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- 1372 B-TONE Ferric Ammonium Citrate BP 43mg, Cyanocobalamin (Vit. B12) 50mcg, Pyridoxine Hydrochloride BP 1.5 mg, Folic Acid BP 1.5 mg, Zinc Sulphate BP 2.33 mg (Eq. to 43 mg of Elemental Iron), 50mcg , 1.5 mg, 1.5 mg, 2.33 mg Syrup 200 ml Glass bottle Amber Glass Heam up bottle 24 Months SANGEETA PHARMA, Plot No-A-35, MIDC-Malegaon, Sinnar Nashik-422103 Maharashtra., India INDIA SANGEETA PHARMA, INDIA SUN ENTERPRISES LTD 2024-05-18 2029-05-17
2 RWANDA-FDA24/HM/0688/0028 BABY GRIPE WATER Sodium Bicarbonate BP; Sodium Citrate BP; Anise Oil BP; Dill Oil BP; Strong Ginger Tincture BP; and Sucrose BP 1.2%; 0.5%; 0.12%; 0.058%; 0.5% and 20.0% per 5ml Oral syrup 36 Months Hebei Huachen Pharmaceutical Group CO., LTD China Laboratory & Allied Ltd Depot Pharmaceutique Le Medical 2025-10-16 2030-10-15
3 Rwanda FDA-HMP-MA-1906 BACTOCLAV DRY SYRUP AMOXICillin 100mg+Potassium |Clavuranate 12.5mg/ 100/12.5 MG SYRUP 1x100 ml amber color glass bottle 24 months MICRO LABS LIMITED MICRO LABS LIMITED. No. 16, Veerasandra Industrial Area, Bangalore-560100. INDIA. INDIA MICRO LABS LIMITED 31, Race Course Road, Bangalore 560 001, Country: India Telephone: 080-22370451-57 Telefax: 080-22370463 Email: global@microlabs.in Phillips Pharmaceuticals (Rwanda) Ltd. 2024-08-17 2029-08-16
4 Rwanda FDA-HMP-MA-0833 BACTOCLAV-625 Amoxicillin 500mg and Potassium clavulanate tablets 125mg 500mg and 125mg Capsules 2 × 10’s Capsules Alu/Alu blister pack 36 Months MICRO LABS LIMITED; Plot no.16&24, veerasandra industrial area. Bangalore-560100, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-09 2029-02-08
5 Rwanda FDA-HMP-MA-0697 BACTOX 125MG/5ML Amoxicillin Trihydrate 125 mg/5ml 125 mg/5ml Powder for oral suspension 60 ml Bottle Amber glass bottles of 60 ml with screw closure and sealing membrane and with a measuring spoon graduated at 2.5 ml and 5 ml 36 Months SANDOZ GmbH, KUNDL, Biochemistrasse 10, A- 6250-Kundl, Austria AUSTRIA LABORATOIRE INNOTECH INTERNATIONAL, FRANCE MEDIASOL PHARMACEUTICAL DEPOT LTD 2023-12-30 2028-12-29
6 Rwanda FDA-HMP-MA-0453 BACTOX 250MG/5ML Amoxicillin Trihydrate 250mg/5ml 250mg/5ml Powder for Suspension 60 ml bottle Amber glass bottle with a graduated measuring spoon (polypropylene) at 2.5 ml and 5 ml in Box 24 months SANDOZ GmbH, and INNOTHERA CHOUZY, Biochemistrasse 10-6250-Kundl, AUSTRIA and Rue Rene Chanterau, Chouzy-sur-Cisse, 41150 Valloiere-sur-Cisse France AUSTRIA and FRANCE LABORATOIRE INNOTECH INTERNATIONAL, FRANCE MEDIASOL PHARMACEUTICAL DEPOT LTD 2023-08-24 2028-08-23
7 Rwanda FDA-HMP-MA-0681 BACTOX 500 Amoxicillin Trihydrate 500 mg 500 mg Capsules 12 capsules Alu/PVC/PVDC blister pack 24 Months INNOTHERA CHOUZY, Rue Rene Chanterau, Chouzy-sur-Cisse, 41150 Valloiere-sur-Cisse France FRANCE LABORATOIRE INNOTECH INTERNATIONAL DEPOT PHARMACEUTIQUE LE MEDICAL 2023-12-10 2028-12-09
8 Rwanda FDA-HMP-MA-0698 BACTOX 500MG/5ML Amoxicillin Trihydrate 500 mg/5ml 500 mg/5ml Powder for oral suspension 60 ml Bottle Amber glass bottles of 60 ml with screw closure and sealing membrane and with a measuring spoon graduated at 2.5 ml and 5 ml 36 Months SANDOZ GmbH, KUNDL, Biochemistrasse 10, A- 6250-Kundl, Austria AUSTRIA LABORATOIRE INNOTECH INTERNATIONAL, FRANCE MEDIASOL PHARMACEUTICAL DEPOT LTD 2023-12-30 2028-12-29
9 RWANDA-FDA24/HM/0486/0014 BACTROKANT Mupirocin BP 2% w/w Ointment 24 Months BILLS BIOTECH PVT. LTD India S KANT HEALTHCARE LTD ABACUS PHARMA (A) Ltd 2026-02-05 2031-02-04
10 Rwanda FDA-HMP-MA-1251 BALFEN Ibuprofen 200 mg 200 mg Film Coated Tablets 10 Tablets Aluminium/PVC blister 36 Months BAL PHARMA LIMITED, 21 & 22 - Bommasandra Industrial Area Bangalore, India INDIA BAL PHARMA LIMITED, INDIA SUN ENTERPRISES LIMITED 2024-05-06 2029-05-05
11 Rwanda FDA-HMP-MA-1231 BALFEN. Ibuprofen BP 400 mg 400 mg Film Coated Tablets 10x10 Tablets Alu-PVC blister pack. 36 Months BAL PHARMA LIMITED, 21 & 22 - Bommasandra Industrial Area, Bangalore - 560099 Karnataka, India. INDIA BAL PHARMA LIMITED. SUN ENTERPRISES LIMITED 2024-05-06 2029-05-05
12 Rwanda FDA-HMP-MA-1252 BALTRIM Sulfamethoxazole 400mg and Trimethoprim 80mg 400mg and 80mg Uncoated Tablets 10 Tablets Aluminium/PVC blister 48 Months BAL PHARMA LIMITED, 21 & 22 - Bommasandra Industrial Area Bangalore, India INDIA BAL PHARMA LIMITED, INDIA SUN ENTERPRISES LIMITED 2024-05-06 2029-05-05
13 Rwanda FDA-HMP-MA-1321 BALTRIM FORTE Trimethoprim 160mg and Sulfamethoxazole 800mg 160mg 800mg Uncoated Tablets 10 ×10 tablets Aluminium/PVC blister strip packed in a unit box with pack insert 48 Months BAL PHARMA LIMITED, 21 & 22 - Bommasandra Industrial Area Bangalore - 560099 Karnataka, India INDIA BAL PHARMA LIMITED, INDIA SUN ENTERPRISES LTD 2024-05-18 2029-05-17
14 Rwanda FDA-HMP-MA-1364 BAROLE 20 Rabeprazole Sodium Capsules 20mg 20mg Enteric Coated Capsules 3x10 and 10x10 Capsules Strips packed in a box 24 Months INVENTIA HEALTHCARE LIMITED, F1-F1/1 Additional Ambernath M.I.D.C., Ambernath (East), Thane 421506, Maharashtra state, India INDIA MEGA LIFESCIENCES (AUSTRALIA) PTY LTD ABACUS PHARMA (A) LTD 2024-05-18 2029-05-17
15 Rwanda FDA-HMP-MA-1225 BAROLE INJECTION Rabeprazole sodium 20mg 20 mg Lyophilized Powder for Injection 1 Vial Type I or Type III and amber colour borosilicate glass 24 Months NAPROD LIFE SCIENCES PVT. LTD. G-17/1, M.I.D.C. Tarapur Industrial Area, Boisar, Dist – Thane – 401506, India INDIA MEGA LIFESCIENCES PUBLIC COMPANY LIMITED, THAILAND ABACUS PHARMA (A) LTD 2024-05-06 2029-05-05
16 Rwanda FDA-HBP-MA-003 BCG VACCINE (FREEZE-DRIED) LIVE ATTENUATED STRAINS OF MYCOBACTERIUM BOVIS 2 X 105 AND 8 X 105 C.F.U. LYOPHILIZED INJECTION 50X1ML VIAL HYDROLYTIC CLASS-I GLASS OF 4 ML + DILUENTS. 24 Months SERUM INSTITUTE OF INDIA PVT. LTD 212/2, HADAPSAR, Pune -411028, India INDIA SERUM INSTITUTE OF INDIA PVT. LTD SUN ENTERPRISES LTD 2021-09-08 2026-09-08
17 Rwanda FDA-HMP-MA-1659 BECLOMIN 250 HFA INHALER BECLOMETHASONE DIPROPIONATE 250 ?g/ Puff Pressurized inhalation solution 19 ml canister Aluminium Canister sealed with Aluminium Metering Valve 24 Months SQUARE PHARMACEUTICAL Ltd Dhaka Unit Kaliakoir, Gazipur -1750, Bangladesh Bangladesh SQUARE PHARMACEUTICAL Ltd DOLIPHARM Limited 2024-08-17 2029-08-16
18 Rwanda FDA-HMP-MA-0691 BECOACTIN SYRUP 200ML Cyproheptadine Hydrochloride USP/ Thiamine Hydrochloride BP/Riboflavin BP/ Pyridoxine Hydrochloride BP/ Niacinamide BP (Nicotinamide)/ Cyanocobalamin BP, (2 mg/1 mg/ 0.5 mg/0.5 mg/10 mg/1 mcg) 2 mg/1 mg/ 0.5 mg/0.5 mg/10 mg/1 mcg Syrup 200ml Bottle PET Bottle of 200ml in a printed carton 24 Months MEYER ORGANICS PVT. LTD, A-177, Road No. 16- Z, Wagle Industrial Estate Thane (W) – 400 604 (India).10D, 2nd phase, Peenya Industrial Area Bangalore – 560058 B INDIA MEYER ORGANICS PVT LTD SUN ENTERPRISES LTD 2023-12-30 2028-12-29
19 Rwanda FDA-HMP-MA-0737 BECOACTIN TABLET Cyproheptadine Hydrochloride U.S.P. 4 mg (anhydrous), Vitamin B1 (as Thiamine Nitrate B.P.) 2 mg, Vitamin B2 (as Riboflavin B.P.) 0.5 mg, Vitamin B6 (as Pyridoxine Hydrochloride B.P.) 1 mg, Nicotinamide B.P 10 mg, Vitamin B12 1 mcg, Glycine B.P. 40 mg, Elemental Iron (as Ferrous Fumarate B.P.) 8 mg, Elemental Zinc 6 mg (as Zinc Sulphate Monohydrate U.S.P.) 4 mg, 2 mg, 0.5 mg, 1 mg, 10 mg, 1 mcg, 40 mg, 8 mg, 6 mg Sugar coated tablets 3X10’s Tablets Aluminium/PVC blister 24 Months MEYER ORGANICS PRIVATE LIMITED, 10D, 2nd phase, Peenya Industrial Area, Bangalore-560058, India INDIA MEYER ORGANICS PRIVATE LIMITED, INDIA SUN ENTERPRISES LTD 2024-01-05 2029-01-04
20 Rwanda FDA-HMP-MA-2046 BECOREN TABLETS Vitamin B1 Mononitrate, Vitamin B2, Vitamin B6, Niacinamide 0.5mg/ 0.5mg/0.5mg/7.5mg Tablets 10×10 Tablets Aluminium/amber PVC blister strip of 10 tablets and 10 of such blister strips are packed in a unit box with pack insert. 24 Months RENE INDUSTRIES LTD RENE INDUSTRIES LTD. Address: Manufacturers of Pharma Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda. Uganda RENE INDUSTRIES LTD,P.O.Box: 6034,KAMPALA, UGANDA. RENE PHARMACY (R) LTD 2024-09-30 2029-09-29
21 RWANDA-FDA25/HM/0301/0002 Bedaquiline Bedaquiline Fumarate 100 mg Uncoated tablet 188’s 36 Months MSN Labs Private Limited Formulation Division, Unit-II, Survey Nos. 1277, 1319 to 1324, Nandigama (Village & Mandal), Rangareddy District, Telangana 509228, India India MSN Laboratories Private Limited SUN ENTERPRISE Ltd 2026-02-05 2031-02-04
22 Rwanda FDA-HMP-MA-1258 BEDAQUILINE TABLETS 100MG Bedaquiline Fumarate, 100mg 100mg Tablet 4x14 Tablets Alu-Alu Blister 24 Months LUPIN LTD, A-28/1, M.I.D.C. Industrial Area, Chikalthana, Aurangabad-431 210 Maharashtra State, India INDIA LUPIN LTD AIVEEN (R) LTD 2024-05-06 2029-05-05
23 Rwanda FDA-HMP-MA-0045 BEKRACINE-100 Cefixime 100mg Powder For Suspension 60ml HDPE BOTTLE IN A CARTON 24 Months BAROQUE PHARMACEUTICALS PVT LTD 192/2&3, Sokhada-388620, Khamahat, Dist Anand Gujarat-India INDIA BEKRA PHARMA UK LTD MULTIPHAR UBIPHARM-RWANDA LTD 2021-01-18 2026-01-18

Grace Period
24 Rwanda FDA-HMP-MA-2035 BEKRAZOL 200/5 ALBENDAZOLE BP 200MG/5ML SUSPENSION 10ml Amber PET bottle 24 months BAROQUE PHARMACEUTICALS PVT. LTD 192/2&3, SOKHADA-388620, KHAMBHAT, DT:ANAND. (GUJ.), INDIA India Bekra Pharma UK Ltd UBIPHARM-RWANDA LTD 2024-09-30 2029-09-29
25 Rwanda FDA-HMP-MA-2036 BEKRAZOL 400 ALBENDAZOLE 400MG 400MG TABLETS 1*1 ALU-PVC Blister 24 Months BAROQUE PHARMACEUTICALS PVT. LTD 192/2&3, SOKHADA-388620, KHAMBHAT, DT:ANAND. (GUJ.), INDIA INDIA Bekra Pharma UK Ltd UBIPHARM-RWANDA LTD 2024-09-30 2029-09-29
26 Rwanda FDA-HMP-MA-1714 BENDURIC 5MG TABLETS Bendroflumethiazide resepine 5mg Tablets 10x10 Tablets BLISTERS/ALUMINIUM FOIL 36 Months COSMOS LIMITED Rangwe road; off Lunga Lunga road, industrial area, P.O. box 41433, GPO 00100 - Nairobi, Kenya KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16
27 Rwanda FDA-HMP-MA-0874 BENYLIN DRY COUGH. Dextromethorphan Hydrobromide 15mg/5ml. 15mg/5ml Syrup 100ml and 200ml Bottles Amber Glass Bottles closed with a white polypropylene cap with expanded polyethylene liner 24 Months JOHNSON & JOHNSON (PTY) LTD, 241 Main Road, Retreat, 7945, Cape Town, South Africa. SOUTH AFRICA JOHNSON & JOHNSON (PTY) LTD, SOUTH AFRICA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-17 2029-02-16
28 Rwanda FDA-HMP-MA-2029 BENYLIN WITH CODEINE Diphenhydramine Hydrochloride, Ammonium Chloride, Codeine Phosphate 12,5MG/125MG/10MG/5ML SYRUP 100ml Bottle Amber glass bottle, having a white polypropylene cap with expanded polyethylene liner, the bottles are packed in individual paper board cartons 36 Months Johnson & Johnson (Pty) Ltd Johnson & Johnson (Pty) Ltd, 241 Main Road, Retreat, 7945, Cape Town, South Africa South Africa Johnson & Johnson (Pty) Ltd WESSEX PHARMACEUTICALS RWANDA LTD 2024-10-27 2029-10-26
29 Rwanda FDA-HMP-MA-2043 BENZALIN BENZATHINE BENZLPENICILLIN FOR INJECTION 2.4 MUI Injection 50 Vials Vials 36 Months Reyoung Pharmaceutical Co., Ltd No.1 Ruiyang Road, Yiyuan County, Shandong Province, P.R. China Telephone:+86-533-3257875 Telefax:+86-533-3257886 E-Mail: info@reyoung.cn China Farmasino Co., Ltd ABACUS PHARMA (A) LTD 2024-09-30 2029-09-29
30 Rwanda FDA-HMP-MA-0924 BENZATHINE BENZYL PENICILLIN Benzathine Benzyl penicillin 2.4 MIU 2.4 MIU Powder for solution for injection Packs of 50 vials of 12ml Type II Glass Vial, Sealed with Aluminium Cap 36 Months REYOUNG PHARMACEUTICAL CO., Ltd, Workshop 301, No. 1, Ruiyang Road, Yiyuan County, Shandong Province, China CHINA REYOUNG PHARMACEUTICAL CO., LTD SUN ENTERPRISES LTD 2024-02-21 2029-02-20
31 Rwanda FDA-HMP-MA-1488 BENZOSED, 5ML Midazolam BP 1mg/ml 1mg/ml Solution for injection 1 Vial of 5ml Amber vial USP type I with 20 mm bromo butyl rubber stopper and 20mm brown flip off seal 24 Months TROIKAA PHARMACEUTICALS LTD, C-1, Sara Industrial Estate, Selaqui, Dehradun-248197, Uttarakhand, India INDIA TROIKAA PHARMACEUTICALS LTD, INDIA ABACUS PHARMA (A) LTD 2024-07-20 2029-07-19
32 Rwanda FDA-HMP-MA-1110 BESICOR 10 Bisoprolol Fumarate Ph.Eur 10mg 10 mg Film-coated tablets 3x 10 tablets Alu-PVC/Alu blisters packed in a carton box along with pack insert 24 Months AJANTA PHARMA LIMITED, Mirza-Palashbari Road, Village Kokjhar, Kamrup (R), Guwahati, Assam - 781128, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19
33 Rwanda FDA-HMP-MA-1157 BESICOR 5 Bisoprolol Fumarate 5mg 5mg Film coated Tablets 3x 10 Tablets Alu-PVC/PVDC blisters packed in a carton 24 Months AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED, INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-27 2029-04-26
34 RWANDA-FDA24/HM/1083/0045 BETACORT Beclometasone Dipropionate Pressurised inhalation 36 AVIK PHARMACEUTICAL LTD. India GENERIX LABORATORIES PRIVATE LIMITED AIVEEN (R) LTD 2026-03-18 2031-03-17
35 Rwanda FDA-HMP-MA-1420 BETADINE ANTISEPTIC CREAM 5% Povidone Iodine 5% 0.05 Topical Cream 10 g and 20 g Polyethylene Tubes 24 Months G.S. PHARMBUTOR PVT. LTD, B-172, Industrial Area, Behror- 301701, Rajasthan, India INDIA MODI-MUNDIPHARMA PRIVATE LIMITED SURGIPHARM (RWANDA) LIMITED 2024-07-18 2029-07-17
36 Rwanda FDA-HMP-MA-1382 BETADINE GERMICIDE GARGLE 2%-MIN Povidone Iodine 2% 0.02 Solution 50 ml and 100 ml Bottles Amber PET bottles 18 months G.S. PHARMBUTOR PVT. LTD, B-172, Industrial Area, Behror- 301701, Rajasthan, India. INDIA MODI-MUNDIPHARMA PRIVATE LIMITED SURGIPHARM (RWANDA) LTD 2024-05-18 2029-05-17
37 Rwanda FDA-HMP-MA-1365 BETADINE OINTMENT 5% W/W Povidone-Iodine USP 5% w/w 5% w/w Ointment 15 g &125 g Tubes Aluminum Collapsible Tubes 24 Months G.S. PHARMBUTOR PVT. LTD, B-172, Industrial Area, Behror – 301 701, Rajasthan, India INDIA MODI-MUNDIPHARMA PRIVATE LIMITED SURGIPHARM (RWANDA) LTD 2024-05-18 2029-05-17
38 Rwanda FDA-HMP-MA-1381 BETADINE STANDARDISED MICROBICIDAL SOLUTION 10% Povidone-Iodine USP 10% w/v 10% w/v Aqueous Topical Solution. 50 ml & 100 ml Bottles Amber colored PET Bottle of 50 ml & 100 ml, Amber colored HDPE bottle of 500 ml, Amber colored Glass bottle of 50 ml & 100 ml 24 months G.S. PHARMBUTOR PVT. LTD, B-172, Industrial Area, Behror – 301 701, Rajasthan, India. INDIA MODI-MUNDIPHARMA PRIVATE LIMITED SURGIPHARM (RWANDA) LTD 2024-05-18 2029-05-17
39 Rwanda FDA-HMP-MA-1421 BETADINE STANDARDISED MICROBICIDAL SOLUTION 5% Povidone-Iodine USP 5% w/v 5% w/v Aqueous Topical Solution 50 ml & 100 ml and 500 ml bottles Amber PET bottle of 50 ml & 100 ml and Brown HDPE bottle of 500 ml 24 Months G.S. PHARMBUTOR PVT. LTD, B-172, Industrial Area, Behror- 301701, Rajasthan, India INDIA MODI-MUNDIPHARMA PRIVATE LIMITED SURGIPHARM (RWANDA) LIMITED 2024-07-18 2029-07-17
40 Rwanda FDA-HMP-MA-0922 BETADINE SURGICAL SCRUB Povidone-Iodine USP 7.5% w/v (available Iodine 0.75% w/v) 0.75% w/v Viscous liquid for Topical 1 Bottle of 50 ml and 500 ml Amber PET bottle and HDPE Bottle 18 Months G.S. PHARMBUTOR PVT. LTD., B-172, Industrial Area, Behror – 301 701, Rajasthan, India INDIA MODI-MUNDIPHARMA PRIVATE LIMITED SURGIPHARM (RWANDA) LTD 2024-02-21 2029-02-20
41 Rwanda FDA-HMP-MA-0776 BETAPYN TABLETS Paracetamol 450mg, caffeine 50mg, Codeine phosphate 10mg and Doxylamine succinate 5mg 450mg, 50mg, 10mg and 5mg Tablets 18 tablets PVC/Aluminium foil blister packs 24 Months ADCOCK INGRAM LIMITED (INDIA) 49, (C&D) Bommasandra Industrial Area, Anekal Taluk, Bangalore, 560099, Karnataka, India INDIA ADCOCK INGRAM LIMITED, SOUTH AFRICA SURGIPHARM (RWANDA) LTD 2023-12-30 2028-12-29
42 Rwanda FDA-HMP-MA-1224 BETASALIC OINTMENT Betamethasone dipropionate eq. to betamethasone 0.5mg/gm and Salicylic acid 30 mg/gm 0.5mg/gm and 30 mg/gm Ointment 15 g tube LDPE bottle 24 Months ATCO LABORATORIES LIMITED, B?18, S.I.T.E., Karachi ?75700, Karachi. Sindh, Pakistan PAKISTAN ATCO LABORATORIES LIMITED, PAKISTAN M/S AFRI HEALTH CARE LTD 2024-05-06 2029-05-05
43 Rwanda FDA-HMP-MA-0246 BETOPTIC 5% EYE DROPS Betaxolol base (equivalent to 5.6 mg betaxolol hydrochloride) 0.05 Sterile Ophthalmic clear colorless solution 5 ml Bottle Low density polyethylene (LDPE) Bottle & dispensing plug and the closure is made of white polypropylene (PP) 36 Months S.A. ALCON-COUVREUR N.V. Rijksweg 14 B-2870 Puurs, Belgium BELGIUM NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11
44 Rwanda FDA-HMP-MA-0440 BETRIM FORTE Sulfamethoxazole BP 800 mg, Trimethoprim BP 160 mg 800 mg, 160 mg Tablets 10x10 tablets Alu-PVD Blisters packed in carton along with insert 36 Months MILAN LABORATORIES (INDIA) PVT LTD, Plot no. 35/36/63/64/65/67/87, J.C.I.E. Ltd., Kamothe, Panvel, Navi Mumbai, India INDIA MILAN LABORATORIES (INDIA) PVT LTD SIGMA PHARMA RWANDA LIMITED 2023-08-24 2028-08-23
45 Rwanda FDA-HMP-MA-0441 BETRIM-480 (CO-TRIMOXAZOLE TABLETS BP 480MG) Sulfamethoxazole BP 400mg and Trimethoprim BP 80mg 400mg and 80mg Tablets 10x10 tablets Alu-PVD Blisters packed in carton along with insert 36 Months MILAN LABORATORIES (INDIA) PVT LTD, Plot no. 35/36/63/64/65/67/87, J.C.I.E. Ltd., Kamothe, Panvel, Navi Mumbai, India INDIA MILAN LABORATORIES (INDIA) PVT LTD SIGMA PHARMA RWANDA LIMITED 2023-08-24 2028-08-23
46 Rwanda FDA-HBP-MA-005 BEVAAS 100 BEVACIZUMAB 100MG/4ML CONCETRATE FOR SOLUTION FOR INJECTION 4ML VIAL USP TYPE I CLEAR GLASS 24 Months HETERO BIOPHARMA LIMITED Sy. No. 458 (part), TSIIC-Formulation SEZ, Polepally (Village), Jadcherla (Mandal), Mahaboobnagar (Disrtict)-509 301, Telangana State, India INDIA HETERO BIOPHARMA LIMITED BION PHARMA GROUP 2022-07-18 2027-07-17
47 Rwanda FDA-HBP-MA-006 BEVAAS 400 BEVACIZUMAB 400MG/16ML CONCETRATE FOR SOLUTION FOR INJECTION 16ML VIAL USP TYPE I CLEAR GLASS 24 Months HETERO BIOPHARMA LIMITED Sy. No. 458 (part), TSIIC-Formulation SEZ, Polepally (Village), Jadcherla (Mandal), Mahaboobnagar (Disrtict)-509 301, Telangana State, India INDIA HETERO BIOPHARMA LIMITED BION PHARMA GROUP 2022-07-18 2027-07-17
48 RWANDA-FDA25/HM/0538/0037 BEVAMAB 100 Bevacizumab 100 mg/4 ml Solution for Intravenous Infusion 24 Intas Pharmaceutical Ltd. India Intas Pharmaceuticals Limited BION PHARMA GROUP (BPG) Ltd 2026-03-14 2031-03-13
49 RWANDA-FDA25/HM/0542/0041 BEVAMAB 400 Bevacizumab 400mg/16ml IV/ INJECTION 24 Intas Pharmaceutical Ltd. India Intas Pharmaceuticals Limited BION PHARMA GROUP (BPG) Ltd 2026-03-14 2031-03-13
50 Rwanda FDA-HMP-MA-1172 BGMET 500 Metformin Hydrochloride BP 500mg 500mg Film Coated Tablet 10 tablets Aluminium / PVC foil Blister packed in carton along with the product insert 36 Months BLISS GVS PHARMA LIMITED, Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Palghar, District Thane – 401404, India INDIA BLISS GVS PHARMA LIMITED SURYA DEPOT PHARMACY LTD 2024-04-21 2029-04-20
51 Rwanda FDA-HMP-MA-0624 BI-PRETERAX 10/2.5MG Perindopril Arginine 10mg & Indapamide 2.5mg 10mg & 2.5mg Film Coated Tablets 30 Film Coated Tablets POLYPROPYLENE CONTAINER 36 Months SERVIER (IRELAND) INDUSTRIES LTD (SII), Goey Road, Arklow-Co. Wicklow, Ireland IRELAND LES LABORATOIRES SERVIER, FRANCE KIPHARMA LTD 2023-12-10 2028-12-09
52 Rwanda FDA-HMP-MA-0268 BICALUTAMIDE 50 MG Bicalutamide 50 mg 50 mg Film coated Tablet 20,28,30,50,60,84,90,98 or 100 film-coated tablets PVC/Aclar/Aluminium blisters 24 Months SALUTAS PHARMA GmbH Otto-von-Guericke-Allee 1, 39179, Barleben, Germany GERMANY SANDOZ GmbH, KUNDL, Austria. SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11
53 Rwanda FDA-HMP-MA-1794 BICATERO 50 Bicalutamide tablets 50 mg Tablets 30’s HDPE Container & 3 x10’s Tablets in blisters High density polyethylene containers / Blister Pack 36 Months HETERO LABS LIMITED UNIT VI SY.No 410-411,TSIIC FORMULATION SEZ,POLEPALLY VILLAGE, JADCHERLA MANDAL, MAHABOOB NAGAR (DIST)-509301, TELENGANA INDIA HETERO DRUGS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16
54 Rwanda FDA-HMP-MA-1715 BICOLEX ENTERIC COATED TABLETS Bisacodil 5mg Tablets 10x10 Tablets BLISTERS/ALUMINIUM FOIL 36 Months COSMOS LIMITED Rangwe road; off Lunga Lunga road, industrial area, P.O. box 41433, GPO 00100 - Nairobi, Kenya KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16
55 Rwanda FDA-HMP-MA-0530 BIFRIL 30MG Zofenopril calcium 30mg 30mg Film coated tablet 4X7 Tablets The blisters are PVC/PVDC/ALU. Blisters are packed in a carton box 36 Months A. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L., Via Campo di Pile,67100, L’ Aquila, Italy ITALY A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A PRAFIN RWANDA LTD 2023-10-05 2028-10-04
56 Rwanda FDA-HMP-MA-0543 BIFRIL PLUS Zofenopril 30mg calcium/hydrochlorothiazide 12.5mg. 30mg /12.5mg Film coated tablet 7 and 28 Film-Coated tablets Polyvinyl chloride/Polyvinylidene chloride/Aluminium packed in in cardboard box 36 Months A. MENARINI MANUFACTURING LOGISTICS AND SERVICES S.R.L., Via Campo di Pile,67100, L’ Aquila, Italy ITALY A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A PRAFIN RWANDA LTD 2023-10-05 2028-10-04
57 Rwanda FDA-HMP-MA-1761 BILAXTEN Bilastine 20 mg Tablets 2x10 Tablets ALU-ALU BLISTER 60 Months FAES FARMA, S.A. Máximo Aguirre, 14; 48940 Leioa (Vizcaya), SPAIN SPAIN FAES FARMA, S,A. C GOMHS Ltd 2024-08-17 2029-08-16
58 Rwanda FDA-HMP-MA-2034 BIMAT BIMATOPROST 0.03% W/V EYE DROPS 3 mL LDPE vial 24 Months Ciron Drugs & Pharmaceuticals Pvt. Ltd N-118, 118/1, 119, 119/1, 119/2, 113 MIDC, Tarapur, Boisar. Dist: Thane – 401506 Maharashtra State INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16
59 Rwanda FDA-HMP-MA-1829 BINFIN 5 Finasteride 5mg Tablets 15 Tablets PVC BLISTER PACK 36 Months HETERO LABS LIMITED IDA, #22-110, Jeedimetla, Hyderabad – 500 055, Telangana. India. INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16
60 Rwanda FDA-HBP-MA-0105 BINOCRIT 10,000 IU/1 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE Epoetin alfa where it is 10000 IU per 1ml corresponding to 84.0 micrograms per 1mL 10000 IU per 1ml Solution for injection 1 or 6 in pre-filled syringes Pre-filled syringes 24 Months IDT BIOLOGIKA GmbH, Am Pharmapark 06861 DessauRosslau, Germany GERMANY SANDOZ PHARMACEUTICALS D.D., SLOVENIA SURGIPHARM (RWANDA) LTD 2024-01-15 2029-01-14
61 Rwanda FDA-HBP-MA-0109 BINOCRIT 2000IU/1ML Epoetin alfa 2000IU per 1ml 2000IU/1ml Sterile solution for injection f 1 and 6 pre-filled syringes, re-filled syringes, glass type I 24 Months IDT BIOLOGIKA GmbH, Am Pharmapark 06861 Dessau-Rosslau, Germany GERMANY SANDOZ PHARMACEUTICALS D.D., SLOVENIA SURGIPHARM (RWANDA) LTD 2024-01-15 2029-01-14
62 Rwanda FDA-HBP-MA-0104 BINOCRIT 4000IU/0.4ML Epoetin alfa 4000IU per 0.4ml 4000IU per 0.4ml Sterile solution for injection 1 and 6 in pre-filled syringes Glass type I pre-filled syringes 24 Months IDT BIOLOGIKA GmbH, Am Pharma Park 06861 Dessau-Rosslau Germany GERMANY SANDOZ PHARMACEUTICALS D.D. SURGIPHARM (RWANDA) LTD 2023-12-30 2028-12-29
63 Rwanda FDA-HBP-MA-0110 BINOCRIT 8000IU/0.8ML Epoetin alfa 8000IU per 0.8ml 8000IU/0.8ML Solution for injection 6 syringes Pre-filled in type I colorless glass syringes, closed with bromobutyl rubber stoppers which are laminated with a fluorocarbon layer. Such 6 syringes are packed in a carton 24 Months IDT BIOLOGIKA GmbH, Am Pharmapark 06861 DessauRo?lau, Germany GERMANY SANDOZ PHARMACEUTICALS D.D., SLOVENIA SURGIPHARM (RWANDA) LTD 2023-12-30 2028-12-29
64 Rwanda FDA-HMP-MA-1464 Biodox capsules DOXYCYCLINE Hyclate 100mg per capsule Capsules 10 x 10 Capsules PVC and aluminium foil blisters packed in a unit box 36 months BIODEAL LABORATORIES LIMITED Plot No.123, Lunga Lunga P.O Box 32040-00600, Nairobi-Kenya KENYA BIODEAL LABORATORIES LIMITED CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-07-27 2029-07-26
65 Rwanda FDA-HMP-MA-1655 BIOFULVIN GRISEOFULVIN USP 500MG TABLETS 10x10 Tablets PVC 188mm clear, Aluminium foil 185mm 36 Months BIODEAL LABORATORIES LTD Plot No.123, Lunga Lunga P.O Box 32040-00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-08-17 2029-08-16
66 Rwanda FDA-HMP-MA-1508 BIOFULVIN 125MG TABLETS GRISEOFULVIN 125mg TABLETS 10x10 Tablets Alu/PVC blister packed in a unit box with literature insert 36 Months BIODEAL LABORATORIES LTD Plot No.123, Lunga Lunga P.O Box 32040-00600, Nairobi-Kenya. KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-07-27 2029-07-26
67 Rwanda FDA-HMP-MA-1509 BIOFULVIN 250MG TABLETS GRISEOFULVINE 250MG TABLETS 10x10 Tablets Alu/PVC foil blisters packed in a unit box with a literature insert 36 Months BIODEAL LABORATORIES LTD Plot No.123, Lunga Lunga P.O Box 32040-00600, Nairobi-Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-07-27 2029-07-26
68 Rwanda FDA-HMP-MA-0739 BIOMOL Paracetamol BP 500mg 500mg Tablets 10 x 10 Tablets Blister pack of 10 x 10`s in unit boxes 36 Months BIODEAL LABORATORIES LTD, Plot No. 123, Lunga Lunga Road, P.O. Box 32040- 00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICAL SUPPLIES LTD 2024-01-08 2029-01-07
69 Rwanda FDA-HMP-MA-2108 Biophenicol Ear Drops Chloramphenicol 5.0%w/v Ear Drops 10ml Bottle Plastic dropper bottles 36 Months BIODEAL LABORATORIES LTD E-17/3, E-17/4 & E-18, M.I.D.C, Tarapur Boisar, Dist. Palghar-401506 KENYA BIODEAL LABORATORIES LIMITED Capital Pharmaceutical Supplies Ltd 2024-10-18 2029-10-17
70 Rwanda FDA-HMP-MA-2134 BIOTRIM 480MG TABLETS TRIMETHOPRIM AND SULPHAMETHOXAZOLE 80mg / 400mg TABLETS 1000 tablets HDPE jars 36 Months BIODEAL LABORATORIES LTD 123 LUNGA LUNGA ROAD P.O. BOX 32040-00600, NAIROBI, KENYA KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICAL SUPPLIES LTD 2024-10-18 2029-10-17
71 Rwanda FDA-HMP-MA-1608 BIOTRIM DS TABLETS Trimethoprim and Sulphamethoxazole 160 mg/800 mg Tablets 10 x 10 Tablets or 1000 tablets Aluminum foil/blister strip or Polythene bag in HDPE jar 36 Months Biodeal Laboratories Ltd 123 Lunga Lunga road, P.O. Box 32040-00600, Nairobi, Kenya. Kenya Biodeal Laboratories Ltd Capital pharmaceutical supplies Ltd 2024-08-17 2029-08-16
72 Rwanda FDA-HMP-MA-1205 BIOTRIM SUSPENSION Trimethoprim 40 mg, and Sulphamethoxazole 200 mg 40 mg, 200 mg suspension 100 ml and 50 ml PET bottles with caps and in unit boxes. 36 Months BIODEAL LABORATORIES LTD, Lunga Lunga Road, P.O. Box 32040-00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICAL SUPPLIES LTD 2024-05-06 2029-05-05
73 RWANDA-FDA25/HM/0400/0023 BioUcenta Ranibizumab 10mg/ml Solution for Injection one vial of 0.23 ml sterile solution 36 Months Polpharma Biologics S.A Poland Bio Usawa Biotechnology limited Rwanda Medical Supply Ltd 2025-10-16 2030-10-15
74 Rwanda FDA-HMP-MA-0363 BISACODYL 5MG TABLETS Bisacodyl BP, 5mg 5mg Enteric Coated Tablets 10x10’s tablets Alu/PVC blister pack 36 Months LABORATORY & ALLIED LTD, Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa road, P.O. Box 42875 GPO 00100, Nairobi, Kenya. KENYA LABORATORY & ALLIED LTD, KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2023-07-08 2028-07-07
75 Rwanda FDA-HMP-MA-0381 BISOPROLOL Bisoprolol fumurate, 2.5 mg 2.5 mg Film-Coated Tablets 2x15 tablets Tablets Packed in Blisters in single Carton 24 Months Salutas Pharma GmbH, & LEK S.A., Otto-von-Guericke-Allee 139179 Barleben, Germany & 16, Podlipie Str.,95-010 Stryków, Poland GERMANY, POLAND Sandoz GmbH, Kundl, Austria SURGIPHARM (RWANDA) LTD 2023-07-08 2028-07-07
76 Rwanda FDA-HMP-MA-0382 BISOPROLOL Bisoprolol fumurate, 5 mg 5 mg Film-Coated Tablets 4x25 tablets Tablets Packed in Bottles in single Carton 24 Months Salutas Pharma GmbH, & LEK S.A., Otto-von-Guericke-Allee 139179 Barleben, Germany & 16, Podlipie Str.,95-010 Stryków, Poland GERMANY, POLAND Sandoz GmbH, Kundl, Austria SURGIPHARM (RWANDA) LTD 2023-07-08 2028-07-07
77 Rwanda FDA-HMP-MA-0383 BISOPROLOL Bisoprolol fumurate, 10 mg 10 mg Film-Coated Tablets 100 tablets Tablets Packed in Blisters 24 Months Salutas Pharma GmbH, & LEK S.A., Otto-von-Guericke-Allee 139179 Barleben, Germany & 16, Podlipie Str.,95-010 Stryków, Poland GERMANY, POLAND Sandoz GmbH, Kundl, Austria SURGIPHARM (RWANDA) LTD 2023-07-08 2028-07-07
78 Rwanda FDA-HMP-MA-0528 BISPANOL TABLETS Hyoscine Butyl Bromide BP 10mg 10mg Tablets 10 x 10, 100 x 10 Tablets Aluminium foil (152mm). PVC Reel 160mm 48 Months REGAL PHARMACEUTICALS LIMITED, Plot No: 7879/18, Off Baba Dogo Road, Ruaraka, P.O BOX 44421-00100, NAIROBI-KENYA KENYA REGAL PHARMACEUTICALS LTD, KENYA ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12
79 Rwanda FDA-HMP-MA-1578 BLEOCIP Bleomycin Sulfate as sterile, freeze-dried powder for reconstitution 15IU Solution for Injection 5 ml Vial Ply-polyehtylene bags/ Aluminimium foil/aluminium tin 36 Months CIPLA LIMITED GOA Unit V, Plot No. S- 103 to S- 105, S-107 to S-112, L-138, L-147, L-147/1 to L-147/3, L-147-A, Verna Industrial Estate, Verna, Salcette, Goa 403 722 INDIA CIPLA LTD KIPHARMA LTD 2024-08-17 2029-08-16
80 Rwanda FDA-HMP-MA-0510 BLOKIUM 100 mg Tablets Atenolol 100 mg 100 mg Tablets 15 tablets and 30 tablets PVC-PVDC/Aluminium blisters 36 Months INDUSTRIAS FARMACÉUTICAS ALMIRALL, S.A. (IFA), Ctra. Nacional II, km 593 E-08740 Sant Andreu de la Barca Barcelona, Spain SPAIN ALMIRALL, S.A, SPAIN MULTIPHAR-UBIPHARM-RWANDA LTD 2023-09-06 2028-09-05
81 Rwanda FDA-HMP-MA-0465 BLOKIUM 50 MG TABLETS Atenolol 50 mg 50 mg Tablets 30 or 15 tablets PVC-PVDC/Aluminium blisters 36 Months INDUSTRIAS FARMACÉUTICAS ALMIRALL, S.A. (IFA), Ctra. Nacional II, km 593 E-08740 Sant Andreu de la Barca Barcelona, Spain SPAIN ALMIRALL, S.A, SPAIN MULTIPHAR-UBIPHARM-RWANDA LTD 2023-09-06 2028-09-05
82 Rwanda FDA-HMP-MA-1896 BONCARE PLUS METHYLSULFONYLMETHANE/ GLUCOSAMINE SULPHATE POTASSIUM CHLORIDE/ CHONDROITIN SULPHATE SODIUM 50MG/750MG/200MG CAPSULE 3 x 10’s Alu / PVDC Blister 36 months. AUROCHEM LABORATORIES (INDIA) PVT. LTD. At 58, Palghar Taluka, Industrial Co.-op. Estate Ltd. Palghar – 401 404, Tel No.: 0252-552332, 0252-554720 District Thane, Maharashtra, INDIA India AUROCHEM LABORATORIES (I) PVT LTD/INDIAPlot No. 8, Palghar Taluka Industrial Co-Operative Estate Limited, District Palghar, 401404, District Thane, Maharashtra-Indi UBIPHARM-RWANDA LTD 2024-08-17 2029-08-16
83 Rwanda FDA-HMP-MA-2067 BORTERO Bortezomib for Injection 3.5mg Injection 1×21 Vials Clear Tubular Vials 36 Months HETERO LABS LIMITED Hetero Labs Limited, Unit-III Hetero Labs Limited, Unit – VI Sy. No.: 410 - 411, TSIIC Formulation SEZ, Polepally village, Jadcherla Mandal, Mahaboob Nagar (Dist) – 509301, Telangana, India INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-09-30 2029-09-29
84 Rwanda FDA-HBP-MA-0037 BORTEZOMIB NEAPOLIS 3.5MG Bortezomib 3.5mg 3.5mg Solution for injection 10 ml Vial Type I transparent glass vial with a grey bromobutyl stopper diameter 20 mm and aluminium seal with a flip off cap diameter 20 mm 24 Months NEAPOLIS PHARMA, Route de Tunis, Km7-B.P.206, 8000 Nabeul, Tunisia TUNISIA NEAPOLIS PHARMA, TUNISIA KIPHARMA LTD 2023-10-13 2028-10-12
85 Rwanda FDA-HMP-MA-1255 BOSUTINIB PFIZER 100 FILM COATED TABLETS Bosutinib monohydrate 100 mg 100 mg Film Coated Tablets 14 or 15 Tablets PVC/Polychlorotrifluoroethene/PVC blister 48 Months PFIZER MANUFACTURING DEUTSCHLAND GmbH Betriebsstätte Freiburg, Mooswaldallee 1, 79090 Freiburg, Germany. GERMAY PFIZER LABORATORIES LIMITED GILMED LIMITED 2024-05-06 2029-05-05
86 Rwanda FDA-HMP-MA-1101 BOSUTINIB PFIZER 400 MG FILM-COATED TABLETS Bosutinib monohydrate 400 mg 400 mg Film Coated Tablets 28 or 30 Tablets PVC/Polychlorotrifluoroethene/PVC blisters 48 Months Pfizer Manufacturing Deutschland GmbH, Betriebsstätte Freiburg Mooswaldallee 1 79090 Freiburg, Germany GERMANY PFIZER LIMITED, UNITED KINGDOM GILMED LIMITED 2024-04-20 2029-04-19
87 Rwanda FDA-HMP-MA-1480 BOSUTINIB PFIZER 500 MG Bosutinib monohydrate 516.98 mg equivalent to Bosutinib 500 mg 500 mg Film Coated Tablets 27 Tablets PVC/Polychlorotrifluoroethene/PVC blister 48 Months PFIZER MANUFACTURING DEUTSCHLAND GmbH, Betriebsstätte Freiburg Mooswaldallee 1, 79090 Freiburg, Germany GERMANY PFIZER LIMITED, UNITED KINGDOM WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-07-20 2029-07-19
88 Rwanda FDA-HMP-MA-0970 BRAIPORIN SYRUP Sodium Valproate BP, 200mg/ml 200mg/ml Syrup Liquid 100 ml Bottle Amber Coloured PET Bottle 24 Months AKUMS DRUGS & PHARMACEUTICALS PLANT II, Plot No. 22, Sector 6-A, IIE, Sidcul, Ranipur, District: Haridwar, Uttarakhand, India INDIA UNOSOURCE PHARMA LIMITED, INDIA AIVEEN RWANDA LTD. 2024-02-26 2029-02-25
89 Rwanda FDA-HMP-MA-1293 BRAMOL INFUSION Paracetamol, 1000 mg/100ml 1000mg/100 ml Solution for infusion 100ml amber glass USP type II vial Amber glass USP type II vial sealed with rubber stopper 24 Months BROOKES PHARMA (PRIVATE) LIMITED, 58 & 59, Plot 15, Korangi Industrial Area, Karachi, Pakistan PAKISTAN BROOKES PHARMA (PRIVATE) LIMITED SUN ENTERPRISES LTD 2024-05-07 2029-05-06
90 RWANDA-FDA25/HM/0292/0044 BREATH EZY 4 MONTELUKAST SODIUM Chewable tablet 24 MSN LABORATORIES PRIVATE LIMITED India MSN Laboratories Private Limited SUN ENTERPRISES LTD 2026-03-14 2031-03-13
91 RWANDA-FDA25/HM/0299/0043 BREATHEZY CW 5 MONTELUKAST SODIUM Chewable Tablets 24 MSN Laboratories Private Ltd. India MSN Laboratories Private Limited SUN ENTERPRISES LTD 2026-03-14 2031-03-13
92 Rwanda FDA-HMP-MA-1264 BREN-200 Ibuprofen BP 200 mg 200 mg Film Coated Tablets 10 x 10 tablets & 1000 tablets Alu/PVC & HDPE Jar 36 Months KOPRAN LIMITED, Village Savroli, Taluka Khalapur, District Raigad – 410202, India INDIA KOPRAN LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-07 2029-05-06
93 Rwanda FDA-HMP-MA-1188 BREN-400 Ibuprofen BP 400 mg 400 mg Film Coated Tablets 10x10 Tablets & 1000 tablets Alu/PVC Blister and HDPE Jar for 1000 tablets 36 Months KOPRAN LIMITED, Village Savroli Khalapur, Dist-Raigad, Maharashtra, India. INDIA KOPRAN LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05
94 Rwanda FDA-HMP-MA-2271 BRENZAVVY® Bexagliflozin 20 mg Prolonged release Tablets  30 and 90 Tablets HDPE Bottle 60 Months Piramal Healthcare UK Ltd Morpeth UK Whalton Road, Morpeth, Northumberland NE61 3YA, UK United kingdom Bamco Africa FLR Ltd 2025-05-12 2030-05-11
95 Rwanda FDA-HMP-MA-1144 BRINZOX Brinzolamide USP 1.0% w/v 1.0% w/v Eye drops 5 ml Vial LDPE vial packed in a ctorn along with insert 36 Months AJANTA PHARMA LIMITED, Mirza - Palashbhari Road, Vill. – Kokhjar, Kamrup (R), Guwahati, Assam – 781128, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-04-27 2029-04-26
96 Rwanda FDA-HMP-MA-1948 BRINZOX T Brinzolamide USP, Timolol Maleate BP 1% w/v + 0.5%w/v Ophthalmic Suspension 5ml LDPE vial packed with HDPE cap 36 Months Ajanta pharma Limited Mirza-Palashbhari Road, Vill.-Kokhjar, Kamrup (R), Guwahati, Assam-781128 Country: India INDIA Ajanta pharma Limited ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16
97 Rwanda FDA-HMP-MA-1591 BROMOLON Brimonidine Tartrate 0.2% w/v Solution 5 mL Bottle 5 mL LDPE bottle 24 Months M/s. FDC LIMITED B-8, MIDC Industrial area, Waluj, Aurangabad – 431136 Maharashtra India. India Bliss GVS Pharma Limited, India Surya Depot Pharmacy Limited 2024-08-17 2029-08-16
98 Rwanda FDA-HMP-MA-2038 BRONCATHIOL ENFANTS Carbocisteine 2% SYRUP 125 ml Bottle of 125 ml 36 Months LAPHAL INDUSTRIES LAPHAL INDUSTRIES Address: Avenue de Provence - 13190 ALLAUCH FRANCE MELISANA PHARMA KIPHARMA LTD 2024-09-30 2029-09-29
99 Rwanda FDA-HMP-MA-0591 BRONQUIDIAZINA CR ORAL SUSPENSION Trimethoprim 80mg, Sulfamethoxazole 400mg, BromhexineHcl 4mg, Sodium Benzoate 250mg and Tolu Balsam Syrup 325mg/5ml 80mg, 400mg, 4mg, 250mg and 325mg/5ml Oral suspension 150ml Bottle Cylindrical glass (type III) bottle, which is amber, no printed and without imperfections and strange particles inside the bottle. 24 Months FAES FARMA, S.A; Address: Maximo Aguirre 14-48940 Leioa (Biscay), Spain SPAIN FAES FARMA, S.A, SPAIN GOMHS LTD 2023-10-13 2028-10-12
100 Rwanda FDA-HMP-MA-0684 BROZELIN Ambroxol Hydrochloride BP 30mg, Salbutamol BP 2mg, Guaiphenesin BP 50mg and Menthol USP 1mg 30mg, 2mg, 50mg and 1mg Syrup 100ml Bottle Amber colour glass bottle 36 Months M/S THE MADRAS PHARMACEUTICALS, No.137-B, Old Mahabalipuram Road, Karappakkam, Chennai-600 096.Tamil Nadu, India INDIA PRISMA PHARMA FZE, U.A.E PRAFIN (RWANDA) LTD 2023-12-10 2028-12-09
101 Rwanda-FDA-HM-1862 BRUFEN SIROP PED. 100ML IBUPROFEN 100mg/5ml SUSPENSION Brufen Syrup, 100mg/5ml, a liquid oral product Aluminum cap and LDPE liner or Polypropylene cap and LDPE liner. 36 months. AbbVie S.r.l. S.R 148 Pontina km 52 snc 04011 Campoverde di Aprilia (LT) ITALY FAMAR A.V.E ANTHOUSSA PLANT B SUN ENTERPRISES LTD 2024-08-17 2029-08-16
102 Rwanda FDA-HMP-MA-1784 BRUTAFLAM-60 Etoricoxib 60mg Tablets 10 Tablets ALU/PVC BLISTER 24 Months MANKIND PHARMA LTD Unit-II, Village Kishanpura, P.O. Jamniwala Tehsil- Paonta Sahib, District Sirmour -173025 (Himachal Pradesh), India. INDIA MANKIND PHARMA LTD WESSEX PHARMACEUTICALS RWANDA LTD 2024-08-17 2029-08-16
103 Rwanda FDA-HMP-MA-1783 BRUTAFLAM-90 Etoricoxib 90mg Tablets 10 Tablets ALU/PVC BLISTER 24 Months MANKIND PHARMA LTD Unit-II, Village Kishanpura, P.O. Jamniwala Tehsil- Paonta Sahib, District Sirmour -173025 (Himachal Pradesh), India. INDIA MANKIND PHARMA LTD WESSEX PHARMACEUTICALS RWANDA LTD 2024-08-17 2029-08-16
104 Rwanda FDA-HBP-MA- 0019 BSV HUMOG 75 HP Menotrophin BP, 75 I.U 75 I.U Lyophilized injection white powder or cake 2 ml Vial. Each vial is accompanied by an ampoule containing 1ml of chloride injection BP USP Type I, Tubular Flint Vial of 2 ml containing sterile, freeze dried white powder having 75 I.U, activity of each FSH and LH. 36 Months BHARAT SERUMS AND VACCINES LIMITED, Plot No. K-27, K-27 Part and K-27/1, Anand Nagar, Jambivili Village, Additional MIDC, Ambernath (East), Thane 421506, Maharashtra State, India. INDIA BHARAT SERUMS AND VACCINES LIMITED, WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11
105 Rwanda FDA-HMP-MA-1893 BUDECOT 0.5MG BUDESONIDEINHALATION SUSPENTION 0.5MG/2ML 0.5MG TABLETS Carton containing 4 combipack pouch having 5 respules of 2 ml each combipack pouch 24 months. CIPLA LTD. Unit I Plot No. 9 & 10 Indore SEZ Phase II Pithampur, Dist Dhar M.P.- 454 775, INDIA. Country: India Telephone: +91 7292 660070. Telefax: + 91 7292 660497 E-Mail: ashish.zitshi@cipla.com India CIPLA LTD/INDIA Unit l,Plot 9, 10 & 15,Indore Special Economic Zone,Phase-ll, Pithampur, District- Dhar,Madhya Pradesh, India – 454775(Termed as “Cipla Indore” henceforth) KIPHARMA LTD 2024-08-17 2029-08-16
106 Rwanda FDA-HMP-MA-2179 BUNASE 200 BUDESONIDE 200MCG Inhalation 1 canister Aluminium plain Canister 36 Months MACLEODS PHARMACEUTICALS LIMITED Oxalis Labs Village Theda,P.O.Lodhimajra , Tehsil Baddi, Distt .Solan (H.P) India INDIA MACLEODS PHARMACEUTICALS LIMITED AIVEEN (R) LTD 2025-01-09 2030-01-08
107 Rwanda FDA-HMP-MA-2308 BUPI Bupivacaine Hydrochloride 0.5% Solution for injection 1x 10ml Ampoule Amber glass ampoule 24 Months SWISS PARENTERALS LTD 808, 809 & 810, Kerala Industrial Estate, GIDC, Nr. Bavla, Dist: Ahmedabad-382220, Gujarat, India INDIA SWISS PARENTERALS LTD Pharmaceutical and Medical Supplies Society Limited 2025-05-12 2030-05-11
108 RWANDA-FDA24/HM/0180/0046 BUPICAINE PF Bupivacaine Hydrochloride BP 5mg/ml STERILE SOLUTION FOR INJECTION 24 Dishman Carbogen Amcis Limited India THEMIS MEDICARE LIMITED WESSEX PHARMACEUTICALS (RWANDA) Ltd 2026-03-18 2031-03-17
109 Rwanda FDA-HMP-MA-1597 BUPITROY HEAVY Bupivacaine Hydrochloride USP 5 mg/ml Solution for injection 4 ml Ampoules Type-I ampoule 24 Months Troikaa Pharmaceuticals Ltd C-1, Sara Industrial Estate, Selaqui, Dehradun-248197, Uttarakhand, India. India Troikaa Pharmaceuticals Ltd Abacus Pharma (A) Limited 2024-08-17 2029-08-16
110 Rwanda FDA-HMP-MA-1115 BURNEM CREAM Acriflavine BPC 1.32mg 1.32 mg Cream 20 gm tube Aluminium collapsible tube 36 Months NEM LABORATORIES PRIVATE LTD. 133, Krishna indl. estate, navghar, vasai road (e), dist. palghar - 401 210. India INDIA NEM LABORATORIES PRIVATE LTD. RENE PHARMACY (R) LTD 2024-04-20 2029-04-19
111 Rwanda FDA-HMP-MA-1760 BUSCOMAX Hyoscine Butylbromide 10 mg Tablets 10x10 Tablets ALU-ALU BLISTER 36 Months MAXTAR BIO-GENICS K. No. 705, Nalagarh road, Malku Majra, (Baddi), Tehsil Nalagarh, Distt. Solan, Himachal Pradesh - 173205, INDIA INDIA MAXTAR BIO-GENICS SUN ENTERPRISES LTD 2024-08-17 2029-08-16
112 Rwanda FDA-HMP-MA-1793 BUSCOREN 10 MG TAB Hyoscine butyl bromide 10 mg Tablets 10x10 Tablets ALUMINIUM/PVC BLISTER 24 Months RENE INDUSTRIES LTD Plot No 680, P.O. BOX 6034, KAMULI, KIREKA, KAMPALA UGANDA RENE INDUSTRIES LTD RENE PHARMACY (R) LTD 2024-08-17 2029-08-16
113 Rwanda FDA-HMP-MA-1162 BUTO-ASMA INHALER Salbutamol 100 micrograms 100 micrograms Pressurised inhalation 1 Container with 200 inhalations Aluminium container 36 Months LABORATORIO ALDO-UNIÓN, S.L. Baronesa de Malda, 73 08950 Esplugues de Llobregat. Barcelona, Spain SPAIN LABORATORIO ALDO-UNIÓN, S.L. GOMHS LTD 2024-04-20 2029-04-19
114 Rwanda FDA-HMP-MA-0827 BYANNLI® 1000 Paliperidone Palmitate 1000mg 1000mg Prolonged-release suspension for injection 1 Prefilled 5 mL syringe and one thin walled 20-gauge (G)x 1½ inch safety needle one assembled prefilled 5 mL syringe and one thin walled 20-gauge (G)x 1½ inch safety needle a carton 24 Months JANSSEN PHARMACEUTICA NV, Turnhoutseweg 30, B-2340 Beerse, Belgium BELGIUM JANSSEN-CILAG INTERNATIONAL NV KIPHARMA LIMITED 2024-02-17 2029-02-16
115 Rwanda FDA-HMP-MA-0826 BYANNLI® 700 Paliperidone Palmitate 700mg 700mg Prolonged-release suspension for injection 1 Prefilled 5 mL syringe and one thin walled 20-gauge (G)x 1½ inch safety needle one assembled prefilled 5 mL syringe and one thin walled 20-gauge (G)x 1½ inch safety needle a carton 24 Months JANSSEN PHARMACEUTICA NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. BELGIUM JANSSEN-CILAG INTERNATIONAL NV KIPHARMA LIMITED 2024-02-17 2029-02-16