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-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

2 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

3 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

4 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

5 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

6 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

7 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

8 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

9 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

10 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

11 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

12 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

13 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

14 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

15 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

16 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

17 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

18 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

19 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

20 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

21 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

22 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

23 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

24 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

25 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

26 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

27 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

28 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

29 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

30 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

31 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

32 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

33 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

34 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

35 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

36 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

37 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

38 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

39 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

40 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

41 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

42 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

43 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

44 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

45 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

46 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

47 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

48 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

49 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

50 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

51 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

52 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

53 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

54 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

55 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

56 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

57 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

58 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

59 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

60 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

61 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

62 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

63 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

64 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

65 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

66 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

67 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

68 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

69 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

70 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

71 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

72 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

73 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

74 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

75 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

76 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

77 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

78 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

79 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

80 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

81 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

82 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

83 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

84 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

85 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

86 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

87 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

88 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

89 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

90 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

91 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

92 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

93 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

94 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

95 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

96 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

97 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

98 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

99 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

100 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

101 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

102 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

103 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

104 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

105 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

106 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

107 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

108 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

109 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

110 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

111 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

112 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

113 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

114 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

115 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

116 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

117 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

118 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

119 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

120 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

121 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

122 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

123 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

124 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

125 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

126 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

127 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

128 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

129 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

130 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

131 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

132 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

133 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

134 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

135 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