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-1198 RABEMAC 20 Rabeprazole Sodium 20 mg 20 mg Delayed Release Tablets 2 x 7 & 4 x 7 tablets Alu / Alu blister pack packed in a carton 36 Months MACLEODS PHARMACEUTICALS LTD. Block N-2, Village Theda, Post Office Lodhimajra, Tehsil Baddi, Distt. Solan, Himachal Pradesh-174 101, India INDIA MACLEODS PHARMACEUTICALS LTD AIVEEN RWANDA LTD 2024-05-06 2029-05-05
2 Rwanda FDA-HMP-MA-1035 RABEPRIDE CAPSULES Rabeprazole Sodium 20mg and Itropride Hydrochloride 150mg 20mg/150mg Hard Gelatin Capsules 3 x 10’s Capsules ALU-ALU Blisters packed in a carton 24 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Road, Ruaraka. P.O. Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED. KENYA SUN ENTERPRISE LTD 2024-02-28 2029-02-27
3 RWANDA-FDA25/HM/0237/0008 RABIVAX-S Purified Rabies Antigen 1 dose of 2.5 IU Lyophilized powder for injection 5.0ml x 5 vials in single carton 36 Months SERUM INSTITUTE OF INDIA PRIVATE LIMITED, 212/2, Hadapsar Pune- 411028, India India Serum Institute of India Pvt. Ltd. SUN ENTERPRISES LTD 2026-02-05 2031-02-04
4 Rwanda FDA-HMP-MA-1456 RACYCLINE EYE OINTMENT. Tetracycline Hydrochloride BP Each gram contains: Tetracycline Hydrochloride BP 10mg in sterilized paraffin base. EYE OINTMENT 1 Tube of 3.5gm Collapsible tubes and contained in a unit box with literature insert 36 Months LABORATORY & ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road. 42875 GPO 00100, Nairobi-Kenya KENYA LABORATORY & ALLIED LIMITED Depot Pharmaceutique Le Medical 2024-07-27 2029-07-26
5 Rwanda FDA-HMP-MA-1160 RALEF 120 Etoricoxib 120mg 120mg Film coated Tablet 7 Tablets Alu-PVC/PVdC blister, packed in a carton alog with patient information leaflet 24 Months AJANTA PHARMA LIMITED, B-4-5-6, MIDC Industrial Area Paithan, Aurangabad, 431148 Dist: Aurangabad Maharashtra, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-27 2029-04-26
6 Rwanda FDA-HMP-MA-0757 RALEF 60 Etoricoxib Tablets 60 mg 60 mg Film coated tablets 7 tablets Alu-PVC/PVDC blister, 1 such blister is packed in a carton along with Patient Information Leaflet 24 Months AJANTA PHARMA LIMITED, Plot No. B-4/5/6, MIDC, Paithan, Aurangabad Maharashtra 431148, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-12-30 2028-12-29
7 Rwanda FDA-HMP-MA-1103 RALEF 90 Etoricoxib 90mg 90mg Film Coated Tablets 7 Tablets Alu-PVC/PVdC blister, 1 such blister is packed in a carton along with patient information Leaflet. 24 Months AJANTA PHARMA LIMITED, Plot No. B-4/5/6, MIDC Area Paithan, Aurangabad-431148, Maharashtra State, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19
8 Rwanda FDA-HMP-MA-1199 RALTEGRAVIR TABLETS Raltegravir Potassium (Amorphous) 400mg 400mg Film coated tablets 60 tablets HDPE Container 100 cc with 38 mm neck (Medium weight), Closure: Child resistant plastic caps with pulp liner 38mm and Desiccant Canister 2.0-gram silica gel 24 Months HETERO LABS LIMITED, Unit-III, Survey No.: 51, 22-110, Industrial Development Area (IDA), Jeedimetla, Hyderabad-500 055 Telangana, India INDIA HETERO LABS LIMITED SUN ENTERPRISES LIMITED 2024-05-06 2029-05-05
9 Rwanda FDA-HMP-MA-1802 RAMIPRIL IMPACT 2.5 MG TABLET Ramipril 2.5 mg Film Coated Tablets 28 Tablets PVC/ALU BOX 36 Months SANOFI WINTHROP INDUSTRIE-TOUS 30-36 AVENUE GUSTAVE EIFFEL 37100 TOURS FRANCE SANOFI-AVENTIS SOUTH AFRICA (PTY) LTD KIPHARMA LTD 2024-08-17 2029-08-16
10 Rwanda FDA-HMP-MA-1128 RANEXA 375 Ranolazine 375 mg prolonged 375 mg Prolonged-release tablet 2x20 Tablets PVC/PVDC/Aluminium blisters packed in a carton 24 Months MENARINI-VON HEYDEN GmbH, Leipziger Stra?e 7-13,01097 - Dresden, Germany GERMANY MENARINI -VON HEYDEN GmbH PRAFIN RWANDA LTD 2024-04-21 2029-04-20
11 Rwanda FDA-HMP-MA-0862 RANEXA 500 MG Ranolazine 500 mg 500 mg Film coated prolonged-release tablets 3x 20 Tablets PVC/PVDC/Aluminium Blisters. Each carton contains 3 blister cards 24 Months MENARINI-VON HEYDEN GMBH, Lei ziger Strasse 7-13, 01097 – Dresden, Germany GERMANY MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. PRAFIN RWANDA LTD 2024-02-17 2029-02-16
12 Rwanda FDA-HMP-MA-0708 RANEXA 750MG Ranolazine 750 mg 750 mg Tablets 60 Tablets packed in PVC/Alu blister 24 Months MENARINI -VON HEYDEN GmbH, Leipziger Stra?e 7-13 01097 Dresden, Germany GERMANY MENARINI INTERNATIONAL OPERATIONAL LUXEMBOURG S.A PRAFÌN RWANDA LTD 2023-12-30 2028-12-29
13 RWANDA-FDA25/HM/0078/0052 Ravidavira Ravidasvir Hydrochloride 200 mg Tablet 28's 24 Months European Egyptian Pharmaceutical Industries Km 25 Alexandria-Cairo Desert Road, Amriya, Alexandria. Egypt Egypt Pharco Pharmaceuticals HELIOS PHARMA Ltd 2025-12-12 2030-12-11
14 Rwanda FDA-HMP-MA-1122 RAYZIUM Esomeprazole Magnesium Trihydrate USP 40mg 40 mg Enteric coated tablet 3 x 10 tablets PVC/ALU blister pack in a carton 36 Months BIODEAL LABORATORIES LTD, Plot no.123, Lunga Lunga P.O. Box 32040-00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-04-20 2029-04-19
15 Rwanda FDA-HMP-MA-1442 RAYZIUM-20 Esomeprazole Magnesium Trihydrate USP 20mg 20mg Enteric coated tablets 3x10 Tablets Blister Pack is packed in a carton along with package insert 36 Months BIODEAL LABORATORIES LTD, 123, Lunga. P.O Box 32040-00600, Nairobi, Kenya. KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-07-20 2029-07-19
16 Rwanda FDA-HMP-MA-1637 RECIM-200 TABLETS Cimetidine 200 mg Tablets 10x10 Tablets Aluminium/ transparent PVC blister 24 Months RENE INDUSTRIES LTD Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda Uganda RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-08-17 2029-08-16
17 Rwanda FDA-HMP-MA-1642 RECODIN Chlorpheniramine Maleate BP and Codeine phosphate 4mg/10mg SYRUP 100ml Bottle Amber PET bottles and sealed with ROPP caps 24 Months RENE INDUSTRIES LTD Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda Uganda RENE INDUSTRIES LTD, UGANDA Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16
18 Rwanda FDA-HMP-MA-1407 RECTONAC-100 Diclofenac Sodium 100 mg 100 mg Suppositories 2 x 5 Suppositories Strip pack 36 Months GALEN PHARMACEUTICALS LTD, 334/5, G.I.D.C Estate, Waghodia- 91760, Dist: - Vadodara, Gujarat, India INDIA GALEN PHARMACEUTICALS LIMITED SUN ENTERPRISES LTD 2024-07-18 2029-07-17
19 Rwanda FDA-HMP-MA- 1332 REGAMOL TABLETS Paracetamol BP 500mg 500mg Uncoated Tablets 10x10 tablets Aluminium/PVC blister strips packed in a unit box 48 Months BAL PHARMA LIMITED, 21 & 22 - Bommasandra Industrial Area Bangalore, India INDIA BAL PHARMA LIMITED, INDIA SUN ENTERPRISES LTD 2024-05-18 2029-05-17
20 Rwanda FDA-HMP-MA-0774 RELCER GEL Aluminium Hydroxide Gel USP 365 mg Magnesium Hydroxide Paste USP 80 mg; Simethicone USP 100 mg and Deglycyrrhizinated Liquoride 400 mg 365 mg, 80 mg, 100 mg and 400 mg Oral Suspension 100/180ml Bottles Amber coloured labelled sealed PET bottle with 10 ml measuring cup, in a printed carton 48 Months GLENMARK PHARMACEUTICALS LTD, Plot No. E-37, 39, D-Road, MIDC, Satpur, Nashik – 422007, Maharashtra, India INDIA GLENMARK PHARMACEUTICALS LTD WESSEX PHARMACEUTICAL (RWANDA) LTD 2024-01-05 2029-01-04
21 Rwanda FDA-HMP-MA-1248 RENE-CPM TABLETS Chlorpheniramine Maleate 4 mg 4 mg Tablets 10 Tablets Aluminium/transparent PVC blister 24 Months RENE INDUSTRIES LTD, Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda UGANDA RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-05-06 2029-05-05
22 Rwanda FDA-HMP-MA-1704 RENECHLOR 250MG CAPS Chloramphenicol BP 250 mg 250mg Capsules 10 capsules Aluminium/PVC blister 36 month Rene Industries Ltd Plot No 680, P.O Box 6034, Kamuli, Kireka, Kamplala Uganda Rene Industries Ltd Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16
23 Rwanda FDA-HMP-MA-1599 RENEDOL TABLETS Paracetamol BP 500 mg Tablets 10x10 or 1000 tablets Aluminum/transparent PVC blister strip or Polythene bag in HDPE container 24 Months Rene Industries Ltd Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda. Uganda Rene Industries Ltd Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16
24 Rwanda FDA-HMP-MA-1907 RENEGEL SUSPENSION ALUMINIUM HYDROXIDE120 MG +MAGNESIUM TRISILICATE 250MG 120mg/250 mg Suspension 1x100 ml amber colored glass bottle with ROPP caps 24 months RENE INDUSTRIES LTD RENE INDUSTRIES LTD. Addresses : Manufacturers of Pharmaceuticals Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda. Country : Uganda. Telephone : +256 414236595, +256 414341416 Telefax : +256 414236596 E-Mail : info@rene.co.ug, rishi@rene.co.ug. UGANDA Rene Industries Ltd Rene Pharmacy (R) Ltd. 2024-08-17 2029-08-16
25 RwandaFDA-HMP-MA-1861 RENESTEN -V CLOTRIMAZOLE 100MG PESSARIES 6*1 BLISTER ALU/PVC BLISTER 36 Months RENE INDUSTRIES LTD Manufacturers of Pharmaceuticals PO Box 6034, Plot No 680, Kamuli, Kireka, Kampala, Uganda. Country: Uganda Telephone: +256 414236595, +256 414341416 Telefax: +256414236596 E-Mail:info@rene.co.ug, rishi@rene.co.ug. UGANDA RENE INDUSTRIES LTDManufacturers of pharmaceuticalsPlot No 680, PO Box 6034Kampala, UgandaTelephone: +2566 414236595,E-mail: info@rene.co.ug RENE PHARMACY LTD RWANDA 2024-08-17 2029-08-16
26 Rwanda FDA-HMP-MA-1247 RENETRIM DS TABLETS Sulfamethoxazole 800mg and Trimethoprim 160mg 800mg and 160mg Tablets 10 Tablets Aluminium/transparent PVC blister 24 Months RENE INDUSTRIES LTD. Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda UGANDA RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-05-06 2029-05-05
27 Rwanda FDA-HMP-MA-1602 RENETRIM TABLETS Sulfamethoxazole and Trimethoprim 400 mg/80 mg Tablets 10x10 or 1000 Tablets Aluminum/transparent PVC blister strip or Polythene bag in HDPE container 36 Months Rene Industries Ltd Plot No.680, P.O. Box 6034 Kamuli, Kireka, Kampala, Uganda. Uganda Rene Industries Ltd Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16
28 Rwanda FDA-HMP-MA-2248 RENNIE PEPPERMINT Calcium carbonate and magnesium carbonate 680mg and 80mg TABLETS Packs of 2, 6, 24, 48 and 96 tablets PVC/aluminium blister pack 36 Months DELPHARM GAILLARD 33, rue de l’industrie 74240 Gaillard France France Bayer East Africa Limited Surgipharm (Rwanda) Ltd 2025-02-04 2030-02-03
29 Rwanda FDA-HMP-MA-2042 RENPRESS TABLETS PROPRANOLOL HYDROCHLORIDE BP 40mg Tablets 10×10 tablets Aluminium/PVC blister strip and carton with pack insert 24 Months RENE INDUSTRIES LTD. RENE INDUSTRIES LTD. Address: Manufacturers of Pharma Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda. Telephone: +256 414236595, +256 414341416 E-Mail: info@rene.co.ug, rishi@rene.co.ug Uganda RENE INDUSTRIES LTD RENE PHARMACY (R) LTD 2024-09-30 2029-09-29
30 Rwanda FDA-HBP-MA-002 REPOITIN 4000 ERYTHROPOIETIN CONCENTRATED SOLUTION B.P 4000 IU/0.4 ML. SOLUTION FOR INJECTION UNIT PACK PRE-FILLED SYRINGE 24 Months SERUM INSTITUTE OF INDIA PVT. LTD 212/2, HADAPSAR, Pune -411028, India INDIA SERUM INSTITUTE OF INDIA PVT. LTD SUN ENTERPRISES LTD 2021-09-08 2026-09-08
31 Rwanda FDA-HBP-MA-0114 REPOITIN 4000 IU Erythropoietin Concentrated Solution B.P. (Epoetin Alfa), 4000 IU/0.4 mL 4000 IU/0.4 mL Solution for injection 1 Vial Type -I glass vial with bromobutyl rubber and aluminium seal having flip off cap 24 Months SERUM INSTITUTE OF INDIA PVT. LTD. 212/2, Hadapsar, Off Soli-Poonawalla Road, Pune - 411028, Maharashtra, India INDIA SERUM INSTITUTE OF INDIA PVT. LTD, INDIA SUN ENTERPRISES LTD 2024-02-28 2029-02-27
32 Rwanda FDA-HMP-MA-1570 RESPIMAX Ambroxol Hydrochloride, Salbutamol Sulfate, Guaifenesin 15MG/1MG/1MG/5ML SYRUP 100ML BOTTLE Amber colour bottle pack, packed in printed and laminated carton 24 MONTHS West Coast Pharmaceutical Works Ltd F.P. No. 17 & 16/5, Meldi Estate, B/s Meldi Mata Temple, Near Gota Railway Crossing, At & Post Gota, Ahmedabad – 382481, Gujarat State (India) INDIA BEKRA PHARMA, United Kingdom UBIPHARM RWANDA LTD 2024-10-27 2029-10-26

Registered
33 Rwanda FDA-HMP-MA-0225 RESTOCIN Paracetamol BP 500 mg+ Phenylephrine Hydrochloride BP 5 mg + Chlorphenamine Maleate BP 2 mg + Anhydrous Caffeine BP 30 mg 500 mg + 5 mg + 2 mg + 30 mg Uncoated Tablets 4x50 Tablets 4 Tablets are packed in a strip Pack. Such 1 strip is packed in a printed catch cover. Such 50 catch covers are packed in a printed carton with a packing insert. 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11
34 Rwanda FDA-HMP-MA-1246 REVIVE Glucose anhydrous 13.5g, sodium chloride 2.6g, trisodium citrate dihydrate BP 2.9g, Potassium chloride 1.5g 13.5g, 2.6g, 2.9g + 1.5g Crystalline Powder 20.5 g Sachet Aluminum printed foil sachet 24 Months RENE INDUSTRIES LTD, Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda UGANDA RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-05-06 2029-05-05
35 Rwanda FDA-HMP-MA-1837 REVOKE -72 Levonorgestrel 750mcg Tablets 1x 2Tablets PVC-PVdC/AUMINIUM BLISTER 36 Months MYLAN LABORATORIES LIMITED Plot No. 20 &.21, Pharmez, Sarkhej - Bavla, National Highway No. 08A, Near Viltage Matoda, TalSanand, Dist.-Ahmedabad,382213. Gujarar State – India INDIA MYLAN LABORATORIES LIMITED PYRAMID PHARMA LTD 2024-08-17 2029-08-16
36 Rwanda FDA-HMP-MA-0395 REXE-DINE ANTISEPTIC MOUTH WASH Povidone Iodine 1% w/v 1% w/v Solution 100ml Bottle Amber colored PET bottles and aluminium closure 36 Months UNIVERSAL CORPORATION LIMITED, P.O. BOX 1748-00902, KIKUYU, KENYA KENYA UNIVERSAL CORPORATION LIMITED SUN ENTERPRISES LTD 2023-08-24 2028-08-23
37 Rwanda FDA-HMP-MA-1593 REZEPINE TABLETS Carbamazepine BP 200 mg Tablets 10 x 10’s or 1000 tablets Aluminium/PVC blister strip or polythene bag in HDPE container 36 Months RENE INDUSTRIES LTD Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda. Uganda Rene Industries Ltd Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16
38 Rwanda FDA-HMP-MA-1579 REZN 20 TABLETS Zinc sulfate monohydrate BP equivalent to elemental Zinc 20 mg Tablets 10 Tablets Blister strip 24 Months RENE INDUSTRIES LTD Plot No 680, P.O. BOX 6034, Kamuli, Kireka, Kampala UGANDA RENE INDUSTRIES LTD RENE PHARMACY 2024-08-17 2029-08-16
39 Rwanda FDA-HMP-MA-1505 RHEUMAC GEL Diclofenac Diethylamine equivalent to 1%w/w Diclofenac Sodium BP 1%w/w Topical Gel 20g Tube Tubes and contained in a unit box with literature insert 36 Months LABORATORY & ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LIMITED Depot Pharmaceutique Le Medical 2024-07-27 2029-07-26
40 Rwanda FDA-HMP-MA-0752 RHEUMAC TABLETS Diclofenac Sodium 50mg 50mg Film coated tablets 10x10’s Tablets Aluminium foil blisters of 10x10’s in a unit box container with literature insert 36 Months LABORATORY & ALLIED LTD, Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD, KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2023-12-30 2028-12-29
41 Rwanda FDA-HBP-MA-0119 RHOCLONE 300MCG Anti Rho-D Immunoglobulin Injection (Monoclonal) 300mcg Liquid for Injection 2ml Vial USP Type I Glass vial 24 Months BHARAT SERUMS AND VACCINES LIMITED, Plot No. K-27, Anand Nagar, Additional M.I.D.C. Ambernath (East), India INDIA BHARAT SERUMS & VACCINES LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LIMITED 2024-04-21 2029-04-20
42 Rwanda FDA-HMP-MA-0377 RIDMAL 40/320 Dihydroartemisinin 40mg and Piperaquine Phosphate 320mg Tablets 40mg and 320mg Film coated tablets 3, 6, 9, & 12 tablets BLISTERS 24 Months AJANTA PHARMA LIMITED, B-4/5/6, M.I.D.C. Area, Paithan, Dist. Aurangabad, Maharashtra, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-07-08 2028-07-07
43 Rwanda FDA-HMP-MA-1707 RIFAMPIN AND ISONIAZID DISPERSIBLE TABLETS 75/50MG (10X10 TAB, 2BOXES AND 18X5 2 BOXES) RIFAMPIN AND ISONIAZID DISPERSIBLE TABLETS 75/50MG 75/50MG TABLETS 1. 1 x 5 T, 2. 1 x 10 T, 3. 3 x 28 T, 4. 14 x 6 T Alu Alu Blister, Alu Alu Strip 24 month Lupin Ltd A-28/1, MIDC Area, Chikalthana, Aurangabad, Aurangabad-431210 India LUPIN Ltd3rd floor, Kalpataru InspireOff Western Express Highway, Santacruz (East)Mumbai-400 055, India.Telephone:91-22-66402323www.lupinworld.com AIVEEN RWANDA LTD 2024-08-17 2029-08-16
44 Rwanda FDA-HMP-MA-2142 RIFAMPIN, ISONIAZID AND PYRAZINAMIDE DISPERSIBLE TABLETS RIFAMPIN, ISONIAZID AND PYRAZINAMIDE 75mg / 50mg / 150mg Dispersible Tablets 3 x 28’s tablets and 10 x 6’s tablets Strip pack Plain Aluminium/Aluminium strips 24 Months LUPIN LIMITED A-28/1, MIDC Area, Chikalthana, Aurangabad, Aurangabad-431210 INDIA LUPIN LIMITED AIVEEN (R) LTD 2024-10-18 2029-10-17
45 Rwanda FDA-HMP-MA-2261 RIFAPENTINE Rifapentine Dispersible Tablets 150 mg Dispersible Tablets 10x10 Tablets PVC/PVDC Blisters 24 Months LUPIN LIMITED A-28/1, MIDC Area, Chikalthana, Aurangabad, Aurangabad-431210, INDIA INDIA LUPIN LIMITED AIVEEN (R) LTD 2025-02-04 2030-02-04
46 Rwanda FDA-HMP-MA-1285 RIFAPENTINE AND ISONIAZID 300MG/300MG TABLETS Rifapentine 300mg and Isoniazid 300mg 300 mg/300 mg Film coated tablets 10’s, 12’s &14’s Tablets Aluminium Strip/Blister 24 Months LUPIN LIMITED, A-28/1, MIDC Area, Chikalthana, Aurangabad, Aurangabad-431210, India INDIA LUPIN LIMITED AIVEEN RWANDA LIMITED 2024-05-07 2029-05-06
47 Rwanda FDA-HMP-MA-1447 RIFAPENTINE TABLETS 300 MG Rifapentine 300mg 300mg Film coated Tablets 3x10 Tablets Strip pack of 10 Tablets such 3 Strips in a carton along with pack insert 24 Months MACLEODS PHARMACEUTICALS LIMITED, Oxalis Labs, Village Theda, P.O Lodhimajra, Baddi, Dist. Solan, Himachal Pradesh, 174101, India INDIA MACLEODS PHARMACEUTICALS LIMITED AIVEEN RWANDA LTD 2024-07-20 2029-07-19
48 Rwanda FDA-HBP-MA-0108 RILAST 100 Rituximab 100mg/10 mL 100mg/10 mL Concentrate for solution for injection 10 ml vial Clear glass vial neutral (USP Type 1) with butyl rubber stopper 30 Months HETERO BIOPHARMA LIMITED; Sy. No. 458 (part), TSIICFormulation SEZ, Polepally (Village), Jadcherla (Mandal), Mahaboobnagar (District) – 509 301, Telangana State, India INDIA M/S Hetero Biopharma Limited, India Vine Pharma LimiteD 2024-01-05 2029-01-04
49 Rwanda FDA-HBP-MA-0107 RILAST 500 Rituximab 500mg/50 mL 500mg/50 mL Concentrate for solution for injection 50 ml vial Clear glass vial neutral (USP Type 1) with butyl rubber stopper 30 Months HETERO BIOPHARMA LIMITED; Sy. No. 458 (part), TSIICFormulation SEZ, Polepally (Village), Jadcherla (Mandal), Mahaboobnagar (District) – 509 301, Telangana State, India INDIA M/S Hetero Biopharma Limited, India Vine Pharma LimiteD 2024-01-05 2029-01-04
50 Rwanda FDA-HMP-MA-1325 RINACET Cetirizine hydrochloride 10mg 10mg Film coated tablets 2x5x10 tablets PVC/Aluminium foil blister pack per unit box 36 Months DAWA LIMITED, Plot No.7879/8, Baba Dogo Road, Ruaraka Nairobi, Kenya KENYA DAWA LIMITED, KENYA SUN ENTERPRISES LTD 2024-05-18 2029-05-17
51 Rwanda FDA-HMP-MA-0418 RINALIN SYRUP Chlorpheniramine maleate, 2mg/5ml 2mg/5ml Syrup 60 ml and 100 ml Bottles Amber Glass Bottles, ROPP CAPS 25 mm Measuring Cup 10ml (25mm) 36 Months REGAL PHARMACEUTICALS LTD, 7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD, KENYA. ABACUS PHARMA (A) LTD 2023-09-06 2028-09-05
52 Rwanda FDA-HMP-MA-1922 RINOGRIP Paracetamol BP, Pheniramine Maleate BP and Ascorbic Acid 0.025g, 0.500g, 0.200g GRANULES 10 Sachets Sachet, printed polyester foil. 24 Months Bliss GVS Pharma Limited Plot 10, 11A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. -Palghar, Thane – 401404 , India India IMEX PHARMA, Maurice Mediasol Pharmaceutical Depot Ltd 2024-08-17 2029-08-16
53 Rwanda FDA-HMP-MA-1939 RIPAXIL 750 Cefuroxime for Injection USP 750MG Powder for Injection 10ml Vial Flint glass vial USP Type III 24 Months Inject Care Parenterals Pvt.Ltd. Plot No. 130, Silvassa Road, G.I.D.C., Vapi, Dist: Valsad, Gujarat State, India INDIA IMEX PHARMA Mediasol Pharmaceutical Depot Ltd 2024-08-17 2029-08-16
54 Rwanda FDA-HMP-MA-2096 RISDONE-2 RISPERIDONE 2MG TABLETS Alu PVC blister of 10 Tablets Alu-PVC Blisters pack 36 Months INTAS PHARMACEUTICALS LIMITED Camp Road, Selaqui, Dehradun, Uttarakhand, India. India INTAS PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17
55 Rwanda FDA-HBP-MA-0023 RITUXIMAB (RIXIMYO) Rituximab, 100mg/10ml 100mg/10ml Solution for infusion 2 or 3 vials of 10ml Clear Type I glass vials with butyl rubber stopper 36 Months LEK PHARMACEUTICALS D.D. & Sandoz GmbH Ljubljana Verovskova 57 1526 Ljubljana, Slovenia and Batch release by Sandoz GmbH Schaftenau Biochemiestrasse 10 6336 Langkampfen, Austria AUSTRIA SANDOZ PHARMACEUTICALS D.D. SURGIPHARM (RWANDA) LTD 2023-07-08 2028-07-07
56 Rwanda FDA-HBP-MA-0024 Rituximab (Riximyo) Rituximab, 500mg/ 50ml 500mg/ 50ml Solution for infusion 1 or 2 vials of 50ml Clear Type I glass vials with butyl rubber stopper 36 Months LEK PHARMACEUTICALS D.D. & Sandoz GmbH Ljubljana Verovskova 57 1526 Ljubljana, Slovenia and Batch release by Sandoz GmbH Schaftenau Biochemiestrasse 10 6336 Langkampfen, Austria AUSTRIA SANDOZ PHARMACEUTICALS D.D. SURGIPHARM (RWANDA) LTD 2023-07-08 2028-07-07
57 Rwanda FDA-HMP-MA-1386 RIVAMAC 10 Rivaroxaban 10 mg 10 mg Film Coated Tablets 4x7 Tablets Alu/white opaque PVC/PE/PVdC blisters packed in a carton along with pack insert 24 months MACLEODS PHARMACEUTICALS LIMITED, Block No.: 2 Village Theda, P.O. Lodhi Majra, Tehsil Baddi, Dist.: Solan, Himachal Pradesh, 174101, India INDIA MACLEODS PHARMACEUTICALS LIMITED AIVEEN RWANDA LIMITED 2024-05-18 2029-05-17
58 Rwanda FDA-HMP-MA-1387 RIVAMAC 20 Rivaroxaban 20 mg 20 mg Film Coated Tablets 4x7 Tablets Alu/white opaque PVC/PE/PVdC blisters packed in a carton along with pack insert 24 months MACLEODS PHARMACEUTICALS LIMITED, Block No.: 2 Village Theda, P.O. Lodhi Majra, Tehsil Baddi, Dist.: Solan, Himachal Pradesh, 174101, India INDIA MACLEODS PHARMACEUTICALS LIMITED AIVEEN RWANDA LIMITED 2024-05-18 2029-05-17
59 Rwanda FDA-HMP-MA-0542 RL Sodium lactate B.P 0.320% w/v, Sodium chloride B.P. 0.600 % w/v, Potassium chloride B.P 0.040 % w/v, Calcium chloride dehydrate B.P. 0.027 % w/v 0.320% w/v, 0.600 % w/v, 0.040 % w/v, 0.027 % w/v Solution for infusion 500ml/250ml, bottles LDPE bottles 36 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12
60 Rwanda FDA-HMP-MA-0201 RL Sodium Lactate solution BP Eq. to Sodium Lactate 0.32% w/v Sodium Chloride BP 0.60% w/v Potassium Chloride BP 0.04% w/v Calcium Chloride Dihydrate BP 0.027% w/v Water for Injections BP q.s. 0.32% w/v 0.60% w/v 0.04% w/v 0.027% w/v Intravenous infusion 1x500ml Bottle LDPE Bottle 36 Months AXA PARENTERALS LIMITED Plot No 936, 937& 939 Vill. Kishanpur, Jamalpur, Roorkee-247667 Distt. Haridwar (Uttarakhand), India. INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-01-25 2028-01-24
61 Rwanda FDA-HMP-MA- 1337 RL-500ML Sodium lactate 0.320% w/v, Sodium chloride 0.600 % w/v, Potassium chloride 0.040 % w/v, Calcium chloride 0.027 % w/v 0.320% w/v, 0.600 % w/v, 0.040 % w/v, 0.027 % w/v Solution for Intravenous Infusion 500 ml bottle LDPE bottle 60 Months AMANTA HEALTHCARE LIMITED Plot no: 876, N.H. No: 8, Hariyala, Kheda-387411, Gujarat, India INDIA AMANTA HEALTHCARE LIMITED, INDIA SUN ENTERPRISES LTD 2024-05-18 2029-05-17
62 Rwanda FDA-HMP-MA-1682 ROCMALINE, oral solution, ampoule L (+) arginine anhydrous basis and DL malic acid 413 mg of L (+) arginine anhydrous basis and 1500 mg of DL malic acid Oral solution 1x 20 ampoules yellow glass ampoules 36 months Biocodex Maroc Biocodex Maroc, Technopole-Aéroport Mohamed VBP126 Niuaceur, Casablanca, Maroc MAROC Frilab 17, rue des Pierres du Niton 1207 Genève – Suisse UBIPHARMA RWANDA LTD 2024-08-17 2029-08-16
63 Rwanda FDA-HMP-MA-2278 ROLINOZ 10MG Cetirizine dihydrochloride 10MG FILM COATED TABLETS 1x10 Tablets Alu-OVC blister 36 Months WORLD MEDICINE ILAC SAN. VE TIC.A.S 15 Temmuz Mah. Cami Yolu Cad. No:50, Günesli, Bagcilar, Istanbul, TURKEY TURKEY WORLD MEDICINE ILAC SAN. VE TIC.A.S GOODMAN INTERNATIONAL ® LTD 2025-05-12 2030-05-11
64 Rwanda FDA-HMP-MA-2020 ROLINOZ ORAL DROPS CETIRIZINE 10MG/ML ORAL DROPS 20ml Bottle 36 Months World Medicine ?laç San. ve Tic. A.?. 15 Temmuz Mah. Camiyolu Cad. No:50, K:1B-Zemin-4-5-6 Güne?li – Ba?c?lar, ?stanbul Turkey World Medicine ?laç San. ve Tic. A.? Goodman International LTD (R) 2024-08-17 2029-08-16
65 Rwanda FDA-HMP-MA-0442 ROSUCHOL 10MG Rosuvastatin 10mg 10mg Film coated tablets 3 x 10 tablets ALU/PVC Blisters 24 Months AJANTA PHARMA LIMITED, B-4-5-6, MIDC Industrial Area Paithan, Aurangabad, 431148, Maharashtra state, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23
66 Rwanda FDA-HMP-MA-0179 ROSUCHOL 20 Rosuvastatin 20mg 20mg Film coated tablets 3X10 Tablets Alu/alu blister pack, such 3 blisters are packed in a carton along with pack insert. 24 Months AJANTA PHARMA LIMITED, B-4-5-6, MIDC Industrial area paithan, Aurangabad, 431148, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2022-12-14 2027-12-13
67 Rwanda FDA-HMP-MA-0151 ROSUMAC 10 Rosuvastatin Calcium Ph. Eur 10mg 10mg Film-coated tablets 4X7 Tablets Alu/Alu Cold Forming Blister Packs 36 Months MACLEODS PHARMACEUTICALS LIMITED, Block N-2, Village: Theda, Post Office: Lodhimajra, Tehsil Baddi, Dist: Solan, Himachal Pradesh – 174 101, India INDIA MACLEODS PHARMACEUTICALS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2022-12-21 2027-12-20
68 Rwanda FDA-HMP-MA-0150 ROSUMAC 20 Rosuvastatin Calcium Ph. Eur 20mg 20mg Film-coated tablets 4X7 Tablets Alu/Alu Cold Forming Blister Packs 36 Months MACLEODS PHARMACEUTICALS LIMITED, Block N-2, Village: Theda, Post Office: Lodhimajra, Tehsil Baddi, Dist: Solan, Himachal Pradesh – 174 101, India INDIA MACLEODS PHARMACEUTICALS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2022-12-21 2027-12-20
69 Rwanda FDA-HBP-MA-0129 ROTARIX Human rotavirus, live attenuated vaccine, 1 dose (1.5 ml) contains: Human rotavirus RIX4414 strain (live, attenuated) not less than 106.0 CCID50 1 dose (1.5 ml) contains: Human rotavirus RIX4414 strain (live, attenuated) not less than 106.0 CCID50 Oral suspension 3 ml tube Polyethylene tubes that are assembled with a polypropylene cap to protect the membrane of the tube which has to be perforated, before use, with the help of the spike located on the top of the cap 36 Months GLAXOSMITHKLINE BIOLOGICALS, Parc de la Noire Epine, Rue Fleming, 20, 1300 Wavre-Belgium BELGIUM GLAXOSMITHKLINE PHARMACEUTICAL KENYA LIMITED KIPHARMA LTD 2024-05-18 2029-05-17
70 RWANDA-FDA25/HM/0162/0033 ROTASIIL-Liquid, Rotavirus Vaccine, Live Attenuated (Oral) (Liquid) Live Attenuated Rotavirus Vaccine (Oral) Serotypes G1, G2, G3, G4 and G9 1 DOSE, 2 DOSE of 2ml Oral solution 2ml-1 dose or 4 ml - 2 doses of 1’s and of 50’s 24 Months SERUM INSTITUTE OF INDIA PVT. LTD 212/2, HADAPSAR, Pune -411028, India India Serum Institute of India Pvt. Ltd. SUN ENTERPRISES LTD 2025-10-16 2030-10-15
71 Rwanda FDA-HMP-MA-1185 RUBEM CREAM Methyl Nicotinate 1%w/w, Capsicum Oleoresin0.1%w/w, Methyl Salicylate 5% w/w 1%w/w, 0.1%w/w, 5% w/w Cream 25g tube Printed aluminum collapsible tube filled with a cap, packed in a unit carton. 36 Months REGAL PHARMACEUTICALS LTD, Plot No:7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi-Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2024-05-06 2029-05-05