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-0235 I-PILL Levonorgestrel BP/Ph.Eur 1.5mg 1.5mg Uncoated tablets 1 tablet Aluminium foil/ PVC/PE/PVDC blister strip 24 Months CIPLA LTD, Unit VIII.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. INDIA CIPLA LTD, INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11
2 Rwanda FDA-HMP-MA-1295 IBICAR-250 Beclometasone Pressurized anhydrous, Inhalation, 250 mcg 250 mcg Pressurized solution filled inhalation 19 ml canister with 200 metered doses 200 Metered Doses. Actuator (19 ml canister) 24 Months GLENMARK PHARMACEUTICALS LIMITED, At: (Unit III), Village Kishanpura, Baddi – Nalagarh Road, Tehsil Baddi, Distt. Solan, Himachal Pradesh 173 205, India INDIA GLENMARK PHARMACEUTICALS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-07 2029-05-06
3 Rwanda FDA-HMP-MA-2216 IBUCOS 200 IBUPROFEN 200 mg TABLETS 10x10 Tablets ALU-PVC foil blisters 36 Months COSMOS LIMITED Rangwe Road; 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
4 Rwanda FDA-HMP-MA-1493 IBUFLAM 100MG/5ML ORAL SUSPENSION IBUPROFEN BP 100mg/5ml SUSPENSION 60ml and 100ml Bottles Amber coloured glass bottles with caps in a unit carton with a pack insert 36 Months BIODEAL LABORATORIES LTD 123 Lunga Lunga road, P.O. Box 32040-00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-07-27 2029-07-26
5 Rwanda FDA-HMP-MA-1486 IBUFLAM 400MG TABLETS Ibuprofen 400mg 400mg Film Coated Tablets 10 x10 tablets PVC/aluminum foils blisters into a unit box with a 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
6 Rwanda FDA-HMP-MA-0825 IBUGO-400 TABLETS Ibuprofen 400mg 400mg Film coated tablets 500 Tablets JAR PACK 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial, Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-02-17 2029-02-16
7 Rwanda FDA-HMP-MA-2122 IBUKANT 200 F IBUPROFEN TABLETS BP 200 MG Tablets 1000s HDPE container 36 months S Kant HEALTHCARE Ltd Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat India S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17
8 Rwanda FDA-HMP-MA-2121 IBUKANT 400 F IBUPROFEN TABLETS BP 400 mg Tablets 1 x 10 tablets PVC/PVDC Aluminium 36 Months S Kant Healthcare Ltd Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396195, Gujarat India S Kant Healthcare Ltd ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17
9 Rwanda FDA-HMP-MA-0504 IBUMEX 200MG TABLET Ibuprofen 200mg 200mg Tablets 10x10 B/P, 100x10 B/P, 100’s in Blister pack, secondary packaging is carton. 48 Months REGAL PHARMACEUTICALS LIMITED, Plot No. 7879/18, Off Baba Dogo Road, Ruaraka, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2023-10-05 2028-10-04
10 Rwanda FDA-HMP-MA-0507 IBUMEX GEL Ibuprofen BP 5.0% w/w 5.0% w/w Gel 25 g tube Aluminium tubes 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, KENYA ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12
11 Rwanda FDA-HMP-MA-1865 IBUPAR CAPLETS Ibuprofen BP and Paracetamol BP 400mg/325mg TABLET 1x10’s Blister pack in unit boxes 36 months. DAWA limited Plot no. 7879/8, baba dogo road, ruaraka.p.o. box 16633 - 00620,nairobi, kenya.email: admin@dawalimited.com Kenya DAWA limited,plot no. 7879/8, baba dogo road, ruaraka.p.o. box 16633 - 00620,nairobi, kenya.email: admin@dawalimited.com SUN ENTEPRISES LTD 2024-08-17 2029-08-16
12 Rwanda FDA-HMP-MA-1619 IBUPAR SUSPENSION Ibuprofen BP 100mg and Paracetamol BP 120mg 100mg/120mg/5ml Oral suspension 60ml and100ml Bottles AMBER COLOURED PET BOTTLE 36 Months Dawa Limited Dawa Limited. Plot No. 7879/8, Baba Dogo Rd, Ruaraka, P.O. Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16
13 Rwanda FDA-HMP-MA-1836 IBUPLUS Ibuprofen and Paracetamol 400 mg/325 mg Tablets 10 Tablets PVC Blister 36 Months SCOTT-EDIL PHARMACIA LTD 56, EPIP, Phase-I, Jharmajri, Baddi-173 205, (HP), India INDIA SCOTT-EDIL PHARMACIA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16
14 Rwanda FDA-HMP-MA-1779 IBUPROFEN AND PARACETAMOL SUSPENSION Ibuprofen BP & Paracetamol BP 100 MG/125MG Suspension 60 ml bottle Glass Bottles 36 Months AURA LIFECARE PVT. LTD. Survey No 254/ 14/1,Jarod ,Savli Road, P.O. Karachiya, Tal-Savli ,Dist : Vadodara-391520. Gujarat State. AURA LIFECARE PVT. LTD. SUN ENTERPRISES LTD 2024-08-17 2029-08-16
15 Rwanda FDA-HMP-MA-0107 IBUPROFEN DENK 400 Ibuprofen 400mg Film Coated Tablet 20 And 100 Tablets PVC/PVDC-ALU 48 Months DENK PHARMA GmbH & Co. KG Göllstr.l 84529 Tittmoning, Germany GERMANY DENK PHARMA GmbH & Co. KG ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2022-07-18 2027-07-17
16 Rwanda FDA-HMP-MA-1734 IBUPROFEN ORAL SUSPENSION Ibuprofen 100 mg/5ml Suspension 100 mg/5 ml PET BOTTLE AND CARTON WITH AN INSERT 36 Months S KANT HEALTHCARE LTD Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat, India Country: India Telephone: +91-260-6539518 Telefax: +91-260-2430527 E-Mail: regulatory@skant.com INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16
17 Rwanda FDA-HMP-MA-0923 IBUPROFEN TABLETS Ibuprofen BP 400mg 400mg Film Coated Tablets 10x10 Tablets Alu-PVC blister packed in a carton along 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
18 Rwanda FDA-HMP-MA-2150 IBUREN SUSPENSION IBUPROFEN 100MG / 5ML Oral Suspension 60ML Amber glass bottles 24 Months RENE INDUSTRIES LTD PO Box 6034, Plot No.680, Kamuli, Kireka, Kampala, Uganda UGANDA RENE INDUSTRIES LTD Rene Pharmacy (R) Ltd 2024-10-18 2029-10-17
19 Rwanda FDA-HMP-MA-1643 IBUREN TABLETS Ibuprofen BP 200mg Film coated tablets 10x10 Tablets Aluminium/ transparent PVC blister 24 Months RENE INDUSTRIES LTD PO Box 6034, Plot No.680, Kamuli, Kireka, Kampala, Uganda Uganda Rene Industries Ltd Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16
20 Rwanda FDA-HMP-MA-0660 IDEOS Calcium carbonate 500 mg/Cholecalciferol 400 IU 500 mg/ 400 IU Chewable tablets 2 or 4 tubes of 15 tablets Polypropylene tube and polyethylene stopper with silica gel desiccant containing 15 tablets 24 Months INNOTHERA CHOUZY, Rue Rene Chantereau, Chouzy-Sur-Cisse 41150 Valloire-Sur-Cisse, France FRANCE LABORATOIRE INNOTECH INTERNATIONAL DEPOT PHARMACEUTIQUE LE MEDICAL 2023-12-10 2028-12-09
21 Rwanda FDA-HBP-MA-0001 iiCARE BILBERRY EXTRACT, LUTEIN AND BETA-CAROTENE 25mg, 15mg and 5mg Soft Gelatin Capsules 3x10 and 5x10 Capsules ALUMINIUM PVC/PVDC BLISTERS PACKED IN UNIT BOXES ALONG WITH PACK INSERT 24 Months MEGA LIFESCIENCES PUBLIC COMPANY LIMITED 384 MOO 4, SOI 6, BANGPOO INDUSTRIAL ESTATE, PATTANA 3 ROAD, PHRAEKSA, MUEANG, SAMUTPRAKARN 10280 THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2024-09-30 2029-09-29
22 Rwanda FDA-HMP-MA-0850 IMAZOLE-V Clotrimazole 100mg 100mg Pessaries Box/ 7 Pessaries Alu/PVC/PE strip 36 Months BLISS GVS PHARMA LIMITED, Plot No. 10, 11 A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Palghar, - 401404, India. INDIA BLISS GVS PHARMA LIMITED SURYA DEPOT PHARMACY LTD 2024-02-09 2029-02-08
23 Rwanda FDA-HMP-MA-1192 IMMU-C EFFERVESCENT SACHET Echinacea Dry Extract 200mg, Vitamin C 500mg, Zinc Sulphate Monohydrate 38.4 mg 200mg, 500mg, 38.4 mg Deep yellowish free flowing granules 1x 10 sachets Paper, extruded LDPE, aluminum foil, extruded LDPE 36 Months ARAB COMPANY FOR PHARMACEUTICALS & MEDICAL PLANTS (MEPACO-MEDIFOOD), Enshas El Raml, Sharkeiya. P.O Box 324 Heliopolis, Egypt EGYPT ARAB CO. FOR PHARMACEUTICALS & MEDICAL PLANTS (MEPACO-MEDIFOOD) ETS CONTINENTAL 2024-05-06 2029-05-05
24 Rwanda FDA-HBP-MA-0130 IMMUNOREL® Human immunoglobulin 2.5g and 5g per 100 ml 5% intravenous infusion in packs contain human immunoglobulin 2.5g and 5g per 100 ml Intravenous infusion 100ml bottles Glass bottles stoppered with a rubber bung. The bung is covered with a tamper-evident cap. 36 Months RELIANCE LIFE SCIENCES PVT. LTD. Plant 4A & 4B, Dhirubhai Ambani Life Sciences Centre (DALC) R-282, TTC Area of MIDC, Thane Belapur Road Rabale, Navi Mumbai, 400701 India INDIA RELIANCE LIFE SCIENCES PVT. LTD. STAR BIOTECH LIMITED 2024-05-18 2029-05-17
25 Rwanda FDA-HMP-MA-1043 IMPLANON NXT Etonogestrel 68 mg 68 mg Implant for subdermal use One implant The blister pack contains one implant which is preloaded in the stainless steel needle of a ready-for-use, disposable, sterile applicator 60 Months NV ORGANON, Kloosterstraat 6 5349 AB Oss. The Netherlands THE NETHERLANDS N.V. ORGANON UBIPHARM-RWANDA LTD 2024-02-28 2029-02-27
26 Rwanda FDA-HMP-MA-2199 IMPLATINZE 500MG/500MG Sterile mixture of Imipenem monohydrate and Cilastatin Sodium 500 mg/500 mg Powder for Solution for IV Infusion 1,10 or 25 Vials Transparent glass (type I) vials 24 Months PHARCO B INTERNATIONAL New Borg El -Arab City, 3rd Industrial Zone, Alexandria, Egypt EGYPT PHARCO B INTERNATIONAL Le medical Ltd 2025-02-04 2030-02-03
27 Rwanda FDA-HMP-MA-1024 INBEC TABLETS Dolutegravir 50mg, Lamivudine 300mg and Abacavir 600mg 50mg/300mg/600mg Tablets 30 Tablets 100CC HDPE CONTAINER 24 Months EMCURE PHARMACEUTICALS LTD, Plot No P-2 I.T.B park, phase II, M.I.D.C, Hinjwadi, Pune-411057, India INDIA EMCURE PHARMACEUTICALS LTD; INDIA ABACUS PHARMA (A) LTD 2024-02-28 2029-02-27
28 Rwanda FDA-HMP-MA-0733 INDICONTIN 1.5 MG TABLETS Indicontin controlled release Tablets 1.5mg 1.5mg Film coated tablets 10 x 10 Tablets Tablets are packed in a blister of printed aluminum foil backed with PVC rigid film.10 such blisters are packed in a box 24 Months MODI-MUNDIPHARMA PVT. LTD, Modipuram - 250 110, U.P., India INDIA MODI-MUNDIPHARMA PRIVATE LIMITED SURGIPHARM (RWANDA) LTD 2024-01-15 2029-01-14
29 Rwanda FDA-HMP-MA-1535 INDOREN CAPSULES INDOMETHACIN BP 25 mg Capsules 10x10 Capsules Aluminium/PVC blister strip of 10 capsules and 10 of such blister strips are packed in a unit box with pack insert 24 Months RENE INDUSTRIES LTD Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda Uganda RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-07-27 2029-07-26
30 Rwanda FDA-HMP-MA-0667 INDOS-25 Indomethacin Capsules BP 25 mg 25 mg Hard gelatin capsules 10x10 Capsules Printed Aluminum foil/PVC foil blister. Such 10 blisters packed in carton along with its package insert 36 Months AGOG PHARMA LTD, Plot No. 33, Section II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai(E). Dist. Thane-401208, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-02 2028-12-01
31 Rwanda FDA-HMP-MA-1694 INFCLAV 228 ORAL SUSP 100 ML AMOXICILLIN/CLAVULANIC ACID 228MG SUSPENSION 100 ml Amber colour glass bottle 24 month Sakar Healthcare Limited Block No. 10-13, Sarkhej-Bavla Highway, Vill: Changodar, Dist: Ahmedabad-382213, Gujarat India (Company) Name: INFINITE HEALTH LIMTEDAddress: P.O BOX 64001-00620, NAIROBICountry: KENYATelephone: +254 733 733341/725 349888E-Mail: info@infinite.com SUN ENTERPRISES LTD 2024-08-17 2029-08-16
32 Rwanda FDA-HMP-MA-1098 INSTACLOP 75 Clopidogrel Bisulfate 75 mg 75 mg Film coated Tablets 3x10 Tablets Aluminium strip foil and such 3 strips are packed into carton along with leaflet 36 Months AJANTA PHARMA LIMITED, AJANTA PHARMA LIMITED, INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19
33 Rwanda FDA-HMP-MA-0180 INSTACLOP PLUS Clopidogrel 75mg & Aspirin 75mg 75mg & 75 mg Hard gelatin capsules 3x10 Capsules Alu-Alu blister pack, such 3 blisters are packed in a printed carton 36 Months AJANTA PHARMA LIMITED, B-4-5-6, MIDC Industrial Area Paithan, Aurangabad, 431148 Dist: Aurangabad Maharashtra, India. INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2022-12-14 2027-12-13
34 Rwanda FDA-HMP-MA-1139 INSTGRA Dolutegravir Tablets 50 mg 50 mg Film Coated Tablets 30, 90 & 180 Tablets HDPE (High Density polyethylene) container 36 Months EMCURE PHARMACEUTICALS LIMITED, Plot No. P-2, I.T.B.T. Park, Phase II, M.I.D.C., Hinjawadi, Pune –411 057, India. INDIA EMCURE PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LIMITED 2024-04-21 2029-04-20
35 Rwanda FDA-HMP-MA-2184 INSUFOR 500MG METFORMIN HYDROCHLORIDE 500MG FILM COATED TABLETS 90 Film coated tablets PVC/PVDC 36 Months World Medicine Ilaç San. ve Tic. A.S. 15 Temmuz Mah. Cami Yolu Cad. No:50, Günesli, Bagcilar, Istanbul, TURKEY Turkey World Medicine Ilaç San. ve Tic. A.S. GOODMAN INTERNATIONAL ® LTD 2025-01-09 2030-01-08
36 Rwanda FDA-HMP-MA-2325 INSUFOR 850MG METFORMIN HYDROCHLORIDE 850MG FILM COATED TABLETS 90 Tablets TRANSPARENT PVC/ALU BLISTER 36 MONTHS WORLD MEDICINE İLAÇ SAN. VE TIC. A.Ş 15 TEMMUZ MAH. CAMI YOLU CAD. NO:50, GÜNEŞLI, BAĞCILAR, ISTANBUL, TURKEY TURKEY WORLD MEDICINE İLAÇ SAN. VE TIC. A.Ş GOODMAN INTERNATIONAL(R) LIMITED 2025-06-19 2030-06-18

Registered
37 Rwanda FDA-HMP-MA-2110 INSUGEN-30/70 (Biphasic) Insulin Injection, Biphasic Isophane Ph.Eur. 100 IU/mL Injection 10ml Vial Vials (USP Type I) 36 Months Biocon Biological Limited Block No. B1,B2,B3, Q13 OF Q1 and W20& unit S18,1 st floor, Block B4, Special Economic zone, Plot No. 2,3,4&5 , Phase IV , Bommasandra-Jigani Link Road, Bomasandra Post, Bengaluru-560099 India Angel Biogenic Pvt Ltd Pyramid Pharma Limited 2024-10-18 2029-10-17
38 Rwanda FDA-HMP-MA-2109 INSUGEN-N (NPH) Insulin Injection, Isophane Ph. Eur. 100IU/mL Injection 10ml Vials (USP Type I) 36 months Biocon Biological Limited Block No. B1,B2,B3, Q13 OF Q1 and W20& unit S18,1 st floor, Block B4, Special Economic zone, Plot No. 2,3,4&5 , Phase IV , Bommasandra-Jigani Link Road, Bomasandra Post, Bengaluru-560099 India Angel Biogenic Pvt Ltd Pyramid Pharma Limited 2024-10-18 2029-10-17
39 Rwanda FDA-HMP-MA-2111 INSUGEN-R (Regular) Insulin Injection, Soluble Ph. Eur. 100 IU/mL Injection 10 ml Vial Vials 36 Months Biocon Biological Limited Block No. B1,B2,B3, Q13 OF Q1 and W20& unit S18,1 st floor, Block B4, Special Economic zone, Plot No. 2,3,4&5 , Phase IV , Bommasandra-Jigani Link Road, Bomasandra Post, Bengaluru-560099 India Angel Biogenic Pvt Ltd Pyramid Pharma Limited 2024-10-18 2029-10-17
40 Rwanda FDA-HBP-MA-0033 INSULATARD® Insulin Human 100 IU/ml 100 IU/ml Suspension for injection 10ml, Vial Glass vial 30 Months NOVO NORDISK PRODUCTION SAS, and Novo Nordisk A/S 45 Avenue d’Orléans F-28000 Chartres, France and Novo Nordisk A/S Novo Allé DK-2880 Bagsværd, Denmark FRANCE AND DENMARK NOVO NORDISK A/S WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-09-11 2028-09-10
41 Rwanda FDA-HBP-MA-0139 INSULIN GLARGINE IMPACT SOLO STAR ® Insulin glargine 5 Solostar pens each of 3ml Solution for injection 3 ML Cartridge TYPE 1 COLOURLESS GLASS CARTRIDGE WITH A BLACK PLUNGER (BROMOBUTYL RUBBER) AND A FLANGED CAP (ALUMINIUM) 36 Months SANOFI-AVENTIS DEUTSCHLAND GmbH INDUSTRIEPARK HOCHST-BRUNINGSTRABE 50,65926 FRANKFURT AM MAIN GERMANY SANOFI-AVENTIS DEUTSCHLAND GmbH KIPHARMA LTD 2024-08-17 2029-08-16
42 Rwanda FDA-HBP-MA-0122 INSULIN GLARGINE, Insulin Glargine Impact 100 Units/ml 100 Units/ml Solution for injection 3 mL cartridge Type I glass, sealed with a flanged cap with inserted laminated sealing disk made of synthetic isoprene rubber (non-product contact side) and Bromo butyl rubber (product contact side) at the top and with a plunger stopper made of Bromo butyl rubber at the bottom. 36 Months SANOFI-AVENTIS DEUTSCHLAND GmbH, Industriepark Höchst Brüningstraße 50 H500, H590, H600, 65926 Frankfurt am Main-Germany GERMANY SANOFI-AVENTIS SOUTH AFRICA (PTY) LTD KIPHARMA LTD 2024-05-06 2029-05-05
43 Rwanda FDA-HBP-MA-0144 Insulin Injection, Biphasic Isophane Ph. Eur Recombinant Human Insulin Ph. Eur. 100 IU/ml Suspension for Injection 10 ml Vial Type I glass ampoules 24 Months M. J. BIOPHARM. PVT LTD L-7, M.I.D.C Industrial Area, Taloja – 410208, Dist- Raigad, Maharashtra, INDIA INDIA Generix Laboratories Pvt. Ltd, India AIVEEN (R) LTD 2025-02-04 2030-02-03
44 Rwanda FDA-HMP-MA-0317 INTACYCLINE SKIN OINTMENT Tetracycline hydrochloride BP 3% w/w 3% w/w Ointment 15g tube Aluminium collapsible tubes. The tubes are then put into unit packets and then wrapped in polythene film in dozens which are packed in outer cartons 24 Months REGAL PHARMACEUTICALS LIMITED Plot No.7879/18, Off Baba Dogo Road, Ruaraka, Postal address: P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11
45 RWANDA-FDA25/HM/0582/0040 Intamab 500 Rituximab 500mg/50 mL INTRAVEOUS INFUSION 36 Intas Pharmaceutical Ltd. India Intas Pharmaceuticals Limited BION PHARMA GROUP (BPG) Ltd 2026-03-14 2031-03-13
46 Rwanda FDA-HMP-MA-0388 INTAMINE CREAM Mepyramine Maleate BP. 2.0% W/W 2.0% W/W CREAM 25 g tube Aluminium tube 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
47 Rwanda FDA-HMP-MA-0325 INTAPLEX TABLETS Nicotinamide BP 15mg; Riboflavin BP 1mg; Thiamine Hydrochloride BP 1 mg 15mg, 1mg, & 1 mg TABLETS 10x10 tablets Alu Foil (152mm) PVC Reel 160mm blister packs, packed in cartons 24 Months REGAL PHARMACEUTICALS LIMITED, Plot No.7879/18, Off Baba Dogo Road, Ruaraka, Postal address: P.O. Box 44421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11
48 Rwanda FDA-HMP-MA-1947 INTELENCE-100 INTRAVIRINE 100MG TABLETS 120 Tablets HDPE Bottle 36 Months Janssen-Cilag S.P.A. Via C. Janssen Borgo S. Michele 04100 Latina, Italy ITALY JANSSEN-CILAG INTERNATIONAL NV GILMED LIMITED 2024-08-17 2029-08-16
49 Rwanda FDA-HMP-MA-1810 INTRAZ Itraconazole Capsules 100 mg Capsules 1×4 Capsules Alu /PVDC Blister 24 Months Aurochem Pharmaceuticals (I) pvt. Ltd 58, Palghar Taluka, Industrial Co.-op. Estate Ltd. Palghar – 401 404, District Thane INDIA OCHOA LABORATORIES SUN ENTERPRISES LTD 2024-08-17 2029-08-16
50 Rwanda FDA-HMP-MA-0412 INTUSSED COUGH SUPPRESSANT Each 5 ml contains: Ephedrine Hydrochloride BP 8mg, Dextromethorphan Hydrobromide BP 8mg, Promethazine Hydrochloride BP 4mg syrup each 5 ml contains: 8mg, 8mg, 4mg Syrup 60ml Bottle Glass Bottle 36 Months REGAL PHARMACEUTICALS LIMITED, P.O. Box 4421-00100, Nairobi, Kenya KENYA REGAL PHARMACEUTICALS LIMITED, KENYA ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23
51 Rwanda FDA-HMP-MA-1084 INVEGA SUSTENNA® 100 MG Paliperidone Palmitate 156mg equivalent to Paliperidone 100mg 100 mg Suspension for injection 1ml Long pre-filled syringe and two needles. Pre-filled syringe (cyclic olefin-copolymer) with a plunger stopper, backstop, and tip cap (bromobutyl rubber) with a 22G 1½-inch safety needle (0.72 mm x 38.1 mm) and a 23G 1-inch safety needle (0.64 mm x 25.4 mm) 24 Months JANSSEN PHARMACEUTICA NV, Tumhoutseweg 30; B2340 Beerse Belgium Tumhoutseweg 30; B2340 Beerse, Belgium BELGIUM JANSSEN-CILAG INTERNATIONAL NV, BELGIUM KIPHARMA LTD 2024-04-20 2029-04-19
52 Rwanda FDA-HMP-MA-1088 INVEGA SUSTENNA® 150 MG Paliperidone Palmitate 234 mg equivalent to Paliperidone 150 mg 150 mg Suspension for injection 2.25ml pre-filled syringe and two needles. Pre-filled syringe with needle (cyclic olefin-copolymer) with a plunger stopper, backstop, and tip cap (bromobutyl rubber) with a 22G 1½-inch safety needle (0.72 mm x 38.1 mm) and a 23G 1-inch safety needle (0.64 mm x 25.4 mm). 24 Months JANSSEN PHARMACEUTICA NV, Tumhoutseweg 30; B2340 Beerse, Belgium Tumhoutseweg 30; B2340 Beerse, Belgium BELGIUM JANSSEN-CILAG INTERNATIONAL NV, BELGIUM KIPHARMA LTD 2024-04-20 2029-04-19
53 Rwanda FDA-HMP-MA-1085 INVEGA SUSTENNA® 25 MG Paliperidone Palmitate 39mg equivalent to Paliperidone 25mg 25 mg Suspension for injection 0.5ml pre-filled syringe and two needles. Pre-filled syringe with needle (cyclic olefin-copolymer) with a plunger stopper, backstop, and tip cap (bromobutyl rubber) with a 22G 1½-inch safety needle (0.72 mm x 38.1 mm) and a 23G 1-inch safety needle (0.64 mm x 25.4 mm). 24 Months JANSSEN PHARMACEUTICA NV, Tumhoutseweg 30; B2340 Beerse, Belgium Tumhoutseweg 30; B2340 Beerse, Belgium BELGIUM JANSSEN-CILAG INTERNATIONAL NV, BELGIUM KIPHARMA LTD 2024-04-20 2029-04-19
54 Rwanda FDA-HMP-MA-1086 INVEGA SUSTENNA® 50 MG Paliperidone Palmitate 78mg equivalent to Paliperidone 50mg 50 mg Suspension for injection 0.5ml pre-filled syringe and two needles. Pre-filled syringe with needle (cyclic olefin-copolymer) with a plunger stopper, backstop, and tip cap (bromobutyl rubber) with a 22G 1½-inch safety needle (0.72 mm x 38.1 mm) and a 23G 1-inch safety needle (0.64 mm x 25.4 mm). 24 Months JANSSEN PHARMACEUTICA NV, Tumhoutseweg 30; B2340 Beerse, Belgium Tumhoutseweg 30; B2340 Beerse, Belgium BELGIUM JANSSEN-CILAG INTERNATIONAL NV, BELGIUM KIPHARMA LTD 2024-04-20 2029-04-19
55 Rwanda FDA-HMP-MA-1087 INVEGA SUSTENNA® 75 MG Paliperidone Palmitate 117mg equivalent to Paliperidone 75mg 75mg Suspension for injection 1ml Long pre-filled syringe and two needles. Pre-filled syringe with needle (cyclic olefin-copolymer) with a plunger stopper, backstop, and tip cap (bromobutyl rubber) with a 22G 1½-inch safety needle (0.72 mm x 38.1 mm) and a 23G 1-inch safety needle (0.64 mm x 25.4 mm). 24 Months JANSSEN PHARMACEUTICA NV, Tumhoutseweg 30; B2340 Beerse, Belgium Tumhoutseweg 30; B2340 Beerse, Belgium BELGIUM JANSSEN-CILAG INTERNATIONAL NV, BELGIUM KIPHARMA LTD 2024-04-20 2029-04-19
56 Rwanda FDA-HMP-MA-2303 INVEL FORTE L METRONIDAZOLE, MICONAZOLE NITRATE AND LIDOCAINE 750 mg, 200 mg and 100 mg Vaginal Suppositories 1x7 Sppositories PVC/PE foil 36 Months BLISS GVS PHARMA LTD Plot No:11, Dewan Udyog Nagar, Aliyali Palghar, Maharashtra,401404, India INDIA Mega Lifesciences Public Company Limited ABACUS PHARMA (A) LTD 2025-05-12 2030-05-11
57 Rwanda FDA-HMP-MA-1489 IRBESARTAN IMPACT 150 MG Irbesartan 150mg 150mg Film Coated Tablets 28 Tablets Opaque PVC/PVDC/Aluminium blisters 36 Months SANOFI WINTHROP INDUSTRIE, 30-36, avenue Gustave Eiffel, Z.I. St. Symphorien 37100 Tours, France FRANCE SANOFI-AVENTIS SOUTH AFRICA (PTY) LTD KIPHARMA LTD 2024-07-20 2029-07-19
58 Rwanda FDA-HMP-MA-1634 Irbesartan Impact 300 mg IRBESARTAN 300mg Film coated tablets 28 Tablets PVC/PVDC/Aluminium blisters 36 Months Sanofi Winthrop Industrie 30-36, avenue Gustave Eiffel, Z.I. St. Symphorien 37100 Tours, France France Sanofi Winthrop Industrie KIPHARMA LTD 2024-08-17 2029-08-16
59 Rwanda FDA-HMP-MA-1974 Irbesartan/Amlodipine Besylate Impact Irbesartan/Amlodipine Besylate Impact 300mg/10mg Film Coated Tablets 28 Tablets PVC /ALU Blisters 36 Months Sanofi Winthrop Industrie 30-36 avenue Gustave Eiffel 37100 Tours France Sanofi-Aventis south africa (pty) ltd KIPHARMA LTD 2024-08-17 2029-08-16
60 Rwanda FDA-HMP-MA-1463 IRBESARTAN/HYDROCHLOROTHIAZIDE IMPACT 300 MG/12.5 MG FILM-COATED TABLETS Irbesartan 300 mg and Hydrochlorothiazide 12,5 mg 300 mg and 12,5 mg Film Coated Tablets 28 Tablets PVC/PVDC/Alu Blisters packed in a box 36 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
61 Rwanda FDA-HMP-MA-1830 IRBIS 150 Irbesartan 150mg Tablets 3x10 Tablets AlU-PVC/PVDC BLISTER PACK 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 LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16
62 Rwanda FDA-HMP-MA-1737 IRBIS 300 Irbesartan 300 mg Tablets 3x10 Tablets Alu-PVC/PVDC 36 Months M/S HETERO LABS LIMITED, UNIT-I Kalyanpur Village, Chakkan Road, Baddi, Dist. Solan (H.P). INDIA HETERO LABS LIMITED BION-PHARMA GROUP Limited 2024-08-17 2029-08-16
63 Rwanda FDA-HMP-MA-1736 IRBIS HT -300/12.5 Irbesartan and Hydrochlorothiazide 300 mg/12.5 mg Film Coated Tablets 3x10 Tablets Alu/PVC/PE/PVdC)BLISTER PACK 36 Months HETERO LABS LIMITED (Unit-V) TSIIC Formulation SEZ, S.No 439, 440, 441 & 458 Polepally village, Jadcherla Mandal, Mahaboob Nagar (Dist) – 509301, Telangana, India Telephone : +91 08542-238400 Telefax : + 91 08542 238404 E-Mail : drkepi@heterodrugs.com INDIA HETERO LABS LIMITED (Unit-V) BION-PHARMA GROUP Limited 2024-08-17 2029-08-16
64 Rwanda FDA-HMP-MA-1993 IRBIS-HT 150/12.5 Irbesartan and Hydrochlorothiazide 150 mg/12.5 mg Tablets 3×10Tablets White Opaque PVC/PVDC Blister and Carton 36 months M/S. Hetero Labs Limited (Unit-V) M/S. Hetero Labs Limited (Unit-V) \\ INDIA Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16
65 Rwanda FDA-HMP-MA-2190 IRYS GLIMEPIRIDE 4MG TABLETS 2x15 TABLETS PVC/ALU Foil strip 36 Months LES LABORATOIRES MEDIS Road of Tunis Km7 BP 206 Nabeul 8000 Tunisia TUNISIA LES LABORATOIRES MEDIS KIPHARMA LTD 2025-01-09 2030-01-08
66 Rwanda FDA-HMP-MA-2191 IRYS GLIMEPIRIDE 3MG TABLETS 2x15 TABLETS PVC/Aluminium foil strip 36 Months LES LABORATOIRES MEDIS Road of Tunis Km7-BP 206, 8000 Nabeul, Tunisia TUNISIA LES LABORATOIRES MEDISLes Laboratoires MédiS, Road of Tunis Km7 BP 206 Nabeul 8000Country: Tunisia Telephone: (+216 – 72) 235 006 / 235 010 / 235 011 Email: contact@labomedis.com KIPHARMA LTD 2025-01-09 2030-01-08
67 Rwanda FDA-HMP-MA-2192 IRYS GLIMEPIRIDE 1MG TABLETS 2x15 TABLETS PVC/Alu foil strip 36 Months LES LABORATOIRES MEDIS Road of Tunis Km7 BP 206 Nabeul 8000 Tunisia TUNISIA LES LABORATOIRES MEDIS KIPHARMA LTD 2025-01-09 2030-01-08
68 Rwanda FDA-HMP-MA-2027 ISONIAZID ISONIAZID 300MG TABLET 10x10 Tablets Amber PVC/PVDC Blister and Aluminium Blister 24 Months Lupin Limited EPIP, SIDCO Industrial Complex Kartholi, Bari Brahmana Jammu (J&K)- 181133, India INDIA Lupin Limited Aiveen ® Ltd 2024-08-17 2029-08-16
69 Rwanda FDA-HMP-MA-0152 ISONIAZID AND RIFAPENTINE COATED TABLETS 300MG/300MG Isoniazid 300 mg and Rifapentine 300 mg 300mg and 300mg Film coated tablets 3 X 12 Tablets Alu-Alu strip packs in a carton along with pack insert 24 Months MACLEODS PHARMACUTICALS LIMITED, At Oxalis Labs Village Theda, P.O Lodhimajra, Baddi, Distt. Solan, Himachal Pradesh, 174101, India INDIA MACLEODS PHARMACEUTICALS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2022-12-21 2027-12-20
70 Rwanda FDA-HMP-MA-0266 ISONIAZID TABLETS BP 100MG Isoniazid BP, 100mg 100mg Uncoated tablets 10x10’s tablets PVC/PVDC Blister in Aluminium seal, such 10 blisters are packed in carton 24 Months LUPIN LIMITED, A-28/1, M.I.D.C Chikalthana, Aurangabad 431210, Maharashtra State, INDIA. INDIA LUPIN LIMITED, INDIA AIVEEN (R) LTD 2023-05-12 2028-05-11
71 Rwanda FDA-HMP-MA-2080 ISONIAZID TABLETS BP 300MG ISONIAZID 300MG TABLETS 10x10 Tablets Amber PVC/PVDC Blister and Aluminium Blister 24 Months Lupin Limited EPIP, SIDCO Industrial Complex Kartholi, Bari Brahmana Jammu (J&K)- 181133, India INDIA Lupin Limited AIVEEN (R) LTD 2024-08-17 2029-08-16
72 Rwanda FDA-HMP-MA-0879 ITACARE Itraconazole Capsules 100 mg 100 mg Capsules 3 x 10 capules Alu/ Alu Blisters. Such 3 Blisters are packed in a printed outer carton along with a pack insert 24 Months MICRO LABS LIMITED, 92, SIPCOT Industrial Complex, HOSUR-635 126. (T.N), India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LIMITED 2024-02-17 2029-02-16
73 Rwanda FDA-HMP-MA-2264 IVIPIME Cefepime Hydrochloride 1gr Dry Powder for Injection 10 mL Vial Flint Moulded Vial and Plactic ampoule with 10ml water for injection placed in a carton along with pack insert. 24 Months VHB MEDI SCIENCES LIMITED Plot No 20-22 & 49-51, IIE, Sector 5, Pantnagar, Rudrapur – 263153, Uttarakhand, India INDIA VHB MEDI SCIENCES LIMITED Droga Pharma (Rwanda) Ltd 2025-02-04 2030-02-03
74 Rwanda-FDA-HM-1877 IVYTUS HEDERACOSIDE C 100ML SYRUP 100ml Amber glass bottle 36 months Neopharma Address of the Site : Plot No. A1 89 – 95, Industrial City of Abu Dhabi, Mussafah, PO Box 72900 Abu Dhabi mailto:neopharma@neopharma.ae UAE NEOPHARMA Plot No. A-1, 89-95, Industrial City of Abu Dhabi(ICAD), P.O Box 72900, Mussafah, Abu Dhabi, UAEUnited Arab Emirates00971 2 550 1000 /00971 2 550 11 99 PHILIPS PHARMACEUTICALS RWANDA LTD 2024-08-17 2029-08-16
75 Rwanda FDA-HMP-MA-2175 IXAROLA 10 RIVAROXABAN 10 10 mg TABLETS 3x10 Tablets Polypropylene)/aluminium blister strips 36 Months BAYER AG & BAYER HEALTHCARE MANUFACTURING S.r.l 51368 Leverkusen, Germany & Via delle Groane, 126 20024 Garbagnate Milanese, Italy Germany & Italy Bayer East Africa Limited SURGIPHARM (RWANDA) LTD 2025-01-09 2030-01-08
76 Rwanda FDA-HMP-MA-2176 IXAROLA 15 RIVAROXABAN 15 15 mg TABLETS 42 tablets Polypropylene)/aluminium blister strips 36 Months BAYER AG & BAYER HEALTHCARE MANUFACTURING S.r.l 51368 Leverkusen, Germany & Via delle Groane, 126 20024 Garbagnate Milanese, Italy Germany & Italy Bayer East Africa Limited SURGIPHARM (RWANDA) LTD 2025-01-09 2030-01-08
77 Rwanda FDA-HMP-MA-2177 IXAROLA 20 RIVAROXABAN 20 20 mg TABLETS 28 Tablets Polypropylene)/aluminium blister strips or colourless, transparent PVC/PVDC/aluminium blister strips 36 Months BAYER AG & BAYER HEALTHCARE MANUFACTURING S.r.l 51368 Leverkusen, Germany & Via delle Groane, 126 20024 Garbagnate Milanese, Italy Germany & Italy Bayer East Africa Limited SURGIPHARM (RWANDA) LTD 2025-01-09 2030-01-08
78 Rwanda FDA-HMP-MA-2188 IXINE 200 CEFIXIME TRIHYDRATE USP 200MG C 1 X10 TABLETS Alu/Alu Blister pack 36 Months GRACURE PHARMACEUTICALS LIMITED E-1105, Industrial Area, Phase-III BHIWADI, PIN-301019, Dist. Alwar, Rajasthan, INDIA INDIA EXPHAR S.A H&H PHARMA LTD 2025-01-09 2030-01-08