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-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

2 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

3 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

4 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

5 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

6 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

7 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

8 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

9 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

10 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

11 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

12 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

13 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

14 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

15 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

16 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

17 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

18 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

19 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

20 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

21 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

22 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

23 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

24 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

25 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

26 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

27 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

28 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

29 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

30 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

31 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

32 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

33 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

34 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

35 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

36 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

37 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

38 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

39 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

40 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

41 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

42 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

43 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

44 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

45 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

46 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

47 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

48 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

49 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

50 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

51 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

52 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

53 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

54 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

55 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

56 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

57 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

58 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

59 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

60 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

61 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

62 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

63 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

64 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

65 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

66 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

67 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

68 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

69 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

70 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

71 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

72 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

73 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

74 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

75 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

76 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

77 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

78 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

79 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

80 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

81 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

82 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

83 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

84 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

85 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

86 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

87 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

88 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

89 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

90 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

91 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

92 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

93 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

94 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

95 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

96 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

97 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

98 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

99 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

100 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

101 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

102 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

103 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

104 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

105 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

106 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

107 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

108 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

109 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

110 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

111 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

112 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

113 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

114 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

115 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

116 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

117 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

118 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

119 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

120 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

121 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

122 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

123 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

124 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

125 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

126 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

127 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

128 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

129 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

130 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

131 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

132 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

133 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

134 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

135 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

136 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

137 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

138 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

139 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

140 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

141 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

142 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

143 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

144 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

145 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

146 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

147 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

148 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

149 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

150 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

151 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

152 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

153 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

154 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

155 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

156 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