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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |

