka Industrial Estate Co-Op Estate Ltd., Boisar Road, Taluka – Palghar 401404 Maharashtra State, India INDIA M/s. NEON LABORATORIES LIMITED SUN ENTERPRISE LTD 2024-08-17 2029-08-16

1799 Rwanda FDA-HMP-MA-1714 BENDURIC 5MG TABLETS Bendroflumethiazide resepine 5mg Tablets 10x10 Tablets BLISTERS/ALUMINIUM FOIL 36 Months COSMOS LIMITED Rangwe road; off Lunga Lunga road, industrial area, P.O. box 41433, GPO 00100 - Nairobi, Kenya KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1800 Rwanda FDA-HMP-MA-2014 KAREMOX-250 AMOXICILLIN 250MG CAPSULE 11 x 10 Tablets and 500 Tablets PVC-Aluminium blister packs or in polythen bag contained in HDPE container 36 months Reyoung Pharmaceutical Co., Ltd No.1 Ruiyang Road Yiyuan county, Shandong Province, P. R.China China KAREMAX INDUSTRIAL LTD SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1801 Rwanda FDA-HMP-MA-1715 BICOLEX ENTERIC COATED TABLETS Bisacodil 5mg Tablets 10x10 Tablets BLISTERS/ALUMINIUM FOIL 36 Months COSMOS LIMITED Rangwe road; off Lunga Lunga road, industrial area, P.O. box 41433, GPO 00100 - Nairobi, Kenya KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1802 Rwanda FDA-HMP-MA-2013 KAREMOX-500 AMOXICILLIN 500MG CAPSULE 10 x 10 Tablets and 500 Tablets PVC-Aluminium blister packs, and in polythen bag contained in HDPE container 36 months Reyoung Pharmaceutical Co., Ltd No.1 Ruiyang Road Yiyuan county, Shandong Province, P. R.China China KAREMAX INDUSTRIAL LTD SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1803 Rwanda FDA-HMP-MA-1558 OXYTOCIN INJECTION Oxytocin injection BP 10IU/ml Solution for injection 10 Ampoules for 1ml AMBER GLASS AMPOULE 24 Months CIRON DRUGS &PHARMACEUTICALS PVT LTD N-118, N-119, N-113, MIDC, Tarapur, Boisar, Dist: Thane-401 506. Maharashtra, India INDIA CIRON DRUGS &PHARMACEUTICALS PVT LTD RENE PHARMACEUTICALS LTD 2024-08-17 2029-08-16

1804 Rwanda FDA-HMP-MA-1716 DOLUTEGRAVIR Dolutegravir 50mg Tablets 30’s, 60’s & 90 Tablets HDPE 48 Months MICRO LABS LIMITED Plot No. S-155 to S-159 & N1, Phase III & IV, Verna Industrial Estate, Verna INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICAL (RWANDA) LIMITED 2024-08-17 2029-08-16

1805 Rwanda FDA-HMP-MA-2015 GABAR 25MG PREGABALIN 25MG Capsules 56 Capsules Blisters of aluminium and Double plastic bag of LDPE 36 months LABORATORIOS LICONSA, S.A Avda. Miralcampo, No7, Polígono Industrial Miralcampo- 19200 Azuqueca Henares (Guadalajara).Spain SPAIN FAES FARMA, S.A., Maximo Aguire 14-48940 Leioa, SpainPhone : 0034944818300Telefax : 0034944818309Email : ihermo@faes.es , ieguidazu@faes.es UBIPHARM-RWANDA LTD 2024-08-17 2029-08-16

1806 Rwanda FDA-HMP-MA-1551 G-OUT PLUS Colchicine Tablets 1mg Film coated Tablets 10 Tablets ALU / WHITE OPAQUE PVC/PVDC BLISTER 24 Months MACLEODS PHARMACEUTICALS LIMITED 304, Atlanta Arcade, Marol Church road, Andheri (East), India INDIA MACLEODS PHARMACEUTICALS LIMITED WESSEX PHARMACEUTICAL (RWANDA)LTD 2024-08-17 2029-08-16

1807 Rwanda FDA-HMP-MA-1717 COSATRIM 400/80 TABLETS Sulphamethoxazole&trimethroprim 400/80mg Tablets 10x10 Tablets, 100 x10 Tablets and in 1000 Tablets PVC/ALUMINIUM and HDPE containers 36 Months COSMOS LIMITED Rangwe road; off Lunga Lunga road, industrial area, P.O. box 41433, GPO 00100 - Nairobi, Kenya KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1808 Rwanda FDA-HMP-MA-2016 LC DOPA LEVODOPA/CARBIDOPA 250MG/ 25MG Film Coated Tablets 50 Tablets Jar pack 36 months AGOG PHARMA LTD Plot No. 33, Sector Ii, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1809 Rwanda FDA-HMP-MA-1559 CO-MICARDIS 40/12.5 TABLETS Telmisartan / Hydrochlorothiazide 40/12.5mg Tablets 7 or 10 Tablets ALU-ALU BLISTER PACK 36 Months BOEHRINGER INGELHEIM ALLAS A.E, 5th km Paiania-Markopoulo Koropi Attiki 19400, Greece GREECE BOEHRINGER INGELHEIM INTERNATIONAL GMBH SURGIPHARM RWANDA LTD 2024-08-17 2029-08-16

1810 Rwanda FDA-HMP-MA-1718 MELASIL TABLETS Metaclopramide HCL 10mg Tablets 10x10 Tablets, 100 x10 Tablets and in 1000 Tablets PVC/ALUMINIUM FOIL and HDPE containers 36 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

1811 Rwanda FDA-HMP-MA-2017 XYLOCAINE GEL 2% XYLOMETAZOLINE HYDROCHLORIDE 20MG GEL 30 g Tube Collapsible tubes and contained in a unit box with literature insert 24 Months RECIPHARM KARLSKOGA AB Björkbornsvägen 5, SE-691 33 Karlskoga Sweden BETA HEALTHCARE INTERNATIONAL LTD SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16

1812 Rwanda FDA-HMP-MA-1560 MICARDIS Telmisartan 80mg Tablets 14, 28, 56, 84 or 98 tablets BLISTER 48 Months BOEHRINGER INGELHEIM ALLAS A.E, 5th km Paiania-Markopoulo Koropi Attiki 19400, Greece GREECE BOEHRINGER INGELHEIM INTERNATIONAL GMBH SURGIPHARM RWANDA LTD 2024-08-17 2029-08-16

1813 Rwanda FDA-HMP-MA-1719 DEXAMED EYE/EAR DROPS Dexamethasone Sodium Phosphate USP 0.1%W/V EYE/EAR DROPS 10mL plastic droppers CLEAR PLASTIC DROPPERS CONTAINED IN A UNIT BOX 24 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

1814 Rwanda FDA-HMP-MA-2018 ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE 60/5/30MG TABLETS 30 tablets & 90 Tablets HDPE Bottle 24 Months CIPLA LTD Unit IV, Plot No. 9 & 10, Pharma Zone, Phase-II, Indore Special Economic Zone, Pithampur, Sector – III, District Dhar, Indore, Madya Pradesh, 454775 INDIA CIPLA LTD Phillips Pharmaceuticals (Rwanda) Ltd 2024-08-17 2029-08-16

1815 Rwanda FDA-HMP-MA-1600 CLOTRINE B PESSARY Clotrimazole Pessary 200 mg Pessaries 1 x 3 pessaries ALU/PVC foils 36 Months Universal Corporation Limited Club Road, Plot No. 13777, P.O Box 1748 – 00902 Kikuyu-Kenya Kenya Universal Corporation Limited Sun Enterprises Ltd 2024-08-17 2029-08-16

1816 Rwanda FDA-HMP-MA-1720 ALTOA SUSPENSION Albendazole 200mg/5ml Suspension 10ml Bottles GLASS/PET BOTTLE 36 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

1817 Rwanda FDA-HMP-MA-2019 VIRALEX INOSINE PRANOBEX 500MG TABLETS 6x10 Tablets, 10 Tablets Printed aluminium foil and PVC/PE/PVDC clear film 24 Months THEMIS MEDICARE LIMITED Sector 6A, Plot No. 16, 17 & 18, IIE, SIDCUL, Haridwar– 249403, Uttarakhand. INDIA INDIA THEMIS MEDICARE LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16

1818 Rwanda FDA-HMP-MA-1599 RENEDOL TABLETS Paracetamol BP 500 mg Tablets 10x10 or 1000 tablets Aluminum/transparent PVC blister strip or Polythene bag in HDPE container 24 Months Rene Industries Ltd Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda. Uganda Rene Industries Ltd Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16

1819 Rwanda FDA-HMP-MA-1721 PHENYTOIN 100MG TABLETS Phenytoin sodium 100mg Tablets 10x10 Tablets, 100 x10 Tablets and in 1000 Tablets PVC/ALUMINIUM FOIL and HDPE containers 36 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

1820 Rwanda FDA-HMP-MA-2020 ROLINOZ ORAL DROPS CETIRIZINE 10MG/ML ORAL DROPS 20ml Bottle 36 Months World Medicine ?laç San. ve Tic. A.?. 15 Temmuz Mah. Camiyolu Cad. No:50, K:1B-Zemin-4-5-6 Güne?li – Ba?c?lar, ?stanbul Turkey World Medicine ?laç San. ve Tic. A.? Goodman International LTD (R) 2024-08-17 2029-08-16

1821 Rwanda FDA-HMP-MA-1607 EFFERALGAN 300 SUPPOSITORY Paracetamol 300 mg Suppositories 10 Suppositories PVC/PE Blisters 36 Months UPSA 979 and UPSA 304 Avenue des Pyrénées 47520 Le Passage – France and avenue du Docteur Jean Bru 47000 agents – France France UPSA SAS, France Kipharma Ltd 2024-08-17 2029-08-16

1822 Rwanda FDA-HMP-MA-1722 COSMAG ANTACID TABLETS Magnesium Trisilicate and Dried Aluminium Hydroxide 250/120mg Tablets 10x10 Tablets and 1000 Tablets PVC/ALUMINIUM FOIL and HDPE containers 36 Months COSMOS LIMITED Rangwe road; off Lunga Lunga road, industrial area, P.O. box 41433, GPO 00100 - Nairobi, Kenya KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1823 Rwanda FDA-HMP-MA-2021 LASTAVIN 80 VALSARTAN USP 80 MG TABLETS 3x10 Tablets ALU/PVC BLISTER 30 Months Ajanta Pharma Limited Plot No. B-4/5/6, MIDC Area Paithan, Aurangabad-431148, Taluka: Paithan, District: Aurangabad Zone 2 Country : India INDIA Ajanta pharma Limited ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1824 Rwanda FDA-HMP-MA-1594 CARTIL FORTE Glucosamine and Chondroitin 500 mg/200 mg Tablets 6×5 Tablets Alu-Alu Blisters 36 Months M/S Skybiotech lifesciences Pvt. Ltd Gut no.: 5, Gevrai Tanda, Paithan Road, Aurangabad (M.S.) India India Galaxy Pharmaceuticals, India Star Biotech Limited 2024-08-17 2029-08-16

1825 Rwanda FDA-HMP-MA-1723 FALCIDIN SP – ANTIMALARIAL TABLETS Sulphadoxine and pyrimethamine 500/25mg Tablets 75 Tablets PVC/ALUMINIUM FOIL 36 Months COSMOS LIMITED Rangwe road; off Lunga Lunga road, industrial area, P.O. box 41433, GPO 00100 - Nairobi, Kenya KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1826 Rwanda FDA-HMP-MA-2022 COFANTRINE ARTEMETER & LUMEFANTRINE 180MG/1080MG POWDER FOR ORAL SUSPENSION 60ml Bottle HDPE 24 Months Bliss GVS Pharma Limited Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane – 401404 Country: India INDIA IMEX PHARMA, Maurice Mediasol Pharmaceutical Depot Ltd 2024-08-17 2029-08-16

1827 Rwanda FDA-HMP-MA-1598 MINT-O-COOL TABLETS Magnesium Trisilicate and Dried Aluminium Hydroxide gel 250 mg/120 mg Tablets 10x10 Tablets Aluminium/transparent PVC blister strip 24 Months RENE INDUSTRIES LTD Plot No.680, P.O. Box 6034 Kamuli, Kireka, Kampala, Uganda. Uganda Rene Industries Ltd Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16

1828 Rwanda FDA-HMP-MA-1724 COZEPAM 5 TABLETS Diazepam 5mg Tablets 10x10 Tablets PVC/ALUMINIUM FOIL 36 Months COSMOS LIMITED Rangwe road; off Lunga Lunga road, industrial area, P.O. box 41433, GPO 00100 - Nairobi, Kenya KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1829 Rwanda FDA-HMP-MA-2023 ANASTROZOLE NEAPOLIS ANASTROZOLE 1MG TABLETS 3x10 Tablets ALU/PVC BLISTER 24 Months NEAPOLIS PHARMA Road of Tunis Km7 BP 206 Nabeul 8000, Tunisia. TUNISIA NEAPOLIS PHARMA KIPHARMA LTD 2024-08-17 2029-08-16

1830 Rwanda FDA-HMP-MA-1605 FOLIC ACID TABLETS Folic acid BP 5 mg Tablets 10x10 or 1000 tablets Aluminum/transparent PVC blister strip or Polythene bag in HDPE container 24 Months RENE INDUSTRIES LTD Plot No.680, P.O. Box 6034 Kamuli, Kireka, Kampala, Uganda. Uganda Rene Industries Ltd Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16

1831 Rwanda FDA-HMP-MA-1725 FUROSEMIDE TABLETS 40MG Furosemide 40mg Tablets 11x10 Tablets PVC/ALUMINIUM BLISTER 36 Months COSMOS LIMITED Rangwe road; off Lunga Lunga road, industrial area, P.O. box 41433, GPO 00100 - Nairobi, Kenya KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1832 Rwanda FDA-HMP-MA-2024 MALAVAN 60 ARTESUNATE 60MG Powder for Injection 1 x 3 AMPOULES Double polyethylene bags thermally sealed and kept in HDPE bottles 24 Months Bliss GVS Pharma Limited Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane –401404, India INDIA IMEX PHARMA, Maurice Mediasol Pharmaceutical Depot Ltd 2024-08-17 2029-08-16

1833 Rwanda FDA-HMP-MA-1591 BROMOLON Brimonidine Tartrate 0.2% w/v Solution 5 mL Bottle 5 mL LDPE bottle 24 Months M/s. FDC LIMITED B-8, MIDC Industrial area, Waluj, Aurangabad – 431136 Maharashtra India. India Bliss GVS Pharma Limited, India Surya Depot Pharmacy Limited 2024-08-17 2029-08-16

1834 Rwanda FDA-HMP-MA-1726 NIFURAN TABLETS Nitrofurantoin BP 100mg Tablets 10x10 Tablets PVC/ALUMINIUM FOIL 36 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

1835 Rwanda FDA-HMP-MA-2025 METRONIDAZOLE ORAL SUSPENSION BP METRONIDAZOLE BENZOATE BP 125MG/5ML ORAL SUSPENSION 100ml Bottle Glass bottle with ROPP cap 36 Months Aura Life Care Pvt Ltd Survey No 254/ 14/1,Jarod ,Savli Road, P.O. Karachiya, Tal-Savli ,Dist : Vadodara-391520. Gujarat State, INDIA INDIA AURA LIFECARE PVT. LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1836 Rwanda FDA-HMP-MA-1603 CHEWCEE TABLETS Ascorbic acid 100 mg Tablet 10x10 Tablets or 1000 tablets Aluminium/amber PVC blister strip or polythene bag in HDPE container 24 Months Rene Industries Ltd Plot No.680, Kamuli, Kireka, Kampala, Uganda. India Rene Industries Ltd Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16

1837 Rwanda FDA-HMP-MA-1727 VINGRAF 1 Tacrolimus 1mg capsules 6x10 Capsules ALUMINIUM FOIL BLISTERS 24 Months M/s RIVPRA FORMULATIONS PVT Plot no.8, sector-6 A, II E, SIDCUR, Haridwar, India INDIA M/s RIVPRA FORMULATIONS PVT ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1838 Rwanda FDA-HMP-MA-2026 GEMCITABINE NEAPOLIS GEMCITABINE HYDROCHLORIDE 1G POWDER FOR SOLUTION FOR INFUSION 1 vial of 1g Type I glass vial 24 Months NEAPOLIS PHARMA Road of Tunis Km7 BP 206 Nabeul 8000, Tunisia. TUNISIA NEAPOLIS PHARMA KIPHARMA LTD 2024-08-17 2029-08-16

1839 Rwanda FDA-HMP-MA-1604 DICLOREN TABLETS Diclofenac Sodium BP 50 mg Tablets 10x10 Tablets Aluminium/PVC blister strip 24 Months RENE INDUSTRIES LTD Plot No.680, Kamuli, Kireka, Kampala, Uganda. India Rene Industries Ltd Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16

1840 Rwanda FDA-HMP-MA-1728 MOMEX Mometasone furoate monohydrate 50µg per actuation Nasal spray 1 bottle with 18 g of suspension HDPE BOTTLE WITH POLYPROPYLENE ACTUATOR 24 Months DEVA HOLDING A.?. Çerkezköy Organize Sanayi Bölgesi (ÇOSB), Karaa?aç Mah. Atatürk Cad., No: 32 Kapakl?- Tekirda?/Turkey Phone: 90 282 73520 00 E-mail: info@deva.com.tr TURKEY DAFRA PHARMA SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1841 Rwanda FDA-HMP-MA-2027 ISONIAZID ISONIAZID 300MG TABLET 10x10 Tablets Amber PVC/PVDC Blister and Aluminium Blister 24 Months Lupin Limited EPIP, SIDCO Industrial Complex Kartholi, Bari Brahmana Jammu (J&K)- 181133, India INDIA Lupin Limited Aiveen ® Ltd 2024-08-17 2029-08-16

1842 Rwanda FDA-HMP-MA-1609 APDROPS Moxifloxacin Hydrochloride Eye Drops 0.5% w/v Eye Drops 3 mL or 5 mL LDPE vial 36 Months Ajanta Pharma Limited Mirza - Palashbhari Road, Vill. – Kokhjar, Kamrup (R), Guwahati, Assam -781128, India. India Ajanta Pharma Ltd, India Abacus Pharma (A) Ltd 2024-08-17 2029-08-16

1843 Rwanda FDA-HMP-MA-1729 URSOLIV 250. Ursodeoxycholic Acid Each Capsule Contains Ursodeoxycholic Acid 250mg Capsules 5x10 Capsules ALUMINIUM FOIL-PVC/PVD FILM 36 Months MEGA LIFESCIENCES PUBLIC COMPANY LIMITED 515 MOO 4, SOI 8, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280. Country: THAILAND Telephone: Telefax: +66-2-401-8686 +66-2-324-0451 E-Mail: snehal@megawecare.com THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1844 Rwanda FDA-HMP-MA-2028 Gastica Suspension Simethicone Emulsion, Calcium Carbonate, Magnesium Hydroxide & Magnesium Trisilicate Suspension 83mg, 400mg, 120mg & 50mg Oral Liquid 200ml Bottle AMBER COLOUR PET ROUND BOTTLES 24 Months ENICAR PHARMACEUTICAL Pvt. Ltd J-214,215,216 M.I.D.C TarapurBoisar, Dist-Palghar- 401506 INDIA ENICAR PHARMACEUTICAL Pvt. Ltd STAR BIOTECH LIMITED 2024-08-17 2029-08-16

1845 Rwanda FDA-HMP-MA-1610 DAWA-CPM TABLET Chlorpheniramine Maleate BP 4 mg Tablets 10x10 Tablets Aluminium foil/Clear PVC blister 36 Months Dawa Limited Plot No: 7879/8, Baba Dogo Road, Ruaraka; POBox 16633-00620, Nairobi, Kenya. Kenya Dawa Limited Sun Enterprises limited 2024-08-17 2029-08-16

1846 Rwanda FDA-HMP-MA-1730 COTRIKANT-480 Trimethoprim BP Sulfamethoxazole BP 80 mg and 400 mg Tablets 10x10 Tablets Alu-PVC BLISTER 36 Months S KANT HEALTHCARE LTD Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat, India Country: India Telephone: +91-260-6539518 Telefax: +91-260-2430527 E-Mail: regulatory@skant.com INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1847 Rwanda FDA-HMP-MA-1608 BIOTRIM DS TABLETS Trimethoprim and Sulphamethoxazole 160 mg/800 mg Tablets 10 x 10 Tablets or 1000 tablets Aluminum foil/blister strip or Polythene bag in HDPE jar 36 Months Biodeal Laboratories Ltd 123 Lunga Lunga road, P.O. Box 32040-00600, Nairobi, Kenya. Kenya Biodeal Laboratories Ltd Capital pharmaceutical supplies Ltd 2024-08-17 2029-08-16

1848 Rwanda FDA-HMP-MA-1731 CIPROKANT-500 Ciprofloxacin Hydrochloride USP 500 mg Tablets 10x10 Tablets Alu-PVC BLISTER 36 Months S KANT HEALTHCARE LTD Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat, India Country: India Telephone: +91-260-6539518 Telefax: +91-260-2430527 E-Mail: regulatory@skant.com INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1849 Rwanda FDA-HMP-MA-1601 CLOTRINE B CREAM Clotrimazole and Betamethasone dipropionate 1%w/w / 0.05% w/w. Cream 15 grams Tubes Collapsible Aluminium tubes 36 Months M/s Universal Corporation Limited P.O. Box 1748-00902, Kikuyu - Kenya. Kenya Universal Corporation Limited Sun Enterprises Ltd 2024-08-17 2029-08-16

1850 Rwanda FDA-HMP-MA-1732 CIPROLAB-500 TABLETS CIPROFLOXACIN HYDROCHLORIDE USP 500 MG Tablets 10x10 Tablets ALU-PVC 36 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road. Postal Address: 42875 GPO 00100, Country: Kenya. Telephone: +254 20 8040306 Telefax: +254 20 8040309 E-Mail: info@laballied.com KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

1851 Rwanda FDA-HMP-MA-1592 PROXYREN CAPSULES Piroxicam USP 20 mg Capsules 10x10 Capsules Aluminium/ PVC blister strip 24 Months RENE INDUSTRIES LTD Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda. Uganda Rene Industries Ltd Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16

1852 Rwanda FDA-HMP-MA-1733 M-DOPAKANT-250 Methyldopa BP 250mg Tablets 10x10 Tablets ALU-PVC BLISTER 36 Months S KANT HEALTHCARE LTD 1802-1805, G.I.D.C. Phase III, Vapi 396195. Gujarat, India. Country: India Telephone: +91-260-6539518 Telefax: +91-260-2430527 E-Mail: regulatory@skant.com INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1853 Rwanda FDA-HMP-MA-1593 REZEPINE TABLETS Carbamazepine BP 200 mg Tablets 10 x 10’s or 1000 tablets Aluminium/PVC blister strip or polythene bag in HDPE container 36 Months RENE INDUSTRIES LTD Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda. Uganda Rene Industries Ltd Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16

1854 Rwanda FDA-HMP-MA-1734 IBUPROFEN ORAL SUSPENSION Ibuprofen 100 mg/5ml Suspension 100 mg/5 ml PET BOTTLE AND CARTON WITH AN INSERT 36 Months S KANT HEALTHCARE LTD Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat, India Country: India Telephone: +91-260-6539518 Telefax: +91-260-2430527 E-Mail: regulatory@skant.com INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1855 Rwanda FDA-HMP-MA-1595 DOL-P TABLET Tramadol and Paracetamol 37.5 mg/325 mg Tablets 1x10 Tablets Alu/Alu Blister 24 Months Genix Pharma (Pvt) Ltd 44, 45B, Korangi Creek Road, Karachi. Pakistan Pakistan Genix Pharma (Pvt) Ltd Bonte Pharma 2024-08-17 2029-08-16

1856 Rwanda FDA-HMP-MA-1735 NEOPRED Neomycin sulfate and Prednisolone sodium phosphate Neomycin sulfate 0.35g +Prednisolone sodium phosphate 0.55g Eye drops 1 vial of 5ml VIALS 24 Months LES LABORATOIRES MEDIS Km 7 Route de Tunis, B.P.206,800 Nabeul, TUNISIA. Country: Tunisia Telephone: (+216-72) 235006/235010/235011 Telephax: (+216-72) 235016/235115/235106 E-mail: contact@labomedis.com TUNISIA LES LABORATOIRES MEDIS KIPHARMA LTD 2024-08-17 2029-08-16

1857 Rwanda FDA-HMP-MA-1596 MICLOCIN CREAM. Miconazole nitrate BP, Clobetasol Propionate BP & Gentamicin (as Sulphate) BP 2% w/w, 0.05% w/w, 0.1% w/w Cream 15 grams Tubes Aluminium tubes 36 Months Dawa Limited Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620. Nairobi, Kenya. Kenya Dawa Limited Sun Enterprises Ltd 2024-08-17 2029-08-16

1858 Rwanda FDA-HMP-MA-1736 IRBIS HT -300/12.5 Irbesartan and Hydrochlorothiazide 300 mg/12.5 mg Film Coated Tablets 3x10 Tablets Alu/PVC/PE/PVdC)BLISTER PACK 36 Months HETERO LABS LIMITED (Unit-V) TSIIC Formulation SEZ, S.No 439, 440, 441 & 458 Polepally village, Jadcherla Mandal, Mahaboob Nagar (Dist) – 509301, Telangana, India Telephone : +91 08542-238400 Telefax : + 91 08542 238404 E-Mail : drkepi@heterodrugs.com INDIA HETERO LABS LIMITED (Unit-V) BION-PHARMA GROUP Limited 2024-08-17 2029-08-16

1859 Rwanda FDA-HMP-MA-1597 BUPITROY HEAVY Bupivacaine Hydrochloride USP 5 mg/ml Solution for injection 4 ml Ampoules Type-I ampoule 24 Months Troikaa Pharmaceuticals Ltd C-1, Sara Industrial Estate, Selaqui, Dehradun-248197, Uttarakhand, India. India Troikaa Pharmaceuticals Ltd Abacus Pharma (A) Limited 2024-08-17 2029-08-16

1860 Rwanda FDA-HMP-MA-1737 IRBIS 300 Irbesartan 300 mg Tablets 3x10 Tablets Alu-PVC/PVDC 36 Months M/S HETERO LABS LIMITED, UNIT-I Kalyanpur Village, Chakkan Road, Baddi, Dist. Solan (H.P). INDIA HETERO LABS LIMITED BION-PHARMA GROUP Limited 2024-08-17 2029-08-16

1861 Rwanda FDA-HMP-MA-1602 RENETRIM TABLETS Sulfamethoxazole and Trimethoprim 400 mg/80 mg Tablets 10x10 or 1000 Tablets Aluminum/transparent PVC blister strip or Polythene bag in HDPE container 36 Months Rene Industries Ltd Plot No.680, P.O. Box 6034 Kamuli, Kireka, Kampala, Uganda. Uganda Rene Industries Ltd Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16

1862 Rwanda FDA-HMP-MA-1738 HENKA 60 Duloxetine Delayed Release Capsules 60 mg Capsules 3x10 Capsules Alu-PVC/PVdC Blister pack. 24 Months M/S HETERO LABS LIMITED, UNIT-I Kalyanpur (Village), Chakkan Road, Baddi (Tehsil), Solan (Dist.), Himachal Pradesh-173205, India. Country : India Telephone : +91 9218677025Telefax : +91 1795245732/247430 E-Mail : prasad.m@heterodrugs.com INDIA HETERO LABS LIMITED BION-PHARMA GROUP Limited 2024-08-17 2029-08-16

1863 Rwanda FDA-HMP-MA-1606 ERYTHROREN Erythromycin 250 mg Tablets 10x10 Tablets Aluminium/PVC blister strips 24 Months Rene Industries Ltd Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda. Uganda Rene Industries Ltd Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16

1864 Rwanda FDA-HMP-MA-1739 GOAB 10 Solifenacin Succinate 10 mg Tablets 3x10 Tablets Alu-PVC Blister pack 24 Months MS. ANNORA PHARMA PRIVATE LIMITED M/S. Annora Pharma Private Limited, Sy.N0.261, Annaram Village Gummadidal Mandal, Sangareddy District. INDIA ANNORA PHARMA PRIVATE LIMITED BION-PHARMA GROUP Limited 2024-08-17 2029-08-16

1865 Rwanda FDA-HMP-MA-1611 ANTADYS Flurbiprofen 100 mg capsules 100 mg Film-coated capsules, 15 or 60 Capsuls PVC/ALUMINIUM BLISTERS PACK 36 Months LABORATOIRES MACORS , RUE DES CAILLOTTES Laboratoires Macors, rue des caillottes, ZI Plaine des Isles, 89000 Auxerre, France FRANCE LABORATOIRE B&O PHARM KIPHARMA LTD 2024-08-17 2029-08-16

1866 Rwanda FDA-HMP-MA-1740 PREGA 75 Pregabalin 75 mg Capsules 10x10 Capsules PVC/ALU BLISTER PACK 36 Months HETERO LABS LIMITED (Unit-III) IDA, #22-110, Jeedimetla, Hyderabad – 500 055, Telangana. Country : India Telephone : +91 1795-247429/245732 Telefax : +91 1795245732/247430 E-Mail : prasad.m@heterodrugs.com jagdish.d@heterodrugs.com INDIA HETERO LABS LIMITED BION-PHARMA GROUP Limited 2024-08-17 2029-08-16

1867 Rwanda FDA-HMP-MA-1612 ARTIM Artemether 80mg/ml 800mg/ml Injection 6x1ml Ampoules USP TYPE I AMBER AMPOULE 24 Months Kilitch Drugs (India) Ltd Kilitch Drugs (India) Ltd, Plot no-C-301/2, M.I.D.C T.T.C, Industrial Area Pawane, Navi, Mumbai-400705, Maharashtra, India INDIA KILITCH DRUGS (INDIA) LIMITED WESSEX PHARMACEUTICAL (RWANDA) LTD 2024-08-17 2029-08-16

1868 Rwanda FDA-HMP-MA-1741 COSMOL TABLETS 500MG Paracetamol 500 mg Tablets 100 Tablets ALU-PVC BLISTER 36 Months COSMOS LIMITED RANGWE ROAD; OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA, P. O. BOX 41433, GPO 00100 - NAIROBI, Country: KENYA. Telephone: +(254-20) 8042200 +(254 (0) 709864000 Telefax: N/A E-Mail: registration@cosmos-pharm.com KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1869 Rwanda FDA-HMP-MA-1625 KRYXANA 200MG FILM-COATED TABLETS Ribociclib 200mg 200mg Film-coated tablets 63 Tablets PCTFE/PVC BLISTER PA/AL/PVC BLISTER 36 Months Lek Pharmaceuticals d.d., Lek Pharmaceuticals d.d., Verovškova ulica 57, Ljubljana, 1526, Slovenia SLOVENIA NVS KENYA LIMITED SURGIPHARM RWANDA LIMITED 2024-08-17 2029-08-16

1870 Rwanda FDA-HMP-MA-1742 ZABITERON-250 Abiraterone Acetate USP 250 mg Tablets 120 Tablets HDPE BOTTLE WITH 1 SILICA GEL PUCH AND COTTON 24 Months ZUVIUS LIFESCIENCES PVT. LTD. B/108,109 & 111, Kanara Business Centre, Near Everest Garden, Link Road, Ghatkopar East), Mumbai-400075, India. Tel. No.: + 91 22 67653561 / +91 22 67653562 E-Mail: info@zuviuslifesciences.in INDIA ZUVIUS LIFESCIENCES PVT. LTD. KIPHARMA LTD 2024-08-17 2029-08-16

1871 Rwanda FDA-HMP-MA-1613 TRIMOXOL SUSPENSION Each 5 ml of oral suspension contains Sulfamethoxazole BP 200mg and Trimethoprim BP 40mg 200mg/40mg/5ml Oral suspension 100ml Botlle PET BOTTLES 36 Months Dawa Limited Dawa Limited. Plot No. 7879/8, Baba Dogo Rd, Ruaraka, P.O. Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1872 Rwanda FDA-HMP-MA-1743 TOTOMOL SUSPENSION Paracetamol BP 120mg/5ml Suspension 60mL/100mL Bottles AMMBER PET/GLASS BOTTLES 36 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road. Postal Address: P.O Box 42875 GPO 00100 Nairobi, Country: Kenya. Telephone: +254 20 8040306 Telefax: +254 20 8040309 E-Mail: info@laballied.com KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

1873 Rwanda FDA-HMP-MA-1614 ARTEMETHER 20MG & LUMEFANTRINE 120MG TABLETS Artemether 20mg & Lumefantrine 120mg tablets 20mg/120mg Tablets 30 x 1 x 6’s, 30 x 1 x 12’s, 30 x 1 x 18’s, 30 x 1 x 24’s Tablets PVC/PRINTED ALUMINIUM FOIL 36 Months Ipca laboratories limited, Ipca laboratories limited, Plot No. 255/1 Village Athal, Silvassa-396230, Union Territory of Dadra and Nagar Haveli and Daman and Diu, India INDIA IPCA LABORATORIES LIMITED SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1874 Rwanda FDA-HMP-MA-1744 SKAZI 200 Azithromycin USP 200 mg/5ml Suspension 15 ml Bottles DOUBLE LDPE-HDPE Bottles 36 Months S KANT HEALTHCARE LTD Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat, India Country:India Telephone:+91-260-6539518 Telefax:+91-260-2430527 E-Mail: regulatory@skant.com INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1875 Rwanda FDA-HMP-MA-1745 SANAXONE Ceftriaxone Sodium USP 1000mg Powder for injection 10ml Vials TYPE III GLASS VIALS-BUTYL RUBBER STOPPER 36 Months M/S SANSE LABORATORIES PVT LTD VI/51B,P.B.NO 2 Kozhuvanal,pala Kottayam-686573 Kerala, Country: India Phone: +914822268877/267799 Fax: +914822269406 Email: info@sancepharma.com Website: www.sancepharma.com INDIA M/S SANSE LABORATORIES PVT LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1876 Rwanda FDA-HMP-MA-1616 BEKRACINE- 200 DISPERSIBLE TABLET Cefixime 200mg 200mg Dispersible Tablets 1×10 Tablets ALUMINIUM /ALUMINIUM BLISTERS PACK 24 Months Baroque Pharmaceuticals Pvt Ltd, Baroque Pharmaceuticals Pvt Ltd, 192/2 & 3, Sokhada-388 620 Tal: Khambhat, Dist. Anand Gujarat, India INDIA Bekra Pharma UK Ltd UBIPHARM RWANDA LTD 2024-08-17 2029-08-16

1877 Rwanda FDA-HMP-MA-1746 CABALIN 25 Pregabalin 25 mg Capsules 2x12 Capsules ALU-PVDC BLISTER 24 Months CACHET PHARMACEUTICALS PVT LTD Thana, Baddi, Himachal Pradesh-173 205 INDIA CACHET PHARMACEUTICALS PVT LTD Wessex Pharmaceuticals Ltd 2024-08-17 2029-08-16

1878 Rwanda FDA-HMP-MA-1617 CLOXVID -250MG Cloxacillin Sodium Capsules USP 250 mg 250mg Hard gelatin capsule 10×10 Capsules ALU/PVC BLISTER 36 Months Scott- Edil Advance Research Laboratories & Education Ltd, Scott- Edil Advance Research Laboratories & Education Ltd, Hill Top Industrial Area, Bhatoli Kalan, Baddi- 173205, (HP), India INDIA Scott-Edil Advance Research Laboratories & Education SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1879 Rwanda FDA-HMP-MA-1747 VALEPSY-300 Gastro-Resistant Sodium Valproate 300 mg Tablets 10x10 Tablets ALU-ALU BLISTER 36 Months MAXTAR BIO-GENICS K.No.705, Nalagarh road, Malku Majra, (Baddi), Tehsil Nalagarh, Distt. Solan, Himachal Pradesh-173205 INDIA MAXTAR BIO-GENICS SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1880 Rwanda FDA-HMP-MA-1618 EFFERALGAN 500 MG, EFFERVESCENT SECABLE Paracetamol 500mg effervescent tablet 500mg Efervescent secable tablets 16 tablets HEAT-SEALED BLISTER PACK (ALUMINIUM /PE)/16 TABLETS IN POLYPROPYLENE TUBE 36 Months UPSA 979, UPSA 979, Avenue des Pyrénées, 47520 Le Passage - France FRANCE UPSA SAS UBIPHARM RWANDA LTD 2024-08-17 2029-08-16

1881 Rwanda FDA-HMP-MA-1748 VALEPSY-200 Gastro-Resistant Sodium Valproate 200 mg Tablets 10x10 Tablets ALU-ALU BLISTER 36 Months MAXTAR BIO-GENICS K.No.705, Nalagarh road, Malku Majra, (Baddi), Tehsil Nalagarh, Distt. Solan, Himachal Pradesh-173205 INDIA MAXTAR BIO-GENICS SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1882 Rwanda FDA-HMP-MA-1626 GLYCOREN TABLETS Glibenclamide 5 mg 5 mg Tablets 10 tablets ALUMINIUM /PVC BLISTERS 36 Months RENE INDUSTRIES LTD Rene Industries Limited, PO Box 6034, Plot No 680, Kamuli, Kireka, Kampala, Uganda UGANDA Rene Industries Limited, RENE PHARMACY (R) LTD 2024-08-17 2029-08-16

1883 Rwanda FDA-HMP-MA-1749 VALEPSY-500 Gastro-Resistant Sodium Valproate 500 mg Tablets 10x10 Tablets ALU-ALU BLISTER 36 Months MAXTAR BIO-GENICS K.No.705, Nalagarh road, Malku Majra, (Baddi), Tehsil Nalagarh, Distt. Solan, Himachal Pradesh-173205, India INDIA MAXTAR BIO-GENICS SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1884 Rwanda FDA-HMP-MA-1619 IBUPAR SUSPENSION Ibuprofen BP 100mg and Paracetamol BP 120mg 100mg/120mg/5ml Oral suspension 60ml and100ml Bottles AMBER COLOURED PET BOTTLE 36 Months Dawa Limited Dawa Limited. Plot No. 7879/8, Baba Dogo Rd, Ruaraka, P.O. Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1885 Rwanda FDA-HMP-MA-1750 CANI-MAKS Clotrimazole BP 1 % w/w Cream 20 g Tubes ALUMINIUM TUBE 36 Months S KANT HEALTHCARE LTD Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat, India INDIA S KANT HEALTHCARE LTD. ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1886 Rwanda FDA-HMP-MA-1629 KETRODOL INJECTION Phytometadione BP inj. 10mg/ml 10mg/ml Solution for Injection 100x 1ml Ampouls AMBER USP TYPE I AMPOULE 24 Months Ciron drugs & Pharmaceuticals Pvt Ltd Ciron drugs & Pharmaceuticals Pvt Ltd, N-118,119,113,119/1,119/2 & 118/1, M.I.D.C., Tarapur, Boisar, Dist. Palghar - 401 506, India INDIA Ciron drugs & Pharmaceuticals Pvt Ltd RENE PHARMACY (R) LTD 2024-08-17 2029-08-16

1887 Rwanda FDA-HMP-MA-1751 PANSIPTIN 100 Sitagliptin Hydrochloride Monohydrate 100 mg Film Coated Tablets 14 Tablets PVC/PE/PVDC-ALUMINIUM BLISTER 36 Months SAG MANUFACTURING, S.L.U. Carretera Nacional I, Km. 36 28750 San Agustin de Guadalix (Madrid), Spain SPAIN MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1888 Rwanda FDA-HMP-MA-1752 DEXAMETHASONE SODIUM PHOSPHATE OPHTHALMIC SOLUTION USP Dexamethasone sodium phosphate USP 0.1 % w/v Eye Drops 1×10 mL HDPE BOTTLE 36 Months MERIT ORGANICS LTD. Plot No. 2104/2/A, G.I.D.C., Sarigam, Bhilad, Dist. Valsad - 396 155, Gujarat, India INDIA MERIT ORGANICS LTD. SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1889 Rwanda FDA-HMP-MA-1621 MUCOLYN SYRUP Each 5ml contains Ammonium Chloride 50mg, Bromhexine Hydrochloride 4mg, Chlorpheniramine Maleate 2mg and Dextromethorphan Hydrobromide 5mg 50mg/4mg/2mg/5mg/5ml Syrup 100ml Botlle AMBER GLASS BOTTLES 36 Months Beta Healthcare International Limited, Beta Healthcare International Limited, Plot No. LR 209/6554, Mogadishu Road, Industrial Area, P.O. BOX 42569-00100 GPO Nairobi, Kenya KENYA Shelys Pharmaceuticals Limited SURGIPHARM RWANDA LIMITED 2024-08-17 2029-08-16

1890 Rwanda FDA-HMP-MA-1753 PANSIPTIN 50 Sitagliptin Hydrochloride Monohydrate 50 mg Film Coated Tablets 2×14 Tablets PVC-PE- PVDC-ALUMINIUM BLISTERS 36 Months SAG MANUFACTURING, S.L.U. Carretera Nacional I, Km. 36 28750 San Agustin de Guadalix (Madrid), Spain SPAIN MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1891 Rwanda FDA-HMP-MA-1754 WHITFIELD’S SKIN OINTMENT Benzoic Acid and Salicylic Acid 6.0%w/w / 3.0%w/w Skin Ointment 20 Grams Tubes ALUMINIUM TUBE 36 Months DAWA LIMITED Plot No.7879/8, Baba Dogo Road, Ruaraka. P.O. BOX 16633-00620 Nairobi, Kenya. KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1892 Rwanda FDA-HMP-MA-1628 EFFERALGAN 500 MG TABLETS Paracetamol Ph Eur, 500mg, tablets 500mg TABLETS 2x8 Tablets ALU/PVC or PVDC 36 months UPSA SAS 304 UPSA SAS 304, Avenue du Docteur Jean Bru 47000 Agen – France FRANCE UPSA SAS UBIPHARM RWANDA LTD 2024-08-17 2029-08-16

1893 Rwanda FDA-HMP-MA-1755 ERYTHROKANT Erythromycin Stearate BP 125 mg/5 ml Suspension 100 ml Bottles PET BOTTLE 36 Months S KANT HEALTHCARE LTD Plot No. 1802-1805, G.I.D.C. Phase III,Vapi 396 195. Gujarat, India INDIA S KANT HEALTHCARE LTD. ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1894 Rwanda FDA-HMP-MA-1757 NYSKA-P Nystatin BP 100,000 IU Suspension 30 ml Bottles GLASS BOTTLE 36 Months S KANT HEALTHCARE LTD Plot No. 1802-1805, G.I.D.C. Phase III,Vapi 396 195. Gujarat, India INDIA S KANT HEALTHCARE LTD. ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1895 Rwanda FDA-HMP-MA-1624 VERZOL® ORAL SUSPENSON 4% Albendazole 400 mg 400 mg/10ml Oral suspension 10ml Bottle BROWN- GLASS BOTTLE 36 Months Gracure Pharmaceuticals Limited, Gracure Pharmaceuticals Limited, E- 1105, Industrial Area, Phase-III Bhiwadi, PIN-301019, Dist. Alwar, Rajasthan, India INDIA Exphar s.a, Belgium H & H PHARMA LTD 2024-08-17 2029-08-16

1896 Rwanda FDA-HMP-MA-1758 DAWASTIN ORAL SUSPENSION Nystatin BP 100,000 IU/mL Suspension 30mL & 12mL Bottles AMBER COLORED GLASS BOTTLES 24 Months DAWA LIMITED Plot No.7879/8, Baba Dogo Road, Ruaraka. P.O. BOX 16633-00620 Nairobi, Kenya. KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1897 Rwanda FDA-HBP-MA-0136 WOSULIN -N-100 IU/ML Neutral Insulin Injection 100 IU/ml 100 IU/ml Injection 10ml Vial GLASS VIAL WITH FLUORINTED POLYMER COATED BROMOBUTYL RUBBER STOPPER (OMMIFLEX) AND FLIP OFF SEAL 24 Months Wockhardt Limited Wockhardt Limited, Biotech Park, H-14/2, M.I.D.C, Waluj, Aurangabad – 431 136, Maharashtra, India INDIA Wockhardt Limited, SURGIPHARM RWANDA LIMITED 2024-08-17 2029-08-16

1898 Rwanda FDA-HMP-MA-1759 TACROVATE FORTE OINTMENT Tacrolimus Ointment 0.1% w/w Ointment 10 grams LAMI TUBE 24 Months AUROCHEM LABORATORIES (I) PVT. LTD. 333, Gundecha Ind. Complex, Akurli Rd, Kandivali East Mumbai - 400 101, India INDIA OCHOA LABORATORIES SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1899 Rwanda FDA-HMP-MA-1555 CO-TRIMOXAZOLE 960 Sulfamethoxazole BP and Trimethoprim BP 800 mg/160 mg Tablets 10 Tablets ALU/PVC BLISTER 36 Months AURA LIFECARE Pvt. LTD , Survey No 254/ 14/1, Jarod, Savli Road, P.O. Karachiya, Tal-Savli, Dist. Vadodara-391520. Gujarat State INDIA AURA LIFECARE Pvt. LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1900 Rwanda FDA-HMP-MA-1760 BUSCOMAX Hyoscine Butylbromide 10 mg Tablets 10x10 Tablets ALU-ALU BLISTER 36 Months MAXTAR BIO-GENICS K. No. 705, Nalagarh road, Malku Majra, (Baddi), Tehsil Nalagarh, Distt. Solan, Himachal Pradesh - 173205, INDIA INDIA MAXTAR BIO-GENICS SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1901 Rwanda FDA-HMP-MA-1556 CO-TRIMOXAZOLE-480 Sulfamethoxazole BP and Trimethoprim BP 400 mg/80 mg Tablets 10 Tablets ALU/PVC BLISTER 36 Months AURA LIFECARE Pvt. LTD , Survey No 254/ 14/1, Jarod, Savli Road, P.O. Karachiya, Tal-Savli, Dist. Vadodara-391520. Gujarat State INDIA AURA LIFECARE Pvt. LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1902 Rwanda FDA-HMP-MA-1761 BILAXTEN Bilastine 20 mg Tablets 2x10 Tablets ALU-ALU BLISTER 60 Months FAES FARMA, S.A. Máximo Aguirre, 14; 48940 Leioa (Vizcaya), SPAIN SPAIN FAES FARMA, S,A. C GOMHS Ltd 2024-08-17 2029-08-16

1903 Rwanda FDA-HMP-MA-1579 REZN 20 TABLETS Zinc sulfate monohydrate BP equivalent to elemental Zinc 20 mg Tablets 10 Tablets Blister strip 24 Months RENE INDUSTRIES LTD Plot No 680, P.O. BOX 6034, Kamuli, Kireka, Kampala UGANDA RENE INDUSTRIES LTD RENE PHARMACY 2024-08-17 2029-08-16

1904 Rwanda FDA-HMP-MA-1762 PANTIN 40 Pantoprazole Sodium 40 mg/vial Injection 1 x 1 Vial TYPE-I 10 ML TUBULAR VIAL 24 Months ASPIRO PHARMA LIMITED Survey No. 321, Biotech Park, Phase III, Karkapatla, Markook Mandal,Siddipet District, Telangana (S)-502281, INDIA INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1905 Rwanda FDA-HMP-MA-1580 LUMITER 80/840 MG Artemeter and Lumefantrine 80mg/480mg Tablets 15 Tablets PVC/PE/PVDC-ALU 24 Months MACLEODS PHARMACEUTICALS LIMITED Oxalis labs G block, village Theda, P.O Lodhimjra, Baddi, Dist.solan, Himachal Pradesh, 174101 INDIA MACLEODS PHARMACEUTICALS LTD AIVEEN RWANDA LTD 2024-08-17 2029-08-16

1906 Rwanda FDA-HMP-MA-1763 CLARITHROMYCIN Clarithromycin 500 mg Film Coated Tablets 7's, 10's, 14's or 21 Tablets PVC/PVDC ALUMINIUM BLISTER 36 Months SANDOZ S.R.L. Street Livezeni nr. 7A RO-540472 Targu Mures, Romania AUSTRIA SANDOZ GmbH SURGIPHARM RWANDA LIMITED 2024-08-17 2029-08-16

1907 Rwanda FDA-HMP-MA-1581 EROSTIN-20 Ebastine 20 mg Tablets 1x10 Tablets ALU/ALU BLISTER 36 Months MICRO LABS LIMITED 92, Sipcot, hour-635 126 INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16

1908 Rwanda FDA-HMP-MA-1764 VERZOL Albendazole USP 200 mg Suspension 10 ml Brown-glass bottle or 20 sticks made of polyethylene terephthalate-aluminium-polyethylene terephthalate polyethylene of 10 ml 10 ML BROWN-GLASS BOTTLE 36 Months GRACURE PHARMACEUTICALS LIMITED E-1105, Industrial Area, Phase-III BHIWADI, PIN-301019, Dist. Alwar, Rajasthan, India INDIA EXPHAR S.A H&H PHARMA LIMITED 2024-08-17 2029-08-16

1909 Rwanda FDA-HMP-MA-1582 EFAVIRENZ 400 MG, LAMIVUDINE 300 MG AND TENOFOVIR DISOPROXIL FUMARATE 300 MG TABLETS Efavirenz USP, Lamivudine USP and Tenofovir Disoproxil fumarate 400 mg/ 300 mg/300mg equivalent to 245 mg Tablets 30 Tablets HDPE CONTAINER 24 Months MACLEODS PHARMACEUTICALS LIMITED Block n2, Theda, P.O Lodhimjra, Tehsil Baddi, Dist. Solan, Himachal Pradesh-174101 INDIA MACLEODS PHARMACEUTICALS LIMITED CAPITAL PHARM SUPPLIES LTD 2024-08-17 2029-08-16

1910 Rwanda FDA-HMP-MA-1765 DICYNONE Etamsylate 250mg/2ml Solution for Injection 4 x 2 ml Ampoules TYPE I GLASS AMPOULE 60 Months DELPHARM Dijon,6 boulevard de l'europe 21800 Quetinyl,France FRANCE OM PHARMA SA KIPHARMA LTD 2024-08-17 2029-08-16

1911 Rwanda FDA-HMP-MA-2032 GLYDA 10 Dapagliflozin Tablets 10mg 10 mg Tablets 10’s Alu/Alu Blister Pack 24 Months HETERO LABS LIMITED M/s Hetero Labs Limited, Unit III Plot no 22 – 110, I.D.A Jeedimetla, Hyderabad, Telangana, India. Pin Code – 500 055 INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1912 Rwanda FDA-HMP-MA-1583 OPELAN ODT-10 Olanzapine oral dispersible 10 mg Tablets 10 Tablets ALU/ALU BLISTER 36 Months MICRO LABS LIMITED 92, Sipcot, hosur-635 126 INDIA MICRO LABS LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LIMITED 2024-08-17 2029-08-16

1913 Rwanda FDA-HMP-MA-1766 ABIRAT 500 Abiraterone Acetate USP 500mg Tablets 60 Tablets HDPE CONTAINER 24 Months M/S HETERO LABS LIMITED, UNIT V TSIIC Formulation SEZ, S.No 439, 440,441 & 458, Polepally Village, Jadcherla (Mandal), Mahaboob Nagar (District)-509301, Telangana State, India. INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1914 Rwanda FDA-HMP-MA-2034 BIMAT BIMATOPROST 0.03% W/V EYE DROPS 3 mL LDPE vial 24 Months Ciron Drugs & Pharmaceuticals Pvt. Ltd N-118, 118/1, 119, 119/1, 119/2, 113 MIDC, Tarapur, Boisar. Dist: Thane – 401506 Maharashtra State INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1915 Rwanda FDA-HMP-MA-1584 CLAMOXYL CAPSULES Amoxicillin trihydrate 500 mg Capsules 12 Tablets PVC LAMINATE/ ALUMINIUM FOIL 36 Months GLAXO WELLCOME PRODUCTION Zone industrielle de la Peyennière 53100 Mayenne FRANCE GLAXO SMITH KLINE PHARMACEUTICALS KENYA KIPHARMA LTD 2024-08-17 2029-08-16

1916 Rwanda FDA-HMP-MA-1767 Es-Omecos Esomeprazole 40 mg Tablets 30 Tablets ALU-ALU BLISTERS 24 Months COSMOS LIMITED rangwe road; off lunga lunga road, industrial area, p. o. box 41433, gpo 00100 - nairobi KENYA. COSMOS LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1917 Rwanda FDA-HMP-MA-0170 AZITRINE-250 AZITHROMYCIN 250MG TABLETS 6 Tablets Alu-PVC foil 36 Months BLISS GVS PHARMA LTD Plot 10, 11-A, 12 Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. - Palghar, District-Thane – 401404. INDIA IMEX PHARMA, Maurice Mediasol Pharmaceutical Depot Ltd 2024-08-17 2029-08-16

1918 Rwanda FDA-HMP-MA-1585 MICROLUT Levonorgestrel 0.03 mg Tablets 35 Tablets PVC/PVDC 60 Months BAYER AG Berlin Müllerstraße 178,13353 Berlin GERMANY BAYER EAST AFRICA LIMITED SURGIPHARM RWANDA LIMITED 2024-08-17 2029-08-16

1919 Rwanda FDA-HMP-MA-1768 Erythrox Erythromycin 125mg/5mL Powder for oral suspension 100mL Bottles HDPE bottles 36 Months DAWA LIMITED Plot No. 7879/8, Baba Dogo Rd, Ruaraka. Address: P.O. BOX 16633-00620 City: Nairobi KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1920 Rwanda FDA-HMP-MA-2070 AVAS 40 ATORVASTATIN 40MG TABLETS 3x10 Tablets ALU-ALU Blisters 36 Months MICRO LABS LIMITED 27, Race Course Road, Bangalore 560 001, Karnataka, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16

1921 Rwanda FDA-HMP-MA-1586 PANADOL ADVANCE TABLET Paracetamol 500 mg Tablets 10's, 20's and 100's Tablets PVC/PET 36 Months GLAXOSMITHKLINE DINGARVAN LIMITED Knockbrack, Dungarvan, Co. Waterford IRELAND GLAXOSMITHKLINE CONSUMER HEALTHCARE (IRELAND) LIMITED SURGIPHARM RWANDA LIMITED 2024-08-17 2029-08-16

1922 Rwanda FDA-HMP-MA-1769 METRONIDAZOLE Metronidazole BP 250 mg Tablets 1000 Tablets HDPE Jar 36 Months AURA LIFECARE PVT. LTD. Survey No. 254/14/1, Jarod, Savli Road, P.O. Karachiya, Tal-Savli, Dist: Vadodara – 391520 Gujarat State, INDIA AURA LIFECARE PVT. LTD. SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1923 Rwanda FDA-HMP-MA-2071 FLEXDOL ® TABLETS IBUPROFEN BP, METHOCARBAMOL USP 200MG/500MG TABLETS 10 tablets PVC/aluminium blister pack. 36 Months GRACURE PHARMACEUTICALS LIMITED E-1105, Industrial Area, Phase-III BHIWADI, PIN-301019, Dist. Alwar Rajasthan, india INDIA EXPHAR S.A/BELGIUMA H&H PHARMA LTD 2024-08-17 2029-08-16

1924 Rwanda FDA-HMP-MA-1587 ESOZIM-40 Esomeprazole magnesium trihyrate 40 mg per unit Capsules 10x10 Hard gelatin capsule ALU/ALU BLISTER 30 Months ZIM LABORATORIES LIMITED B-21/22, MIDC Area, Kalmeshwar, Nagpur 441 501, Maharashtra State INDIA ZIM LABORATORIES LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1925 Rwanda FDA-HMP-MA-1770 CISATREX Cisatracurium besilate 2mg/ml Injectable Solution, 5 Ampoules of 5ml Box 24 Months LES LABORATOIRES MÉDIS Route de Tunis.Km7-B.P.206,8000 Nabeul, TUNISIA LES LABORATOIRES MÉDIS KIPHARMA LTD 2024-08-17 2029-08-16

1926 Rwanda FDA-HMP-MA-2072 SMOFKABIVEN GLUCOSE 42%/AA/, LIPID EMULSION 20%. Amino acid solution with electrolytes (Alanine 7.1 g, Arginine 6.1 g, Glycine 5.6 g, Histidine1.5 g, Isoleucine2.5 g, Leucine3.8 g, Lysine3.4 g, Methionine2.2 g, Phenylalanine2.6 g, Proline5.7 g, Serine3.3 g, Taurine0.5 g, Threonine2.2 g, Tryptophan1.0 g, Tyrosine0.20 g, Calcium chloride0.28 g, Sodium glycerophosphate 2.1 g, Magnesium sulphate0.61 g, Potassium chloride 2.3 g, Sodium acetate1.7 g, Zinc sulphate0.0066 g, Glucose127 g, Soya-bean oil, refined11.4 g, Medium-chain triglycerides11.4 g, Olive oil, refined9.5 g, Fish oil, rich in omega-3-acids5.7 g.) 7.1 g, 6.1 g, 5.6 g, 1.5 g, 2.5 g, 3.8 g, 3.4 g, 2.2 g, 2.6 g, 5.7 g, 3.3 g, 0.5 g, 2.2 g, 1.0 g, 0.20 g, 0.28 g, 2.1 g, 0.61 g, 2.3 g, 1.7 g, 0.0066 g, 127 g, 11.4 g, 11.4 g, 9.5 g, 5.7 g. EMULSION FOR INFUSION 493 ml, 986 ml, 1477 ml, 1970 ml, 2463 ml Three chamber bag system 24 Months FRESENIUS Kabi AB Rapsgatan 7, SE-751 74, Uppsala, Sweden Sweden FRESENIUS KABI SOUTH AFRICA PTY) LTD SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16

1927 Rwanda FDA-HMP-MA-1588 COLCIBID-200 Celecoxib 200 mg Capsules 10x10 Capsules ALU/PVC BLISTER 36 Months ZIM LABORATORIES LIMITED B-21/22, MIDC Area, Kalmeshwar, Nagpur 441501, Maharashtra State INDIA ZIM LABORATORIES LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1928 Rwanda FDA-HMP-MA-1771 EASCOF-D Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride & Chlorpheniramine Maleate Syrup 10mg/5mg/2mg Syrup 100 ml Bottles Bottle in one carton along with its pack insert. 24 Months CACHET PHARMACEUTICALS PVT LTD Village - Thana, Near Baddi, Tehsil- Nalagarh, Dist.- Solan, Himachal Pradesh - 173205, INDIA CACHET PHARMACEUTICALS PVT SURGIPHARM RWANDA LIMITED 2024-08-17 2029-08-16

1929 Rwanda FDA-HMP-MA-2073 SMOFKABIVEN PERIPHERAL AMINO ACID SOLUTION WITH ELECTROLYTES, GLUCOSE 13%& LIPID EMULSION (1000 ml contains: Glucose71g, Alanine4.4g, Arginine3.8g, Glycine3.5g, Histidine0.93g, Isoleucine1.6g, Leucine2.3g, Lysine2.1g, Methionine1.3g, Phenylalanine1.6g, Proline3.5g, Serine2.1g, Taurine0.32g, Threonine1.4 g, Tryptophan0.63 g, Tyrosine 0.12 g, Valine2.0 g, Calcium chloride0.18 g, Sodium glycerophosphate1.3 g, Magnesium sulphate0.38 g, Potassium chloride1.4 g, Sodium acetate1.1 g, Zinc sulphate0.004 g, Soya-bean oil, refined8.5 g, Medium-chain triglycerides 8.5 g, Olive oil, refined7.0 g, Fish oil, rich in omega-3-acids4.2 g per 1000ml) 71g, 4.4g, 3.8g, 3.5g, 0.93g, 1.6g, 2.3g, 2.1g, 1.3g, 1.6g, 3.5g, 2.1g, 0.32g, 1.4 g, 0.63 g, 0.12 g, 2.0 g, 0.18 g, 1.3 g, 0.38 g, 1.4 g, 1.1 g, 0.004 g, 8.5 g, 8.5 g, 7.0 g, 4.2 g EMULSION FOR INFUSION 1206 ml, 1448 ml, 1904 ml , 4x1206 ml three chamber inner bag is made of transparent Excel® film and equipped with a port system 24 Months FRESENIUS Kabi AB Rapsgatan 7, SE-751 74, Uppsala, Sweden Sweden FRESENIUS KABI SOUTH AFRICA PTY) LTD SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16

1930 Rwanda FDA-HMP-MA-1589 EMITINO Ondansetron USP 8 mg Tablets 10 Tablets ALU/ALU BLISTER 24 Months CACHET PHARMACEUTIVAL Pvt.LTD Village-Thana, Baddi, Dist. Solan, Himachal Pradesh-173 205 INDIA CACHET PHARMACEUTICALS Pvt LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16

1931 Rwanda FDA-HMP-MA-1772 Wellness Paracetamol Pseudoephedrine HCl Dextromethorphan HBr 325 mg/30 mg/4.5 mg Film Coated Tablets 10x10 Tablets Carton box containing 1 0r 2 (AL / transparent PVC/PVDC ) 36 Months LIPTIS FOR PHARMACEUTICALS & MEDICAL PRODUCTS (S.A.E). Plot no. B/2, 6th industrial zone, 6th of October City. EGYPT LIPTIS FOR PHARMACEUTICALS & MEDICAL PRODUCTS GOODMAN INTERNATIONAL LTD (R) 2024-08-17 2029-08-16

1932 Rwanda FDA-HMP-MA-2074 DREZ-V GEL MICONAZOLE NITRATE & METRONIDAZOLE GEL 2%, 1% GEL 30 g and 5 g tubes Aluminium tubes & Applicator packed in a carton 24 Months STEDMAN PHARMACEUTICALS PVT. LTD C-4, SIDCO Pharmaceutical Complex, Alathur, Thiruporur 603 110, Tamil Nadu, INDIA INDIA STEDMAN PHARMACEUTICAL, PVT. LTD ESCORTS PHARMACEUTICALS LTD 2024-08-17 2029-08-16

1933 Rwanda FDA-HMP-MA-1590 KEMOXYL 500 CAPSULES Amoxicillin BP (Trihydrate) 500 mg Capsules 10x10 Capsules ALU/PVC BLISTER 36 Months LABORATORY & ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, next to Libra House, Mombasa Road. Postal Address:42875 GPO 00100 KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

1934 Rwanda FDA-HMP-MA-1773 CAPETERO Capecitabine 500mg Tablets 120 Tablets HDPE container pack 36 Months HETERO LABS LIMITED UNIT – VI Sy. No.: 410 - 411, TSIIC Formulation SEZ, Polepally village, Jadcherla Mandal, Mahaboob Nagar, (Dist) – 509301, Telangana, INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1935 Rwanda FDA-HMP-MA-2075 AZITAR-500 Azithromycin (Dihydrate) USP 500MG TABLETS 1x3 Tablets Alu-Alu Blister 36 Months MAXTAR BIO-GENICS K.NO. 705, NALAGARH ROAD, MALKU MAZRA, (Baddi), TEHSIL NALARH, DISTT. SOLAN, H.P. India INDIA MAXTAR BIO-GENICS SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1936 Rwanda FDA-HMP-MA-1573 EROCIN250 Erythromycin stearate BP 250 mg Tablets 10x10 Tablets ALU/PVC BLISTER 36 Months MAXTAR BIO-GENECS K No. 705, Nalagarh road, Malku Majra, (Baddi), Tehsil Nalagarh, Distt. Solan, Himachal Pradesh-1732205 INDIA MAXTAR BIO-GENICS SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1937 Rwanda FDA-HMP-MA-1774 TOPHEN-100 Phenytoin 100 mg Film Coated Tablets 10x10 Tablets Blister Pack 36 Months AGOG PHARMA LTD Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, INDIA AGOG PHARMA LTD. SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1938 Rwanda FDA-HMP-MA-2076 DOLIMEX-300 PARACETAMOL BP 300MG POWDER FOR ORAL SOLUTION 12 Sachet of 4g Sachet of laminated foil (Glassin paper + Aluminium + LDPE). 24 Months Bliss GVS Pharma Limited Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane – 401404 INDIA India IMEX PHARMA, Maurice KIPHARMA LTD 2024-08-17 2029-08-16

1939 Rwanda FDA-HMP-MA-1574 AGOLACTONE-25 Spironolactone BP 25 mg Tablets 10 Tablets ALU/PVC BLISTER 36 Months AGOG PHARMA LTD Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1940 Rwanda FDA-HMP-MA-1775 DYGLI– M Sitagliptin Phosphate USP + Metformin Hydrochloride BP 50mg /1000 mg Tablets 3x10 Tables Alu/Alu Printed Aluminum foil / Alu/Alu base foil 24 Months BAFNA PHARMACEUTICALS LTD. No.147, Madhavaram Redhills High Road, Grantlyon, Vadakarai Post, Chennai – 600 052. India Tel: 0091 – 44 - 26320366 INDIA PRISMA PHARMA FZE PRAFIN RWANDA LTD 2024-08-17 2029-08-16

1941 Rwanda FDA-HMP-MA-1575 D-TAM Tamsulosin and Dutasteride 0.4mg/ 0.5mg Tablets 3x10 Tablets ALU/ALU BLISTER 36 Months SKYBIOTECH LIFESCIENCES Pvt.Ltd Gut no.: 5, Gevrai tanda, Paithan road, Aurangabad (m.s.) INDIA STAR BIOTECH LIMITED STAR BIOTECH LIMITED 2024-08-17 2029-08-16

1942 Rwanda FDA-HMP-MA-1776 ARTEMETHER AND LUMEFANTRINE Artemether and Lumefantrine 80mg/480 mg Tablets 1x6 Tablets Alu-PVC blister 36 Months AURA LIFECARE PVT. LTD. Address: Survey No 254/ 14/1, Jarod ,Savli Road, P.O. Karachiya, Tal-Savli , Dist : Vadodara-391520. Gujarat State. INDIA AURA LIFECARE PVT. LTD. SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1943 Rwanda FDA-HMP-MA-2078 MALAVAN 60 Combipack of Artesunate injection, Sodium Chloride injection BP and Sodium Bicarbonate injection BP 60MG POWDER FOR INJECTION 1 kit Glass vials and ampoules 24 Months Bliss GVS Pharma Limited Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane –401404Country: India INDIA IMEX PHARMA, Maurice Mediasol Pharmaceutical Depot Ltd 2024-08-17 2029-08-16

1944 Rwanda FDA-HMP-MA-1576 NOZINAN 25 MG Levomepromazine maleate acid 25 mg Tablets 20 Tablets PVC CLEAR/ALU BLISTER 36 Months SANOFI S.P.S Strada Statale 17, Km 22 67019 Scoppito (AQ) ITALY SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2024-08-17 2029-08-16

1945 Rwanda FDA-HMP-MA-1777 TOTACEF-1000 Cefepime hydrochloride (Sterile) USP 1000 mg Powder for Injection 20 ml Vials Clear transparent USP Type-I glass vial 24 Months MANKIND PHARMA LIMITED Village Kishanpura, P.O. Jamniwala Tehsil- Paonta Sahib, District Sirmour -173025 (Himachal Pradesh), INDIA MANKIND PHARMA LIMITED WESSEX PHARMACEUTICALS(RWANDA) LTD 2024-08-17 2029-08-16

1946 Rwanda FDA-HMP-MA-2079 DEXO Dexamethasone Sodium Phosphate USP 4mg/ml Solution for injection 2ml Ampoule Amber Ampoule 24 Months KILITCH DRUGS (INDIA) LTD 37/39, Ujagar Industrial Estate, W.T.Patil Marg, Deonar, Mumbai- 400 088, Maharashtra INDIA INDIA KILITCH DRUGS (INDIA) LTD SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1947 Rwanda FDA-HMP-MA-1577 PANFOR PR-500 Metformin Hydrochloride Prolonged Release Tablets 500 mg Tablets 10 Tablets ALU FOIL-PVC/PVDC FILM-DMF grade 24 Months INVENTIA HEALTH LIMITED F1-F1/1-F75/1, Additional Ambernath M.I.D.C., Ambernath (East) - 421 506, Dist. Thane INDIA MEGA LIFESCIENCE PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1948 Rwanda FDA-HMP-MA-1778 AZITRINE -500 Azithromycin (as dihydrate) USP 500 mg Film Coated Tablets 3 Tablets Alu-PVC foil 36 Months BLISS GVS PHARMA LIMITED Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Palghar, District- Thane – 401404 INDIA BLISS GVS PHARMA LIMITED MEDIASOL PHARMACEUTICAL DEPOT LTD 2024-08-17 2029-08-16

1949 Rwanda FDA-HMP-MA-2080 ISONIAZID TABLETS BP 300MG ISONIAZID 300MG TABLETS 10x10 Tablets Amber PVC/PVDC Blister and Aluminium Blister 24 Months Lupin Limited EPIP, SIDCO Industrial Complex Kartholi, Bari Brahmana Jammu (J&K)- 181133, India INDIA Lupin Limited AIVEEN (R) LTD 2024-08-17 2029-08-16

1950 Rwanda FDA-HMP-MA-1578 BLEOCIP Bleomycin Sulfate as sterile, freeze-dried powder for reconstitution 15IU Solution for Injection 5 ml Vial Ply-polyehtylene bags/ Aluminimium foil/aluminium tin 36 Months CIPLA LIMITED GOA Unit V, Plot No. S- 103 to S- 105, S-107 to S-112, L-138, L-147, L-147/1 to L-147/3, L-147-A, Verna Industrial Estate, Verna, Salcette, Goa 403 722 INDIA CIPLA LTD KIPHARMA LTD 2024-08-17 2029-08-16

1951 Rwanda FDA-HMP-MA-1779 IBUPROFEN AND PARACETAMOL SUSPENSION Ibuprofen BP & Paracetamol BP 100 MG/125MG Suspension 60 ml bottle Glass Bottles 36 Months AURA LIFECARE PVT. LTD. Survey No 254/ 14/1,Jarod ,Savli Road, P.O. Karachiya, Tal-Savli ,Dist : Vadodara-391520. Gujarat State. AURA LIFECARE PVT. LTD. SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1952 Rwanda FDA-HMP-MA-2081 Jadelle 2 x 75 mg implants Levonorgestrel 75mg Implants 1x10 sets of 2 subdermal implants Peelable Film bag PE nonwoven and PET/PE 60 Months BAYER OY turkuPansiontie 4720210 TurkuFinland Finland Bayer East Africa Limited SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16

1953 Rwanda-FDA-HM-1852 K-FLAM DICLOFENAC POTASSIUM 50MG TABLETS 10 sachets x 1 g, HMHDPE Bag, Fiber board Drum / HDPE Drum 36 months Neopharma Address: Plot No. A-1, 89-95. Industrial city of Abu Dhabi (ICAD), P.O Box 72900, ABU Dhabi, UAE Country: United Arab Emirates Telephone: 00971 2 550 1000 Telefax: 00971 2 550 11 99 UAE NEOPHARM89A1 – 95A1, Industrial City of Abu Dhabi, Mussafah,PO Box 72900 Abu Dhabi, UAETel: 00971 2 5501000Fax: 00971 2 5501199Email: neopharma@neopharma.ae PHILIPS PHARMACEUTICALS RWANDA LTD 2024-08-17 2029-08-16

1954 Rwanda FDA-HMP-MA-1780 FLUDARABINE PHOSPHATE NEAPOLIS Fludarabine Phosphate 25mg/ml Solution for Injection 1 vial of 2 ml Glass vials packed in a box 24 Months NEAPOLIS PHARMA Road of Tunis Km7 BP 206 Nabeul 8000, Tunisia NEAPOLIS PHARMA KIPHARMA LTD 2024-08-17 2029-08-16

1955 Rwanda FDA-HMP-MA-2082 AUGMENTIN 500/62.5MG AMOXICILLIN /CLAVULANIC ACID 500MG/62.5MG TABLETS 2x8 tablets PVC/Aluminium/Polyamide Cold Formed blister 24 Months Glaxo Wellcome Production ZI de la Peyenniere 53100 Mayenne FRANCE GlaxoSmithKline Pharmaceutical Kenya Limited KIPHARMA LTD 2024-08-17 2029-08-16

1956 Rwanda FDA-HMP-MA-1853 TENOFOVIR/LAMIVUDINE TENOFOVIR/LAMIVUDINE 300MG/300MG TABLET 30’s HDPE container. 30’s HDPE container. 24 months HETERO LABS LTD Unit-III) Address: 22-110, Industrial Development Area (IDA), Jeedimetla Hyderabad-500 055 Telangana. India HETERO LAB LTD SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1957 Rwanda FDA-HMP-MA-2083 SERETIDE 50/250MCG DISKUS SALMETEROL XINAFOATE MICRONIZED /FLUTICASONE PROPRIONATE MICRONIZED 50µG/250µG Powder for oral inhalation 28 s or 60s Aluminium foil laminate strip 24 Months Glaxo Wellcome Production Zone Industrielle No. 2 23 Rue Lavoisier 27000 Evreux France GlaxoSmithKline Pharmaceutical Kenya Limited KIPHARMA LTD 2024-08-17 2029-08-16

1958 Rwanda FDA-HMP-MA-1853 MONTEMAC-5 MONTELUKAST 5MG CHEWABLE TABLETS 10 Tablets Alu/Alu Blister pack 36 months. MACLEODS PHARMACEUTICALS LIMITED 304, Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai- 400 059, India, E-mail: exports@macleodspharma.com India Macleods Pharmaceuticals Limited,Village-Theda, P.O. Lodhimajra, Tehsil Baddi, District Solan, Himachal Pradesh, India-174101 AIVEEN RWANDA LTD 2024-08-17 2029-08-16

1959 Rwanda FDA-HMP-MA-2084 CIPYNE PARACETAMOL/ IBUPROFEN/ CODEINE PHOSPHATE 250MG/ 200MG/ 10MG Capsules 30s and 100 Capsules No. 2 White round HDPE jars with HDPE screw cap with an aluminium foil and plastic on board (Induction sealing liner) No. 4 White round HDPE jars with HDPE screw cap with an aluminium foil and plastic on board (Induction sealing liner), PVC/ Aluminium foil blister pack 24 Months VARICHEM PHARMACEUTICALS PVT LTD Address: 194 Gleneagles Road, Willlowvale, Harare -Zimbabwe, Telephone: +263 8677620181-7 Telefax: N/A E-Mail: kampotap@varipharm.co.zw Zimbabwe VARICHEM PHARMACEUTICALS PVT LTD ACTIVIS PHARMA LTD 2024-08-17 2029-08-16

1960 Rwanda-FDA-HM-1854 VALSAR HT 160/25 VALSARTAN AND HYDROCHLOROTHIAZIDE 160MG/25MG TABLETS 10’s Alu-Alu Blister pack 24 Months Hetero Labs Limited (Unit-V) Address : TSIIC Formulation SEZ, S.No 439, 440, 441 & 458 Polepally village, Jadcherla Mandal, Mahaboob Nagar (Dist) –509301, Telangana. Country : India Telephone : +91-8542-238400 Telefax : +91-8542 238404 E-Mail : contact@heterodrugs.com India HETERO LAB LTD BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1961 Rwanda FDA-HMP-MA-0710 EROCIN-250 EURTHROMYCIN STREATE BP 250MG TABLETS 10x10 Tablets Alu-PVC blisters packed in a unit carton 36 Months LABORATORY & ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LIMITED Depot Pharmaceutique Le Medical 2024-08-17 2029-08-16

1962 Rwanda-FDA-HM-1855 VALSAR HT 80/12.5 VALSARTAN AND HYDROCHLOROTHIAZIDE 80MG/12.5MG TABLETS 10’s Alu-Alu Blister pack 24 Months Hetero Labs Limited (Unit-V) Address : TSIIC Formulation SEZ, S.No 439, 440, 441 & 458 Polepally village, Jadcherla Mandal, Mahaboob Nagar (Dist) –509301, Telangana. Country : India Telephone : +91-8542-238400 Telefax : +91-8542 238404 India HETERO LAB LTD BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1963 Rwanda FDA-HMP-MA-2085 EFFERALGAN 1000 MG FRUITS ROUGES COMPRIME EFFERVESCENT PARACETAMOL 1000MG EFFERVESCENT TABLETS 8 effervescent tablets The polyethylene stopper and Polypropylene Tube 36 Months UPSA SAS 304, Avenue du Docteur Jean Bru 47000 Agen – France FRANCE UPSA SAS UBIPHARM-RWANDA LTD 2024-08-17 2029-08-16

1964 Rwanda-FDA-HM-1856 EFAVIRENZ,LAMIVUDINE,TENOFOVIR FUMARATE EFAVIRENZ,LAMIVUDINE,TENOFOVIR FUMARATE 600MG/300MG/300MG TABLETS 30’s HDPE container 24 Months Hetero Labs Limited (Unit-III) Address: Industrial Development Area (IDA), : Jeedimetla : Hyderabad-500 055 : Telangana. Country: India Telephone : 91-40-23096171/72/73/74 Telefax : 91-40-23095105, 23097756, 23140376 E-Mail: contact@heterodrugs.com India HETERO LAB LTD BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1965 Rwanda FDA-HMP-MA-2086 GLIPMEVIA 50/1000 SITAGLIPTIN + METFORMIN HCL 50/1000MG TABLETS 3x10 Tablets Alu-Alu Blister 24 Months FREDUM PHARMACEUTICALS LIMITED 14,15,16, Zorbian Industrial Complex, Veoor, Palghar(E) -401404 India FREDUM PHARMACEUTICALS LIMITED STAR BIOTECH LIMITED 2024-08-17 2029-08-16

1966 Rwanda FDA-HMP-MA-1857 DYNACORT-18 DEFLAZACORT,18MG 18 mg Tablets 3 x 10’s tablets Alu-Alu Blister pack 36 months. SKYBIOTECH LIFE SCIENCES PVT LTD : Gut no.5, Gevrai Tanda, Paithan road, Aurangabad (M.S) India. India Star Biotech Limited 1st floor, Prestige House, Rwandex, Kigali-Rwanda Telephone: (+250) 785377688 / (+250) 787229914 Email: shantilal.bhanderi@yahoo.com STAR BIOTECH RWANDA 2024-08-17 2029-08-16

1967 Rwanda FDA-HMP-MA-2086 LC DOPA LEVODOPA/ CARBIDOPA 250MG/ 25MG FILM COATED TABLETS 50 Tablets Jar pack 36 Months AGOG PHARMA LTD Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane India AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1968 Rwanda FDA-HMP-MA-1858 EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE 200/300MG TABLET HDPE Bottle of 30’s count, 90\\\'s count. HDPE Bottle 36 months. Laurus Labs Limited (Unit-II) Plot No: 19, 20 & 21, Western Sector, APSEZ, Gurajapalem village, Rambilli Mandal Anakapalli District, Andhra Pradesh, India. 531011, India India LAURUS LABS Limited, 2ND Floor, Serene Chambers, Road No.-7, Banjara Hills, Hydrabad, Telangana. Post Code: 500034, India, Email: info@lauruslabs.com CAPITAL PHARMACEUTICALS SUPPLIES 2024-08-17 2029-08-16

1969 Rwanda FDA-HMP-MA-2087 XYLOCAINE GEL 2% XYLOMETAZOLINE HYDROCHLORIDE 20MG GEL 30 g Tube Collapsible tube made of aluminium internally coated with protective lacquer 24 Months RECIPHARM KARLSKOGA AB Björkbornsvägen 5, SE-691 33 Karlskoga Sweden BETA HEALTHCARE INTERNATIONAL LTD SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16

1970 Rwanda FDA-HMP-MA-1859 MICROMOX EYE DROP MOXIFLOXACIN AS HYDROCHLORIDE 0.5%W/V EYE DROPS 5 ml ophthalmic solution in 5 ml Sterile Translucent LDPE container Sterile Translucent LDPE container with Sterile HDPE double safe White cap 36 months. MICRO LABS LIMITED . Plot No., 113 to 116Phase IV, KIADB Industrial Area Bommasandra, Bangalore – 560 099. India MICRO LABS LIMITEDNO 27, Race course Road,Bangalore-560 001IndiaTel: +91 8022370451-54Fax: +91 80 2237 0463Email: global@microlabs.in WESSEX PHARMACEUTICALS RWANDA LTD 2024-08-17 2029-08-16

1971 Rwanda FDA-HMP-MA-2088 LAMIVUDINE/ZIDOVUDINE LAMIVUDINE/ZIDOVUDINE 150/300MG TABLETS 60 Tablets HDPE Container 48 Months HETERO LABS LIMITED Industrial Development Area (IDA), : Jeedimetla : Hyderabad-500 055 : Telangana. INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1972 Rwanda-FDA-HM-1860 LEVANIX-500 LEVOFLOXACIN HEMIHYDRATE 500MG TABLET 7 tablets Alu/Alu blister and placed in a printed carton along with a pack insert 36 months Neopharma 89A1 – 95A1, Industrial City of Abu Dhabi, Mussafah, PO Box 72900 Abu Dhabi, UAE Tel: 00971 2 5501000 Fax: 00971 2 5501199 UAE NEOPHARM89A1-95A1, Industrial City of Abu DhabiMussafah,PO Box 7290 Abu Dhabi,UAEEmail: neopharma@neopharma.ae PHILIPS PHARMACEUTICALS RWANDA LTD 2024-08-17 2029-08-16

1973 Rwanda FDA-HMP-MA-2089 Emtricitabine and Tenofovir Disoproxil fumarate Tablets 200mg /300 mg Emtricitabine and Tenofovir Disoproxil fumarate 200/300MG TABLETS 30 Tablets HDPE container 24 Months HETERO LABS LIMITED (Unit-III) Hetero Labs Limited Industrial Development Area (IDA) Jeedimetla Hyderabad-500 055 Telangana India HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

1974 RwandaFDA-HMP-MA-1861 RENESTEN -V CLOTRIMAZOLE 100MG PESSARIES 6*1 BLISTER ALU/PVC BLISTER 36 Months RENE INDUSTRIES LTD Manufacturers of Pharmaceuticals PO Box 6034, Plot No 680, Kamuli, Kireka, Kampala, Uganda. Country: Uganda Telephone: +256 414236595, +256 414341416 Telefax: +256414236596 E-Mail:info@rene.co.ug, rishi@rene.co.ug. UGANDA RENE INDUSTRIES LTDManufacturers of pharmaceuticalsPlot No 680, PO Box 6034Kampala, UgandaTelephone: +2566 414236595,E-mail: info@rene.co.ug RENE PHARMACY LTD RWANDA 2024-08-17 2029-08-16

1975 Rwanda-FDA-HM-1862 BRUFEN SIROP PED. 100ML IBUPROFEN 100mg/5ml SUSPENSION Brufen Syrup, 100mg/5ml, a liquid oral product Aluminum cap and LDPE liner or Polypropylene cap and LDPE liner. 36 months. AbbVie S.r.l. S.R 148 Pontina km 52 snc 04011 Campoverde di Aprilia (LT) ITALY FAMAR A.V.E ANTHOUSSA PLANT B SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1976 Rwanda FDA-HMP-MA-2091 VOLTFAST DICLOFENAC POTASSIUM 50MG POWDER FOR SOLUTION 9 sachets Sachets 24 Months Mipharm S.P.A Via Bernardo Quaranta, 12 - 20141 Milano (MI) ITALY NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16

1977 RwandaFDA-HMP-MA-1863 ESOMAC 20 ESOMEPRASOLE MAGNESIUM DEHYDRATE 20MG TABLETS Carton containing 2 Alu-Alu blister strip of 7 tablets. ? - Carton containing 3 Alu-Alu blister strip of 10 tablets. ALU/PVC BLISTER 24 Months CIPLA LTD Address: Cipla Goa, Unit IV, Plot No. L-139 to L-146, Verna Industrial Estate, Verna Salcette, Goa 403722, India Telephone: +91 832 2889000 /2889199 /2889101 Telefax: + 91 832 2782479 / 2782598 / 2782805 E-mail: ciplagoa@cipla.com INDIA CIPLA LTD/INDIACipla house, peninsula business park, Ganpatrao Kadam Marg lower Parel, Mumbai, India Telephone: 91 22 25756558 Telefax: 91 22 24826120 E-mail: globalra@cipla.com KIPHARMA LTD 2024-08-17 2029-08-16

1978 Rwanda FDA-HMP-MA-2092 MYCOREN-V PESSARIES NYSTATIN 100000UI PESSARIES 15 pessaries Aluminium/ PVC blister strip of 15 pessaries and 1 of such blister strip is packed in a unit box with pack insert 24 Months RENE INDUSTRIES LTD RENE INDUSTRIES LTD UGANDAAddresses: Manufacturers of Pharmaceuticals Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda. Country: Uganda. Telephone : +256 414236595, +256 414341416 Telefax: +256 414236596 E-mail: info@rene.co.ug, rishi@rene.co.ug. Uganda RENE INDUSTRIES LTD RENE PHARMACY (R) LTD 2024-08-17 2029-08-16

1979 Rwanda FDA-HMP-MA-1865 IBUPAR CAPLETS Ibuprofen BP and Paracetamol BP 400mg/325mg TABLET 1x10’s Blister pack in unit boxes 36 months. DAWA limited Plot no. 7879/8, baba dogo road, ruaraka.p.o. box 16633 - 00620,nairobi, kenya.email: admin@dawalimited.com Kenya DAWA limited,plot no. 7879/8, baba dogo road, ruaraka.p.o. box 16633 - 00620,nairobi, kenya.email: admin@dawalimited.com SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1980 Rwanda FDA-HMP-MA-1864 CIRATRO ATROPINE SULPHATE INJECTION BP 1MG/ML SOLUTION 1 ml Amber type I Ampoule. Amber type I Ampoul 36 Months CIRON DRUGS & PHARMACEUTICALS PVT LTD N-118, N-119, MIDC, Tarapur, Boisar, Dist: Thane-401 506. Maharashtra, India Tel. No. : +91-22-26781138/26780659 INDIA CIRON DRUGS AND PHARMACEUTICALS PVT.LTD RENE PHARMACY (R) LTD 2024-08-17 2029-08-16

1981 Rwanda FDA-HMP-MA-1866 TROGYL SUSPENSION METRONIDAZOLE BENZOATE 60ML & 100ML ORAL SUSPENSION 100mls/60mls in PET bottles PET bottles with a cap and unit carton, Amber coloured bottles 36 months. BIODEAL LABORATORIES LTD LTD, PLOT NO. 123, LUNGA LUNGA ROAD, P.O. BOX 32040-00600, NAIROBI, KENYA Kenya BIODEAL LABORATORIES LTD/KENYAAddress: PLOT NO. 123, LUNGA LUNGA ROAD, P.O. BOX 32040- 00600, NAIROBI.Country: KENYA.Telephone: +254 720 333 829.Telefax: N/AE-Mail: regulatoryaffairs@biodealkenya.com CAPITAL PHARMACEUTICAL SUPPLIES LTD 2024-08-17 2029-08-16

1982 Rwanda FDA-HMP-MA-1876 LYSODOL 100 ACECLOFENAC 100MG TABLETS 1x30 Tablets ALU/PVC BLISTER 36 Months Tirupati Medicare Ltd Plant Address:10D, IInd Phase, Peenya Industrial Area, Bangalore.560 058Postal Address: A-177, Road No. 16-Z, Wagle Estate, Thane 400604(Mumbai),Post code:400604,Town: Thane (Mumbai),Country: IndiaTel No: (91) (22) 25820640,Fax: (91) (22) 25828016, Email: nbhusari@meyer.co.in INDIA MEYER ORGANICS PVT.LTD SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1983 RwandaFDA-HMP-MA-1867 HELIGO 500 TINIDAZOLE+CLARITHROMYCIN+LANSOPRAZOLE 500MG/500MG/30MG TABLET 7 strip (kit) ALU/PVC BLISTER 24 Months INTAS PHARMACEUTICALS LTD Address: Camp road, Selaqui, Dehradun- 248197, Uttarakhand, India Country: India INDIA INTAS PHARMACEUTICALS LTD/INDIACorporate House, Near Sola Bridge, S. G. Highway, Thaltej, Ahmedabad - 380054 - Gujarat – INDIA. ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

1984 Rwanda FDA-HMP-MA-1872 LYSODOL 200SR ACECLOFENAC 200MG TABLETS 30 Tablets ALU/PVC BLISTER 36 Months Tirupati Medicare Ltd Plant Address:10D, IInd Phase, Peenya Industrial Area, Bangalore.560 058Postal Address: A-177, Road No. 16-Z, Wagle Estate, Thane 400604(Mumbai),Post code:400604,Town: Thane (Mumbai),Country: IndiaTel No: (91) (22) 25820640,Fax: (91) (22) 25828016, Email: nbhusari@meyer.co.in INDIA MEYER ORGANICS PVT.LTD SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1985 RwandaFDA-HMP-MA-1868 DUPHALAC 200ML LACTULOSE 66.50% SYRUP 200 ml and 1000 ml HDPE 24 Months ABBOTT LABORATOIRES LTD Veerweg 12 8121 AA Olst The Netherlands. NETHERLANDS ABBOTT LABORATOIRES B.V SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1986 Rwanda FDA-HMP-MA-1873 LYSODOL MR ACECLOFENAC & PARACETAMOL & CHLORZOXAZONE 100/500/250 MG TABLETS 3x10 Tablets ALU/PVC BLISTERS 36 Months Tirupati Medicare Ltd Plant Address:10D, IInd Phase, Peenya Industrial Area, Bangalore.560 058Postal Address: A-177, Road No. 16-Z, Wagle Estate, Thane 400604(Mumbai),Post code:400604,Town: Thane (Mumbai),Country: IndiaTel No: (91) (22) 25820640,Fax: (91) (22) 25828016, Email: nbhusari@meyer.co.in INDIA MEYER ORGANICS PVT.LTD SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1987 RwandaFDA-HMP-MA-1869 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 9%W/V IV INFUSION 500 ml PE Bottle PE Bottle 36 Months REALCADE LIFESCIENCE PVT. LTD Survey No. 891-892, Y - Junction, At Narmada Canal, Karannagar, Ta.: Kadi, Kadi, Gujarat - 382715, India Email Address : field.realcade@gmail.com INDIA LUMIERE LIFE SCIENCEAddress: SHEETAL, NO-16/17 LALBAUG SHOPPING CENTER, MANJALPUR VADODARA, -390011, GUJARAT. Country: INDIATelephone: +91-9825038695Telefax: +91-9825038695E-Mail: ketan@lumierelife.com PHARMACEUTICAL &MEDICAL SUPPLIES SOCIETY LTD (PMSS) 2024-08-17 2029-08-16

1988 Rwanda FDA-HMP-MA-1874 LYSODOL P ACECLOFENAC & PARACETAMOL 100/50 MG TABLETS 1x30 Tablets ALU/PVC BLISTER S 36 Months Tirupati Medicare Ltd Plant Address:10D, IInd Phase, Peenya Industrial Area, Bangalore.560 058Postal Address: A-177, Road No. 16-Z, Wagle Estate, Thane 400604(Mumbai),Post code:400604,Town: Thane (Mumbai),Country: IndiaTel No: (91) (22) 25820640,Fax: (91) (22) 25828016, Email: nbhusari@meyer.co.in INDIA MEYER ORGANICS PVT.LTD SUN ENTEPRISES LTD 2024-08-17 2029-08-16

1989 RwandaFDA-HMP-MA-1870 ACTILOR SYRUP DESLORATADINE SYRUP 2.5MG/5ML SYRUP 150ML 150ML Amber Glass Bottle with CR Cap 36 Months NEOPHARMA Address: Plot No. A-1, 89-95, Industrial City of Abu Dhabi (ICAD), P. O Box 72900, Mussafah, Abu Dhabi, UAE Country: United Arab Emirates UNITED ARAB EMIRATES NEOPHARMA PHILIPS PHARMACEUTICALS RWANDA LTD 2024-08-17 2029-08-16

1990 Rwanda FDA-HMP-MA-0503 FLOBOID EYE DROPS OFLOXACIN 0.3%W/V EYE DROPS 5ml Bottle BFS LDPE bottle with Golden Brown HDPE cap with spike such 1 LDPE bottle packed in a printed outer carton 36 Months MICRO LABS LIMITED Plot Nos.113 - 116, IV Phase, KIADB Bommasandra Industrial Area, Anekal Taluk, Bangalore – 560 099. INDIA India MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16

1991 RwandaFDA-HMP-MA-1871 OFZOLE 30 TABS OFLOXACIN + ORNIDAZOLE 200MG/500MG TABLET 1x10’s ALU/PVC BLISTER 24 Months CORONA REMEDIES PVT LTD Address: Village Jatoli, Post Office - Oachghat, Tehsil Solan, Dist. Solan Himachal Pradesh – 173223. Country: India INDIA CORONA REMEDIES PVT LTD AIVEEN RWANDA LTD 2024-08-17 2029-08-16

1992 Rwanda FDA-HMP-MA-1562 AMARYL-M 2/500 IR GLIMEPIRIDE +METFORMIN 2MG+ 500MG FILM COATED TABLETS 60 & 100 tablets or Blister packs of 3x10 Tablets Low density polyethylene film bags are used as primary packaging. Blister packs 36 Months HANDOK INC KOREA Handok Inc., 78, Daepungsandan-ro, Daeso-myeon, Eumseong-gun, Chungcheongbuk-do, KOREA KOREA Sanofi Aventis Kenya Limited KIPHARMA LTD 2024-08-17 2029-08-16

1993 RwandaFDA-HMP-MA-1875 DYNACORT 30MG DEFLAZACORT 30MG TABLET 3 x 10’s ALU/PVC BLISTER 36 Months SKYBIOTECH LIFE SCIENCES PVT LTD Factory: Gut no.5, Gevrai Tanda, Paithan road, Aurangabad (M.S) India INDIA GALAXYPHARMACEUTICALSBuilding No. 36, Gala No. 2, 3, 4A, Kopar, Purna, Bhiwandi, Thane -421302, Mumbai (Maharashtra) INDIA;Telephone No: 022-49719061/022-49718955Email: info@galaxy-pharmaceuticals.com / md@galaxy-pharmaceuticals.com STAR BIOTECH RWANDA 2024-08-17 2029-08-16

1994 Rwanda FDA-HMP-MA-1664 DACINAZOLE CREAM Miconazole nitrate BP 2%w/w CREAM 15 g Tube Aluminium tube 36 Months DAWA LIMITED Plot No: 7879/8, Baba Dogo road, Ruaraka, P.O Box 16633-00620, Nairobi –Kenya Kenya DAWA LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

1995 RwandaFDA-HMP-MA-1899 Hydroxyurea 1000 HGC Hydroxyurea 1000 mg 1000 mg Tablet 3x10’s HDPE 24 Months Haupt Pharma Amareg GmbH Donaustaufer Strasse 378 D-93055 Regensburg Germany Sandoz Pharmaceutical d.dAddress: Donaustaufer Strasse 378, 93055 Regensburg, GermanyCountry: GermanyTelephone:+254 711592940Telefax: N/A E-Mail: david.odhiambo@novartis.com Surgipharm Rwanda Address: P.O Box 2414 CCOAIB Building, KN 5 Rd 18 Boulevard de l’Umuganda Country: Rwanda 2024-08-17 2029-08-16

1996 Rwanda FDA-HMP-MA-0182 PYRAMAX GRANULE FOR ORAL SUSPENSION PYRONARIDINE TETRAPHOSPHATE/ ARTESUNATE 60MG/20MG ORAL SUSPENSION 90 SACHETS SAHETS CONSISTING OF LAYERS OF POLYESTER, ALUMINIUM AND POLYETHYLENE 24 Months SHIN POONG PHARM. CO., LTD Address: 70, Sandan-ro 19beon-gil, Danwon-gu, Ansan-si, Gyeonggi-do, Republic of KoreaCountry : Republic of Korea REPUBLIC OF KOREA SHIN POONG PHARM.CO.,LTD QUALMED LIMITED 2024-08-17 2029-08-16

1997 Rwanda-FDA-HM-1877 IVYTUS HEDERACOSIDE C 100ML SYRUP 100ml Amber glass bottle 36 months Neopharma Address of the Site : Plot No. A1 89 – 95, Industrial City of Abu Dhabi, Mussafah, PO Box 72900 Abu Dhabi mailto:neopharma@neopharma.ae UAE NEOPHARMA Plot No. A-1, 89-95, Industrial City of Abu Dhabi(ICAD), P.O Box 72900, Mussafah, Abu Dhabi, UAEUnited Arab Emirates00971 2 550 1000 /00971 2 550 11 99 PHILIPS PHARMACEUTICALS RWANDA LTD 2024-08-17 2029-08-16

1998 Rwanda FDA-HMP-MA-0183 PYRAMAX TABLETS PYRONARIDINE TETRAPHOSPHATE/ ARTESUNATE 180/60MG TABLETS 90 Tablets Aluminium/PVC 24 Months SHIN POONG PHARM. CO., LTD Address: 70, Sandan-ro 19beon-gil, Danwon-gu, Ansan-si, Gyeonggi-do, Republic of KoreaCountry : Republic of Korea REPUBLIC OF KOREA SHIN POONG PHARM.CO.,LTD QUALMED LIMITED 2024-08-17 2029-08-16

1999 Rwanda-FDA-HM-1878 DUPHASTON DYDROGESTERONE 10MG TABLET This medicine is presented as flm-coated tablets. Box of 20 Strips made of PVC and aluminium. 60 Months Abbott Biologicals B.V Veerweg 12 8121 AA Olst Netherlands ABBOTT LABORATOIRES B.V LTD/ITALY Veerweg 12,81 21 AA O1st The NetherlandsTel: 0031-570-568211Fax: 0031-570-562899 SUN ENTERPRISES LTD 2024-08-17 2029-08-16

2000 Rwanda FDA-HMP-MA-1680 TRIALGIC IBUPROFEN/PARACETAMOL/CAFFEINE 200MG/325MG/30MG Capsules 2 X 12 Capsules ALU/transparent PVC film blisters 36 Months Medreich Limited Medreich Limited. Plot/Building Number: No. 11, 12, 13, 14, and 15 Street/Area Name: Poojaramanahalli Village, Hoskote Taluk, City: Bangalore Rural District. Postal/Pin Code: 562114. State: Karnataka, India INDIA B&O Pharm KIPHARMA LTD 2024-08-17 2029-08-16

2001 RwandaFDA-HMP-MA-1879 DUSPATALIN MEBEVERINE 200MG CAPSULES 30’s ALU/PVC BLISTER 36 Months ABBOTT BIOLOGICALS BV Abbott Biologicals B.V. Veerweg 12 8121 AA Olst The Netherlands NETHERLANDS ABBOTT BIOLOGICALS BV), Olst, TheNetherlands SUN ENTERPRISES LTD 2024-08-17 2029-08-16

2002 Rwanda FDA-HMP-MA-1880 ACUDOL 15 INJ KETOTOLAC TROMETHAMANE 15MG/ML IV INJECTION 21’s count 2R,2ml Amber Color Tubular glass vial,USP Type-I with 13mm serum grey bromo butyl rubber stopper (RS) and 13mm orange color flip of seal 24 months ASPIRO PHARMA LIMITED Sy. No. 321, Biotech Park, Phase-III, Karkapatla Village,Markook Mandal. Siddipet District,Telangana, India. India ASPIRO PHARMA LIMITED H.No.8-3-166/7/1,3rd Floor, Erragadda,Hyderabad-18, Telangana State, IndiaTelephone: +91-40-23704925,Fax: +91-40-23704926Web: www.aspiropharma.com E-mail: vinodkumar.u@aspiropharma.com SUN ENTEPRISES LTD 2024-08-17 2029-08-16

2003 Rwanda FDA-HMP-MA-1881 ACUDOL 30 INJ KETOTOLAC TROMETHAMANE 30MG/ML IV INJECTION 21’s count 2R,2ml Amber Color Tubular glass vial,USP Type-I with 13mm serum grey bromo butyl rubber stopper (RS) and 13mm orange color flip of seal 24 months ASPIRO PHARMA LIMITED Sy. No. 321, Biotech Park, Phase-III, Karkapatla Village,Markook Mandal. Siddipet District,Telangana, India. India ASPIRO PHARMA LIMITED H.No.8-3-166/7/1,3rd Floor, Erragadda,Hyderabad-18, Telangana State, IndiaTelephone: +91-40-23704925,Fax: +91-40-23704926Web: www.aspiropharma.com E-mail: vinodkumar.u@aspiropharma.com SUN ENTEPRISES LTD 2024-08-17 2029-08-16

2004 Rwanda FDA-HMP-MA-1882 PHARMADOL - 10 PARACETAMOL CAPLETS 500MG 500MG TABLETS 10×10’s Alu-PVC Blisters pack 36 months M/S SKYBIOTECH LIFESCIENCES PVT. LTD Gut no.: 5, Gevrai Tanda, Paithan Road, Aurangabad (M.S.) India, E-Mail :skybiotech.medicine@gmail.com India Star Biotech LimitedAddress: 1st floor, Prestige House, Rwandex, Kigali-Rwanda STAR BIOTECH RWANDA 2024-08-17 2029-08-16

2005 Rwanda-FDA-HM-1883 FEBUDAY 80 FEBUXOSTAT 80 MG TABLETS 1x10`s and 3x10`s Alu-Alu blister pack 36 months MSN LABORATORIES PRIVATE LIMITED Address: Plot No.: 42, ANRICH Industrial Estate, Bollaram, Sangareddy District, Pin Code – 502325, Telangana. Country: India Telephone: +91-8458-304950/937 Telefax:+91-8458-279938 E-Mail: bharatreddy@msnlabs.com India MSN LABORATORIES PRIVATE LIMITED MSN House , Plot No :C-24Sanath Nagar Industrial Estate, Sanath Nagar Hyderabad , Telangana , Pincode: 500018.IndiaCn : U24239TG2003PTC04153Phone : +91-40-30438600Fax:+91-40-30438798 ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

2006 Rwanda FDA-HMP-MA-1884 FEBUDAY 40 FEBUXOSTAT 40 MG TABLETS 1x10`s and 3x10`s Alu-Alu blister pack 36 months MSN LABORATORIES PRIVATE LIMITED Address: Plot No.: 42, ANRICH Industrial Estate, Bollaram, Sangareddy District, Pin Code – 502325, Telangana. Country: India India MSN LABORATORIES PRIVATE LIMITED MSN House , Plot No :C-24Sanath Nagar Industrial Estate, Sanath Nagar Hyderabad , Telangana , Pincode: 500018.IndiaCn : U24239TG2003PTC04153Phone : +91-40-30438600Fax:+91-40-30438798 ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

2007 Rwanda FDA-HMP-MA-1885 NERVILIN NT PREGABALIN 75MG TABLET 3x10 capsules Alu-Alu blister pack 36 months. DAWA limited Plot No. 7879/8, Baba Dogo Road, Ruaraka. P.o. Box 16633 - 00620, Nairobi, Kenya. E-mail: admin@dawalimited.com Kenya DAWA limited,plot no. 7879/8, baba dogo road, ruaraka.p.o. box 16633 - 00620,nairobi, kenya.email: admin@dawalimited.com SUN ENTEPRISES LTD 2024-08-17 2029-08-16

2008 Rwanda FDA-HMP-MA-1886 NAC MR 10 TABS DICLOFENAC POTASSIUM/PARACETAMOL/ CHLORZOXANE 50MG/325MG/250MG TABLET 1x10. Alu/Alu blister. 36 months. CORONA REMEDIES PVT LTD Village Jatoli, Post Office – Oachghat, Tehsil Solan, Dist. Solan, Himachal Pradesh – 173233, India. India CORONA REMEDIES PVT LTD AIVEEN RWANDA LTD 2024-08-17 2029-08-16

2009 RwandaFDA-HMP-MA-1887 GACET -125 ACETAMINOPHEN UPS 125MG SUPPOSITORY 2x5’s ALU/PVC BLISTER 36 Months Bliss GVS Pharma Limited Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali Village, Taluka Palghar, Thane 401404 Maharashtra State,India INDIA BLISS GVS PHARMA LTD SURYA DEPOT PHARMACY LTD 2024-08-17 2029-08-16

2010 Rwanda FDA-HMP-MA-1888 ATAZOR-R-300/100 ATANAVIR SULPHATE/RITONAVIR 300/100MG TABLETS 30’s count, 90’s count and 180’s count HDPE container pack 36 months. EMCUREPHARMACEUTICALSLTD Plot No. P-1 & P-2, I.T.B.T. Park, Phase II, MIDC, Hinjwadi, Pune-411 057 Maharashtra, India India EMCUREPHARMACEUTICALSLTD,Plot No. P-1&P-2. I.T.B.TPark, Phase II, M.I.D.C,Hinjwadi, Pune – 411 057,India Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

2011 RwandaFDA-HMP-MA-1889 TRANGEL ULTRA DICLOFENAC DIETYLAMINE +METHYL SALICYLATE+MENTHOL+CAPSICUM OLEORESIN 10/80/60/0.15MG GEL 20mg Aluminium collapsible Tubes 36 Months NEM LABORATORIES PVT. LTD 133, Krishna Ind. Estate, Navghar Rd., Vasai (E), Dist. Thane- 401210 Country: INDIA INDIA NEM LABORATORIES PVT LTD, Address: 133, Krishna Ind. Estate, Navghar Rd., Vasai (E), Dist. Thane- 401210 Country: India Telephone: 0250-239002/3Telefax: 0250-2392905 E-Mail: nemlabs@gmail.com RENE PHARMACY LTD RWANDA 2024-08-17 2029-08-16

2012 Rwanda FDA-HMP-MA-2101 METAPIR-50 TOPIRAMATE USP 50MG TABLETS 10 tablets Alu / Alu blister 36 Months MICRO LABS LIMITED 92, SIPCOT, Hosur-635 126, Tamil Nadu India MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16

2013 Rwanda FDA-HMP-MA-1890 ARBITEL H-80 TELMISARTAN AND HYDRCHLOROTHIAZIDE 80MG/12.5MG Tablets 3x10\'s Alu-Alu 24 Months MICROLABS LTD 92. SIPCOT, industrial complex, HOSUR-635126, TAMIL NADU, INDIA India MICRO LABS LIMITED Wessex Pharmaceuticals Rwanda Ltd 2024-08-17 2029-08-16

2014 Rwanda FDA-HMP-MA-2102 CO-TRIMOXAZOLE SULFAMETHOXAZOLE/ TRIMETHOPRIM 240MG/40MG TABLETS 100 ml Glass bottle 36 Months AURA LIFECARE PVT. LTD Survey No 254/ 14/1,Jarod ,Savli Road, P.O. Karachiya, Tal-Savli ,Dist : Vadodara-391520. Gujarat State. India AURA LIFECARE PVT. LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

2015 Rwanda FDA-HMP-MA-1891 VITALIPID NOVUM ADULT RETINOL PALMITATE, PHYTOMENADIONE, ERGOCALCIFEROL, DL-?-TOCOPHEROL Retinol palmitate, 194.1 ?g, Phytomenadione, 15 ?g, Ergocalciferol, 0.5 ?g dl-?-Tocopherol 0.91 mg SOLUTION FOR INFUSION 10 ml Vitalipid N Adult is filled in 10 ml, break-off ampoules. 24 months. FRESENIUS KABI SOUTH AFRICA PTY) LTD Fresenius Kabi AB, Rapsgatan 7, SE-751 74 Uppsala, Sweden Sweden FRESENIUS KABI SOUTH AFRICA PTY) LTD, Address: Stand 7, Growthpoint Park2 Tonetti Street, Halfway HouseSouth Africa, 1685Tel: +27 11 545 0000Telefax: +27 11 545 0060Email: martie.snyman@fresenius-kabi.com SURGIPHARM RWANDA LTD 2024-08-17 2029-08-16

2016 Rwanda FDA-HMP-MA-2103 Hydroxyurea 100 HGC Hydroxyurea 100 mg TABLETS 60, 90 and 120 Tablets High density polyethylene (HDPE) 24 Months Haupt Pharma Amareg GmbH Haupt Pharma Amareg GmbH Address: Donaustaufer Strasse 378 D-93055 Regensburg Germany Sandoz Pharmaceutical d.d SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16

2017 Rwanda FDA-HMP-MA-1892 NERVILIN 75MG CAPS PREGABALIN 75MG CAPSULES 3 packs X10 tablets Alu alu blister packs 24 months. DAWA LIMITED. Plot no. 7879/8, baba dogo road, ruaraka. P.o. box 16633 - 00620, Nairobi, Kenya. Email: admin@dawalimited.com Kenya DAWA LTD/KENYA, Plot No 7879/8, Baba Dogo Road -Ruaraka P.O Box 16633-00620, NAIROBI KENYA. Tel: 0724764747, 0735764747. Fax: +254-20-8561550. Emaiadmin@dawalimited.com SUN ENTERPRISES LTD 2024-08-17 2029-08-16

2018 Rwanda FDA-HMP-MA-2104 XENDA 100 Bendamustine Hydrochloride Monohydrate 100 mg Injection 1×1 Vial VAILS (Fiolax Amber Tubular Glass Vials , Rubber stopper) 36 Months HETERO LABS LIMITED Hetero Labs Limited, Unit – VI Sy.No.410-411, TSIIC Formulation SEZ, Polepalle Village, Jadcherla Mandal, Mahabubnagar District, Pincode 509301, Telangana State, India. India HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

2019 Rwanda FDA-HMP-MA-1893 BUDECOT 0.5MG BUDESONIDEINHALATION SUSPENTION 0.5MG/2ML 0.5MG TABLETS Carton containing 4 combipack pouch having 5 respules of 2 ml each combipack pouch 24 months. CIPLA LTD. Unit I Plot No. 9 & 10 Indore SEZ Phase II Pithampur, Dist Dhar M.P.- 454 775, INDIA. Country: India Telephone: +91 7292 660070. Telefax: + 91 7292 660497 E-Mail: ashish.zitshi@cipla.com India CIPLA LTD/INDIA Unit l,Plot 9, 10 & 15,Indore Special Economic Zone,Phase-ll, Pithampur, District- Dhar,Madhya Pradesh, India – 454775(Termed as “Cipla Indore” henceforth) KIPHARMA LTD 2024-08-17 2029-08-16

2020 Rwanda FDA-HMP-MA-1894 NEBTAS-H NEBIVOLOL HYDROCHLORIDE+HYDROCHLORTHIAZIDE 5MG/12.5MG TABLET 3x10 tablets Alu/Alu Blister Pack 36 months. INTAS PHARMACEUTICALS LTD Camp Road, Selaqui – 248 197, Dehradun, Uttarakhand, India India INTAS PHARMACEUTICALS LTD/INDIACorporate House, Near Sola Bridge, S. G. Highway, Thaltej, Ahmedabad - 380054 - Gujarat – INDIA. ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

2021 RwandaFDA-HMP-MA-1895 DYNACORT SUSPENSION DEFLAZACORT 6MG/5ML SUSPENSION 60ml Amber Glass Bottle 36 Months M/s. Skybiotech Life sciences Pvt.Ltd. Gut no.5, Gevrai Tanda, Paithan road, Aurangabad (M.S) India. INDIA GALAXYPHARMACEUTICALSBuilding No. 36, Gala No. 2, 3, 4A, Kopar, Purna, Bhiwandi, Thane -421302, Mumbai (Maharashtra) INDIA;Telephone No: 022-49719061/022-49718955Email: info@galaxy-pharmaceuticals.com / md@galaxy-pharmaceuticals.com STAR BIOTECH RWANDA 2024-08-17 2029-08-16

2022 Rwanda FDA-HMP-MA-1896 BONCARE PLUS METHYLSULFONYLMETHANE/ GLUCOSAMINE SULPHATE POTASSIUM CHLORIDE/ CHONDROITIN SULPHATE SODIUM 50MG/750MG/200MG CAPSULE 3 x 10’s Alu / PVDC Blister 36 months. AUROCHEM LABORATORIES (INDIA) PVT. LTD. At 58, Palghar Taluka, Industrial Co.-op. Estate Ltd. Palghar – 401 404, Tel No.: 0252-552332, 0252-554720 District Thane, Maharashtra, INDIA India AUROCHEM LABORATORIES (I) PVT LTD/INDIAPlot No. 8, Palghar Taluka Industrial Co-Operative Estate Limited, District Palghar, 401404, District Thane, Maharashtra-Indi UBIPHARM-RWANDA LTD 2024-08-17 2029-08-16

2023 Rwanda FDA-HMP-MA-1898 PARACETAMOL INFUSION 10MG/ML PARACETAMOL 10MG/ML Intravenous infusion 1x100 ml Type II glass vial 36 months Aculife Healthcare Private Limited Aculife Healthcare Private Limited, Village- Sachana, Taluka-Viramgam, District - Ahmedabad – 382150, Gujarat, India INDIA ACULIFE HEALTHCARE PRIVATE LIMITED COMMERCE HOUSE-V , Besides Vodafone House, Prahladgnar Corporate Road, Ahmedabad-380051, Gujarat, India, Email: sumittripathi@aculife.co.in SUN ENTERPRISES LTD 2024-08-17 2029-08-16

2024 Rwanda FDA-HMP-MA-1900 OXYNIR INJ OXYTOCIN 10IU/ML Intravenous injection 5x10x1ml glass Ampoule USP Type I 24 months Aculife Healthcare Pvt. Ltd Aculife Healthcare Pvt. Ltd. Sachana, Taluka; Viramgam, Ahmedabad - 382 150. Gujarat, India. INDIA Aculife Healthcare Pvt. Ltd.Address: Village: Sachana, Tal: Viramgam, Dist: AhmedabadCountry: India SUN ENTERPRISES LTD 2024-08-17 2029-08-16

2025 Rwanda FDA-HMP-MA-1901 Lofen gel DICLOFENAC DIETHYLAMINE BP 1% w/w Tropical gel 1x20g Lami tube 24 months Bal Pharma Limited. Bal Pharma Limited; Unit-IV, 1,2,3 & 69, Sector no. 4, IIE SIDCUL Pantnagar (U.S. Nagar) Uttarakhand. INDIA Bal Pharma Limited,5th Floor, Laxmi Narayan Complex, 10/1, Palace Road, Vasanth Nagar,India. Sun enterprises Ltd 2024-08-17 2029-08-16

2026 Rwanda FDA-HMP-MA-1902 PILORECT Haemorrhoidal Suppositories BP 0.25%w/w ,3.00%w/w ,5.00%w/w .0.50%w/w Suppositories 2 blisters x 5 suppositories PVC-PE Blisters 36 months Meridian Enterprises Pvt. Ltd. Meridian Enterprises Pvt. Ltd.Plot No. 418, G.I.D.C.Kabilpore, Navsari – 396424 Gujarat (India). INDIA Meridian Enterprises Pvt. Ltd. ABACUS PHARMA (A) LTD. 2024-08-17 2029-08-16

2027 Rwanda FDA-HMP-MA-1903 COLDRIL SUSPENSION PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE 120MG+10MG+1MG/5ML SUSPENSION 1x100 ml amber colored glass bottle with aluminium ROPP capped 36 months Beta Healthcare International Ltd. Beta Healthcare International Ltd P.O. Box 42569-00100, Nairobi, Plot No. LR 209/6554, Mogadishu Road, Industrial Area Kenya. KENYA BETA HEALTHCARE INTERNATIONAL SURGIPHARM RWANDA LTD 2024-08-17 2029-08-16

2028 Rwanda FDA-HMP-MA-1904 ULTRA-LEVULE 250 MG SACHETS SACCHAROMYCES BOULARDII CNCM I-745 250MG Powder for oral suspension 10 sachets sachet box 36 months BIOCODEX BIOCODEX Address: 1 Avenue Blaise Pascal 60000 Beauvais.Country: France FRANCE BIOCODEX FORTILAB RWANDA 2024-08-17 2029-08-16

2029 Rwanda FDA-HMP-MA-1905 CANDIMALE-15 ORNIDAZOLE + MICONAZOLE 2%+2% CREAM 15G ALUMINIUM COLLAPSIBLE TUBES 30 months Meyer Organics Pvt. Ltd. Meyer Organics Pvt., B - 46, Phase II, M.I.D.C., Dombivali (E)-421201, Thane (INDIA). INDIA MEYER ORGANICS PVT LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

2030 Rwanda FDA-HMP-MA-1906 BACTOCLAV DRY SYRUP AMOXICillin 100mg+Potassium |Clavuranate 12.5mg/ 100/12.5 MG SYRUP 1x100 ml amber color glass bottle 24 months MICRO LABS LIMITED MICRO LABS LIMITED. No. 16, Veerasandra Industrial Area, Bangalore-560100. INDIA. INDIA MICRO LABS LIMITED 31, Race Course Road, Bangalore 560 001, Country: India Telephone: 080-22370451-57 Telefax: 080-22370463 Email: global@microlabs.in Phillips Pharmaceuticals (Rwanda) Ltd. 2024-08-17 2029-08-16

2031 Rwanda FDA-HMP-MA-1907 RENEGEL SUSPENSION ALUMINIUM HYDROXIDE120 MG +MAGNESIUM TRISILICATE 250MG 120mg/250 mg Suspension 1x100 ml amber colored glass bottle with ROPP caps 24 months RENE INDUSTRIES LTD RENE INDUSTRIES LTD. Addresses : Manufacturers of Pharmaceuticals Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda. Country : Uganda. Telephone : +256 414236595, +256 414341416 Telefax : +256 414236596 E-Mail : info@rene.co.ug, rishi@rene.co.ug. UGANDA Rene Industries Ltd Rene Pharmacy (R) Ltd. 2024-08-17 2029-08-16

2032 Rwanda FDA-HMP-MA-1682 ROCMALINE, oral solution, ampoule L (+) arginine anhydrous basis and DL malic acid 413 mg of L (+) arginine anhydrous basis and 1500 mg of DL malic acid Oral solution 1x 20 ampoules yellow glass ampoules 36 months Biocodex Maroc Biocodex Maroc, Technopole-Aéroport Mohamed VBP126 Niuaceur, Casablanca, Maroc MAROC Frilab 17, rue des Pierres du Niton 1207 Genève – Suisse UBIPHARMA RWANDA LTD 2024-08-17 2029-08-16

2033 Rwanda FDA-HMP-MA-2035 BEKRAZOL 200/5 ALBENDAZOLE BP 200MG/5ML SUSPENSION 10ml Amber PET bottle 24 months BAROQUE PHARMACEUTICALS PVT. LTD 192/2&3, SOKHADA-388620, KHAMBHAT, DT:ANAND. (GUJ.), INDIA India Bekra Pharma UK Ltd UBIPHARM-RWANDA LTD 2024-09-30 2029-09-29

2034 Rwanda FDA-HMP-MA-2036 BEKRAZOL 400 ALBENDAZOLE 400MG 400MG TABLETS 1*1 ALU-PVC Blister 24 Months BAROQUE PHARMACEUTICALS PVT. LTD 192/2&3, SOKHADA-388620, KHAMBHAT, DT:ANAND. (GUJ.), INDIA INDIA Bekra Pharma UK Ltd UBIPHARM-RWANDA LTD 2024-09-30 2029-09-29

2035 Rwanda FDA-HMP-MA-2037 MYCODEAL SOLUTION BIFONAZOLE 1.0 %w/v Solution 15ml HDPE bottle with a nozzle packed in a unit carton with literature insert. 36 Months BIODEAL LABORATORIES LIMITED BIODEAL LABORATORIES LTD 123 LUNGA LUNGA ROAD P.O. BOX 32040-00600, NAIROBI. KENYAN. KENYA BIODEAL LABORATORIES LIMITED CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-09-30 2029-09-29

2036 Rwanda FDA-HMP-MA-2038 BRONCATHIOL ENFANTS Carbocisteine 2% SYRUP 125 ml Bottle of 125 ml 36 Months LAPHAL INDUSTRIES LAPHAL INDUSTRIES Address: Avenue de Provence - 13190 ALLAUCH FRANCE MELISANA PHARMA KIPHARMA LTD 2024-09-30 2029-09-29

2037 Rwanda FDA-HMP-MA-2077 SODIUM CHLORIDE 0.9% W/V AND GLUCOSE 5% W/V INTRAVENOUS INFUSION BP Sodium Chloride 0.9% w/v and Glucose 5% w/v Intravenous Infusion BP 0.9% w/v & 5% w/v INTRAVENOUS INFUSION 500 ml LDPE bottle 36 Months B. BRAUN PHARMACEUTICALS EPZ LIMITED No. 18474/84, Athi River, P.O. Box 51200-00100, Nairobi, Kenya. KENYA B. Braun Pharmaceuticals EPZ Limited LE MEDICAL LTD 2024-09-30 2029-09-30

2038 Rwanda FDA-HMP-MA-2039 TRIXONE CEFTRIAXONE SODIUM INJECTION BP 1G Powder for Injection 10 Vials Vials 36 Months Reyoung Pharmaceutical Co., Ltd Ruiyang Road, Yiyuan County, Shandong Province, P.R. China CHINA Farmasino Co., Ltd ABACUS PHARMA (A) LTD 2024-09-30 2029-09-29

2039 Rwanda FDA-HMP-MA-2268 ULGICID SUSPENSION (CHERRY) ALGINIC ACID, MAGNESIUM HYDROXIDE,ALUMINIUM HYDROXIDE,MAGNESIUM TRISILICATE&SIMETICONE SUSPENSION 200 mg, 250mg, 250mg, 250mg, 125mg SUSPENSION 200 ml Amber Colour glass brute bottle with 25 mm Aluminium PP cap. 30 Months SAI MIRRA INNOPHARM PVT. LTD 288 & 299, SIDCO Estate Ambattur, Chennai - 600 098, Tamil Nadu. India Tel: 91 - 44 – 4204 3223 EMail: export@saimirra.com INDIA PRISMA PHARMA FZE PRAFIN RWANDA LTD 2024-09-30 2029-09-29

2040 Rwanda FDA-HMP-MA-2040 GMYCIN-80 Gentamicin Injection 80mg/2ml Injection 10 Ampoules Glass ampoules packed on trays. 10 trays/box 36 Months Reyoung Pharmaceutical Co., Ltd No.1 Ruiyang Road, Yiyuan County, Shandong Province , P.R. China CHINA Farmasino Co., Ltd ABACUS PHARMA (A) LTD 2024-09-30 2029-09-29

2041 Rwanda FDA-HMP-MA-2269 PACLITERO 300 Paclitaxel Injection USP 300mg/50mL Injection 1 VIAL OF 50ML GLASS Vials 36 Months HETERO LABS LIMITED Unit-VI Sy.No.410 & 411, TSIIC Formulation SEZ Polepally (V), Jadcherla (M) Mahaboobnagar District, Telangana, India INDIA Hetero Labs Limited 7-2-A2, Hetero Corporate Industrial Estates Sanath Nagar, Hyderabad-500 018 Telangana, India BION PHARMA GROUP LTD 2024-09-30 2029-09-29

2042 Rwanda FDA-HMP-MA-2041 ASTHAREN TABLETS Salbutamol Sulphate 4mg Tablets 10×10 Tablets Aluminium/Pvc Blister Strip And Carton With Pack Insert 24 Months RENE INDUSTRIES LTD RENE INDUSTRIES LTD. Address: Manufacturers of Pharma Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda. Telephone: +256 414236595, +256 414341416 E-Mail: info@rene.co.ug, rishi@rene.co.ug UGANDA RENE INDUSTRIES LTD RENE PHARMACY (R) LTD 2024-09-30 2029-09-29

2043 Rwanda FDA-HMP-MA-2042 RENPRESS TABLETS PROPRANOLOL HYDROCHLORIDE BP 40mg Tablets 10×10 tablets Aluminium/PVC blister strip and carton with pack insert 24 Months RENE INDUSTRIES LTD. RENE INDUSTRIES LTD. Address: Manufacturers of Pharma Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda. Telephone: +256 414236595, +256 414341416 E-Mail: info@rene.co.ug, rishi@rene.co.ug Uganda RENE INDUSTRIES LTD RENE PHARMACY (R) LTD 2024-09-30 2029-09-29

2044 Rwanda FDA-HMP-MA-2043 BENZALIN BENZATHINE BENZLPENICILLIN FOR INJECTION 2.4 MUI Injection 50 Vials Vials 36 Months Reyoung Pharmaceutical Co., Ltd No.1 Ruiyang Road, Yiyuan County, Shandong Province, P.R. China Telephone:+86-533-3257875 Telefax:+86-533-3257886 E-Mail: info@reyoung.cn China Farmasino Co., Ltd ABACUS PHARMA (A) LTD 2024-09-30 2029-09-29

2045 Rwanda FDA-HMP-MA-2044 AVASTIN Bevacizumab 100mg/4ml CONCENTRATE FOR SOLUTION FOR INFUSION 4ML VIAL RUBBER-STOPPERED VIAL. 24 Months Roche Diagnostics GmbH and F. Hoffmann-La Roche Ltd Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim Germany, and F. Hoffmann-La Roche Ltd Wurmisweg CH-4303 Kaiseraugst Switzerland Germany and SWITZERLAND Roche Registration GmbH KIPHARMA LTD 2024-09-30 2029-09-29

2046 Rwanda FDA-HMP-MA-2045 MABTHERA RITUXIMAB 1400mg/117ml Solution for subcutaneous injection 15 mL VIAL Type I glass vial (USP / Ph. Eur.) 20 mm butyl rubber, fluoro-resin laminated liquid-type stopper (USP / Ph. Eur.) aluminum overseal with plastic flip-off disk. 36 Months F. HOFFMANN-LA ROCHE AG WURMISWEG F. Hoffmann-La Roche AG Wurmisweg 4303 Kaiseraugst Switzerland SWITZERLAND F. HOFFMANN-LA ROCHE LTD KIPHARMA LTD 2024-09-30 2029-09-29

2047 Rwanda FDA-HMP-MA-2046 BECOREN TABLETS Vitamin B1 Mononitrate, Vitamin B2, Vitamin B6, Niacinamide 0.5mg/ 0.5mg/0.5mg/7.5mg Tablets 10×10 Tablets Aluminium/amber PVC blister strip of 10 tablets and 10 of such blister strips are packed in a unit box with pack insert. 24 Months RENE INDUSTRIES LTD RENE INDUSTRIES LTD. Address: Manufacturers of Pharma Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda. Uganda RENE INDUSTRIES LTD,P.O.Box: 6034,KAMPALA, UGANDA. RENE PHARMACY (R) LTD 2024-09-30 2029-09-29

2048 Rwanda FDA-HMP-MA-2047 DIFENASOL DICLOFENAC SODIUM 0.1% Eye drops solution 5ml LDPE Bottle in a cardboard box. 36 Months Ahlcon Parenterals (India) Ltd Ahlcon Parenterals (India) Ltd Address: SP 918, Phase III Bhiwadi 301019 Rajasthan, India Tel: +91 (01493) 225304,305,306,307 INDIA Exphar SA H&H Pharma Ltd 2024-09-30 2029-09-29

2049 Rwanda FDA-HMP-MA-2048 EASCOF-LS SYRUP LEVOSALBUTAMOL SULPHATE/ AMBROXOL HYDROCHLORIDE/ GUAIPHENESIN 1MG/30MG/50MG/5ML SYRUP 100 ml round Pet Bottle 24 Months CACHET PHARMACEUTICALS PVT. LTD 415, Shah Nahar Industrial Estate, Dr. E. Moses Road, Worli, Mumbai-400 018 INDIA CACHET PHARMACEUTICALS PVT. LTD/INDIA SUN ENTERPRISES LTD 2024-09-30 2029-09-29

2050 Rwanda FDA-HMP-MA-2049 SPAMOX ORAL SUSPENSION 250 Amoxicillin trihydrate BP 250MG/5ML POWDER FOR ORAL SUSPENSION 100 ml Amber Colored Glass Bottle packed in a carton with leaflet and measuring cup 24 Months SPARSH BIO-TECH PVT. LTD Plot No. 1; Survey No. 242/243/244, Lakhabavad, Jamnagar-361 006 India SPARSH BIO-TECH PVT.LTD ABACUS PHARMA (A) LTD 2024-09-30 2029-09-29

2051 Rwanda FDA-HMP-MA-2050 FLUCYTOSINE TABLETS 500MG FLUCYTOSINE 500MG TABLETS 100 Tablets HDPE Container 24 Months Macleods Pharmaceuticals Limited Macleods Pharmaceuticals Limited, Plot No.50 to 54A, SEZ, Phase II, Pithampur, Dist.: Dhar Madhya Pradesh, 454774 India Macleods Pharmaceuticals Limited AIVEEN (R) LTD 2024-09-30 2029-09-29

2052 Rwanda FDA-HMP-MA-2051 UNIVIR 200 MG TABLETS Acyclovir 200 mg 200 mg Tablets 3x10 Tablets Packed in ALU/ALU blisters which are then packed in unit boxes. 36 Months UNIVERSAL CORPORATION LIMITED Universal Corporation Limited Address: P.O. Box 1748-00902, Kikuyu - Kenya. Telephone: +254 734 513075, +254 721 922210, +254 786 911512 Email: info@ucl.co.ke INDIA UNIVERSAL CORPORATION LIMITED SUN ENTERPRISES LTD 2024-09-30 2029-09-29

2053 Rwanda FDA-HMP-MA-2052 Jadelle Sine Inserter Levonorgestrel 75 mg Implants 1 x 10 Implants 10 sets of two implants 60 Months BAYER OY Bayer Oy, Turku Pansiontie 47 20210 Turku Finland Finland Bayer East Africa Ltd SURGIPHARM (RWANDA) LTD 2024-09-30 2029-09-29

2054 Rwanda FDA-HMP-MA-2053 UNIVIR CREAM ACYCLOVIR 5% W/W Cream 10 grams Tube ALU Tubes which are then packed in unit boxes. 36 Months UNIVERSAL CORPORATION LIMITED Universal Corporation Limited Address: P.O. Box 1748-00902, Kikuyu - Kenya. Telephone+254 734 513075, +254 721 922210, +254 786 911512 Email: info@ucl.co.ke KENYA UNIVERSAL CORPORATION LIMITED SUN ENTERPRISES LTD 2024-09-30 2029-09-29

2055 Rwanda FDA-HMP-MA-2054 A-CERUMEN EAR HYGIENE SOLUTION IN UNIDOSE SOLUTION OF SODIUM ACYL SARCOSINATE, SUCROSE LAURATE SOLUTION 15%, 5% EAR DROPS 10x2ml Doses Polyethylene low density unidose bottelpack container 36 Months LABORATOIRES GILBERT Avenue du general de gaulle 14200 Herouville Saint- Clair France FRANCE LABORATOIRES GILBERT GOHMS LTD 2024-09-30 2029-09-29

2056 Rwanda FDA-HMP-MA-2055 A-CERUMEN EAR HYGIENE SOLUTION IN SPRAY SOLUTION OF SODIUM ACYL SARCOSINATE SUCROSE LAURATE SOLUTION 15%, 5% EAR DROPS 40 ml Bottle HDPE Bottle 36 Months LABORATOIRES GILBERT 928 avenue du General de Gaulle, France, Tel. +33608663386Fax. +33231439500E-mail: ar-exp-dossier@labogilbert.fr FRANCE LABORATOIRES GILBERT GOMHS Ltd 2024-09-30 2029-09-29

2057 Rwanda FDA-HMP-MA-2056 KETOZ Ketoconazole 2% w/w Cream 15mg tube Aluminium tube 36 Months S KANT HEALTHCARE LTD S KANT HEALTHCARE LIMITED. PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT, INDIA Tel : 91-260-6538518 Email: skhcl@skant.com INDIA S KANT HEALTHCARE LTD SUN ENTERPRISES LTD 2024-09-30 2029-09-29

2058 Rwanda FDA-HMP-MA-2057 SILVERKANT SILVER SULPHADIAZINE 1% w/w Cream 30g Tube Aluminium collapsible tube 36 Months S KANT HEALTHCARE LTD S KANT HEALTHCARE LIMITED. PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT, INDIA INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2024-09-30 2029-09-29

2059 Rwanda FDA-HMP-MA-2058 ATRONA-40 ATORVASTATIN CALCIUM 40 mg Tablets 3x10 Tablets Alu-Alu Blister pack 36 Months ZOTA HEALTHCARE LTD Zota Healthcare Ltd. plot no 169, Surat Special Economic Zone, Near Sachin Railway Station, Sachin, Surat-394 230, Gujart, India. INDIA ZOTA HEALTHCARE LTD Taha Healthcare Ltd 2024-09-30 2029-09-29

2060 Rwanda FDA-HMP-MA-2059 CDTEL-H TELMISARTAN AND HYDROCHLOROTHIAZIDE 40 mg/12.5 mg Tablets 3x10 Tablets Alu-Alu Blister pack 36 Months ZOTA HEALTHCARE LTD Zota Healthcare Ltd. at plot no 169, Surat Special Economic Zone, Near Sachin Railway Station, Sachin, Surat-394 230, Gujarat, India INDIA ZOTA HEALTHCARE LTD Taha Healthcare Ltd 2024-09-30 2029-09-29

2061 Rwanda FDA-HMP-MA-2060 ABIRAT 250 Abiraterone Acetate Tablets USP 250 mg TABLETS 120 Tablets HDPE container pack 24 Months HETERO LABS LIMITED Hetero Labs Limited, Unit V Address: TSIIC Formulation SEZ, S.No 439, 440,441 & 458, Polepally Village, Jadcherla (Mandal), Mahaboob Nagar (District)-509301, Telangana State, India. INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-09-30 2029-09-29

2062 Rwanda FDA-HMP-MA-2061 ARTENAM BETA-ARTEMETHER 10MG/1ML INJECTION 7 Ampules Glass Ampoules 48 Months SOLUPHARM GmbH Industriestra?e3 34212, Melsungen Germany Germany ARENCO PHARMACEUTICA N.V KIPHARMA LTD 2024-09-30 2029-09-29

2063 Rwanda FDA-HMP-MA-2062 APRETUDE CABOTEGRAVIR 30MG Film Coated Tablets 30 tablets HDPE Container 36 Months Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) Priory Street Ware Hertfordshire SG12 0DJ United Kingdom ViiV Healthcare Pty Ltd KIPHARMA LTD 2024-09-30 2029-09-29

2064 Rwanda FDA-HMP-MA-2063 Hyoscine Butylbromide Tablets BP 10mg Hyoscine Butylbromide 10 mg Tablets 1000 tablets HDPE jar 36 Months ANGEL BIOGENICS PVT. LTD angelpharma3511@gmail.com INDIA ANGEL BIOGENICS PVT. LTD SUN ENTERPRISES LTD 2024-09-30 2029-09-29

2065 Rwanda FDA-HMP-MA-2064 AMINOPHYLINE TABLETS BP 100MG Aminophylline 100mg TABLETS 1000 Tablets HDEP jar 36 Months ANGEL BIOGENICS PVT. LTD Tirupati complex, First floor, Shapar-Veraval, Rajkot - 360024, Gujarat INDIA ANGEL BIOGENICS PVT. LTD SUN ENTERPRISES LTD 2024-09-30 2029-09-29

2066 Rwanda FDA-HMP-MA-2065 CALCIUM GLUCONATE INJECTION BP 10% w/v Calcium Gluconate 10% w/v Injection 10 Ampoules 10 Ampoules of 10ml in plastic try, such tray packed in carton 24 Months ANGEL BIOGENICS PVT. LTD angelpharma3511@gmail.com INDIA ANGEL BIOGENICS PVT. LTD SUN ENTERPRISES LTD 2024-09-30 2029-09-29

2067 Rwanda FDA-HMP-MA-2066 HALOPERIDOL INJECTION BP 5mg/ml Haloperidol BP 5mg/ml Injection 10 Ampoules Glass Ampoules packed in plastic tray, such tray packed in carton 24 Months ANGEL BIOGENICS PVT. LTD Tirupati Complex, 1st Floor, Shapar-Veraval, rajkot – 360024, gujarat, indiawork at. :46/4-7, dehgam road, village -zaktal. - dehgam, dist - gandhinagar - 382 330 INDIA ANGEL BIOGENICS PVT. LTD SUN ENTERPRISES LTD 2024-09-30 2029-09-29

2068 Rwanda FDA-HMP-MA-2067 BORTERO Bortezomib for Injection 3.5mg Injection 1×21 Vials Clear Tubular Vials 36 Months HETERO LABS LIMITED Hetero Labs Limited, Unit-III Hetero Labs Limited, Unit – VI Sy. No.: 410 - 411, TSIIC Formulation SEZ, Polepally village, Jadcherla Mandal, Mahaboob Nagar (Dist) – 509301, Telangana, India INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-09-30 2029-09-29

2069 Rwanda FDA-HMP-MA-2068 HARTEZE 20 RIVAROXABAN 20MG TABLETS 14 tablets & 28 tablets Aluminium Strip reel 36 Months COSMOS LIMITED Rangwe Road, Off Lunga Lunga Road, Industrial Area, Plot No. L/R 209/13268, P. O. Box 41433, GPO 00100, Nairobi, KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-09-30 2029-09-29

2070 Rwanda FDA-HMP-MA-2069 HARTEZE 10 RIVAROXABAN 10MG TABLETS 14 tablets & 28 tablets Aluminium Strip reel 36 Months COSMOS LIMITED Rangwe Road, Off Lunga Lunga Road, Industrial Area, Plot No. L/R 209/13268, P. O. Box 41433, GPO 00100, Nairobi KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-09-30 2029-09-29

2071 Rwanda FDA-HBP-MA-0001 iiCARE BILBERRY EXTRACT, LUTEIN AND BETA-CAROTENE 25mg, 15mg and 5mg Soft Gelatin Capsules 3x10 and 5x10 Capsules ALUMINIUM PVC/PVDC BLISTERS PACKED IN UNIT BOXES ALONG WITH PACK INSERT 24 Months MEGA LIFESCIENCES PUBLIC COMPANY LIMITED 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2024-09-30 2029-09-29

2072 Rwanda FDA-HMP-MA-2270 DICLOKANT-50 Diclofenac Sodium BP 50 mg TABLETS 10x10 Tablets Alu-PVC blister 36 Months S KANT HEALTHCARE LTD Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat, India INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2024-10-10 2029-10-09

2073 Rwanda FDA-HMP-MA-2119 CONSTIGO LACTULOSE 10G/15ML Solution for injection 200 ml HDPE-bottles 36 Months AURA LIFECARE PVT. LTD Survey No 254/ 14/1,Jarod ,Savli Road, P.O. Karachiya, Tal-Savli ,Dist : Vadodara-391520. Gujarat State India AURA LIFECARE PVT. LTD SUN ENTERPRISES LTD 2024-10-18 2029-10-17

2074 Rwanda FDA-HMP-MA-2120 NEOTAGMIN NEOSTIGMINE METHYLSULFATE 0.5MG/ML SOLUTION FOR INJECTION 1mL Ampoule USP Type – I clear glass Ampoules 24 Months THEMIS MEDICARE LIMITED Sector 6A, Plot No. 16, 17 & 18, IIE, SIDCUL, Haridwar, Uttarakhand – 249403 India THEMIS MEDICARE LIMITED Wessex Pharmaceuticals (Rwanda) Ltd 2024-10-18 2029-10-17

2075 Rwanda FDA-HMP-MA-2121 IBUKANT 400 F IBUPROFEN TABLETS BP 400 mg Tablets 1 x 10 tablets PVC/PVDC Aluminium 36 Months S Kant Healthcare Ltd Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396195, Gujarat India S Kant Healthcare Ltd ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

2076 Rwanda FDA-HMP-MA-2122 IBUKANT 200 F IBUPROFEN TABLETS BP 200 MG Tablets 1000s HDPE container 36 months S Kant HEALTHCARE Ltd Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat India S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

2077 Rwanda FDA-HMP-MA-2123 LOSARZED 50 Losartan Potassium BP/USP 50 mg Tablets 3x10 Tablets Alu-Alu forming foil 36 months ZOTA HEALTHCARE LTD Plot No. 169, Surat Special Economic Zone, Near Sachin Railway Station, Sachin, Dist: Surat,-394 230 Gujarat State India ZOTA HEALTHCARE LTD Taha Healthcare Ltd 2024-10-18 2029-10-17

2078 Rwanda FDA-HMP-MA-2124 LOSARZED-H Losartan Potassium, Hydrochlorothiazide 50/12.5MG Tablets 3x10 Tablets Alu-Alu Blister 36 Months Zota Healthcare Ltd plot no 169, Surat Special Economic Zone, Near Sachin Railway Station, Sachin, Surat-394 230, Gujart India ZOTA HEALTHCARE LTD Taha Healthcare Ltd 2024-10-18 2029-10-17

2079 Rwanda FDA-HMP-MA-2125 ZYFORGE 5/80 Amlodipine and Valsartan Tablets USP 5mg / 80mg Tablets 10’s (3x10 Tablets) Alu-Alu blisters 24 Months ZYDUS LIFESCIENCES LIMITED Kundaim Industrial Estate, Plot No.203-213, Kundaim, Goa 403 115, India India ZYDUS LIFESCIENCES LIMITED ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

2080 Rwanda FDA-HMP-MA-2126 ZYFORGE 5/160 Amlodipine and Valsartan USP 5mg / 160mg Tablets 3x10 Tablets Alu-Alu Blisters pack 24 Months ZYDUS LIFESCIENCES LIMITED Kundaim Industrial Estate, Plot No.203-213, Kundaim, Goa 403 115, India India ZYDUS LIFESCIENCES LIMITED ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

2081 Rwanda FDA-HMP-MA-2127 ZYFORGE 10/160 Amlodipine and Valsartan USP 10mg / 160mg Tablets 3x10 tablets Alu-Alu Blisters pack 24 Months ZYDUS LIFESCIENCES LIMITED Kundaim Industrial Estate, Plot No.203-213, Kundaim, Goa 403 115, India India ZYDUS LIFESCIENCES LIMITED ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

2082 Rwanda FDA-HMP-MA-2128 VANKO-WM VANCOMYCIN 500MG LYOPHILISATE FOR SOLUTION FOR INFUSION 1 Glass vial of 10ml 10 ml transparent Type I glass vial Bromobutyl grey lyophilized single notched stopper transparent flip-off cap. 36 Months World Medicine ?laç San. ve Tic. A.?. 15 Temmuz Mah. Cami Yolu Cad. No. 50, Güne?li, Ba?c?lar, Istanbul, Turkey TURKEY World Medicine ?laç San. ve Tic. A.?. GOODMAN INTERNATIONAL ® LTD 2024-10-18 2029-10-17

2083 Rwanda FDA-HMP-MA-2129 CHLOZINE TABLETS CHLORPROMAZINE HYDROCHLORIDE BP 100MG TABLETS Jar pack of 1000 tablets HDPE Jar 36 Months AGOG PHARMA LTD Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-10-18 2029-09-17

2084 Rwanda FDA-HMP-MA-2130 FLUOXINE ® 750 CIPROFLOXACIN HYDROCHLORIDE USP 750MG TABLETS Box of 10 tablets PVC- Aluminium foil with printings 36 Months GRACURE PHARMACEUTICALS LIMITED E-1105, Industrial Area, Phase-III BHIWADI, PIN-301019, Dist. Alwar, Rajasthan, India INDIA EXPHAR S.A. H&H PHARMA LTD 2024-10-18 2029-02-17

2085 Rwanda FDA-HMP-MA-2131 CLARITYNE TABLETS LORATADINE 10MG TABLETS 10\'s PVC/PVDC 36 Months Bayer Bitterfeld GmbH Bayer Bitterfeld OT Greppin Salegaster Chausse 1, 06803 Bitterfeld-Wolfen, Germany GERMANY BAYER EAST AFRICA LIMITED SURGIPHARM (RWANDA) LTD 2024-10-18 2029-10-17

2086 Rwanda FDA-HMP-MA-2132 VITAREN SYRUP Vitamin A (as Palmitate), Thiamine HCL (Vitamin B1), Riboflavin Sodium Phosphate (Vitamin B2), Pyridoxine HCL (Vitamin B6), Cholecalciferol (Vitamin D), Nicotinamide 1500 I.U / 1mg / 1mg / 0.5mg / 100 I.U / 10mg SYRUP 60ml Amber glass bottles 24 Months RENE INDUSTRIES LTD Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda UGANDA RENE INDUSTRIES LTD RENE PHARMACY (R) LTD 2024-10-18 2029-10-17

2087 Rwanda FDA-HMP-MA-2133 NORMAGUT CAPSULES Saccharomyces boulardii 250MG CAPSULES 1x10\'s ALU-PVC/PVDC 24 Months ARDEYPHARM GmbH LOERFELDSTR, 20 58313 HERDECKE, GERMANY GERMANY MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

2088 Rwanda FDA-HMP-MA-2134 BIOTRIM 480MG TABLETS TRIMETHOPRIM AND SULPHAMETHOXAZOLE 80mg / 400mg TABLETS 1000 tablets HDPE jars 36 Months BIODEAL LABORATORIES LTD 123 LUNGA LUNGA ROAD P.O. BOX 32040-00600, NAIROBI, KENYA KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICAL SUPPLIES LTD 2024-10-18 2029-10-17

2089 Rwanda FDA-HMP-MA-2135 URINORM FEBUXOSTAT 80MG TABLETS 2 x 14 Tablets Al-PVC Blister 24 Months EMCURE PHARMACEUTICALS LIMITED Plot No. P-1 & P-2, I.T.B.T. Park, Phase II, MIDC, Hinjwadi, Pune-411 057 Maharashtra India EMCURE PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

2090 Rwanda FDA-HMP-MA-2136 PANTOTAB-L PANTOPRAZOLE 40MG Capsules 10 Capsules Alu/Alu blister 24 months MICRO LABS LIMITED 92, SIPCOT, Hosur-635 126 India MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-10-18 2029-10-17

2091 Rwanda FDA-HMP-MA-2137 MURAXAL-10 ALFUZOSIN HYDROCHLORIDE 10MG TABLETS 1x10 Tablets Aluminium Strip reel 24 Months MICRO LABS LIMITED 92, Sipcot, Industrial Complex, Hosur-635126, Tamil Nadu, India, E-Mail:Mra@Microlabs.In India MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-10-18 2029-10-17

2092 Rwanda FDA-HMP-MA-2138 AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN AND CLAVULANATE POTASSIUM 625 MG TABLETS 10 tablets ALU/PVC 36 Months REYOUNG PHARMACEUTICAL CO., LTD No. 1. Ruiyang Road, Yiyuan County, Shandong Province, P. R. China CHINA REYOUNG PHARMACEUTICAL CO., LTD SUN ENTERPRISES LTD 2024-10-18 2029-10-17

2093 Rwanda FDA-HMP-MA-2139 SODIUM CHLORIDE GRIFOLS 0.9% SOLUTION FOR INFUSION BP SODIUM CHLORIDE 0.9% (900mg/100ml) / 250ml SOLUTION FOR INFUSION 250ML The polypropylene bags (Fleboflex) 24 Months LABORATORIOS GRIFOLS, S.A Polígono Industrial Los Llanos. C/ Marte nº 4. 30565 Las Torres de Cotillas, Murcia SPAIN LABORATORIOS GRIFOLS, S.A Bion Pharma Group (BPG) Limited 2024-10-18 2029-10-17

2094 Rwanda FDA-HMP-MA-2140 UNIVIR 400 ACYCLOVIR 400MG TABLETS 1 x 10\'s ALU/ALU blisters 36 Months UNIVERSAL CORPORATION LIMITED P.O. Box 1748-00902, Kikuyu, Kenya KENYA UNIVERSAL CORPORATION LIMITED SUN ENTERPRISES LTD 2024-10-18 2029-10-17

2095 Rwanda FDA-HMP-MA-2141 COLDEASE SYRUP Paracetamol BP, Chlorpheniramine Maleate BP, Pseudoephedrine Hydrochloride BP 120mg / 2mg / 15mg SYRUP 100ML PET bottles 24 Months RENE INDUSTRIES LTD Plot No 680, P.O. Box 6034, Kamuli, Kireka, Kampala UGANDA RENE INDUSTRIES LTD Rene Pharmacy (R) Ltd 2024-10-18 2029-10-17

2096 Rwanda FDA-HMP-MA-2142 RIFAMPIN, ISONIAZID AND PYRAZINAMIDE DISPERSIBLE TABLETS RIFAMPIN, ISONIAZID AND PYRAZINAMIDE 75mg / 50mg / 150mg Dispersible Tablets 3 x 28’s tablets and 10 x 6’s tablets Strip pack Plain Aluminium/Aluminium strips 24 Months LUPIN LIMITED A-28/1, MIDC Area, Chikalthana, Aurangabad, Aurangabad-431210 INDIA LUPIN LIMITED AIVEEN (R) LTD 2024-10-18 2029-10-17

2097 Rwanda FDA-HMP-MA-2143 EROCIN DRY MIXTURE ERYTHROMYCIN STEARATE 125mg / 5mL Dry Powder for Oral Suspension 100mL / 60mL Amber glass / HDPE bottles 36 Months LABORATORY & ALLIED LTD Plot no. 209/10349, Opposite Sameer business Park, next to Libra house, Mombasa Road. P. O. Box 42875, GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-10-18 2029-10-17

2098 Rwanda FDA-HMP-MA-2144 UNIPEN DRY SYRUP PHENOXYMETHYLPENICILLIN POTASSIUM BP 125mg / 5mL SYRUP 125 mL Amber glass bottles 36 Months REGAL PHARMACEUTICALS LTD Plot no: 7879/18, off Baba Dogo Road, Ruaraka. Postal Address: P.O.Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

2099 Rwanda FDA-HMP-MA-2149 Sodium Chloride Grifols 0.9% Solution for infusion BP Sodium Chloride Grifols 0.9% Solution for infusion BP 0.9% (900 mg/100 mL) /1000ML Injection 1000ml The polypropylene bags (Fleboflex) 24 Months LABORATORIOS GRIFOLS, S.A Polígono Industrial Los Llanos. C/ Marte nº 4. 30565 Las Torres de Cotillas, Murcia Spain LABORATORIOS GRIFOLS, S.A BION PHARMA GROUP LTD 2024-10-18 2029-10-17

2100 Rwanda FDA-HMP-MA-2147 Sodium Chloride Grifols 0.9% Solution for infusion BP Sodium Chloride Grifols 0.9% Solution for infusion BP 0.9% (900 mg/100 mL) 100ML Injection 100ml polypropylene bags (Fleboflex) 24 Months LABORATORIOS GRIFOLS, S.A Polígono Industrial Los Llanos. C/ Marte nº 4. 30565 Las Torres de Cotillas, Murcia Spain LABORATORIOS GRIFOLS, S.A BION PHARMA GROUP LTD 2024-10-18 2029-10-17

2101 Rwanda FDA-HMP-MA-2145 ABLADO DT ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM AND LAMIVUDINE 60 MG / 5 MG / 30 MG TABLETS 90\'s & 180’s HDPE Container 24 Months APL Healthcare Limited Unit-IV, Plot No 16, APIIC, Multi Products SEZ, Menakuru Village, Naidupeta Mandal, Tirupati District, Andhra Pradesh, India INDIA AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-10-18 2029-10-17

2102 Rwanda FDA-HMP-MA-2150 IBUREN SUSPENSION IBUPROFEN 100MG / 5ML Oral Suspension 60ML Amber glass bottles 24 Months RENE INDUSTRIES LTD PO Box 6034, Plot No.680, Kamuli, Kireka, Kampala, Uganda UGANDA RENE INDUSTRIES LTD Rene Pharmacy (R) Ltd 2024-10-18 2029-10-17

2103 Rwanda FDA-HMP-MA-2152 DAPIFLOZIN 10 DAPAGLIFLOZIN (AMORPHOUS) 5 MG 10 mg Tablets 3x10 tablets Alu Alu blister 36 Months Inventia Healthcare Limited F1-F1/1-F75/1, Additional Ambernath M.I.D.C., Ambernath (East), Thane 421506, Maharashtra State, India India MEGA LIFESCIENCES(AUSTRALIA) PTY LIMITED ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

2104 Rwanda FDA-HMP-MA-2151 CALM 5 TABLETS DIAZEPAM BP 5MG TABLETS 10x10\'s Alu/PVC blister packs 36 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-10-18 2029-10-17

2105 Rwanda FDA-HMP-MA-2153 UNIXIL 250 DISPERSIBLE TABLET AMOXICILLIN TRIHYDRATE 250MG TABLETS 10 x 10 Tablets Alu/PVDC Blisters 24 Months REGAL PHARMACEUTICALS LTD Plot No. 7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

2106 Rwanda FDA-HMP-MA-2154 CANESTEN SOFT GEL OVULE CLOTRIMAZOLE 500 mg Soft Gel Capsules 1 x 1 Capsules PVC/PVdC/PVC laminate blister with an aluminium foil lid 36 Months BERLIMED S.A Francisco Alonso, 7 28806 Alcalá de Henares, Madrid, SPAIN SPAIN BAYER EAST AFRICA LIMITED Sun enterprises Ltd 2024-10-18 2029-10-17

2107 Rwanda FDA-HMP-MA-2155 CANDIDERM CREAM Clotrimazole, Anhydrous Beclomethasone Dipropionate and Gentamicin Sulphate 15GM CREAM 15 g Tube Aluminium Collapsible tube packed in a carton 36 Months GLENMARK PHARMACEUTICALS LIMITED Plot No. E-37, 39, D-Road, MIDC, Satpur, Nashik – 422007, Maharashtra, India INDIA GLENMARK PHARMACEUTICALS LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-10-18 2029-10-17

2108 Rwanda FDA-HMP-MA-2157 SYXTEN 5% CARBOCISTEINE 5% Syrup 100 mL Amber Pet Bottles 36 Months S KANT HEALTHCARE LTD. Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat. India INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

2109 Rwanda FDA-HMP-MA-2156 ORAL REHYDRATION SALTS GLUCOSE ANHYDROUS BP, SODIUM CHLORIDE BP, SODIUM (TRISODIUM) CITRATE BP, POTASSIUM CHLORIDE BP 13.5GM / 2.6GM / 2.90GM / 1.50GM ORAL POWDER 20.6g / 10.3g Aluminium foil sachets 36 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road P.O Box 42875-00100 Nairobi. Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2024-10-18 2029-10-17

2110 Rwanda FDA-HMP-MA-2158 DOXY CAPSULES DOXYCYCLINE 100MG CAPSULES 10 x 10 Tablets Alu / PVC blister packs 36 Months LABORATORY & ALLIED LIMITED Plot No:209/10349, Opposite Sameer Business Park, Mombasa road, Kenya KENYA LABORATORY & ALLIED LIMITED DEPOT PHARMACEUTIQUE LE MEDICAL 2024-10-18 2029-10-17

2111 Rwanda FDA-HMP-MA-2159 SYXTEN 2% CARBOCISTEINE 2% Syrup 125 mL Amber Pet Bottles 36 Months S KANT HEALTHCARE LTD. Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat. India INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

2112 Rwanda FDA-HMP-MA-2160 TENOFOVIR DISOPROXIL FUMARATE/ LAMIVUDINE/ DOLUTEGRAVIR TABLETS TENOFOVIR DISOPROXIL FUMARATE/ LAMIVUDINE/ DOLUTEGRAVIR 300MG / 300 MG / 50MG TABLETS 28’s, 30’s, 56’s, 60’s, 84’s, 90’s, 168’s and 180’s HDPE bottles 36 Months STRIDES PHARMA SCIENCE LIMITED KRS Gardens, Tablet Block36/7, Suragajakkanahalli, Indlavadi cross, Anekal Taluk, Bengaluru – 562 106 INDIA STRIDES PHARMA SCIENCE LIMITED SUN ENTEPRISES LTD 2024-10-18 2029-10-17

2113 Rwanda FDA 24 HM 0010 FEMIFER IRON (II) HYDROXIDE POLYMALTOSE/FOLIC ACID/ASCORBIC ACID Syrup 24 BEKRA PHARMA UK LTD PHARMACIE CELIA LTD 2024-10-18 2029-10-17

2114 Rwanda FDA-HMP-MA-2267 SODIUM CHLORIDE GRIFOLS 0.9% SOLUTION FOR INFUSION BP Sodium Chloride Grifols 0.9% Solution for infusion BP 0.9% (900 mg/100)/ 50mL Solution for Infusion 50 mL of solution x 115 bags The polypropylene bags (Fleboflex) 18 Months LABORATORIOS GRIFOLS, S.A. Polígono Industrial Zeta. C/ Logística, 2. 08150 Parets del Vallès, Barcelona, spain SPAIN LABORATORIOS GRIFOLS, S.A. BION PHARMA GROUP LTD 2024-10-18 2029-10-17

2115 Rwanda FDA-HMP-MA-2090 GRISORAL-250 Griseofulvin 250 MG Tablets 10x10 Tablets Alu foil - plain PVC blister 36 Months BAL PHARMA LIMITED Unit-I, 21,22,Bommasandra industrial area, Bangalore-560099, India.Email: delregulatory@balpharma.com India BAL PHARMA LIMITED SUN ENTERPRISES LTD 2024-10-18 2029-10-17

2116 Rwanda FDA-HMP-MA-2093 THERMODOL PARACETAMOL 1.0% W/V SOLUTION FOR INFUSION 100 ml LDPE bottle LPDE bottle and printed carton with insert 24 Months AKUMS DRUGS AND PHARMACEUTICALS LTD Plot no.2,3,4 & 5, Sector-6B, IIE., SIDCUL, Ranipur, Haridwar-249403, Uttarakhand, India. India UNOSOURCE PHARMA LTD AIVEEN (R) LTD 2024-10-18 2029-10-17

2117 Rwanda FDA-HMP-MA-2094 UNOKETRO KETOROLAC TROMETHAMINE 30MG/ML SOLUTION FOR INJECTION PVC tray of 10 x1 ml Amber colored ampoule PVC tray contains 10 ampoules of amber colour glass of 1 ml with pack insert 24 Months AKUMS DRUGS AND PHARMACEUTICALS LTD Plot no.2,3,4 & 5, Sector-6B, IIE., SIDCUL, Ranipur, Haridwar-249403, Uttarakhand, INDIA India UNOSOURCE PHARMA LTD AIVEEN (R) LTD 2024-10-18 2029-10-17

2118 Rwanda FDA-HMP-MA-2095 PARACETAMOL B.BRAUN 10MG/ML SOLUTION FOR INFUSION PARACETAMOL 10MG/ML INTRAVENOUS SOLUTION FOR INFUSION 10 x 50ml. 10 x100ml ( Ecoflac® Plus LDPE bottle ) LDPE bottles 18 Months B. Braun Medical S.A Carretera de Terrassa, 121 08191 Rubi (Barcelona), Spain SPAIN B. BRAUN MELSUNGEN AG KIPHARMA LTD 2024-10-18 2029-10-17

2119 Rwanda FDA-HMP-MA-2096 RISDONE-2 RISPERIDONE 2MG TABLETS Alu PVC blister of 10 Tablets Alu-PVC Blisters pack 36 Months INTAS PHARMACEUTICALS LIMITED Camp Road, Selaqui, Dehradun, Uttarakhand, India. India INTAS PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

2120 Rwanda FDA-HMP-MA-2097 CARBAMAZEPINE CARBAMAZEPINE 400 mg TABLETS 4 x 14’s Alu-PVC/PVDC blister pack 36 Months MEDREICH LIMITED No. 4/3, Avalahalli, Anianapura Post, Kanakapura Road, Bengaluru – 560 062, India India Imperial Medical Solutions FZE SURGIPHARM (RWANDA) LTD 2024-10-18 2029-10-17

2121 Rwanda FDA-HMP-MA-2098 PAINEX Paracetamol, Aspirin and Caffeine anhydrous 500mg / 500mg / 50mg TABLETS 25 x 4 glassine foil strips of 100 tablets Glassine foil strips 24 Months RENE INDUSTRIES LTD Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda UGANDA RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-10-18 2029-10-17

2122 Rwanda FDA-HMP-MA-2099 THROMBAN 5 APIXABAN 5mg TABLETS Blister pack of 10’s (3x10 Tablets) Alu-PVC/PVDC blister pack 24 Months ZYDUS LIFESCIENCES LIMITED Kundaim Industrial Estate, Plot No.203-213, Kundaim, Goa 403 115, India India ZYDUS LIFESCIENCES LIMITED ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

2123 Rwanda FDA 24 HM 0001 FUROSEMIDE TAB Furosemide 40mg Tablet 10 36 Months IPCA LABORATORIES LIMITED Plot no. 255/ 1 Village: athal, silvassa-396230 Dadra and nagar haveli India COSMOS LIMITED SUN ENTERPRISES LTD/KIMIRONKO BRANCH 2024-10-18 2029-10-17

2124 Rwanda FDA-HMP-MA-2100 THROMBAN 2.5 APIXABAN 2.5MG TABLETS Blister pack of 10’s (3x10 Tablets) Alu PVC/PVDC Blister pack 24 Months Zydus Lifesciences Limited Kundaim Industrial Estate, Plot No.203-213, Kundaim, Goa 403 115, India India ZYDUS LIFESCIENCES LIMITED ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

2125 Rwanda FDA-HMP-MA-2105 PANFOR SR-1000 METFORMIN 1000 mg Tablets 10 tablets Alu-Alu film Blisters 24 months INVENTIA HEALTH LIMITED F1-F1/1-F75/1, Additional Ambernath M.I.D.C., Ambernath (East), Thane 421506, Maharashtra State India MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

2126 Rwanda FDA-HMP-MA-2107 Sitamet tablets 50/500 mg Sitagliptin Phosphate Monohydrate 50 mg and Metformin Hydrochloride USP 500 mg 50/500 mg FILM COATED TABLETS 4x7 Tablets Alu-PVC blister 36 Months CCL Pharmaceuticals (Pvt.) Ltd 62-Industrial Estate, Kot Lakhpat, Lahore-54770 Pakistan CCL Pharmaceuticals (Pvt.) Ltd DEPOT PHARMACEUTIQUE LE MEDICAL 2024-10-18 2029-10-17

2127 Rwanda FDA-HMP-MA-2106 Sita-Met Tablet 50/1000mg Sitagliptin Phosphate Monohydrate 50 mg and Metformin Hydrochloride USP 1000 mg 50/1000mg Film Coated Tablets 4x7 Tablets Alu-PVC blisters 24 Months CCL Pharmaceuticals (Pvt.) Ltd 62-Industrial Estate, Kot Lakhpat, Lahore-54770 Pakistan CCL Pharmaceuticals (Pvt.) Ltd Depot Pharmaceutique Le Medical 2024-10-18 2029-10-17

2128 Rwanda FDA-HMP-MA-2108 Biophenicol Ear Drops Chloramphenicol 5.0%w/v Ear Drops 10ml Bottle Plastic dropper bottles 36 Months BIODEAL LABORATORIES LTD E-17/3, E-17/4 & E-18, M.I.D.C, Tarapur Boisar, Dist. Palghar-401506 KENYA BIODEAL LABORATORIES LIMITED Capital Pharmaceutical Supplies Ltd 2024-10-18 2029-10-17

2129 Rwanda FDA-HMP-MA-2109 INSUGEN-N (NPH) Insulin Injection, Isophane Ph. Eur. 100IU/mL Injection 10ml Vials (USP Type I) 36 months Biocon Biological Limited Block No. B1,B2,B3, Q13 OF Q1 and W20& unit S18,1 st floor, Block B4, Special Economic zone, Plot No. 2,3,4&5 , Phase IV , Bommasandra-Jigani Link Road, Bomasandra Post, Bengaluru-560099 India Angel Biogenic Pvt Ltd Pyramid Pharma Limited 2024-10-18 2029-10-17

2130 Rwanda FDA-HMP-MA-2110 INSUGEN-30/70 (Biphasic) Insulin Injection, Biphasic Isophane Ph.Eur. 100 IU/mL Injection 10ml Vial Vials (USP Type I) 36 Months Biocon Biological Limited Block No. B1,B2,B3, Q13 OF Q1 and W20& unit S18,1 st floor, Block B4, Special Economic zone, Plot No. 2,3,4&5 , Phase IV , Bommasandra-Jigani Link Road, Bomasandra Post, Bengaluru-560099 India Angel Biogenic Pvt Ltd Pyramid Pharma Limited 2024-10-18 2029-10-17

2131 Rwanda FDA-HMP-MA-2111 INSUGEN-R (Regular) Insulin Injection, Soluble Ph. Eur. 100 IU/mL Injection 10 ml Vial Vials 36 Months Biocon Biological Limited Block No. B1,B2,B3, Q13 OF Q1 and W20& unit S18,1 st floor, Block B4, Special Economic zone, Plot No. 2,3,4&5 , Phase IV , Bommasandra-Jigani Link Road, Bomasandra Post, Bengaluru-560099 India Angel Biogenic Pvt Ltd Pyramid Pharma Limited 2024-10-18 2029-10-17

2132 Rwanda FDA-HMP-MA-2112 Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate 50 mg / 300 mg / 300 mg Tablets 30’s, 90’s & 180 Tablets HDPE Bottle 36 Months MICRO LABS LIMITED Address: Plot No. S-155 to S-159 & N1, Phase III & IV, Verna Industrial Estate, Verna Salcette Goa – 403722 India MICRO LABS LIMITED Wessex Pharmaceuticals (Rwanda) Ltd 2024-10-18 2029-10-17

2133 Rwanda FDA-HMP-MA-2113 CHLOROMYCETIN Chloramphenicol 0.5%w/v Ear Drops 10ml Bottle LDPE Bottle 24 Months SCOTT-EDIL PHARMACIA LIMITED 56, EPIP, Phase-I, Jharmajri, Baddi-173 205, (HP) India SCOTT-EDIL PHARMACIA LIMITED SUN ENTERPRISES LTD 2024-10-18 2029-10-17

2134 Rwanda FDA-HMP-MA-2114 DURART 800 Darunavir Tablets 800 mg Tablets 1x30 Tablets Aluminium induction 36 Months MYLAN LABORATORIES LIMITED Plot No. H-12 and H-13), MIDC, Waluj Industrial Area, Aurangabad-431136. Maharashtra India MYLAN LABORATORIES LIMITED Pyramid Pharma Limited 2024-10-18 2029-10-17

2135 Rwanda FDA-HMP-MA-2115 GACET 500 Paracetmol Effervescent Granules 500 MG Effervescent Granules 10 sachets Laminate foil 24 Months BLISS GVS PHARMA LTD Survey No. 43- 44, Vevoor village , Palghar 401404 India BLISS GVS PHARMA LTD Surya Depot Pharmacy Ltd 2024-10-18 2029-10-17

2136 Rwanda FDA-HMP-MA-2116 AVIRAX Aciclovir Tablets BP 200 mg Tablets 10 tablets Alu-PVDC blister 36 months S Kant HEALTHCARE Ltd Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat India S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

2137 Rwanda FDA-HBP-MA-0140 GARDASIL 9 Human Pappilomavirus L1 Virus Like Particle Type 6, 11, 16, 18, 31, 33, 45, 52, 58 Each 0.5 ml dose contains approximately: 30 ?g HPV Type 6 L1 protein, 40 ?g HPV Type 11 L1 protein, 60 ?g HPV Type 16 L1 protein, 40 ?g HPV Type 18 L1 protein, 20 ?g HPV Type 31 L1 protein, 20 ?g HPV Type 33 L1 protein, 20 ?g HPV Type 45 L1 protein, 20 ?g HPV Type 52 L1 protein, and 20 ?g HPV Type 58 L1 protein. Suspension for injection 10 vials GLASS Vials 36 Months Merck Sharp & Dohme LLC 770 Sumneytown Pike West Point, Pennsylvania, 19486 USA MSD Morocco UBIPHARM-RWANDA LTD 2024-10-18 2029-10-17

2138 Rwanda FDA-HMP-MA-2117 CYCLOREN TABLETS ACYCLOVIR 200 mg Tablets 10 tablets Aluminium / PVC blister strip 24 Months RENE INDUSTRIES LTD Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala Uganda RENE INDUSTRIES LTD RENE PHARMACY (R) LTD 2024-10-18 2029-10-17

2139 Rwanda FDA-HMP-MA-2118 Movicol Paediatric Polyethylene Glycol 6.563 g, Sodium Chloride 154.4 mg, Sodium Bicarbonate 89.3 mg and Potassium Chloride 25.1 mg 6.563 g, 154.4 mg, 89.3 mg and 25.1 mg Powder 3 Sachets Sachets 24 Months Win-Medicare Pvt. Ltd Modipuram – 250 110,U.P India Win-Medicare Pvt. Ltd Surgipharm (Rwanda) Ltd 2024-10-18 2029-10-17

2140 Rwanda FDA-HMP-MA-2148 Sodium Chloride Grifols 0.9% Solution for infusion BP Sodium Chloride Grifols 0.9% Solution for infusion BP 0.9% (900 mg/100 mL) /500ML Infusion 500 mL The polypropylene bags (Fleboflex) 24 months LABORATORIOS GRIFOLS, S.A Polígono Industrial Los Llanos. C/ Marte nº 4. 30565 Las Torres de Cotillas, Murcia Spain LABORATORIOS GRIFOLS, S.A Bion Pharma Group (BPG) Limited 2024-10-25 2029-10-24

2141 Rwanda FDA-HMP-MA-1570 RESPIMAX Ambroxol Hydrochloride, Salbutamol Sulfate, Guaifenesin 15MG/1MG/1MG/5ML SYRUP 100ML BOTTLE Amber colour bottle pack, packed in printed and laminated carton 24 MONTHS West Coast Pharmaceutical Works Ltd F.P. No. 17 & 16/5, Meldi Estate, B/s Meldi Mata Temple, Near Gota Railway Crossing, At & Post Gota, Ahmedabad – 382481, Gujarat State (India) INDIA BEKRA PHARMA, United Kingdom UBIPHARM RWANDA LTD 2024-10-27 2029-10-26

Registered

2142 Rwanda FDA-HMP-MA-2029 BENYLIN WITH CODEINE Diphenhydramine Hydrochloride, Ammonium Chloride, Codeine Phosphate 12,5MG/125MG/10MG/5ML SYRUP 100ml Bottle Amber glass bottle, having a white polypropylene cap with expanded polyethylene liner, the bottles are packed in individual paper board cartons 36 Months Johnson & Johnson (Pty) Ltd Johnson & Johnson (Pty) Ltd, 241 Main Road, Retreat, 7945, Cape Town, South Africa South Africa Johnson & Johnson (Pty) Ltd WESSEX PHARMACEUTICALS RWANDA LTD 2024-10-27 2029-10-26

2143 Rwanda FDA-HMP-MA-2146 DAPIFLOZIN 5 DAPAGLIFLOZIN (AMORPHOUS) 5 MG 5mg Tablets 3x10 tablets Alu Alu blister 36 months Inventia Healthcare Limited F1-F1/1-F75/1, Additional Ambernath M.I.D.C., Ambernath (East), Thane 421506, Maharashtra State, India India MEGA LIFESCIENCES(AUSTRALIA) PTY LIMITED ABACUS PHARMA (A) LTD 2024-10-29 2029-10-28

2144 Rwanda FDA-HMP-MA-2167 GYNOZOL MICONAZOLE NITRATE 400 mg VAGINAL SOFT GELATIN CAPSULES 3 VAGINAL SOFT GELATIN CAPSULES PVC/Al Blisters 36 Months SAFE for Pharmaceuticals (Safe Pharma) 2nd Industrial Zone, Section No.3, Block 31, New Borg El Arab city, Alexandria, Egypt EGYPT PHARCO PHARMACEUTICALS HELIOS PHARMA Ltd 2025-01-09 2030-01-08

2145 Rwanda FDA-HMP-MA-2168 AKUROSE Iron Sucrose Injection USP 20 mg/ml Injection 5ml Amber glass coloured glass ampoule USP type I 36 months AKUMS DRUGS & PHARMACEUTICALS LTD Plot No. 2,3,4,5, Sector 6B, IIE, SIDCUL, Ranipur, Haridwar – 249403, Uttarakhand INDIA UNOSOURCE PHARMA LTD AIVEEN (R) LTD 2025-01-09 2030-01-08

2146 Rwanda FDA-HMP-MA-2169 DOBATAF-3 Dolutegravir, Emtricitabine and Tenofovir Alafenamide 50 mg/200 mg/25 mg TABLETS 30’s & 90’s HDPE Container 24 Months APL HEALTHCARE LIMITED Unit- IV), (Formerly known as Aurobindo Pharma Limited, Unit-X) Plot No.16, APIIC , Multi Products SEZ,Menakuru Village, Naidupeta Mandal Tirupati District, Andhra Pradesh INDIA Aurobindo Pharma Limited PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2025-01-09 2030-01-08

2147 Rwanda FDA-HMP-MA-2170 Heparin Sodium Injection BP Heparin Sodium Injection BP 25000IU/5ml Injection 5 mL USP type I clear glass vial 36 months M/s. Gland Pharma Limited Survey No. 143 to 148, 150 & 151, Near Gandimaisamma Cross Roads, D.P. Pally, Dundigal Post, Dundigal - Gandimaisamma Mandal, Medchal-Malkajgiri District, Hyderabad - 500 043, Telangana INDIA M/s. Gland Pharma Limited Africa Healthcare Network Rwanda Ltd 2025-01-09 2030-01-08

2148 Rwanda FDA-HMP-MA-2171 OSTEOMIN TABLETS Glucosamine Sulphate 2kcl 667mg Equivalent to Glucosamine Sulphate 500mg and Chondroitin Sulphate 400mg 500 mg & 400 mg TABLETS 3x10 Tablets PVC/PVDC film 36 Months MEGA LIFESCIENCES (Australia) Pty. Ltd 60 National Avenue, SouthEast Business Park, Pakenham, Victoria, Australia 3089 Australia MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2025-01-09 2030-01-08

2149 Rwanda FDA-HMP-MA-2172 DOLUTEGRAVIR SODIUM 50MG, LAMIVUDINE USP 300 MG, TENOFOVIR DISOPROXIL FUMARATE 300 MG DOLUTEGRAVIR SODIUM, LAMIVUDINE USP, TENOFOVIR DISOPROXIL FUMARATE 50 MG, 300 MG, 300 MG TABLETS 30 TABLETS; 90 TABLETS and 180 TABLETS HDPE container 36 Months CIPLA LTD Goa Unit VII, Unit VII PD II Plot No. S-103 to S-105, S-107 to S-112 & L-147, L-147/1 to L-147/3, L-147/A & L-138 Verna Industrial Estate, Verna, Salcette, Goa – 403 722 INDIA CIPLA LTD PHILIPS PHARMACEUTICALS (RWANDA) LTD 2025-01-09 2030-01-08

2150 Rwanda FDA-HMP-MA-2173 CELEBIB 100 CELECOXIB 100 mg CAPSULES 3x10 Capsules ALU-Clear PVC/PVdC blister 48 Months MACLEODS PHARMACEUTICALS LIMITED Block N2, Village Theda, Post Office Lodhimajra, Tehsil Baddi, District Solan, Himachal Pradesh – 174101 INDIA MACLEODS PHARMACEUTICALS LIMITED AIVEEN (R) LTD 2025-01-09 2030-01-08

2151 Rwanda FDA-HMP-MA-2174 VENTOMAC 100 SALBUTAMOL PRESSURIZED INHALATION 100 MCG Inhalation One aluminum plain Canister Aluminium plain Canister 36 Months MACLEODS PHARMACEUTICALS LIMITED At Oxalis Labs Village Theda, P.O. Lodhimajra , Tehsil Baddi, Distt .Solan (H.P) INDIA MACLEODS PHARMACEUTICALS LIMITED AIVEEN (R) LTD 2025-01-09 2030-01-08

2152 Rwanda FDA-HMP-MA-2175 IXAROLA 10 RIVAROXABAN 10 10 mg TABLETS 3x10 Tablets Polypropylene)/aluminium blister strips 36 Months BAYER AG & BAYER HEALTHCARE MANUFACTURING S.r.l 51368 Leverkusen, Germany & Via delle Groane, 126 20024 Garbagnate Milanese, Italy Germany & Italy Bayer East Africa Limited SURGIPHARM (RWANDA) LTD 2025-01-09 2030-01-08

2153 Rwanda FDA-HMP-MA-2176 IXAROLA 15 RIVAROXABAN 15 15 mg TABLETS 42 tablets Polypropylene)/aluminium blister strips 36 Months BAYER AG & BAYER HEALTHCARE MANUFACTURING S.r.l 51368 Leverkusen, Germany & Via delle Groane, 126 20024 Garbagnate Milanese, Italy Germany & Italy Bayer East Africa Limited SURGIPHARM (RWANDA) LTD 2025-01-09 2030-01-08

2154 Rwanda FDA-HMP-MA-2177 IXAROLA 20 RIVAROXABAN 20 20 mg TABLETS 28 Tablets Polypropylene)/aluminium blister strips or colourless, transparent PVC/PVDC/aluminium blister strips 36 Months BAYER AG & BAYER HEALTHCARE MANUFACTURING S.r.l 51368 Leverkusen, Germany & Via delle Groane, 126 20024 Garbagnate Milanese, Italy Germany & Italy Bayer East Africa Limited SURGIPHARM (RWANDA) LTD 2025-01-09 2030-01-08

2155 Rwanda FDA-HMP-MA-2178 TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300 MG TABLETS 30 Tablets HDPE Container 36 Months MACLEODS PHARMACEUTICALS LIMITED Unit II, Phase II/Phase III Plot No. 25 – 27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman – 396210, India INDIA MACLEODS PHARMACEUTICALS LIMITED AIVEEN (R) LTD 2025-01-09 2030-01-08

2156 Rwanda FDA-HMP-MA-2180 METROREN TABLETS METRONIDAZOLE BENZOATE 200 MG Tablets 10 tablets &1000 tablets Aluminium/transparent PVC blister strip and in polythene bag and contained in HDPE Container 24 Months RENE INDUSTRIES LTD Manufacturers of Pharma Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda UGANDA RENE INDUSTRIES LTD RENE PHARMACY (R) LTD 2025-01-09 2030-01-08

2157 Rwanda FDA-HMP-MA-2181 KETAPIL Ketamine Hydrochloride Injection 50mg/ml Injection 10ml Vial Amber colour USP Type-I glass vial 36 Months Psychotropics India Limited Plot No.12 & 12A, Industrial Park-II, Phase-I, Salempur Mehdood-2, Haridwar-249403, (Uttarakhand India Psychotropics India Limited Pharmaceutical and Medical Supplies Society Limited 2025-01-09 2030-01-08

2158 Rwanda FDA-HBP-MA-0141 V-IMMUNE Human Normal Immunoglobulin for Intravenous Administration B.P 5 % 5% Injection 1x100mL Vials USP Typle 1 glass 36 Months Virchow Biotech Pvt Ltd Survey No.172 Part, Gagillapur(V), Dundigal Gandimaisamma (M), Medchal- Malkajgiri (D) Telangana-500043, India India Virchow Healthcare Pvt Ltd Droga Pharma (Rwanda) Ltd 2025-01-09 2030-01-08

2159 Rwanda FDA-HMP-MA-2183 PROMETIN ELIXIR Promethazine Hydrochloride 5mg/5ml Oral Solution 60mL/100mL Amber PET/glass bottle 36 Months LABORATORY & ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road. KENYA LABORATORY & ALLIED LIMITED Depot Pharmaceutique Le Medical 2025-01-09 2030-01-08

2160 Rwanda FDA-HMP-MA-2182 D5 500ML Glucose Intravenous Infusion B.P 5%V/W INTRAVENOUS INFUSION 500ml &1000ml Plastic granules, Nipple Head Protective cap, Euro Head Cap 36 Months ACULIFE HEALTHCARE PVT. LTD Village- Sachana, Tal -Viramgam, District- Ahmedabad - 382 150 Gujarat, India INDIA ACULIFE HEALTHCARE PVT. LTD SUN ENTERPRISES LTD 2025-01-09 2030-01-08

2161 Rwanda FDA-HMP-MA-2184 INSUFOR 500MG METFORMIN HYDROCHLORIDE 500MG FILM COATED TABLETS 90 Film coated tablets PVC/PVDC 36 Months World Medicine Ilaç San. ve Tic. A.S. 15 Temmuz Mah. Cami Yolu Cad. No:50, Günesli, Bagcilar, Istanbul, TURKEY Turkey World Medicine Ilaç San. ve Tic. A.S. GOODMAN INTERNATIONAL ® LTD 2025-01-09 2030-01-08

2162 Rwanda FDA-HMP-MA-2185 ABLEPT-300 GABAPENTINE 300MG CAPSULES 3x10 Capsules Alu/Alu Blister pack 36 Months MICRO LABS LIMITED 92, Sipcot, Industrial Complex, Hosur-635126, Tamil Nadu, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2025-01-09 2030-01-08

2163 Rwanda FDA-HMP-MA-2186 VILDARIL M 50/1000 VILDAGLIPTIN/ METFORMIN HYDROCHLORIDE 50/1000 MG TABLETS 3x10 Tablets Alu/Alu blisters 24 Months AJANTA PHARMA LIMITED Plot No. Z/103/A, Dahej SEZ II, Bharuch, Gujarat – 392130. Country: India. INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2025-01-09 2030-01-08

2164 Rwanda FDA-HMP-MA-2187 VILDARIL M 50/850 VILDAGLIPTIN/ METFORMIN HYDROCHLORIDE 50/850 MG TABLETS 3x10 Tablets Alu/Alu blister pack 24 Months AJANTA PHARMA LIMITED Plot No. Z/103/A, Dahej SEZ II, Bharuch, Gujarat – 392130, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2025-01-09 2030-01-08

2165 Rwanda FDA-HMP-MA-2188 IXINE 200 CEFIXIME TRIHYDRATE USP 200MG C 1 X10 TABLETS Alu/Alu Blister pack 36 Months GRACURE PHARMACEUTICALS LIMITED E-1105, Industrial Area, Phase-III BHIWADI, PIN-301019, Dist. Alwar, Rajasthan, INDIA INDIA EXPHAR S.A H&H PHARMA LTD 2025-01-09 2030-01-08

2166 Rwanda FDA-HMP-MA-2189 LOMOH 40 ENOXAPARIN SODIUM 40MG/ML SOLUTION FOR INJECTION 1ML Glass USP Type I pre-filled syringe 24 Months EMCURE PHARMACEUTICALS LIMITED Plant IV, Plot No. P1 & P-2. I.T.B.T Park, Phase II, M.I.D.C, Hinjwadi, Pune – 411 057, Maharashtra, India INDIA EMCURE PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2025-01-09 2030-01-08

2167 Rwanda FDA-HMP-MA-2190 IRYS GLIMEPIRIDE 4MG TABLETS 2x15 TABLETS PVC/ALU Foil strip 36 Months LES LABORATOIRES MEDIS Road of Tunis Km7 BP 206 Nabeul 8000 Tunisia TUNISIA LES LABORATOIRES MEDIS KIPHARMA LTD 2025-01-09 2030-01-08

2168 Rwanda FDA-HMP-MA-2191 IRYS GLIMEPIRIDE 3MG TABLETS 2x15 TABLETS PVC/Aluminium foil strip 36 Months LES LABORATOIRES MEDIS Road of Tunis Km7-BP 206, 8000 Nabeul, Tunisia TUNISIA LES LABORATOIRES MEDISLes Laboratoires MédiS, Road of Tunis Km7 BP 206 Nabeul 8000Country: Tunisia Telephone: (+216 – 72) 235 006 / 235 010 / 235 011 Email: contact@labomedis.com KIPHARMA LTD 2025-01-09 2030-01-08

2169 Rwanda FDA-HMP-MA-2192 IRYS GLIMEPIRIDE 1MG TABLETS 2x15 TABLETS PVC/Alu foil strip 36 Months LES LABORATOIRES MEDIS Road of Tunis Km7 BP 206 Nabeul 8000 Tunisia TUNISIA LES LABORATOIRES MEDIS KIPHARMA LTD 2025-01-09 2030-01-08

2170 Rwanda FDA-HMP-MA-2193 MP 40 METHYLPREDNISOLONE HYDROGEN SUCCINATE 40MG POWDER FOR SOLUTION FOR INJECTION 1 x 1 pack Transparent type I glass vial 24 Months LES LABORATOIRES MEDIS Road of Tunis Km7 BP 206 Nabeul 8000 Tunisia TUNISIA LES LABORATOIRES MEDIS KIPHARMA LTD 2025-01-09 2030-01-08

2171 Rwanda FDA-HMP-MA-2194 EMITOSS SOLUTION ONDANSENTRON HYDROCHLORIDE DIHYDRATE 2MG/5ML Oral Solution 30 ml PET Bottle 36 Months ENICAR PHARMACEUTICALS PVT. LTD J-214, 215, 216,M.I.D.C, TARAPUR INDUSTRIAL AREA, BOISAR, TALUKA PALGHAR, DIST. PALGHAR 401 506, MAHARASHTRA, INDIA INDIA GALAXY PHARMACEUTICALS LTD, KENYA STAR BIOTECH LIMITED 2025-01-09 2030-01-08

2172 Rwanda FDA-HMP-MA-2195 CLAVUMOCCID-500 AMOXICILLIN/POTASSIUM CLAVULANATE 500MG/62.5MG POWDER FOR ORAL SUSPENSION Box of 20 sachets Polyester Film 24 Months Medicef Pharma Plot No 28, 29 & 48 Phase-1, EPIP Jharmajri, Baddi, Distt. Solan (H.P) Pays: India INDIA IMEX PHARMA Mediasol Pharmaceutical Depot Ltd 2025-01-09 2030-01-08

2173 Rwanda FDA-HMP-MA-2196 WILLGO CR Aceclofenac 200MG TABLETS 5x2x10 Tablets /10x10 Tablets Alu-Alu blister pack 36 Months PANACEA BIOTEC PHARMA Ltd Wholly-owned Subsidiary of Panacea Biotec Ltd. Malpur, Baddi, Distt. Solan (H.P.) - 173 205, India. INDIA PANACEA BIOTEC PHARMA LIMITED AIVEEN (R) LTD 2025-01-09 2030-01-08

2174 Rwanda FDA-HMP-MA-2179 BUNASE 200 BUDESONIDE 200MCG Inhalation 1 canister Aluminium plain Canister 36 Months MACLEODS PHARMACEUTICALS LIMITED Oxalis Labs Village Theda,P.O.Lodhimajra , Tehsil Baddi, Distt .Solan (H.P) India INDIA MACLEODS PHARMACEUTICALS LIMITED AIVEEN (R) LTD 2025-01-09 2030-01-08

2175 Rwanda FDA-HMP-MA-2265 LAEOVATE CREAM BETAMETHASONE BP (AS VALERATE) 0.1% W/W CREAM 15gm Collapsible tubes 36 Months LABORATORY & ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, next to Libra House, Mombasa Road KENYA LABORATORY & ALLIED LIMITED Depot Pharmaceutique Le Medical 2025-01-09 2030-01-08

2176 Rwanda FDA-HMP-MA-2266 ADRENALINE AGUETTANT ADRENALINE TARTRATE 1MG/ML SOLUTION FOR INJECTION Box of 1 or 10 syringes of 5ml Polypropylene pre-filled syringes 24 Months LABORATOIRE AGUETTANT 1, rue Alexander Fleming 69007 LYON France Laboratoire AguettantAdress: 1, rue Alexander Fleming-69007 LyonCounty: France Telephone: +33(0)478615141Email: regulatory.export-dm@aguettant.fr PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2025-01-09 2030-01-08

2177 Rwanda FDA-HMP-MA-2197 DECLOPHEN FAST Diclofenac Potassium 50 mg Granules for Oral Solution 10x2g LDPE-AL-LDPE-Paper 24 Months PHARCO PHARMACEUTICALS KM 31, Alexandria-Cairo Desert Road, Amriya, Alexandria, Egypt. EGYPT PHARCO PHARMACEUTICALS Le Medical Ltd 2025-02-04 2030-02-03

2178 Rwanda FDA-HMP-MA-2198 AMEROPEM Meropenem Trihydrate and Sodium Carbonate anhydrous/ 1140.95 mg (Eq to Meropenem 1 g 1G Powder for Solution for IV Injection/Infusion 1 vial/box Colorless transparent glass vial closed with a bromobutyl rubber stopper and sealed with an aluminium/polypropylene plastic cap fitted with detachable flip top. 24 Months PHARCO B INTERNATIONAL New Borg El Arab City, 3rd Industrial Zone Alexandria, Egypt EGYPT PHARCO B INTERNATIONAL Le medical Ltd 2025-02-04 2030-02-03

2179 Rwanda FDA-HMP-MA-2199 IMPLATINZE 500MG/500MG Sterile mixture of Imipenem monohydrate and Cilastatin Sodium 500 mg/500 mg Powder for Solution for IV Infusion 1,10 or 25 Vials Transparent glass (type I) vials 24 Months PHARCO B INTERNATIONAL New Borg El -Arab City, 3rd Industrial Zone, Alexandria, Egypt EGYPT PHARCO B INTERNATIONAL Le medical Ltd 2025-02-04 2030-02-03

2180 Rwanda FDA-HMP-MA-2202 TICANASE NASAL SPRAY Fluticasone Propionate 50 mcg Nasal Spray 12gm An amber glass (type III) bottle with white polypropylene nasal spray head, capped with transparent polypropylene cap and INOX pump 24 Months EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES Km 25 Alexandria-Cairo Desert Road, Amriya, Alexandria. Egypt. EGYPT EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES HELIOS PHARMA Ltd 2025-02-04 2030-02-03

2181 Rwanda FDA-HMP-MA-2200 PROGEST 200 mg Soft Gelatin Capsules Progesterone Micronised 200 mg Soft Gelatin Capsules 30 Capsules Al/transparent PVC blister 36 Months TECHNO PHARMA EGYPT 4th Industrial Zone, part No.1,2,21,22 Block 2 EGYPT PHARCO PHARMACEUTICALS HELIOS PHARMA Ltd 2025-02-04 2030-02-03

2182 Rwanda FDA-HMP-MA-2201 PROGEST 100 mg Soft Gelatin Capsules Progesterone Micronised 100 mg Soft Gelatin Capsules 24 Capsules Al/Transparent PVC Blister 36 Months TECHNO PHARMA 4th Industrial Zone, New Borg El-Arab City, Alexandria EGYPT PHRACO PHARMACEUTICALS HELIOS PHARMA Ltd 2025-02-04 2030-02-03

2183 Rwanda FDA-HMP-MA-2203 AEROTROPA NEBULIZER SOLUTION Ipratropium Bromide Monohydrate 500.000 mcg & Salbutamol Sulphate 2.500 mg 500 mcg & 2.500 mg Nebulizer Solution 10 x 2.5 ml Ampoules Type I glass ampoules 36 Months PHARCO B INTERNATIONAL New Borg El Arab City, 3rd Industrial Zone, Alexandria, Egypt EGYPT EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES HELIOS PHARMA Ltd 2025-02-04 2030-02-03

2184 Rwanda FDA-HMP-MA-2204 HAEMOJET Syrup Ferric Hydroxide Polymaltose Complex 50 mg/5 ml SYRUP 100ml Bottle PET amber plastic bottle, polypropylene plastic cap with LDPE plastic ring 36 Months PHARCO B INTERNATIONAL Cairo Desert Road KM 25, P.O Box 111, El Manshia Alex. Amriya, Alexandria, Egypt EGYPT EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES HELIOS PHARMA Ltd 2025-02-04 2030-02-03

2185 Rwanda FDA-HMP-MA-2206 FARCOLIN Salbutamol Sulphate 0.121 g (Equivalent to Salbutamol 0.1 g) 0.1 g Respirator Solution 20 ml Bottle LDPE plastic dropper bottle 36 Months PHARCO PHARMACEUTICALS Kilo 31 Alexandria-Cairo Desert Road, Alexandria-Egypt. EGYPT PHARCO PHARMACEUTICALS HELIOS PHARMA Ltd 2025-02-04 2030-02-03

2186 Rwanda FDA-HMP-MA-2207 TICANASE PLUS Azelastine Hydrochloride: 137 mcg / dose (0.137 ml) Fluticasone propionate 50 mcg / dose (0.137 ml) 137 mcg /50 mcg Nasal Spray 15 ml Bottle Type III glass bottle 24 Months EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES Cairo Desert Road KM 25, PO Box 111, El Manshia Alex., Amriya. Alexandria, Egypt EGYPT EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES HELIOS PHARMA Ltd 2025-02-04 2030-02-03

2187 Rwanda FDA-HMP-MA-2205 HAEMOJET Each Ampoule (2 ml) contains Elemental Iron 100 mg (As Ferric Hydroxide Polymaltose) 100 mg/ 2ml Solution for IM Injection/IV Infusion 2 x 3 mL or 2 x 6 mL Type I glass ampoules 24 Months PHARCO B INTERNATIONAL New Borg El Arab City, 3rd Industrial Zone, Alexandria, Egypt. & EUROPEAN EGYPTIAN PHARM. IND.:Cairo Desert Road KM 25, Alexandria, Egypt EGYPT EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES HELIOS PHARMA Ltd 2025-02-04 2030-02-03

2188 Rwanda FDA-HMP-MA-2208 XILONE Syrup Prednisolone Sodium Phosphate (6.7 mg) (equivalent to Prednisolone) (5mg) 5 mg/5ml SYRUP 100 ml Bottle Amber (type III) glass bottle, with white polypropylene cap with (LDPE) cap foam liner 36 Months EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES Cairo Desert Road KM 25, PO Box 111, El Manshia Alex. Town: Amriya, Alexandria, Egypt EGYPT EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES HELIOS PHARMA Ltd 2025-02-04 2030-02-03

2189 Rwanda FDA-HMP-MA-2209 NORHINOSE Nasal Spray Mometasone Furoate Monohydrate 0.052 mg Nasal Spray 18gm suspension of 120 doses An amber glass (type III) glass bottle 24 Months EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES Cairo Desert Road KM 25, P.O Box 111, El Manshia Alex, Egypt EGYPT Amriya for Pharmaceutical Industries HELIOS PHARMA Ltd 2025-02-04 2030-02-03

2190 Rwanda FDA-HMP-MA-2210 TREXOZOLA Letrozole 2.5 mg TABLETS 10 Film coated tablets Al/Transparent colourless PVC strip 24 Months TECHNO PHARMA EGYPT 4th Industrial Zone, part No.1,2,21,22 Block 2, Egypt EGYPT TECHNO PHARMA EGYPT Le Medical Ltd 2025-02-04 2030-02-03

2191 Rwanda FDA-HMP-MA-2211 LASTMOL TABLETS SALBUTAMOL 4 mg TABLETS 10x10’s in blisters & 1000’s in HDPE containers Aluminium Foil and PVC Foil blisters, HDPE Plastic containers 36 Months LABORATORY & ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road, Nairobi-Kenya. KENYA LABORATORY & ALLIED LIMITED DEPOT PHARMACEUTIQUE LE MEDICAL 2025-02-04 2030-02-03

2192 Rwanda FDA-HMP-MA-2212 ALEVE NAPROXEN SODIUM 220 MG TABLETS 1x12 tablets PVC Blisters 36 Months Bayer Bitterfeld GmbH Salegaster Chaussee 1, OT Greppin, Bitterfeld-Wolfen, Saxony-Anhalt 06803, Germany Germany Bayer East Africa Limited Surgipharm (Rwanda) Ltd 2025-02-04 2030-02-03

2193 Rwanda FDA-HMP-MA-2213 ALERBIX BILASTINE 2.5 MG/ML ORAL SOLUTION 120ml Bottle An amber glass bottle (Type III glass), sealed with an aluminium screw cap, with tamper-proof closure system and LDPE liner 36 Months FAES FARMA, S.A Máximo Aguirre, 14; 48940 Leioa Spain SPAIN LABORATORIOS VITORIA S.A/ PORTUGAL UBIPHARM-RWANDA LTD 2025-02-04 2030-02-03

2194 Rwanda FDA-HMP-MA-2214 DICLOFENAC SODIUM DICLOFENAC SODIUM 75MG/3ML SOLUTION FOR INJECTION 1 or 5 ampoules Colourless neutral glass ampoules, glass type I 24 Months LEK PHARMACEUTICALS D.D. Verovškova ulica 57 1526 Ljubljana Slovenia SLOVENIA Sandoz GmbH SURGIPHARM (RWANDA) LTD 2025-02-04 2030-02-03

2195 Rwanda FDA-HMP-MA-2215 SALBUT 4 SALBUTAMOL SULPHATE 4 mg TABLETS 10x10 Tablets ALUMINIUM/PVC BLISTER 36 Months COSMOS LIMITED Rangwe Road; Off Lunga Lunga, Industrial Area P.O Box 41433, GPO 00100-Nairobi Kenya KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2025-02-04 2030-02-03

2196 Rwanda FDA-HMP-MA-2216 IBUCOS 200 IBUPROFEN 200 mg TABLETS 10x10 Tablets ALU-PVC foil blisters 36 Months COSMOS LIMITED Rangwe Road; Off Lunga Lunga, Industrial Area P.O Box 41433, GPO 00100-Nairobi Kenya KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2025-02-04 2030-02-03

2197 Rwanda FDA-HBP-MA-0142 CYVAC R21 Malaria Vaccine (Recombinant, Adjuvanted) 5mcg per 0.5mL Solution for Injection Pack of 50 Vials Glass vial stoppered with rubber stopper followed by sealing with flip-off aluminium seals 24 Months Serum Institute of India Pvt. Ltd 212/2, Hadapsar, Pune - 411 028, India India Serum Institute of India Pvt. Ltd SUN ENTEPRISES LTD 2025-02-04 2030-02-03

2198 Rwanda FDA-HMP-MA-2217 ZINNIA P Levonorgestrel 0.15mg + Ethinylestradiol 0.03mg 150mcg + 30mcg tablets 28 Tablets Clear transparent PVC/PVdC-Alu blister cards 36 Months MYLAN LABORATORIES LIMITED Mylan Laboratories Limited Plot No. 1606-1609, G. I. D.C. Sarigam, Dist. Valsad, Gujrat, India.396155 India MYLAN LABORATORIES LIMITED Pyramid Pharma Limited 2025-02-04 2030-02-03

2199 Rwanda FDA-HMP-MA-2218 PHENOBARBITAL 30MG TABLETS Phenobarbital 30 mg Tablets 10x10 Tablets ALUMINIUM/PVC BLISTERS 36 Months COSMOS LIMITED Off Lunga Lunga, Industrial Area P.O Box 41433, GPO 00100-Nairobi Kenya KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2025-02-04 2030-02-03

2200 Rwanda FDA-HMP-MA-2219 LARTEM FORTE Artemether and Lumefantrine 80/480mg TABLETS 1x6 Tablets Alu/PVC-PVDC blister 36 Months S KANT HEALTHCARE LTD PLOT NO. 1802-1805, G.I.D.C. PHASE III, VAPI 396 195. GUJARAT, INDIA INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2025-02-04 2030-02-03

2201 Rwanda FDA-HMP-MA-2220 CANESTEN CREAM Clotrimazole 10mg/1g Cutaneous cream 1 Aluminium Tube Collapsible Aluminium Tube 36 Months GP Grenzach Produktions GmbH Emil-Barell-Str. 7 79639 Grenzach-Wyhlen ,Germany GERMANY Bayer East Africa Limited Surgipharm (Rwanda) Ltd 2025-02-04 2030-02-03

2202 Rwanda FDA-HMP-MA-2221 UNOTATION Tranexamic Acid Injection BP 500mg/5ml Injection 5 x 5 ml Glass Ampoules 36 Months AKUMS DRUGS & PHARMACEUTICALS LTD Plot No. 2, 3, 4 & 5, Sector-6B, IIE, Sidcul, Ranipur, Haridwar-249403, Uttarakhand, India INDIA UNOSOURCE PHARMA LIMITED AIVEEN (R) LTD 2025-02-04 2030-02-03

2203 Rwanda FDA-HMP-MA-2222 TRADMIN Tramadol 50mg/ml Injection 5x2 ml Glass Ampoules 24 Months AKUMS DRUGS & PHARMACEUTICALS LTD Plot No. 2, 3, 4 & 5, Sector-6B, IIE, Sidcul, Ranipur, Haridwar-249403, Uttarakhand, India INDIA UNOSOURCE PHARMA LIMITED AIVEEN (R) LTD 2025-02-04 2030-02-03

2204 Rwanda FDA-HMP-MA-2223 TAZOGARD PIPERACILLIN + TAZOBACTAM 400mg/500mg Powder for Injection 30 ml Vial USP type III Glass vial 36 Months AKUMS DRUGS & PHARMACEUTICALS LTD Plot No. 2, 3, 4 & 5, Sector-6B, IIE, Sidcul, Ranipur, Haridwar-249403, Uttarakhand, India INDIA UNOSOURCE PHARMA LIMITED AIVEEN (R) LTD 2025-02-04 2030-02-03

2205 Rwanda FDA-HMP-MA-2224 TELMI-80 CT TELMISARTAN + HYDROCHLOROTHIAZIDE 80MG +12.5MG TABLETS 3x10 Tablets ALU/ALU Blisters 36 Months FREDUN PHARMACEUTICALS LTD 14,15,16, Zorbian Industrial Complex, Veoor, Palghar (E)-401 404. Dist: Thane. INDIA INDIA GALAXY PHARMACEUTICALS LTD, KENYA STAR BIOTECH LTD 2025-02-04 2030-02-03

2206 Rwanda FDA-HMP-MA-2225 TELMI-80 AMH TELMISARTAN + AMLODIPINE + HYDROCHLOTHIAZIDE 80MG + 5MG + 12.5MG TABLETS 3x10 Tablets ALU/ALU Blisters 36 Months FREDUN PHARMACEUTICALS LTD 14,15,16, Zorbian Industrial Complex, Veoor, Palghar (E)-401 404. Dist: Thane. INDIA INDIA GALAXY PHARMACEUTICALS LTD, KENYA STAR BIOTECH LTD 2025-02-04 2030-02-03

2207 Rwanda FDA-HMP-MA-2226 TELMI-40 AMH TELMISARTAN + AMLODIPINE + HYDROCHLOTHIAZIDE 40MG+ 5MG+ 12.5MG TABLETS 3x10 Tablets ALU/ALU Blisters 36 Months FREDUN PHARMACEUTICALS LTD 14,15,16, Zorbian Industrial Complex, Veoor, Palghar (E)-401 404. Dist: Thane. INDIA INDIA GALAXY PHARMACEUTICALS LTD, KENYA STAR BIOTECH LTD 2025-02-04 2030-02-03

2208 Rwanda FDA-HMP-MA-2227 TELMI-80 TELMISARTAN 80MG TABLETS 3x10 Tablets ALU/ALU Blisters 36 Months FREDUN PHARMACEUTICALS LTD 14,15,16, Zorbian Industrial Complex, Veoor, Palghar (E)-401 404. Dist: Thane. INDIA INDIA GALAXY PHARMACEUTICALS LTD, KENYA STAR BIOTECH LTD 2025-02-04 2030-02-03

2209 Rwanda FDA-HMP-MA-2228 TELMI-40 TELMISARTAN 40MG TABLETS 3x10 Tablets ALU/ALU Blisters 36 Months FREDUN PHARMACEUTICALS LTD 14,15,16, Zorbian Industrial Complex, Veoor, Palghar (E)-401 404. Dist: Thane. INDIA INDIA GALAXY PHARMACEUTICALS LTD, KENYA STAR BIOTECH LTD 2025-02-04 2030-02-03

2210 Rwanda FDA-HMP-MA-2229 TELMI-80 H TELMISARTAN + HYDROCHLOROTHIAZIDE 80MG + 12.5MG TABLETS 3x10 Tablets ALU/ALU Blisters 36 Months FREDUN PHARMACEUTICALS LTD 14,15,16, Zorbian Industrial Complex, Veoor, Palghar (E)-401 404. Dist: Thane. INDIA INDIA GALAXY PHARMACEUTICALS LTD, KENYA STAR BIOTECH LTD 2025-02-04 2030-02-03

2211 Rwanda FDA-HMP-MA-2230 TELMI-40 CT TELMISARTAN + CHLORTHALIDONE 40MG+ 12.5MG TABLETS 3x10 Tablets ALU/ALU Blisters 36 Months FREDUN PHARMACEUTICALS LTD 14,15,16, Zorbian Industrial Complex, Veoor, Palghar (E)-401 404. Dist: Thane. INDIA INDIA GALAXY PHARMACEUTICALS LTD, KENYA STAR BIOTECH LTD 2025-02-04 2030-02-03

2212 Rwanda FDA-HMP-MA-2231 TELMI-40 H TELMISARTAN + HYDROCHLOROTHIAZIDE 40MG + 12.5MG TABLETS 3x10 Tablets ALU/ALU Blisters 36 Months FREDUN PHARMACEUTICALS LTD 14,15,16, Zorbian Industrial Complex, Veoor, Palghar (E)-401 404. Dist: Thane. INDIA INDIA GALAXY PHARMACEUTICALS LTD, KENYA STAR BIOTECH LTD 2025-02-04 2030-02-03

2213 Rwanda FDA-HMP-MA-2232 CLARITYNE SYRUP Loratadine 1mg/ml Syrup 100ml Bottle Amber glass bottles closed with a tamperevident child-proof polypropylene cap with polyethylene liner and a polyethylene breaking ring. 36 Months ORGANON HEIST BV Belgium Industriepark 30 Heist-op-den-Berg, 2220, Belgium Belgium Bayer East Africa Limited Surgipharm (Rwanda) Ltd 2025-02-04 2030-02-03

2214 Rwanda FDA-HMP-MA-2233 CLARINASE REPETABS Loratadine +Pseudoephedrine sulphate 5MG+120MG Tablets 14 tablets LDPE/Al All-aluminum blisters 24 Months SAG MANUFACTURING SLU Carretera N-1, km 36 28750 San Agustin de Guadalix Spain SPAIN Bayer East Africa Limited Surgipharm (Rwanda) Ltd 2025-02-04 2030-02-03

2215 Rwanda FDA-HMP-MA-2234 GVIA-M TABLET 50MG/1000MG Sitagliptin Phosphate Monohydrate and Metformin Hydrochloride USP 50mg and 1000mg TABLETS 60 Tablets ALU/ALU Blisters 24 Months GENIX PHARMA (PVT.) LTD 44, 45-B, Korangi Creek Road, Karachi, Pakistan PAKISTAN GENIX PHARMA (PVT.) LTD ETS CONTINENTAL LTD 2025-02-04 2030-02-03

2216 Rwanda FDA-HMP-MA-2235 HYOSCINE BUTYLBROMIDE Hyoscine Butylbromide 10 mg TABLETS 10x10 Capsules PVC/Aluminium Blisters 36 Months COSMOS LIMITED Rangwe Road; Off Lunga Lunga, Industrial Area P.O Box 41433, GPO 00100-Nairobi Kenya KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2025-02-04 2030-02-03

2217 Rwanda FDA-HMP-MA-2236 DOLUTEGRAVIR AND LAMIVUDINE TABLETS DOLUTEGRAVIR AND LAMIVUDINE 50 mg/ 300 mg TABLETS 30 TABLETS and 90 TABLETS HDPE Bottles 24 Months CIPLA LIMITED Goa (Unit-VII) and (Unit VII- PD II), Plot No. S- 103 to S- 105, S-107 to S-112, L-147, L-147/1 to L-147/3, L-147/A & L- 138, Verna Industrial Estate, Verna, Salcette, Goa – 403 722 India CIPLA LIMITED Phillips Pharmaceuticals (Rwanda) Ltd 2025-02-04 2030-02-03

2218 Rwanda FDA-HBP-MA-0143 VAXIRAB N Inactivated final bulk of rabies vaccine ?2.5IU/Vial ?2.5 IU/Vial Solution for injection 3 ml Vial Flint tubular vial USP I 36 Months ZYDUS LIFESCIENCES LIMITED Survey No. 417, 419 & 420, Sarkhej – Bavla, National Highway No.8 A, Village - Moraiya, Taluka - Sanand, Dist. - Ahmedabad - 382 210, Gujarat State INDIA ZYDUS LIFESCIENCES LIMITED ABACUS PHARMA (A) LTD 2025-02-04 2030-02-03

2219 Rwanda FDA-HMP-MA-2237 PREDNISOLONE 5 MG TABLETS Prednisolone 5 mg TABLETS 10x10 Tablets PVC Blisters 36 Months COSMOS LIMITED Rangwe Road; Off Lunga Lunga, Industrial Area P.O Box 41433, GPO 00100-Nairobi KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2025-02-04 2030-02-03

2220 Rwanda FDA-HMP-MA-2238 EPIBALIN 50 Pregabalin USP 50 mg Capsules 1x10 Capsules & 3x10 Capsules ALU-PVC/PVdC Blisters 36 Months MSN LABORATORIES PRIVATE LIMITED (Formulations Division) Plot No.: C – 24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, Pincode: 500 018 INDIA MSN LABORATORIES PRIVATE LIMITED ABACUS PHARMA (A) LTD 2025-02-04 2030-02-03

2221 Rwanda FDA-HMP-MA-2239 PENVIR 500 Famciclovir 500 mg Tablets 3x10 Tablets ALU-PVC/PVdC Blisters 24 Months HETERO LABS LIMITED TSIIC Formulation SEZ, S.No 439, 440,441 & 458, Polepally Village, Jadcherla (Mandal), Mahaboob Nagar (District)-509301, Telangana State INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2025-02-04 2030-02-03

2222 Rwanda FDA-HMP-MA-2240 FORTIWIN-4 Procaine benzylpenicillin and Benzylpenicillin sodium 3,000,000 I.U and 1,000,000 I.U Powder for injection 20 ml Vial USP type II glass mould vial 36 Months REYOUNG PHARMACEUTICAL CO., LTD No.1 Ruiyang Road, Yiyuan County, Shandong Province P.R.CHINA FARMASINO. CO., LTD ABACUS PHARMA (A) LTD 2025-02-04 2030-02-03

2223 Rwanda FDA-HMP-MA-2241 CONCOR 10 MG Bisoprolol fumarate 10 mg TABLETS 30 Tablets Alu/PVC Blisters 60 Months MERCK HEALTHCARE KGA 250 Frankfurter Strasse, 64271 Darmstadt Germany Merck (Pty) Ltd SURGIPHARM (RWANDA) LTD 2025-02-04 2030-02-03

2224 Rwanda FDA-HMP-MA-2242 CONCOR 5 MG Bisoprolol fumarate 5 mg Tablets 30 Tablets Alu/PVC Blisters 60 Months MERCK HEALTHCARE KGA 250 Frankfurter Strasse, 64271 Darmstadt Germany Merck (Pty) Ltd SURGIPHARM (RWANDA) LTD 2025-02-04 2030-02-03

2225 Rwanda FDA-HMP-MA-2243 NATOA SUSPENSION Mebendazole BP 100 mg/5ml Oral suspension 30 ml Bottle Amber glass/PET bottle 36 Months LABORATORY & ALLIED LIMITED Plot no. 209/10349, Opposite Sameer business Park, next to Libra house, Mombasa Road. P. O. Box 42875, GPO 00100, Nairobi KENYA LABORATORY & ALLIED LIMITED Depot Pharmaceutique Le Medical 2025-02-04 2030-02-03

2226 Rwanda FDA-HMP-MA-2245 GLUCOMET 500 MG FILM COATED TABLETS Metformin Hydrochloride BP 500 mg TABLETS 2X14, 4X14, 10X10, 8X18 Tablets PVC Blisters 36 Months COSMOS LIMITED Rangwe Road; Off Lunga Lunga, Industrial Area P.O Box 41433, GPO 00100-Nairobi KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2025-02-04 2030-02-03

2227 Rwanda FDA-HMP-MA-2244 GLUCOMET 850 MG FILM COATED TABLETS Metformin Hydrochloride BP 850 mg TABLETS 2X14, 4X14, 10X10, 8X14 Tablets PVC Blisters 36 Months COSMOS LIMITED Rangwe Road; Off Lunga Lunga, Industrial Area P.O Box 41433, GPO 00100-Nairobi KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2025-02-04 2030-02-03

2228 Rwanda FDA-HMP-MA-2246 LEVOBUPIVACAINE Levobupivacaine hydrochloride 56.33 mg/ ampoule Solution for injection 5x10 ml ampoules Type I glass ampoule 36 Months ALTAN PHARMACEUTICALS, S.A. Altan Pharmaceuticals, S.A. Company name: Altan Pharmaceuticals, S.A. Address: Avda. de la Constitución 198 – 199 Country: Spain Telephone: Telefax: Polígono Industrial Monte Boyal 45950 Casarrubios del Monte (Toledo) 00 34 91 818 83 10 E-Mail: spain.regulatory@ethypharm.com SPAIN Altan Pharma Ltd/ Ireland KIPHARMA LTD 2025-02-04 2030-02-03

2229 Rwanda FDA-HMP-MA-2247 SANMOL PARACETAMOL 1000MG/100ML SOLUTION FOR INFUSION 100 ml Bottle Bottle 100 mL clear type II 24 Months PT. SANBE FARMA PT. SANBE FARMA Jl. Industri Cimareme No. 8, Desa Cimareme, Kecamatan Ngamprah, Kabupaten Bandung Barat Indonesia Telephone: +62 22 6867966 INDONESIA PT SANBE FARMA AFRIHEALTH CARE LIMITED 2025-02-04 2030-02-03

2230 Rwanda FDA-HMP-MA-2248 RENNIE PEPPERMINT Calcium carbonate and magnesium carbonate 680mg and 80mg TABLETS Packs of 2, 6, 24, 48 and 96 tablets PVC/aluminium blister pack 36 Months DELPHARM GAILLARD 33, rue de l’industrie 74240 Gaillard France France Bayer East Africa Limited Surgipharm (Rwanda) Ltd 2025-02-04 2030-02-03

2231 Rwanda FDA-HMP-MA-2249 ABLADO Abacavir sulfate, Dolutegravir sodium and Lamivudine 600 mg /50 mg /300 mg Tablets 30 Tablets HDPE Container 36 Months APL HEALTHCARE LIMITED (SUBSIDIARY OF AUROBINDO PHARMA LTD) Unit-IV, Plot No 16, APIIC, Multi Products SEZ, Menakuru Village, Naidupeta Mandal, Tirupati District, Andhra Pradesh, India INDIA AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2025-02-04 2030-02-03

2232 Rwanda FDA-HMP-MA-2250 CLOPIDOGREL IMPACT CLOPIDOGREL 75mg Film-coated tablets 28 Tablets Transparent PVC/PVDC blister packs, sealed by a sheet of cold-rolled aluminium foil 36 Months SANOFI WINTHROP INDUSTRIE 1 rue de la Vierge. Ambares et Lagrave, 33565 Carbon Blanc cedex. France. FRANCE SANOFI-AVENTIS SOUTH AFRICA (PTY) LTD KIPHARMA LTD 2025-02-04 2030-02-03

2233 Rwanda FDA-HMP-MA-2251 STATINOR 10 Rosuvastatin 10 mg Tablets 1x10 Tablets Alu- Alu blister pack 36 Months HETERO LABS LIMITED Unit V, TSIIC Formulation SEZ, S.No 439, 440,441 & 458, Polepally Village, Jadcherla (Mandal), Mahaboob Nagar (District)-509301, Telangana State, India. INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2025-02-04 2030-02-03

2234 Rwanda FDA-HMP-MA-2252 STATINOR 20 Rosuvastatin 20 mg Tablets 1x10 Tablets Alu- Alu blister pack 24 Months HETERO LABS LIMITED Unit-V Sy. No. 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Village, Jadcherla Mandal, Mahaboobnagar District, Telangana, India INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2025-02-04 2030-02-03

2235 Rwanda FDA-HMP-MA-2253 GEFITINIB GEFITINIB Ph.Eur. 250 MG TABLETS 3x10 Tablets Clear PVC/Plain ALU blister pack in aluminium foil 24 Months CIPLA LIMITED GOA (UNIT-X) Address: Plot No. S-103 to S-105, S-107 to S-112, L-138, L-147, L-147/1 to L-147/3, L-147/A, Verna Industrial Estate, Verna, Salcette, Goa 403722, India INDIA CIPLA LIMITED KIPHARMA LTD 2025-02-04 2030-02-03

2236 Rwanda FDA-HMP-MA-2254 UNOSEMIDE 10 Furosemide BP 10mg/ml Injection 2ml Ampoules Amber colour glass ampoules 36 Months AKUMS DRUGS & PHARMACEUTICALS LTD Plot No 2,3,4 and 5, Sector 6B IIE, SIDCUL, Ranipur, Haridwar – 249403, Uttarakhand, India INDIA UNOSOURCE PHARMA LIMITED AIVEEN (R) LTD 2025-02-04 2030-02-03

2237 Rwanda FDA-HMP-MA-2255 ZOLID Linezolid 600 mg Tablets 1x10 Tablets Alu- Alu blister pack 36 Months HETERO LABS LIMITED Unit V, TSIIC Formulation SEZ, S.No 439, 440,441 & 458, Polepally Village, Jadcherla (Mandal), Mahaboob Nagar (District)-509301, Telangana State, India. INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2025-02-04 2030-02-03

2238 Rwanda FDA-HMP-MA-2256 TEMOTERO 20 TEMOZOLAMIDE 20 mg Capsules 4x5 Capsules Amber glass container 24 Months HETERO LABS LIMITED Unit VI APIIC Formulation SEZ, Survey No. 410 & 411, Polepally Village, Jadcherla, Mahaboob Nagar – 509 301, Andhra Pradesh, INDIA. & UNIT-V, Sy.No.439, 440, 441 & 458, TSIIC Formulation SEZ, Polepalle (V), Jadcherla (M),MAHABUBNAGAR (D), Telangana State, INDIA. INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2025-02-04 2030-02-03

2239 Rwanda FDA-HMP-MA-2257 PANFOR-STG 50/1000 Sitagliptin hydrochloride Monohydrate and Metformin hydrochloride 50 mg/ 1000 mg Tablets 14 x 4 Tablets ALU-PVC/PVDC blister 24 Months SAG MANUFACTURING S.L.U Crtra. N-1, Km 36, San Agustin de Guadalix, 28750 Madrid, Spain SPAIN MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2025-02-04 2030-02-03

2240 Rwanda FDA-HMP-MA-2258 APIBAN 5 Apixaban 5 mg Tablets 1x10\'s, 3x10\'s & 10x10 Tablets Alu-PVC/PVDC Blister Packs 36 Months MSN LABORATORIES PRIVATE LIMITED MSN House Plot No.: C – 24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, Pincode: 500 018, India. INDIA MSN LABORATORIES PRIVATE LIMITED ABACUS PHARMA (A) LTD 2025-02-04 2030-02-03

2241 Rwanda FDA-HMP-MA-2259 VASTEN 25 CINNARIZINE 25MG TABLETS 10 Tablets Clear PVC foil, Printed Blister and Aluminium foil 24 Months LINCOLN PHARMACEUTICALS LTD Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2025-02-04 2030-02-03

2242 Rwanda FDA-HMP-MA-2260 EMPADIL-M 12.5/1000 EMPAGLIFLOZIN USP + METFORMIN HCL USP 12.5/1000 MG TABLETS 3x10 Tablets Alu-Alu Blisters 24 Months AJANTA PHARMA LIMITED Z/103/A, Dahej SEZ II, Bharuch – 392 130, Gujarat State, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2025-02-04 2030-02-03

2243 Rwanda FDA-HMP-MA-2262 TROGYL PLUS TABLET METRONIDAZOLE/ DILOXANIDE FUROATE 200MG/ 250MG TABLETS 10x10 Tablets Alu-PVC Blisters 36 Months BIODEAL LABORATORIES LTD 123, Lunga Lunga P.O BOX 32040-00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICAL SUPPLIES LIMITED 2025-02-04 2030-02-03

2244 Rwanda FDA-HMP-MA-2263 SARTILOS LOSARTAN POTASSIUM 50MG TABLETS 3x10 Tablets PVC/Alu blisters 36 Months BIODEAL LABORATORIES LTD 123, LUNGA LUNGA P.O BOX 32040-00600, NAIROBI, KENYA KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICAL SUPPLIES LIMITED 2025-02-04 2030-02-03

2245 Rwanda FDA-HMP-MA-2261 RIFAPENTINE Rifapentine Dispersible Tablets 150 mg Dispersible Tablets 10x10 Tablets PVC/PVDC Blisters 24 Months LUPIN LIMITED A-28/1, MIDC Area, Chikalthana, Aurangabad, Aurangabad-431210, INDIA INDIA LUPIN LIMITED AIVEEN (R) LTD 2025-02-04 2030-02-04

2246 Rwanda FDA-HBP-MA-0144 Insulin Injection, Biphasic Isophane Ph. Eur Recombinant Human Insulin Ph. Eur. 100 IU/ml Suspension for Injection 10 ml Vial Type I glass ampoules 24 Months M. J. BIOPHARM. PVT LTD L-7, M.I.D.C Industrial Area, Taloja – 410208, Dist- Raigad, Maharashtra, INDIA INDIA Generix Laboratories Pvt. Ltd, India AIVEEN (R) LTD 2025-02-04 2030-02-03

2247 Rwanda FDA-HMP-MA-2264 IVIPIME Cefepime Hydrochloride 1gr Dry Powder for Injection 10 mL Vial Flint Moulded Vial and Plactic ampoule with 10ml water for injection placed in a carton along with pack insert. 24 Months VHB MEDI SCIENCES LIMITED Plot No 20-22 & 49-51, IIE, Sector 5, Pantnagar, Rudrapur – 263153, Uttarakhand, India INDIA VHB MEDI SCIENCES LIMITED Droga Pharma (Rwanda) Ltd 2025-02-04 2030-02-03

2248 Rwanda FDA-HMP-MA-2271 BRENZAVVY® Bexagliflozin 20 mg Prolonged release Tablets  30 and 90 Tablets HDPE Bottle 60 Months Piramal Healthcare UK Ltd Morpeth UK Whalton Road, Morpeth, Northumberland NE61 3YA, UK United kingdom Bamco Africa FLR Ltd 2025-05-12 2030-05-11

2249 Rwanda FDA-HMP-MA-2272 HELMADOL 400MG FILM COATED TABLETS ALBENDAZOLE 400MG FILM COATED TABLETS 2 Tablets 2 tablets/ box 36 Months WORLD MEDICINE ILAC SAN. VE TIC.A.S 15 Temmuz Mah. Cami Yolu Cad. No:50, Günesli, Bagcilar, Istanbul, TURKEY TURKEY WORLD MEDICINE ILAC SAN. VE TIC.A.S GOODMAN INTERNATIONAL ® LTD 2025-05-12 2030-05-11

2250 Rwanda FDA-HMP-MA-2273 DIARTEM IG ADULT DIHYDROARTEMISININ/ PIPERAQUIN 120MG/960MG TABLETS 3 tablets per blister Aluminium laminate/ Aluminium foil blisters 36 Months BLISS GVS PHARMA LTD Plot 10, 11-A, 12; Survey No. 38/1, dewan Udyog Nagar, Aliyali, Palghar, District- Thane -401404. INDIA IMEX PHARMA Mediasol Pharmaceutical Depot Ltd 2025-05-12 2030-05-11

2251 Rwanda FDA-HMP-MA-2274 MEDIVEN-S OINTMENT Betamethasone dipropionate BP & Salicylic acid BP 0.05%/ 3.0% W/W OINTMENT 15gm Aluminium Tubes 36 Months REGAL PHARMACEUTICALS LIMITED Plot No.: 7879/18, Off Baba Dogo Road, Ruaraka, Postal address: P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2025-05-12 2030-05-11

2252 Rwanda FDA-HMP-MA-2275 SERTOFEN 1.25% GEL DEXKETOPROFEN 1.25% GEL 60g/tube Lacquered aluminium tube 36 Months WORLD MEDICINE ILAC SAN. VE TIC.A.S 15 Temmuz Mah. Cami Yolu Cad. No:50, Günesli, Bagcilar, Istanbul, TURKEY TURKEY WORLD MEDICINE ILAC SAN. VE TIC.A.S GOODMAN INTERNATIONAL ® LTD 2025-05-12 2030-05-11

2253 Rwanda FDA-HMP-MA-2276 NEUTRAGEL SUSPENSION MAGNESIUM HYDROXIDE/ ALUMINIUM HYDROXIDE/ SIMETHICONE 400MG/ 318.4MG/ 50MG/10ML ORAL SOLUTION 100ml/200ml 100ml Natural round HDPE bottle with white polypropylene screw cap 200ml natural round HDPE bottle with white LDPE concap 200ml type II amber glass bottle with polypropylene screwcap 2Litres HDPE container with polypropylene screw cap 24 Months VARICHEM PHARMACEUTICALS (PVT) LTD 194 Gleneagles Road, Willlowvale, Harare, Zimbwabwe Zimbwabwe VARICHEM PHARMACEUTICALS (PVT) LTD ACTIVIS PHARMA LTD 2025-05-12 2030-05-11

2254 Rwanda FDA-HMP-MA-2277 PAEDIATRIC COTRIMOXAZOLE SULPHAMETHOXAZOLE&TRIMETHOPRIM 100MG/20MG TABLETS 10x10 Tablets Alu-Pvc blister pack 36 Months LINCOLN PHARMACEUTICALS LIMITED Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar, Gujarat , India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2025-05-12 2030-05-11

2255 Rwanda FDA-HMP-MA-2278 ROLINOZ 10MG Cetirizine dihydrochloride 10MG FILM COATED TABLETS 1x10 Tablets Alu-OVC blister 36 Months WORLD MEDICINE ILAC SAN. VE TIC.A.S 15 Temmuz Mah. Cami Yolu Cad. No:50, Günesli, Bagcilar, Istanbul, TURKEY TURKEY WORLD MEDICINE ILAC SAN. VE TIC.A.S GOODMAN INTERNATIONAL ® LTD 2025-05-12 2030-05-11

2256 Rwanda FDA-HMP-MA-2279 CLEAR T GEL CLINDAMYCIN PHOSPHATE USP+ TRETINOIN USP 1%/0.025% GEL 20g Lami Tube 24 Months AUROCHEM LABORATORIES (I) PVT LTD 333, Gundecha Ind. Complex, Akurli Rd, Kandivali East Mumbai - 400 101, India INDIA OCHOA LABORATORIES SUN ENTERPRISES LTD 2025-05-12 2030-05-11

2257 Rwanda FDA-HMP-MA-2280 GYNOFAST VAGINAL SUPPOSITORY CLINDAMYCIN/ CLOTRIMAZOLE 100MG/200MG VAGINAL SUPPOSITORIES 3 Suppositories PVC/PE Foil 24 Months BLISS GVS PHARMA LIMITED Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Palghar, District- Thane – 401404. INDIA IMEX Pharma Mediasol Pharmaceutical Depot Ltd 2025-05-12 2030-05-11

2258 Rwanda FDA-HMP-MA-2281 DICLO-DENK 100 RETARD DICLOFENAC SODIUM 100MG PROLONGED-RELEASE TABLETS 10 or 100 tablets PVC/PVDC/Aluminium blister 36 months DENK PHARMA GmbH & Co. KG Prinzregentenstr. 79, 81675 München Production site: Göllstr.1, 84529 Tittmoning Germany DENK PHARMA GmbH & Co. KG, Germany HERILY-AGENCE DE MARKETING LTD 2025-05-12 2030-05-11

2259 Rwanda FDA-HMP-MA-2282 VIVIAN MR TABLETS CHLORZOXAZONE + DICLOFENAC SODIUM + PARACETAMOL 250MG, 50MG, 325MG TABLETS 10 Tablets Alu-PVC blister 36 Months LINCOLN PHARMACEUTICALS LIMITED Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2025-05-12 2030-05-11

2260 Rwanda FDA-HMP-MA-2283 CLARIE OD CLARITHROMYCIN 500 mg TABLETS 1 x 7 Tablets PVC/PDVC/ALU blister 48 Months IND-SWIFT LIMITED Off. NH-21, Village Jawaharpur, Tehsil Derabassi, District SAS Nagar (Mohali) Punjab-140507 INDIA IND-SWIFT LIMITED LOTUS MEDICAL GROUP LTD 2025-05-12 2030-05-11

2261 Rwanda FDA-HMP-MA-2284 TELSWIFT H 80 Telmisartan and Hydrochlorothiazide 80mg and 12.5mg TABLETS 1x7 Tablets & 1x10 Tablets Alu- Alu blister pack 24 months IND SWIFT LIMITED Off. NH-21, Village Jawaharpur, Tehsil Derabassi, District SAS Nagar (Mohali) Punjab-140507 INDIA IND SWIFT LIMITED LOTUS MEDICAL GROUP LTD 2025-05-12 2030-05-11

2262 Rwanda FDA-HMP-MA-2285 TELSWIFT H 40 Telmisartan 40mg and Hydrochlorothiazide 12.5mg 40 mg / 12.5 mg Tablets 3x10 Tablets Alu- Alu blister pack 24 months IND SWIFT LIMITED Off. NH-21, Village Jawaharpur, Tehsil Derabassi, District SAS Nagar (Mohali) Punjab-140507 INDIA IND SWIFT LIMITED Lotus Medical Group Ltd 2025-05-12 2030-05-11

2263 Rwanda FDA-HMP-MA-2286 TELSWIFT 80 Telmisartan 80mg 80 mg Tablets 3x10 Tablets Alu- Alu blister pack 36 Months IND SWIFT LIMITED Off. NH-21, Village Jawaharpur, Tehsil Derabassi, District SAS Nagar (Mohali) Punjab-140507 INDIA IND SWIFT LIMITED Lotus Medical Group Ltd 2025-05-12 2030-05-11

2264 Rwanda FDA-HMP-MA-2287 TELSWIFT 40 Telmisartan 40mg 40 mg Tablets 3x10 Tablets Alu- Alu blister pack 36 Months IND SWIFT LIMITED Off. NH-21, Village Jawaharpur, Tehsil Derabassi, District SAS Nagar (Mohali) Punjab-140507 INDIA IND SWIFT LIMITED Lotus Medical Group Ltd 2025-05-12 2030-05-11

2265 Rwanda FDA-HMP-MA-2288 SWAMLO 10 Amlodipine Besilate BP 10 mg Tablets 10x10 Tablets PVC/PVDC aluminium blister strips 36 Months IND SWIFT LIMITED Off. NH-21, Village Jawaharpur, Tehsil Derabassi, District SAS Nagar (Mohali) Punjab-140507 INDIA IND SWIFT LIMITED Lotus Medical Group Ltd 2025-05-12 2030-05-11

2266 Rwanda FDA-HMP-MA-2289 SWAMLO 5 Amlodipine Besilate BP 5 mg Tablets 10x10 Tablets PVC/PVDC Aluminium Blister Strips 36 Months IND SWIFT LIMITED Off. NH-21, Village Jawaharpur, Tehsil Derabassi, District SAS Nagar (Mohali) Punjab-140507 INDIA IND SWIFT LIMITED Lotus Medical Group Ltd 2025-05-12 2030-05-11

2267 Rwanda FDA-HMP-MA-2290 NETAZOX 500 NITAZOXANIDE 500 mg Tablets 1x6 Tablets ALU/PVC BLISTER 36 Months IND SWIFT LIMITED IND SWIFT LIMITED, Industrial Growth Center Phase I, Samba, 184121 J&K, India INDIA IND SWIFT LIMITED Lotus Medical Group Ltd 2025-05-12 2030-05-11

2268 Rwanda FDA-HMP-MA-2291 NETAZOX 100MG/5ML NITAZOXANIDE 100mg/5ml ORAL SUSPENSION 30ml HDPE Bottle 30 Months IND SWIFT LIMITED Off. NH-21, Village Jawaharpur, Tehsil Derabassi, District SAS Nagar (Mohali) Punjab-140507 INDIA IND SWIFT LIMITED Lotus Medical Group Ltd 2025-05-12 2030-05-11

2269 Rwanda FDA-HMP-MA-2292 PREZEL 150 PREGABALIN 150 mg Capsules 3x10 Capsules PVC/PVDC aluminium blister strips 24 Months IND SWIFT LIMITED Off. NH-21, Village Jawaharpur, Tehsil Derabassi, District SAS Nagar (Mohali) Punjab-140507 INDIA IND SWIFT LIMITED Lotus Medical Group Ltd 2025-05-12 2030-05-11

2270 Rwanda FDA-HMP-MA-2293 PREZEL 75 PREGABALIN 75 mg Capsules 3x10 Capsules PVC/PVDC aluminium blister strips 24 Months IND SWIFT LIMITED Off. NH-21, Village Jawaharpur, Tehsil Derabassi, District SAS Nagar (Mohali) Punjab-140507 INDIA IND SWIFT LIMITED Lotus Medical Group Ltd 2025-05-12 2030-05-11

2271 Rwanda FDA-HMP-MA-2294 FERROTONE CAPSULES Each soft gel capsule contains: Ferrous Fumarate 162.0mg providing Elemental Iron 53.25mg per capsule Folic Acid 0.75mg (750mcg) Vitamin B12 0.0075mg (7.50mcg) 53.25mg, 0.75mg (750mcg) ,0.0075mg (7.50mcg) Capsules 1x10 Capsules ALU/PVC BLISTER 24 Months MEGA LIFESCIENCES PUBLIC COMPANY LIMITED Mega Lifesciences Public Company Limited 384 Soi 6, Pattana 3 Road, Bangpoo Industrial Estate Moo 4, Praeksa, Mueang Samutprakarn, Samutprakarn 10280, Thailand THAILAND Mega Lifesciences Public Company Limited ABACUS PHARMA (A) LTD 2025-05-12 2030-05-11

2272 Rwanda FDA-HMP-MA-2295 CARDINOL 25MG FILM COATED TABLETS ATENOLOL 25 mg Film Coated Tablets 2x14 Tablets ALU/PVC BLISTER 36 Months COSMOS LIMITED Plot No. L/R 209/13268, Rangwe Road, Off Lunga Lunga Road, Industrial Area, P. O. Box 41433, GPO 00100, Nairobi, Kenya KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2025-05-12 2030-05-11

2273 Rwanda FDA-HMP-MA-2296 DREZ SOLUTION IODATED, PROVIDONE & METRONIZADOLE SOLUTION 30ML/100ML/500ML SOLUTION 30ML Amber Glass Bottle 24 Months STEDMAN PHARMACEUTICALS PVT. LTD C-4, SIDCO Pharmaceutical Complex, Alathur, Thiruporur 603 110, Tamil Nadu, Country: INDIA INDIA STEDMAN PHARMACEUTICALS PVT. LTD ESCORTS PHARMACEUTICALS (RWANDA) Limited 2025-05-12 2030-05-11

2274 Rwanda FDA-HMP-MA-2297 DREZ OINTMENT IODINATED, PROVIDONE & METRONIDAZOLE OINTMENT 5%, 5% & 1% OINTMENT 10g & 30g Amber Glass Bottle 24 Months STEDMAN PHARMACEUTICALS PVT. LTD C-4, SIDCO Pharmaceutical Complex, Alathur, Thiruporur 603 110, Tamil Nadu, Country: INDIA INDIA STEDMAN PHARMACEUTICALS PVT. LTD ESCORTS PHARMACEUTICALS (RWANDA) Limited 2025-05-12 2030-05-11

2275 Rwanda FDA-HMP-MA-2298 DREZ POWDER IODATED, PROVIDONE & METRONIZADOLE POWDER 5%, 5% & 1% POWDER 10g HDPE Bottle 24 Months STEDMAN PHARMACEUTICALS PVT. LTD C-4, SIDCO Pharmaceutical Complex, Alathur, Thiruporur 603 110, Tamil Nadu, Country: INDIA INDIA STEDMAN PHARMACEUTICALS PVT. LTD ESCORTS PHARMACEUTICALS (RWANDA) Limited 2025-05-12 2030-05-11

2276 Rwanda FDA-HMP-MA-2299 PRECIDEX INJECTION Dexmedetomidine 100mcg/ml Injection 2x2ml Ampoules Type I glass ampoule 24 Months BROOKES PHARMA (PRIVATE) LIMITED 58-59, Sector No. 15, Korangi Industrial Area, Karachi-74900 Country: Pakistan PAKISTAN BROOKES PHARMA (PRIVATE) LIMITED LE MEDICAL LTD 2025-05-12 2030-05-11

2277 Rwanda FDA-HMP-MA-2302 TENGLYN TENELIGLIPTIN 20 mg TABLETS 3x10 Tablets ALU/PVC BLISTERS 24 Months ZYDUS LIFESCIENCES LIMITED Kundaim Industrial Estate, Plot No. 203-213, Kundaim, Goa - 403 115, INDIA INDIA ZYDUS LIFESCIENCES LIMITED ABACUS PHARMA (A) LTD 2025-05-12 2030-05-11

2278 Rwanda FDA-HBP-MA-0145 MEASLES AND RUBELLA VACCINE (LIVE) (ATTENUATED, FREEZE DRIED) MEASLES VIRUS AND RUBELLA VIRUS 1000 CCID50 & 1000 CCID50 INJECTION 1x50 Vials Type I glass vial 30 Months SERUM INSTITUTE OF INDIA PVT. LTD 212/2, HADAPSAR, Pune -411028, India INDIA SERUM INSTITUTE OF INDIA PVT. LTD SUN ENTERPRISES LTD 2025-05-12 2030-05-11

2279 Rwanda FDA-HMP-MA-2303 INVEL FORTE L METRONIDAZOLE, MICONAZOLE NITRATE AND LIDOCAINE 750 mg, 200 mg and 100 mg Vaginal Suppositories 1x7 Sppositories PVC/PE foil 36 Months BLISS GVS PHARMA LTD Plot No:11, Dewan Udyog Nagar, Aliyali Palghar, Maharashtra,401404, India INDIA Mega Lifesciences Public Company Limited ABACUS PHARMA (A) LTD 2025-05-12 2030-05-11

2280 Rwanda FDA-HBP-MA-0146 HUCOG-5000 HP CHORIONIC GONADOTROPHIN 5000HP INJECTION 2ml Ampoules GLASS Vials 36 Months BHARAT SERUMS AND VACCINES LIMITED Plot No. K-27, K-27 Part and K-27/1, Anand Nagar.Jambivili Village, Additional MIDC, Ambernath (East), Thane 421506, Maharashtra State, India INDIA BHARAT SERUMS AND VACCINES LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2025-05-12 2030-05-11

2281 Rwanda FDA-HMP-MA-2304 COLOSAR-DENK 50/12.5 LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE 50MG/12.5MG FILM COATED TABLETS 28 Film Coated Tablets Aluminum/aluminum blister 48 Months DENK PHARMA GmbH & Co. KG Göllstr. 1, 84529 Tittmoning, Germany Production site: Göllstr. 1, 84529 Tittmoning, Germany GERMANY DENK PHARMA GmbH & Co. KG HERILY AGENCE MARKERTING LTD 2025-05-12 2030-05-11

2282 Rwanda FDA-HMP-MA-2305 HYOSWISS HYOSCINE BUTYLBROMIDE 20mg/ml Solution for Injection 10 X 1 ml Ampoules A clear glass ampoule is packed in a carton along with an insert 36 Months SWISS PARENTERALS LTD 808, 809 & 810, Kerala Industrial Estate, Nr. Bavla, Dist. Ahmedabad - 382 220, Gujarat, India INDIA SWISS PARENTERALS LTD Pharmaceutical and Medical Supplies Society Limited 2025-05-12 2030-05-11

2283 Rwanda FDA-HMP-MA-2306 TROPIN 1MG Atropine Sulfate Monohydrate 1MG/ML Solution for injection 10 X 1 Plain glass ampoule in a plastic tray 36 Months SWISS PARENTERALS LTD 808, 809 & 810, Kerala Industrial Estate, G.I.D.C., Nr. Bavla, Dist: Ahmedabad-382220, Gujarat, India INDIA SWISS PARENTERALS LTD Pharmaceutical and Medical Supplies Society Limited 2025-05-12 2030-05-11

2284 Rwanda FDA-HMP-MA-2307 DICLOSWISS Diclofenac Sodium 25mg/3ml Solution for injection 10 x 3 ml Ampoules Plain glass ampoules 36 Months SWISS PARENTERALS LTD 808, 809 & 810, Kerala Industrial Estate, GIDC, Nr. Bavla, Dist: Ahmedabad-382220, Gujarat, India INDIA SWISS PARENTERALS LTD Pharmaceutical and Medical Supplies Society Limited 2025-05-12 2030-05-11

2285 Rwanda FDA-HMP-MA-2308 BUPI Bupivacaine Hydrochloride 0.5% Solution for injection 1x 10ml Ampoule Amber glass ampoule 24 Months SWISS PARENTERALS LTD 808, 809 & 810, Kerala Industrial Estate, GIDC, Nr. Bavla, Dist: Ahmedabad-382220, Gujarat, India INDIA SWISS PARENTERALS LTD Pharmaceutical and Medical Supplies Society Limited 2025-05-12 2030-05-11

2286 Rwanda FDA-HMP-MA-2309 LEVOTOP PF 1.5% EYE DROPS Levofloxacin 1.5% w/v Ophthalmic Solution 1x 5ml LDPE Vial 24 Months AJANTA PHARMA LIMITED Mirza - Palashbari Road, Village Kokjhar, Kamrup (R), Guwahati, Assam-781128, INDIA INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2025-05-12 2030-05-12

2287 Rwanda FDA-HMP-MA-2310 PARACO-DENK 500/30 Paracetamol & Codeine 500 mg/30 mg TABLETS 2x10 tablets PVC/Aluminium blisters 60 Months Bene-Arzneimittel GmbH Herterichstr Herterichstr. 1-3 81479 München Germany DENK PHARMA GmbH & Co. KG HERILY-AGENCE DE MARKETING LTD 2025-05-12 2030-05-11

2288 Rwanda FDA-HMP-MA-2311 LOSAR-DENK 100 LOSARTAN POTASSIUM 100 mg Film Coated Tablets 2x14 Tablets PVC/PE/PVdC opaque white blister pack 36 Months DENK PHARMA GmbH & Co. KG Prinzregentenstr. 79, 81675 München, Germany Manufacturing site address: Göllstr. 1, 84529 Tittmoning, Germany Germany DENK PHARMA GmbH & Co. KG HERILY-AGENCE DE MARKETING LTD 2025-05-12 2030-05-11

2289 Rwanda FDA-HMP-MA-2312 TIMONIDIN Brimonidine Tartrate Ph. Eur. & Timolol Maleate USP 0.2 % W/V & 0.5 % W/V Ophthalmic Solution 1x5ml HDPE white dropper bottle with open nozzle single pilfer proof Gamma radiated cap 24 Months KILITCH DRUGS (INDIA) LTD Plot no C-301/2, MIDC T.T.C, Industrial Area, Pawane village, Navi Mumbai -400705, Maharashtra, India INDIA KILITCH DRUGS (INDIA) LTD SUN ENTERPRISES LTD 2025-05-12 2030-05-11

2290 Rwanda FDA-HMP-MA-2313 PYROLATE INJECTION Glycopyrrolate 0.2mg/ml Solution for Injection 1x10 Ampoules Amber Glass Ampoules 24 Months BROOKES PHARMA (PRIVATE) LIMITED 58-59, Sector 15, Korangi Industrial Area, Karachi-74900, Pakistan PAKISTAN BROOKES PHARMA (PRIVATE) LIMITED LE MEDICAL LTD 2025-05-12 2030-05-11

2291 Rwanda FDA-HMP-MA-2314 AMOXICLAV-DENK 1000/125 Amoxicillin and Clavulanic acid 1000 mg/125mg Powder for oral suspension 8 or 12 sachets in a carton Sachets with a foil structure consisting of paper, polyethylene, aluminum, and Surlyn layers 36 Months PENCEF PHARMA GmbH Breitenbachstrasse 13 - 14 D-13509 Berlin GERMANY DENK PHARMA GmbH & Co. KG HERILY-AGENCE DE MARKETING LTD 2025-05-12 2030-05-11

2292 Rwanda FDA-HBP-MA-0002 SITCOM CREAM Euphorbia Prostrata Dry Extract Ethanolic 80%V/V 1% w/w Cream 30g Laminated collapsible tubes 24 Months Panacea Biotec Limited B-1 Ext. / A-27, MCIE,Mathura Road, New Delhi-110044,Country: India INDIA Panacea Biotec Limited AIVEEN (R) LTD 2025-05-12 2030-05-11

2293 Rwanda FDA-HBP-MA-0003 SITCOM TABLET Euphorbia Prostrata Dry Extract 100mg Film coated Tablets 7X2 Tablets White opaque PVdC coated PVC blister strip 36 Months Panacea Biotec Limited Panacea Biotec LimitedB-1 Ext. / A-27, MCIE,Mathura Road, New Delhi-110044,Country: India India Panacea Biotec Limited AIVEEN (R) LTD 2025-05-12 2030-05-11

2294 Rwanda FDA-HMP-MA-2317 EUTHYROX 50 LEVOTHYROXINE SODIUM 50 µG Tablets 100 Tablets ALU/ALU BLISTER 36 MONTHS MERCK HEALTHCARE KGAA Frankfurter Strasse 250 64293 Darmstadt, Germany GERMANY MERCK (PTY) LTD SURGIPHARM RWANDA LTD 2025-06-18 2030-06-18

Registered

2295 Rwanda FDA-HMP-MA-2347 JUSTEEZ-50 VILDAGLIPTIN 50MG TABLETS 15 TABLETS ALU-ALU/ PRINTED BLISTER FOIL 24 Months EMCURE PHARMACETICALS LTD Lane No.3, Phase-II, SIDCO Industrial Complex, Bari-Brahmana, Jammu-181 133, India India EMCURE PHARMACEUTICALS LTD/INDIA ABACUS PHARMA (A) LTD 2025-06-19 2030-06-18

Registered

2296 Rwanda FDA-HMP-MA-2316 TORAS-DENK 5 Toresemide 5 mg TABLETS 30 Tablets BLISTER STRIPS 36 MONTHS DENK PHARMA GMBH & CO. KG PRINZREGENTENSTR. 79 81675 MÜNCHEN, GERMANY GERMANY DENK PHARMA GMBH & CO. KG HERILY - AGENCE DE MARKETING LTD 2025-06-19 2030-06-18

Registered

2297 Rwanda FDA-HMP-MA-2319 KOF OFF SYRUP 100ML Chlorpheniramine Maleate 2mg + Pseudoephedrine HCl 30mg + Ammonium Chloride 100mg + Sodium Citrate 60mg + Menthol 0.5mg 2mg/30mg/100mg/60mg/0.5mg SYRUP 100ML Bottle AMBER COLOURED PET BOTTLE 24 MONTHS RENE INDUSTRIES LTD PO BOX 6034, PLOT NO 680, KAMULI, KIREKA, KAMPALA, UGANDA UGANDA RENE INDUSTRIES LTD RENE PHARMACY (R) LTD 2025-06-19 2030-06-18

Registered

2298 Rwanda FDA-HMP-MA-2320 PRELYNCA-150 PREGABALIN 150MG CAPSULES 28 Capsules PVC/ALUMINUM FOIL BLISTERS 36 MONTHS PHARMATHEN INTERNATIONAL SA INDUSTRIAL PARK SAPES; RODOPI PREFECTURE, BLOCK NO 5, RODOPI 693000, ELLAS, GREECE GREECE MEGA LIFESCIENCES (AUSTRALIA) PTY. LTD ABACUS PHARMA (A) LTD 2025-06-19 2030-06-18

Registered

2299 Rwanda FDA-HMP-MA-2321 FLEXSA 1500 CRYSTALLINE GLUCOSAMINE SULFATE 1500 MG POWDER FOR ORAL SOLUTION 30 sachets PRINTED ALUMINIUM FOIL SACHETS 24 MONTHS MEGA LIFESCIENCES PUBLIC COMPANY LIMITED 515, SOI 8, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, MOO 4, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280, THAILAND THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2025-06-19 2030-06-18

Registered

2300 Rwanda FDA-HMP-MA-2318 EUTHYROX 100 LEVOTHYROXINE SODIUM 100 µG TABLETS 30 Tablets ALU/ALU BLISTER 36 MONTHS MERCK HEALTHCARE KGAA Frankfurter Straße 250 64293 Darmstadt Germany GERMANY MERCK (PTY) LTD SURGIPHARM RWANDA LTD 2025-06-19 2030-06-18

Registered

2301 Rwanda FDA-HMP-MA-2322 CEFTRIAXONE IG 1000MG CEFTRIAXONE 1000MG Dry Powder for Injection 1 VIAL WITH 10ML STERILE WATER FOR INJECTION GLASS VIAL USP TYPE III 24 MONTHS INJECTCARE PARENTERALS PVT LTD PLOT NO. 130, SILVASSA ROAD, GIDC, VAPI – 396 195, DIST - VALSAD, INDIA INDIA IMEX GENERICS KIPHARMA LTD 2025-06-19 2030-06-18

Registered

2302 Rwanda FDA-HMP-MA-2323 DASATINIB NEAPOLIS 70MG DASATINIB 70MG FILM COATED TABLETS 60 Tablets ALU/ALU BLISTER PACK 24 MONTHS NEAPOLIS PHARMA Road of Tunis, km 7-B.P.206, 8000 Nabeul, TUNISIA TUNISIA NEAPOLIS PHARMA KIPHARMA LTD 2025-06-19 2030-06-18

Registered

2303 Rwanda FDA-HMP-MA-2324 MAXITAM-500 AMOXYCILLIN TRIHYDRATE 500MG CAPSULES 10x10 Tablets PVC BLISTERS 24 MONTHS AMN LIFE SCIENCE PVT. LTD SURVEY NO. 67/P-1, AT. VILLAGE -MALAV, AREA- BHILAD, TAL. UMBERGOAN, DIST. VALSAD, GUJRAT, PIN- 396105, INDIA INDIA AMN LIFE SCIENCE PVT. LTD AIVEEN RWANDA LTD 2025-06-19 2030-06-18

Registered

2304 Rwanda FDA-HMP-MA-2325 INSUFOR 850MG METFORMIN HYDROCHLORIDE 850MG FILM COATED TABLETS 90 Tablets TRANSPARENT PVC/ALU BLISTER 36 MONTHS WORLD MEDICINE İLAÇ SAN. VE TIC. A.Ş 15 TEMMUZ MAH. CAMI YOLU CAD. NO:50, GÜNEŞLI, BAĞCILAR, ISTANBUL, TURKEY TURKEY WORLD MEDICINE İLAÇ SAN. VE TIC. A.Ş GOODMAN INTERNATIONAL(R) LIMITED 2025-06-19 2030-06-18

Registered

2305 Rwanda FDA-HMP-MA-2326 FOLISURGE 150 RECOMBINANT-HUMAN FOLLICLE STIMULATING HORMONE 150 IU/0.24 mL SOLUTION FOR INJECTION GLASS SYRINGE (TYPE I,0.5 mL) TYPE I GLASS PREFILLED SYRINGE 24 MONTHS INTAS PHARMACEUTICALS LIMITED PLOT NO.423 /P/A., SARKHEJ BAVLA HIGHWAY, VILLAGE: - MORAIYA,TAL- SANAND DIST. AHMEDABAD –382 213 GUJARAT STATE, INDIA INDIA INTAS PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2025-06-19 2030-06-18

Registered

2306 Rwanda FDA-HMP-MA-2327 DOBESIL H CREAM 30 GRM CALCIUM DOBESILATE 0.5 %, LIDOCAINE 3.0 % W/W, HYDROCORTISONE ACETATE 0.25 % W/W & ZINC OXIDE 5.0 % 0.5 %, 3.0 % W/W, 0.25 % W/W & 5.0 % CREAM 30G TUBE ALUMINIUM TUBE OF 30G 24 MONTHS AUROCHEM LABORATORIES (I) PVT LTD 58, PALGHAR TALUKA, INDUSTRIAL CO.-OP. ESTATE LTD. PALGHAR-401 404, DISTRICT THANE, MAHARASHTRA, INDIA INDIA OCHOA LABORATORIES SUN ENTERPRISES LTD 2025-07-11 2030-07-10

Registered

2307 Rwanda FDA-HMP-MA-2328 EMITOSS INJECTION ONDANSENTRON HYDROCHLORIDE DIHYDRATE 4MG/2ML SOLUTION FOR INJECTION AMPOULE OF 2 ML USP TYPE I GLASS AMPOULE 24 MONTHS STERIL-GENE LIFE SCIENCES (P) LTD NO. 45, MANGALAM MAIN ROAD, MANGALAM VILLAGE, VILLIANUR COMMUNE, PUDUCHERRY-605110. INDIA INDIA GALAXY PHARMACEUTICALS LTD STAR BIOTECH LTD 2025-07-11 2030-07-10

Registered

2308 Rwanda FDA-HMP-MA-2329 DACOF EXPECTORANT SYRUP DIPHENHYDRAMINE HCL BP 14MG, AMMONIUM CHLORIDE BP 135.0MG, SODIUM CITRATE BP 57.0MG AND MENTHOL 1.1MG 14MG, 135.0MG, 57.0MG AND 1.1MG/5ml SYRUP 100ML BOTTLE AMBER COLOURED PET BOTTLES IN A UNIT BOX WITH LITERATURE INSERT INCLUDED 36 MONTHS DAWA LIMITED PLOT NO. 7879/8, BABA DOGO RD, RUARAKA. P.O. BOX 16633-00620. NAIROBI, KENYA KENYA DAWA LIMITED SUN ENTERPRISES LTD 2025-07-11 2030-07-10

Registered

2309 Rwanda FDA-HMP-MA-2330 STOPACID SUSPENSION ALUMINIUM HYDROXIDE BP 120MG AND MAGNESIUM TRISILICATE BP 250MG 120mg and 250mg/5ml Oral Suspension 100ML BOTTLE AMBER-COLOURED PET IN THE UNIT BOX, WITH LITERATURE INSERT 36 MONTHS DAWA LIMITED PLOT NO. 7879/8, BABA DOGO RD, RUARAKA. P.O. BOX 16633-00620. NAIROBI, KENYA. KENYA. DAWA LIMITED SUN ENTERPRISES LTD 2025-07-11 2030-07-10

Registered

2310 Rwanda FDA-HMP-MA-2331 DAZOLE CREAM CLOTRIMAZOLE BP 1.0% w/w Cream for external use only 20GM CREAM TUBE COLLAPSIBLE ALUMINUM TUBES IN A UNIT CARTON WITH A LITERATURE INSERT 36 MONTHS DAWA LIMITED PLOT NO. 7879/8, BABA DOGO RD, RUARAKA. P.O. BOX 16633-00620. NAIROBI, KENYA KENYA. DAWA LIMITED SUN ENTERPRISES LTD 2025-07-11 2030-07-10

Registered

2311 Rwanda FDA-HMP-MA-2333 MEFTAL FORTE CREAM METHYL SALICYLATE BP: 30.0% W/W, MENTHOL USP: 10.0% W/W, CAMPHOR USP: 5.0% W/W 30.0% W/W, 10.0% W/W, 5.0% W/W CREAM 1 Tube of 50G A printed LAMI WITH RED CAP OF 50 GM 24 MONTHS MEPROMAX LIFESCIENCES PVT. LTD 16-PHARMACITY, SELAQUI, DEHRADUN, UTTRAKHAND, 248197, INDIA INDIA BLUE CROSS LABORATORIES PVT LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2025-07-11 2030-07-10

Registered

2312 Rwanda FDA-HMP-MA-2334 PRINORELAX 30MG CYCLOPENTOLATE HYDROCHLORIDE 30MG CAPSULES 10 CAPSULES HDPE BOTTLE IN A CARTOON BOX 24 MONTHS LIPTIS FOR PHARMACEUTICAL AND MEDICAL PRODUCTS (S.A.E) PLOT NO. B/2, 6TH INDUSTRIAL ZONE, 6TH OF OCTOBER CITY, EGYPT EGYPT LIPTIS FOR PHARMACEUTICAL AND MEDICAL PRODUCTS (S.A.E) GOODMAN INTERNATIONAL (R) LIMITED 2025-07-11 2030-07-10

Registered

2313 Rwanda FDA-HMP-MA-2335 AMLOLAAN LOSARTAN POTASSIUM +AMLODIPINE BESILATE 50MG/5MG TABLETS 3x10 Tablets ALU -ALU BLISTER PACK 36 MONTHS STALLION LABORATORIES PVT. LTD C-1B 305/2, 3, 4 & 5, G.I.D.C, KERALA (BAVLA), DIST. AHMEDABAD, GUJARAT, INDIA INDIA STALLION LABORATORIES PVT. LTD GLAXO PHARMA WHOLESALE LTD 2025-07-11 2030-07-10

Registered

2314 Rwanda FDA-HMP-MA-2336 MOLNAFLU MOLNUPIRAVIR 200MG CAPSULES 4X10 Tablets PVC/PE/PVDC– ALUMINIUM FOIL BLISTER PACK 24 MONTHS AUROBINDO PHARMA LIMITED SURVEY NO. 313 & 314, BACHUPALLY, BACHUPALLY MANDAL, MEDCHAL-MALKAJGIRI DISTRICT, TELANGANA STATE, ZIP CODE: 500090. INDIA INDIA AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2025-07-11 2030-07-10

Registered

2315 Rwanda FDA-HMP-MA-2337 XAROBAN-15 RIVAROXABAN 15MG FILM COATED TABLETS 1X10 Tablets ALU ALU BLISTER (1 X 10’S)/ UNIT CARTON 24 MONTHS SEARLE COMPANY LIMITED F319.S.I.T.E,KARACHI, PAKISTAN. TEL:0092-21-32578001, FAX:0092-21-32564667 PAKISTAN SEARLE COMPANY LIMITED SURGIPHARM RWANDA LTD 2025-07-11 2030-07-10

Registered

2316 Rwanda FDA-HMP-MA-2338 LEVOFLOS LEVOFLOXACIN 750MG TABLETS 10 TABLETS ALU-ALU BLISTER 36 MONTHS SALVAVIDAS PHARMACEUTICAL PVT. LTD 29 XCELON INDUSTRIAL PARK-1, B/H INTAS PHARMACEUTICALS, VASNA-CHACHARWADI TA SANAND, AHMEDABAD, GUJARAT – 382213 INDIA INDIA SALVAVIDAS PHARMACEUTICAL PVT. LTD GLAXO PHARMA WHOLESALE LTD 2025-07-11 2030-07-10

Registered

2317 Rwanda FDA-HMP-MA-2315 DUTASOLIN TAMSULOSINE + DUTASTERIDE 0.4MG+0.5MG Capsules 3x10 capsules ALU-ALU BLISTERS 36 Months GLOBELA PHARMA PVT. LIMITED PLOT NO. 358, ROAD NO. 3, SACHIN -GIDC., SURAT, 394230, GUJARAT INDIA INDIA GLOBELA PHARMA PVT. LIMITED AFRIPHARM LTD 2025-07-11 2030-07-10

2318 Rwanda FDA-HMP-MA-2339 PENIREN TABLETS PHENOXYMETHYLPENICILLIN POTASSIUM 250MG TABLETS 10X10 TABLETS ALU-PVC BLISTER PACK 24 MONTHS RENE INDUSTRIES LTD P.O BOX 6034, PLOT NO.680, KAMULI, KIREKA, KAMPALA, UGANDA UGANDA RENE INDUSTRIES LTD RENE PHARMACY (R) LTD 2025-09-11 2030-09-10

Registered

2319 Rwanda FDA-HMP-MA-2340 POVIDONE IODEE IG (125ML) POVIDONE IODINE (1 % W/V AVAILABLE IODINE) USP (10 % W/V) 10 % W/V TOPICAL SOLUTION 1 BOTTLE HDPE BOTTLE 30 MONTHS ENICAR PHARMACEUTICALS PVT. LTD PLOT NO. J-214/215/216, MIDC, TARAPUR, BOISAR, THANE 401506 MAHARASHTRA STATE, INDIA INDIA IMEX GENERICS MEDIASOL PHARMACEUTICAL DEPOT LIMITED 2025-09-11 2030-09-10

Registered

2320 Rwanda FDA-HMP-MA-2341 GLICOR MR GLICLAZIDE BP 60MG TABLETS 3X10 TABLETS ALU-ALU BLISTER PACK 36 MONTHS STALLION LABORATORIES PVT. LTD LTD 817, 8TH FLOOR, DEVPATH, OFF C. G. ROAD, B/H LAL BUNGLOW, AHMEDABAD GUJARAT, INDIA INDIA STALLION LABORATORIES PVT. LTD GLAXO PHARMA WHOLESALE LTD 2025-09-11 2030-09-10

Registered

2321 Rwanda FDA-HMP-MA-2342 LOKIT OMEPRAZOLE 20MG CAPSULES 10X10 CAPSULES ALU/ALU STRIP 36 MONTHS KOPRAN LTD VILLAGE SAVROLI KHALAPUR, DIST-RAIGAD, MAHARASHTRA, INDIA INDIA KOPRAN LTD PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2025-09-11 2030-09-10

Registered

2322 Rwanda FDA-HMP-MA-2343 HALO-SWISS HALOPERIDOL 5MG/ML, 1ML INJECTION 5 MG/ML Solution for Injection. 36 Months SWISS PARENTERALS LTD, 808,809 & 810 Kerala Industrial Estate, G.I.D.C., Bavla, Dist. Ahmedabad – 382220, Gujarat, India India SWISS PARENTERALS LTD. PHARMACEUTICAL AND MEDICAL SUPPLIES SOCIETY (PMSS) Ltd 2025-09-19 2030-09-18

2323 Rwanda FDA-HMP-MA-2344 LEVANEXT 250 LEVETIRACETAM 250mg Film-coated tablets, 24 Months MSN Labs Private Limited India MSN Laboratories Private Limited SUN ENTERPRISES LTD 2025-09-19 2030-09-18

2324 Rwanda FDA-HMP-MA-2346 MenFive [Meningococcal (A, C, Y, W, X) Polysaccharide Conjugate Vaccine (Freeze-Dried)] 1 Dose, 5 Dose Lyophilized powder for injection 36 Months SERUM INSTITUTE OF INDIA PVT. LTD 212/2, HADAPSAR, Pune -411028, India India Serum Institute of India Pvt. Ltd. SUN ENTERPRISES LTD 2025-09-19 2030-09-18

2325 Rwanda FDA-HMP-MA-2345 LEVANEXT 500 Levetiracetam 500 mg 500 mg Film Coated Tablets 24 Months MSN Labs Private Limited India MSN Laboratories Private Limited SUN ENTERPRISE Ltd 2025-09-19 2030-09-18

2326 RWANDA-FDA24/HM/1067/0016 KIRACLAV® 112.5 powder for oral suspension AMOXICILLIN+CLAVULANATE POTASSIUM 100mg/12.5mg Graules for Oral suspension 60 ml 24 Months DSM Sinochem Pharmaceuticals India Private Limited (Now known as Centrient Pharmaceuticals). India BEKRA PHARMA LTD UBIPHARM-RWANDA LTD 2025-09-23 2030-09-22

2327 RWANDA-FDA23/HM/0192/0009 Paracetamol Suppositories 125 mg Paracetamol 125MG SUPPOSITORY 4x5 pessaries 36 Months Hebei Jiheng(Group) Pharmaceutical Co., Ltd. China Reyoung Pharmaceutical Co., Ltd. JM PHARMACY Ltd 2025-09-23 2030-09-22

2328 RWANDA-FDA23/HM/0303/0012 Phenobarbitone Tablets Phenobarbital BP 30mg ORAL TABLET 1000's 36 Months Harman Finochem Limited India Laboratory & Allied Ltd Depot Pharmaceutique Le Medical 2025-09-23 2030-09-22

2329 RWANDA-FDA23/HM/0438/0010 DUTASOLIN TAMSULOSINE + DUTASTERIDE 0.4MG+0.5MG Capsules 3x10 capsules 36 Months PELLTECH HEALTH CARE PVT. LTD. India Globela Pharma Private Limited AFRIPHARM LTD 2025-09-23 2030-09-22

2330 RWANDA-FDA23/HM/0395/0011 Clotrine 500mg Pessary CLOTRIMAZOLE 500mg Pessary 1 pessary 36 Months UNIVERSAL CORPORATION LIMITED CLUB ROAD; PLOT NO.13777 PAST KIKUYU POST OFFICE, KIKUYU TOWN, KENYA Kenya UNIVERSAL CORPORATION LIMITED - KENYA SUN ENTERPRISE Ltd 2025-09-23 2030-09-22

2331 RWANDA-FDA24/HM/1015/0008 Levetiracetam UCB LEVETIRACETAM 100 mg/ml Solution for Oral administration 36 Months UCB PHARMA S.A Z.I.I DE PLANCHY Switzerland UCB Pharma SA VINE PHARMA LTD 2025-09-23 2030-09-22

2332 RWANDA-FDA25/HM/0241/0013 FAWAR FRUIT Effervescent Granules Sodium Bicarbonate, Citric acid anhydrous and Tartaric acid 2.80 g, 0.82 g and 1.33 g GRANULES SACHET 5G X 6 SACHETS 24 Months Pharco Pharmaceuticals Industries Alexandria-Cairo Desert Road Km 31, Amriya, Alexandria, Egypt Egypt Pharco Pharmaceuticals LE MEDICAL LTD 2025-09-23 2030-09-22

2333 RWANDA-FDA24/HM/1064/0021 GYNAGONE KIT. Each Kit contains: 2 Azithromycin (Zerocin) tablets 500mg each, 4 Secnidazole (Labgentil) tablets 500mg each & 1 Fluconazole (Ucozole) capsule 150mg in a unit box. Capsules, tablets, 1 x 7’s 36 Months Anuh Pharma Ltd. India Laboratory & Allied Ltd Depot Pharmaceutique Le Medical 2025-09-30 2030-09-29

2334 RWANDA-FDA25/HM/0239/0019 Ameropem 0.5g Meropenem Trihydrate USP 500mg POWDER FOR SOLUTION FOR INJECTION OR INFUSION 1x 1Vial 24 Months PHARCO B INTERNATIONAL New Borg El-Arab 3rd Industrial Zone, Alexandria, Egypt Egypt Pharco B International LE MEDICAL LTD 2025-09-30 2030-09-29

2335 RWANDA-FDA25/HM/0190/0020 Ciprofloxacin IV Ciprofloxacin USP 200mg/100mL Solution for Intravenous Infusion 100 mL 36 Months PHARCO B INTERNATIONAL New Borg El-Arab 3rd Industrial Zone, Alexandria, Egypt Egypt AMRIYA PHARMACEUTICALS LE MEDICAL LTD 2025-09-30 2030-09-29

2336 Rwanda FDA-HMP-MA-2349 LASTAVIN HTZ 160/12.5 VALSARTAN AND HYDROCHLOROTHIAZIDE USP 160 MG/12.5 MG TABLETS 3X10 TABLETS ALU-ALU BLISTER OF 10 TABLETS. SUCH 3 BLISTERS OF 10 TABLETS EACH ALONG WITH PACKAGE INSERT IN A CARTON 30 MONTHS AJANTA PHARMA LIMITED B-4-5-6, MIDC INDUSTRIAL AREA, PAITHAN, AURANGABAD, 431148, DIST: AURANGABAD, MAHARASHTRA, INDIA INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2025-10-09 2030-10-08

Registered

2337 Rwanda FDA-HMP-MA-2350 SEVCAR 400 SEVELAMER CARBONATE 400MG TABLETS 5X10 TABLETS 10 TABLETS ARE PACKED IN ALU-ALU BLISTER; SUCH 5 BLISTER ALONG WITH THE PACK INSERT IS PACKED IN A CARTON 24 MONTHS EMCURE PHARMACETICALS LTD PLOT NO. P-2. I.T.B.T PARK, PHASE II, M.I.D.C, HINJWADI, PUNE – 411 057, INDIA INDIA EMCURE PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2025-10-09 2030-10-08

Registered

2338 Rwanda FDA-HMP-MA-2351 TENECTASE TENECTEPLASE INJECTION 20MG LYOPHILIZED POWDER FOR INJECTION 1 VIAL GLASS VIAL TYPE I, WITH A GREY BROMOBUTYL RUBBER STOPPER AND A FLIP-OFF CAP FILLED 24 MONTHS GENNOVA BIOPHARMACEUTICALS LTD BLOCK 1, PLOT NO: P-1 & P-2, I.T. B.T. PARK, PHASE-II, M.I.D.C., HINJAWADI, PUNE- 411057, INDIA INDIA GENNOVA BIOPHARMACEUTICALS LTD SUN ENTERPRISES LTD 2025-10-09 2030-10-08

Registered

2339 Rwanda FDA-HMP-MA-2352 Z-COT 15 RIVAROXABAN TABLETS BP 15MG TABLETS 3X10 TABLETS 10 TABLETS IN ALUMINUM – PVC/PVDC BLISTER PACK, 3 BLISTERS IN A PRINTED CARTON ALONG WITH PACK INSERT 24 MONTHS AJANTA PHARMA LIMITED MIRZA-PALASHBARI ROAD, VILL-KOKJHAR, KAMRUP (R), GUWAHATI, ASSAM- 781128, INDIA INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2025-10-09 2030-10-08

Registered

2340 Rwanda FDA-HMP-MA-2353 MOFILET 500 MYCOPHENOLATE MOFETIL 500MG TABLETS 6X10 TABLETS 10 TABLETS ARE PACKED IN AN ALU-ALU BLISTER STRIP. 6 STRIPS OF 10 TABLETS EACH ARE PACKED IN A PRINTED CARTON ALONG WITH A LEAFLET 24 MONTHS EMCURE PHARMACETICALS LTD LANE NO.3, PHASE-II, SIDCO INDUSTRIAL COMPLEX, BARI-BRAHMANA, JAMMU – 181 133, INDIA INDIA EMCURE PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2025-10-09 2030-10-08

Registered

2341 Rwanda FDA-HMP-MA-2354 APMALT IRON (III) HYDROXIDE POLYMALTOSE 100MG TABLETS 12 TABLETS 12’S TABLETS IN A PP TUBE WITH 0.125 GM COTTON POLYESTER BALL, 1 SUCH PP TUBE IN A PRINTED CARTON WITH INSERT 24 MONTHS AJANTA PHARMA LIMITED GUT. NO. 11/12/14/15, CHITEGAON, PAITHAN ROAD. AURANGABAD 431105, MAHARASHTRA STATE, INDIA INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2025-10-09 2030-10-08

Registered

2342 Rwanda FDA-HMP-MA-2355 XEBISCO 75 PREGABALIN USP 75MG CAPSULES 3X10 CAPSULES THREE BLISTERS OF 10 CAPSULES TO BE PACKED IN ONE CARTON ALONG WITH LEAFLET 24 MONTHS BLISS GVS PHARMA LIMITED SURVEY NO. 43- 44, VEVOOR VILLAGE, PALGHAR 401404, INDIA INDIA BLISS GVS PHARMA LIMITED SURYA DEPOT PHARMACY LTD 2025-10-09 2030-10-08

Registered

2343 Rwanda FDA-HMP-MA-2356 MOVICOL POLYETHYLENE GLYCOL 13.125 G, SODIUM CHLORIDE 350.7 MG, SODIUM BICARBONATE 178.5 MG AND POTASSIUM CHLORIDE FOR ORAL SOLUTION 46.6 MG 13.125G/350.7MG/178.5MG/46.6MG POWDER FOR ORAL SOLUTION 10 SACHETS SACHET OF PRINTED QUARD LAMINATE ALUMINIUM FOIL 240MM. 10 SACHETS OF 13.81G EACH ARE PACKED IN OUTER CARTON WITH A PACK INSERT 24 MONTHS WIN-MEDICARE PVT. LTD MODIPURAM -250 110, UP, INDIA INDIA WIN-MEDICARE PVT. LTD SURGIPHARM RWANDA LTD 2025-10-09 2030-10-08

Registered

2344 Rwanda FDA-HMP-MA-2348 LASTAVIN HTZ 80/12.5 VALSARTAN AND HYDROCHLOROTHIAZIDE USP 80 MG/12.5 MG TABLETS 3X10 TABLETS ALU-ALU BLISTER OF 10 TABLETS. SUCH 3 BLISTERS OF 10 TABLETS EACH ALONG WITH PACKAGE INSERT IN A CARTON 30 MONTHS AJANTA PHARMA LIMITED B-4-5-6, MIDC INDUSTRIAL AREA, PAITHAN, AURANGABAD, 431148, DIST: AURANGABAD, MAHARASHTRA, INDIA INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2025-10-10 2030-10-08

Registered

2345 RWANDA-FDA24/HM/0628/0030 D5 500 GLUCOSE INTRAVENOUS INFUSION BP 5%w/v Solution for infusion. 1 x 500 mL 24 Months Tirupati Starch and Chemical Limited India Alfa Pharmaceuticals Limited AIVEEN (R) LTD 2025-10-16 2030-10-15

2346 RWANDA-FDA25/HM/0275/0032 CEZON-SB CEFTRIAXONE + SULBACTAM 1000mg &1.5 gm DRY POWDER FOR INJECTIOM 24 Months STERILE INDIA PVT. LTD India VELLINTON HEALTHCARE DROGA PHARMA (RWANDA) Ltd 2025-10-16 2030-10-15

2347 RWANDA-FDA25/HM/0261/0039 Simulect 20 mg powder and solvent for solution for infusion or injection BASILIXIMAB 20mg Powder for Solution for Injection/Infusion 36 Months NOVARTIS PHARMA S.A.S. France Novartis Pharma AG Surgipharm Rwanda Ltd. 2025-10-16 2030-10-15

2348 RWANDA-FDA25/HM/0186/0029 GYNOZOL Vaginal Cream MICONAZOLE NITRATE 0.8 G Vaginal Cream 40g Cream 36 Months Pharco Pharmaceuticals Industries Alexandria-Cairo Desert Road Km 31, Amriya, Alexandria, Egypt Egypt Pharco Pharmaceuticals HELIOS PHARMA Ltd 2025-10-16 2030-10-15

2349 RWANDA-FDA24/HM/0548/0024 PRASUSAFE 10 PRASUGREL 10mg Film-coated tablets, 3x10's 24 Months MSN Laboratories Private Ltd. Plot No. 42, Anrich Industrial Estate, Bollaram, Sangareddy District – 502 325, Telangana, India. India MSN Laboratories Private Limited ABACUS PHARMA (A) Ltd 2025-10-16 2030-10-15

2350 RWANDA-FDA25/HM/0300/0034 Tacrocord 1 TACROLIMUS USP 1 mg Capsules 24 Months Concord Biotech Limited India Prisma Pharma FZE PRAFIN RWANDA LTD 2025-10-16 2030-10-15

2351 RWANDA-FDA25/HM/0400/0023 BioUcenta Ranibizumab 10mg/ml Solution for Injection one vial of 0.23 ml sterile solution 36 Months Polpharma Biologics S.A Poland Bio Usawa Biotechnology limited Rwanda Medical Supply Ltd 2025-10-16 2030-10-15

2352 RWANDA-FDA23/HM/0304/0036 FERROUS SULPHATE TABLETS Ferrous Sulphate USP 200mg Film-Coated Tablet 1000’s 36 Months Shreeji Industries India Laboratory & Allied Ltd Depot Pharmaceutique Le Medical 2025-10-16 2030-10-15

2353 RWANDA-FDA24/HM/0140/0027 ZINRO ORNIDAZOLE 0.5%W/V Solution for infusion. 100 ml 36 Months Zhejiang Supour Pharmaceutical Co. Ltd China Abacus Parenteral Drugs Limited ABACUS PHARMA (A) Ltd 2025-10-16 2030-10-15

2354 RWANDA-FDA24/HM/0688/0028 BABY GRIPE WATER Sodium Bicarbonate BP; Sodium Citrate BP; Anise Oil BP; Dill Oil BP; Strong Ginger Tincture BP; and Sucrose BP 1.2%; 0.5%; 0.12%; 0.058%; 0.5% and 20.0% per 5ml Oral syrup 36 Months Hebei Huachen Pharmaceutical Group CO., LTD China Laboratory & Allied Ltd Depot Pharmaceutique Le Medical 2025-10-16 2030-10-15

2355 RWANDA-FDA24/HM/0129/0026 KAVIDEZA DISTAB Abacavir, Dolutegravir and Lamivudine Dispersible Tablets 60 mg / 5 mg/ 30 mg Film-Coated Tablet 90's & 180's 24 Months MYLAN LABORATORIES LIMITED Plot No. 11,12 & 13, IndoreSpecial Economic Zone,Pharma Zone, Phase-II,Sector-III, Pithampur -454775, Dhar (MP) India India Mylan Laboratories Limited PYRAMID PHARMA LIMITED 2025-10-16 2030-10-15

2356 RWANDA-FDA25/HM/0132/0037 ZERCYM ESOMEPRAZOLE 40 mg Lyophilized injection white powder or cake 24 Months EVEREST ORGANICS LIMITED India MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) Ltd 2025-10-16 2030-10-15

2357 RWANDA-FDA25/HM/0144/0022 Pregabalin-Denk 75 Pregabalin 75mg Hard Gelatin Capsules 28 hard capsules 24 Months KOPRAN RESEARCH LABORATORIES LTD India DENK PHARMA GmbH & Co. KG Herily - Agence de Marketing Ltd 2025-10-16 2030-10-15

2358 RWANDA-FDA25/HM/0162/0033 ROTASIIL-Liquid, Rotavirus Vaccine, Live Attenuated (Oral) (Liquid) Live Attenuated Rotavirus Vaccine (Oral) Serotypes G1, G2, G3, G4 and G9 1 DOSE, 2 DOSE of 2ml Oral solution 2ml-1 dose or 4 ml - 2 doses of 1’s and of 50’s 24 Months SERUM INSTITUTE OF INDIA PVT. LTD 212/2, HADAPSAR, Pune -411028, India India Serum Institute of India Pvt. Ltd. SUN ENTERPRISES LTD 2025-10-16 2030-10-15

2359 RWANDA-FDA25/HM/0100/0038 Tamsumac 0.4 TAMSULOSIN HYDROCHLORIDE USP 0.4 MG Hard Gelatin Capsules 36 Months Macleods Pharmaceuticals limited India MACLEODS PHARMACEUTICALS LTD AIVEEN (R) LTD 2025-10-16 2030-10-15

2360 RWANDA-FDA24/HM/1081/0035 HIDROFEROL 0.266MG SOFT CAPSULES Calcifediol Monohydrate 266MCG Soft Capsules 48 Months CARBOGEN AMCIS B.V. Netherlands FAES FARMA, S.A. UBIPHARM-RWANDA LTD 2025-10-16 2030-10-15

2361 RWANDA-FDA25/HM/0233/0031 LINCRET M 1000 LINAGLIPTIN/METFORMIN HYDROCHLORIDE 2.5MG &1000mg Film Coated Tablet 1x10's, 3x10's & 10x10's 24 Months MSN Laboratories Private Limited – Formulation Division Formulations Division, Unit-II, Survey Nos. 1277, 1319 to 1324, Nandigama (Village & Mandal), Rangareddy District, Telangana 509228, India India MSN Laboratories Private Limited SUN ENTERPRISES LTD 2025-10-16 2030-10-15

2362 Rwanda FDA-HMP-MA-2357 AGOPINE SR TABLETS NIFEDIPINE SUSTAINED RELEASED TABLETS BP 20MG TABLETS 10X10 TABLETS ALU/ALU BLISTER PACK 24 MONTHS AGOG PHARMA LTD PLOT NO. 33, SECTOR II, THE VASAI TALUKA INDUSTRIAL CO-OP. ESTATE LTD., GAURAIPADA, VASAI (E), DIST. THANE, INDIA INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2025-10-17 2030-10-16

Registered

2363 RWANDA-FDA24/HM/0876/0050 Atosar Losartan Potassium BP 50 mg Film-coated tablets, 24 Months Vasudha Pharma Chem Limited (Unit-II) India CORONA REMEDIES PVT LTD SUN ENTERPRISES LTD 2025-12-12 2030-12-11

2364 RWANDA-FDA25/HM/0145/0044 Pregabalin-Denk 150 Pregabalin 150mg Hard Gelatin Capsules 28 hard capsules 24 Months KOPRAN RESEARCH LABORATORIES LIMITED India DENK PHARMA GmbH & Co. KG Herily - Agence de Marketing Ltd 2025-12-12 2030-12-11

2365 RWANDA-FDA25/HM/0105/0049 Sitamac 100 SITAGLIPTIN USP 100 mg Film Coated Tablet 24 Months Macleods Pharmaceuticals limited India MACLEODS PHARMACEUTICALS LTD AIVEEN (R) LTD 2025-12-12 2030-12-11

2366 RWANDA-FDA25/HM/0051/0041 Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension 60mg/5mg/30mg Abacavir, Dolutegravir and Lamivudine 60mg/5mg/30mg TABLET FOR ORAL SUSPENSION 30's; 60's; 90's; 120's and 180's 36 Months Laurus Labs Limited, India Lupin Limited AIVEEN (R) LTD 2025-12-12 2030-12-11

2367 RWANDA-FDA24/HM/0793/0046 KAINAZ FLUCONAZOLE BP 0.2%w/v Solution for infusion. 1x 100ml 24 Months meheco PHARMACEUTICALS PVT LTD India KAIRUKI PHARMACEUTICALS INDUSTRY LIMITED KIPHARMA Ltd 2025-12-12 2030-12-11

2368 RWANDA-FDA25/HM/0078/0052 Ravidavira Ravidasvir Hydrochloride 200 mg Tablet 28's 24 Months European Egyptian Pharmaceutical Industries Km 25 Alexandria-Cairo Desert Road, Amriya, Alexandria. Egypt Egypt Pharco Pharmaceuticals HELIOS PHARMA Ltd 2025-12-12 2030-12-11

2369 RWANDA-FDA25/HM/0024/0053 Grateziano SOFOSBUVIR 400 mg Film-coated tablets, 28's 36 Months European Egyptian Pharmaceutical Industries Km 25 Alexandria-Cairo Desert Road, Amriya, Alexandria. Egypt Egypt European Egyptian Pharmaceutical Industries HELIOS PHARMA Ltd 2025-12-12 2030-12-11

2370 RWANDA-FDA25/HM/0077/0051 Daclavir Daclatasvir dihydrochloride 60 mg Film Coated Tablet 28's 24 Months European Egyptian Pharmaceutical Industries Km 25 Alexandria-Cairo Desert Road, Amriya, Alexandria. Egypt Egypt Dawood Pharma HELIOS PHARMA Ltd 2025-12-12 2030-12-11

2371 RWANDA-FDA25/HM/0295/0048 Tacrocord 0.5 Tacrolimus Capsules USP 0.5 mg Capsules 24 Months Concord Biotech Limited India Prisma Pharma FZE PRAFIN RWANDA LTD 2025-12-12 2030-12-11

2372 RWANDA-FDA25/HM/0312/0045 Abacavir, Dolutegravir and Lamivudine Abacavir, Dolutegravir and Lamivudine tablets 60/5/30 mg Dispersible tablet 30 tablets and 90 tablets 24 Months Laurus Labs Limited, India CIPLA LTD INDIA Phillips Pharmaceuticals Rwanda 2025-12-12 2030-12-11

2373 RWANDA-FDA25/HM/0620/0042 Lenacapavir Gilead 300 mg film-coated tablets Lenacapavir sodium 300 mg TABLES 1x4 tablets 36 Months ROTTENDORF PHARMA GMBH OSTENFELDER STRASSE 51 – 61, 59320 ENNIGERLOH, NORTH RHINE-WESTPHALIA, GERMANY GERMANY Gilead Sciences Ireland UC MITDASH LTD 2025-12-12 2030-12-11

Registered

2374 RWANDA-FDA25/HM/0617/0043 Lenacapavir Gilead 464 mg solution for injection Lenacapavir sodium 464 mg/1.5ml Solution for Injection. 2x 1 Vials 36 Months Patheon Italia S.p.A. Italy Gilead Sciences Ireland UC MITDASH LTD 2025-12-12 2030-12-11

2375 RWANDA-FDA23/HM/0116/0020 Diclofenac Sodium injection DICLOFENAC SODIUM 75MG PER 3ML Liquid for Injection 10x10's 36 Months REYOUNG PHARMACEUTICAL CO., Ltd. No.1 Ruiyang Road Yiyuan county, Shandong Province, P. R. China China Reyoung Pharmaceutical Co., Ltd SUN ENTERPRISES LTD 2026-02-05 2031-02-04

2376 RWANDA-FDA23/HM/0587/0021 Siropil Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets 50 mg/ 300 mg/ 300 mg Film-Coated Tablet 24 Months EMCURE PHARMACETICALS LTD/INDIA Emcure Pharmaceuticals Limited ABACUS(Ltd) DOWNTOWN BRANCH 2026-02-05 2031-02-04

2377 RWANDA-FDA24/HM/0486/0014 BACTROKANT Mupirocin BP 2% w/w Ointment 24 Months BILLS BIOTECH PVT. LTD India S KANT HEALTHCARE LTD ABACUS PHARMA (A) Ltd 2026-02-05 2031-02-04

2378 RWANDA-FDA24/HM/0914/0001 Celebib 200 CELECOXIB 200 mg Hard Gelatin Capsules 48 Months Macleods Pharmaceuticals limited India MACLEODS PHARMACEUTICALS LTD AIVEEN (R) LTD 2026-02-05 2031-02-04

2379 RWANDA-FDA23/HM/0414/0013 ARMEZA 80/480 Artemether and Lumefantrine 80 mg / 480 mg ORAL TABLET 36 Months Vital Laboratories Pvt Ltd India UNIZA LIFECARE PVT. LTD. ABACUS PHARMA (A) Ltd 2026-02-05 2031-02-04

2380 RWANDA-FDA24/HM/0530/0011 AVIRAX Aciclovir BP 5% w/w Cream 36 Months Great Pacific Exports Pvt. Ltd India S KANT HEALTHCARE LTD ABACUS PHARMA (A) Ltd 2026-02-05 2031-02-04

2381 RWANDA-FDA24/HM/0611/0018 KENIZA Ketoconazole BP 2% w/w Cream 36 Months AARTI DRUGS LIMITED,Mahendra Industrial Estate Plot No. – 109 –D Road No.29, Sion (East), Mumbai – 400 022. India UNIZA LIFECARE PVT. LTD. ABACUS PHARMA (A) Ltd 2026-02-05 2031-02-04

2382 RWANDA-FDA24/HM/0910/0016 Hydrocortisone Sodium Succinate For Injection BP 100 mg Hydrocortisone Sodium succinate Eq.to Hydrocortisone 100 mg Dry Powder for injection or infusion 36 Months SYMBIOTEC PHARMALAB LIMITED India Lincoln Pharmaceuticals Limited ABACUS PHARMA (A) Ltd 2026-02-05 2031-02-04

2383 RWANDA-FDA25/HM/0255/0010 LEVANEXT 750 LEVETIRACETAM 750 mg Tablets 120's count 36 Months MSN Laboratories Private Limited – Formulation Division Formulations Division, Unit-II, Survey Nos. 1277, 1319 to 1324, Nandigama (Village & Mandal), Rangareddy District, Telangana 509228, India India MSN Laboratories Private Limited SUN ENTERPRISES LTD 2026-02-05 2031-02-04

2384 RWANDA-FDA25/HM/0237/0008 RABIVAX-S Purified Rabies Antigen 1 dose of 2.5 IU Lyophilized powder for injection 5.0ml x 5 vials in single carton 36 Months SERUM INSTITUTE OF INDIA PRIVATE LIMITED, 212/2, Hadapsar Pune- 411028, India India Serum Institute of India Pvt. Ltd. SUN ENTERPRISES LTD 2026-02-05 2031-02-04

2385 RWANDA-FDA25/HM/0287/0007 Zapacid 30 LANSOPRAZOLE 30MG Hard Gelatin Capsules 24 Months Smilax Laboratories Ltd India Win-Medicare Private Limited Surgipharm Rwanda Ltd. 2026-02-05 2031-02-04

2386 RWANDA-FDA24/HM/0769/0004 5D GLUCOSE 5% W/V Solution for infusion. 1 x 500 ml 24 Months WEIFANG SHENGTAI MEDECINE CO LTD THE EAST OF CHANGDA ROAD,CHANGLE COUNTY WEIFANG, SHANDONG PROVINCE,CHINA China KAIRUKI PHARMACEUTICALS INDUSTRY LIMITED KIPHARMA Ltd 2026-02-05 2031-02-04

2387 RWANDA-FDA24/HM/0806/0005 KAIMET METRONIDAZOLE B.P 0.5%w/v Solution for Infusion 1x100ml 24 Months HUANGGANG QIHENG Sanitary Product Co., LTD HUANGGANG QIHENG Sanitary Product Co., LTD China KAIRUKI PHARMACEUTICALS INDUSTRY LIMITED KIPHARMA Ltd 2026-02-05 2031-02-04

2388 RWANDA-FDA25/HM/0087/0006 KAICET Paracetamol 1% W/V Solution for infusion. 100 ml 24 Months Anhui BBCA Likang Pharmaceutical Co.LTD China KAIRUKI PHARMACEUTICALS INDUSTRY LIMITED KIPHARMA Ltd 2026-02-05 2031-02-04

2389 RWANDA-FDA25/HM/0301/0002 Bedaquiline Bedaquiline Fumarate 100 mg Uncoated tablet 188’s 36 Months MSN Labs Private Limited Formulation Division, Unit-II, Survey Nos. 1277, 1319 to 1324, Nandigama (Village & Mandal), Rangareddy District, Telangana 509228, India India MSN Laboratories Private Limited SUN ENTERPRISE Ltd 2026-02-05 2031-02-04

2390 RWANDA-FDA24/HM/0066/0003 Epibalin 75 Pregabalin 75mg Capsule 1 x 10's or 3 x 10's 36 Months MSN LABORATORIES PRIVATE LIMITED PLOT NO.: 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANGAREDDY DISTRICT, PIN CODE. 502325, TELANGANA, INDIA India MSN Laboratories Private Limited SUN ENTERPRISES LTD 2026-02-05 2031-02-04

2391 RWANDA-FDA25/HM/0147/0009 CALQUENCE™ Acalabrutinib 100 mg Film-coated tablets, 6x10 tablets 36 Months AstraZeneca AB Gärtunavägen, 152 57 Södertälje, Sweden Sweden AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2026-02-05 2031-02-04

2392 RWANDA-FDA25/HM/0385/0012 Lidocaine & Adrenaline Injection BP (21.33 mg + 0.0125 mg/ml) Lidocaine Hydrochloride BP 21.33 mg/ml & Adrenaline Acid Tartrate Eq. to Adrenaline BP 0.0125 mg/ml Solution for Injection. 30ml 24 Months SWATI SPENTOSE PRIVATE LIMITED, UNIT-I India Lincoln Pharmaceuticals Limited ABACUS PHARMA (A) Ltd 2026-02-05 2031-02-04

2393 RWANDA-FDA25/HM/0134/0017 Aarciflox-500 Ciprofloxacin USP 500 mg Film-coated tablets, 36 Months AARTI DRUGS LIMITED. India. PINNACLE LIFESCIENCES PVT. LTD. ABACUS PHARMA (A) Ltd 2026-02-05 2031-02-04

2394 RWANDA-FDA25/HM/0419/0019 OXALIPLATIN 5MG/ML solution for infusion OXALIPLATIN 5 mg/ml (filling size: 100 mg/20 ml) Concentrate for solution for infusion 1's 48 Months HERAEUS MEDICAL GMBH Germany ONCOPHARM WHOLESALE ONCOPHARM RWANDA LTD 2026-02-05 2031-02-04

2395 RWANDA-FDA25/HM/0493/0015 Trastmab 440 Trastuzumab lyophilized powder for concentrate for solution for infusion 21 mg/mL Lyophilized powder for reconstitution for injectio 20ml 36 Months INTAS PHARMACEUTICALS LIMITED, Plot No. 423/P/A Sarkhej - Bavla Highway. Moraiya, Taluka: Sanand Ahmedabad – 382 213 Gujarat, India India Intas Pharmaceuticals Limited BION PHARMA GROUP (BPG) Ltd 2026-02-05 2031-02-04

2396 RWANDA-FDA23/HM/0295/0027 PIROCAM 20 CAPSULES PIROXICAM BP 20mg Capsules 2x10’s or 10x10’s contained in a unit box 36 Months APEX HEALTHCARE LIMITED. India Laboratory & Allied Ltd Depot Pharmaceutique Le Medical 2026-02-06 2031-02-05

2397 RWANDA-FDA24/HM/0311/0026 VENTO ASMA-250 Beclometasone dipropionate 250 mcg Inhaler 1 x 200 doses 36 Months AVIK PHARMACEUTICAL LTD. India Farmasino Co., Ltd. ABACUS PHARMA (A) Ltd 2026-02-06 2031-02-05

2398 RWANDA-FDA24/HM/0228/0023 ESOMEPRAZOLE 40 MG, GASTRO-RESISTANT CAPSULE, HARD Esomeprazole Magnesium dihydrate 40MG Capsule 28 24 Months CIPLA LTD India Ethypharm KIPHARMA Ltd 2026-02-06 2031-02-05

2399 RWANDA-FDA24/HM/0782/0025 OLMAC Olanzapine 10mg Film Coated Tablet 24 Months MACLEODS PHARMACEUTICALS LIMITED 304, Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai- 400 059, India MACLEODS PHARMACEUTICALS LTD AIVEEN (R) LTD 2026-02-06 2031-02-05

2400 RWANDA-FDA24/HM/0087/0028 Emtricitabine and Tenofovir Alafenamide Tablets 200 mg/25 mg EMTRICITABINE AND TENOFOVIR ALAFENAMIDE 200 mg/25 mg ORAL TABLET 30's, 90's and 180's 24 Months Mylan Laboratories Limited Plot no: 11, 12 & 13, Indore SEZ, Pharma Zone, Phase-II, Sector-III, Pithampur – 454775, Dist. Dhar (MP) India India Mylan Laboratories Limited PYRAMID PHARMA LIMITED 2026-02-06 2031-02-05

2401 RWANDA-FDA24/HM/0310/0022 VENTOCARE Salbutamol sulfate 100mcg AEROSOL 200 metered doses 36 Months Supriya Lifescience Ltd. India Farmasino Co., Ltd. ABACUS PHARMA (A) Ltd 2026-02-06 2031-02-05

2402 RWANDA-FDA24/HM/0666/0024 Candesartan Cilexetil 8 mg Tablets CANDESARTAN CILEXITIL 8 mg Tablet 24 Months Chromo Laboratories Indian Private Limited. India Imperial Medical Solutions FZE Surgipharm Rwanda Ltd. 2026-02-06 2031-02-05

2403 RWANDA-FDA23/HM/0155/0034 OMITRON SOLUTION ONDANSETRON ORAL SOLUTION USP Oral solution 36 CADILA PHARMACEUTICAL LTD. India Aura Lifecare Pvt. Ltd. SUN ENTERPRISE Ltd 2026-03-14 2031-03-13

2404 RWANDA-FDA24/HM/0950/0033 SEZUMA 440 TRASTUZUMAB Lyophilized powder for injection 36 HETERO BIOPHARMA LIMITED India HETERO BIOPHARMA LIMITED BION PHARMA GROUP (BPG) Ltd 2026-03-14 2031-03-13

2405 RWANDA-FDA24/HM/0954/0032 SEZUMA 150 TRASTUZUMAB Lyophilized powder for injection 36 HETERO BIOPHARMA LIMITED India HETERO BIOPHARMA LIMITED BION PHARMA GROUP (BPG) Ltd 2026-03-14 2031-03-13

2406 RWANDA-FDA25/HM/0010/0031 USOPENTIN 300 GABAPENTIN Capsule 36 Hikal Limited India Usopharma Ltd Usopharma Ltd 2026-03-14 2031-03-13

2407 RWANDA-FDA25/HM/0035/0030 Maxflow Capsule 0.4mg TAMSULOSIN HYDROCHLORIDE USP Hard Gelatin Capsules 24 Lee Pharma Limited India CCL Pharmaceuticals (Pvt.) Ltd Depot Pharmaceutique Le Medical 2026-03-14 2031-03-13

2408 RWANDA-FDA24/HM/0725/0029 ATSTAT 10 ATORVASTATIN CALCIUM TRIHYDRATE PH. EUR Film Coated Tablets 24 Synthimed Labs Private Limited India Ind-Swift Limited LOTUS MEDICAL GROUP Ltd 2026-03-14 2031-03-13

2409 RWANDA-FDA25/HM/0163/0035 PNEUMOSIL Suspension of injection 36 SERUM INSTITUTE OF INDIA PVT. LTD India Serum Institute of India Pvt. Ltd. SUN ENTERPRISES LTD 2026-03-14 2031-03-13

2410 RWANDA-FDA25/HM/0226/0042 Ganfort Bimatoprost 0,3 mg and Timolol maleate equivalent to 5 mg timolol Eye drops, solution 24 ALLERGAN PHARMACEUTICALS IRELAND Ireland AbbVie Pty Ltd PRAFIN RWANDA LTD 2026-03-14 2031-03-13

2411 RWANDA-FDA25/HM/0292/0044 BREATH EZY 4 MONTELUKAST SODIUM Chewable tablet 24 MSN LABORATORIES PRIVATE LIMITED India MSN Laboratories Private Limited SUN ENTERPRISES LTD 2026-03-14 2031-03-13

2412 RWANDA-FDA25/HM/0299/0043 BREATHEZY CW 5 MONTELUKAST SODIUM Chewable Tablets 24 MSN Laboratories Private Ltd. India MSN Laboratories Private Limited SUN ENTERPRISES LTD 2026-03-14 2031-03-13

2413 RWANDA-FDA25/HM/0379/0036 Morphine Oral Solution Morphine sulfate Oral solution 36 Macfarlan Smith Limited United Kingdom Macarthys Laboratories Ltd. T/A Martindale Pharma KIPHARMA Ltd 2026-03-14 2031-03-13

2414 RWANDA-FDA25/HM/0507/0039 Trastmab 150 TRASTUZUMAB LYOPHILISATE FOR CONCENTRATE FOR SOLUTION FOR INFUSION 36 Intas Pharmaceutical Ltd. India Intas Pharmaceuticals Limited BION PHARMA GROUP (BPG) Ltd 2026-03-14 2031-03-13

2415 RWANDA-FDA25/HM/0531/0038 EPOFIT 4000IU Recombinant Human Erythropoietin INJECTION USP 24 Intas Pharmaceutical Ltd. India Intas Pharmaceuticals Limited BION PHARMA GROUP (BPG) Ltd 2026-03-14 2031-03-13

2416 RWANDA-FDA25/HM/0538/0037 BEVAMAB 100 Bevacizumab 100 mg/4 ml Solution for Intravenous Infusion 24 Intas Pharmaceutical Ltd. India Intas Pharmaceuticals Limited BION PHARMA GROUP (BPG) Ltd 2026-03-14 2031-03-13

2417 RWANDA-FDA25/HM/0542/0041 BEVAMAB 400 Bevacizumab 400mg/16ml IV/ INJECTION 24 Intas Pharmaceutical Ltd. India Intas Pharmaceuticals Limited BION PHARMA GROUP (BPG) Ltd 2026-03-14 2031-03-13

2418 RWANDA-FDA25/HM/0582/0040 Intamab 500 Rituximab 500mg/50 mL INTRAVEOUS INFUSION 36 Intas Pharmaceutical Ltd. India Intas Pharmaceuticals Limited BION PHARMA GROUP (BPG) Ltd 2026-03-14 2031-03-13

2419 RWANDA-FDA24/HM/0180/0046 BUPICAINE PF Bupivacaine Hydrochloride BP 5mg/ml STERILE SOLUTION FOR INJECTION 24 Dishman Carbogen Amcis Limited India THEMIS MEDICARE LIMITED WESSEX PHARMACEUTICALS (RWANDA) Ltd 2026-03-18 2031-03-17

2420 RWANDA-FDA24/HM/1083/0045 BETACORT Beclometasone Dipropionate Pressurised inhalation 36 AVIK PHARMACEUTICAL LTD. India GENERIX LABORATORIES PRIVATE LIMITED AIVEEN (R) LTD 2026-03-18 2031-03-17

2421 RWANDA-FDA25/HB/0202/0047 GINSOMIN EVE GINSENG EXTRACT (EQ. TO DRIED GINSENG ROOTS 200 MG) and multivitamins SOFTGEL CAPSULES 24 DALIANT TIANSHAN INDUSTRIAL CO., LTD China MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) Ltd 2026-03-18 2031-03-17

2422 RWANDA-FDA25/HM/0185/0048 Tecnovula Clomiphene Citrate (Micronized) ORAL TABLET 36 Technopharma Egypt Egypt TechnoPharma Egypt HELIOS PHARMA Ltd 2026-03-18 2031-03-17