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-0195 HACTOSEC® SYRUP Levodropropizine 6mg/ml, Syrup 6mg/ml Syrup 150ml Bottle Amber coloured type III glass bottle with coloured LDPE joint 24 Months BILIM ILAÇ San.ve Tic. A.? GOSB 1900 Sokak, N° 1904 41480 Gebze, Kocaeli, Turkey TURKEY DAFRA PHARMA GmbH, Switzerland SUN ENTERPRISES LTD 2022-12-21 2027-12-20
2 Rwanda FDA-HMP-MA-2205 HAEMOJET Each Ampoule (2 ml) contains Elemental Iron 100 mg (As Ferric Hydroxide Polymaltose) 100 mg/ 2ml Solution for IM Injection/IV Infusion 2 x 3 mL or 2 x 6 mL Type I glass ampoules 24 Months PHARCO B INTERNATIONAL New Borg El Arab City, 3rd Industrial Zone, Alexandria, Egypt. & EUROPEAN EGYPTIAN PHARM. IND.:Cairo Desert Road KM 25, Alexandria, Egypt EGYPT EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES HELIOS PHARMA Ltd 2025-02-04 2030-02-03
3 Rwanda FDA-HMP-MA-2204 HAEMOJET Syrup Ferric Hydroxide Polymaltose Complex 50 mg/5 ml SYRUP 100ml Bottle PET amber plastic bottle, polypropylene plastic cap with LDPE plastic ring 36 Months PHARCO B INTERNATIONAL Cairo Desert Road KM 25, P.O Box 111, El Manshia Alex. Amriya, Alexandria, Egypt EGYPT EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES HELIOS PHARMA Ltd 2025-02-04 2030-02-03
4 Rwanda FDA-HMP-MA-2343 HALO-SWISS HALOPERIDOL 5MG/ML, 1ML INJECTION 5 MG/ML Solution for Injection. 36 Months SWISS PARENTERALS LTD, 808,809 & 810 Kerala Industrial Estate, G.I.D.C., Bavla, Dist. Ahmedabad – 382220, Gujarat, India India SWISS PARENTERALS LTD. PHARMACEUTICAL AND MEDICAL SUPPLIES SOCIETY (PMSS) Ltd 2025-09-19 2030-09-18
5 Rwanda FDA-HMP-MA-2066 HALOPERIDOL INJECTION BP 5mg/ml Haloperidol BP 5mg/ml Injection 10 Ampoules Glass Ampoules packed in plastic tray, such tray packed in carton 24 Months ANGEL BIOGENICS PVT. LTD Tirupati Complex, 1st Floor, Shapar-Veraval, rajkot – 360024, gujarat, indiawork at. :46/4-7, dehgam road, village -zaktal. - dehgam, dist - gandhinagar - 382 330 INDIA ANGEL BIOGENICS PVT. LTD SUN ENTERPRISES LTD 2024-09-30 2029-09-29
6 Rwanda FDA-HMP-MA-2069 HARTEZE 10 RIVAROXABAN 10MG TABLETS 14 tablets & 28 tablets Aluminium Strip reel 36 Months COSMOS LIMITED Rangwe Road, Off Lunga Lunga Road, Industrial Area, Plot No. L/R 209/13268, P. O. Box 41433, GPO 00100, Nairobi KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-09-30 2029-09-29
7 Rwanda FDA-HMP-MA-2068 HARTEZE 20 RIVAROXABAN 20MG TABLETS 14 tablets & 28 tablets Aluminium Strip reel 36 Months COSMOS LIMITED Rangwe Road, Off Lunga Lunga Road, Industrial Area, Plot No. L/R 209/13268, P. O. Box 41433, GPO 00100, Nairobi, KENYA COSMOS LIMITED SUN ENTERPRISES LTD 2024-09-30 2029-09-29
8 Rwanda FDA-HMP-MA- 0823 HEDEX CAPLETS Aspirin 400mg, Paracetamol 200mg and Caffeine 50mg 400mg, 200mg and 50mg Caplets 10x10 Caplets PVC/Aluminium foil blister 24 Months BETA HEALTHCARE INTERNATIONAL LIMITED, Plot No.L.R 209/6554 Mogadishu Road, Industrial Area, Nairobi, Kenya KENYA BETA HEALTHCARE INTERNATIONAL LIMITED SURGIPHARM (RWANDA) LTD 2024-01-30 2029-01-29
9 Rwanda FDA-HMP-MA-0431 HEDON TABLETS Aspirin BP 300mg, Paracetamol BP 250 mg& Caffeine Anhydrous BP 30 mg 300mg, 250 mg & 30 mg Tablets 50 x 2’s tablets Hedon Printed Polypaper – Front and Hedon Printed Polypaper – Back in S/P Unit Carton 36 Months REGAL PHARMACEUTICALS LIMITED. Address: Plot No.: 7879/18, Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi. Country: Kenya KENYA REGAL PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23
10 RwandaFDA-HMP-MA-1867 HELIGO 500 TINIDAZOLE+CLARITHROMYCIN+LANSOPRAZOLE 500MG/500MG/30MG TABLET 7 strip (kit) ALU/PVC BLISTER 24 Months INTAS PHARMACEUTICALS LTD Address: Camp road, Selaqui, Dehradun- 248197, Uttarakhand, India Country: India INDIA INTAS PHARMACEUTICALS LTD/INDIACorporate House, Near Sola Bridge, S. G. Highway, Thaltej, Ahmedabad - 380054 - Gujarat – INDIA. ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16
11 Rwanda FDA-HMP-MA-2272 HELMADOL 400MG FILM COATED TABLETS ALBENDAZOLE 400MG FILM COATED TABLETS 2 Tablets 2 tablets/ box 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
12 Rwanda FDA-HMP-MA-0794 HELMINTOX 250MG Pyrantel embonate 250mg 250mg Film-coated tablets 3 tablets PVC/Aluminium Blister 36 Months INNOTHERA CHOUZY, Rue Rene Chantereau, Chouzy-surCisse, 41150 Valloire-sur-Cisse, France FRANCE LABORATOIRE INNOTECH INTERNATIONAL DEPOT PHARMACEUTIQUE LE MEDICAL 2024-01-05 2029-01-04
13 Rwanda FDA-HMP-MA-0948 HELMINTOX® ORAL SUSPENSION Pyrantel Embonate 125 mg/2.5 ml 125 mg/2.5 ml Oral suspension 15ml Bottle Type III glass bottle, crimped with a varnished aluminium (al) cap including a watertight polyethylene (PE) packed in a printed carton along with packing insert 36 Months INNOTHERA CHOUZY, Rue Rene Chantereau, Chouzy-sur-Cisse, 41150 Valloire-sur-Cisse, France FRANCE LABORATOIRE INNOTECH INTERNATIONAL DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-26 2029-02-25
14 Rwanda FDA-HMP-MA-1840 HENKA 30 Duloxetine Hydrochloride 30 mg. Capsules 3 x 10’s Capsules ALU-PVC/PVDC BLISTER PACK 24 Months HETERO LABS LIMITED Unit-I Address: Kalyanpur (Village), Chakkan Road, Baddi (Tehsil), Solan (Dist.), Himachal Pradesh-173205, India INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16
15 Rwanda FDA-HMP-MA-1738 HENKA 60 Duloxetine Delayed Release Capsules 60 mg Capsules 3x10 Capsules Alu-PVC/PVdC Blister pack. 24 Months M/S HETERO LABS LIMITED, UNIT-I Kalyanpur (Village), Chakkan Road, Baddi (Tehsil), Solan (Dist.), Himachal Pradesh-173205, India. Country : India Telephone : +91 9218677025Telefax : +91 1795245732/247430 E-Mail : prasad.m@heterodrugs.com INDIA HETERO LABS LIMITED BION-PHARMA GROUP Limited 2024-08-17 2029-08-16
16 Rwanda FDA-HMP-MA-0805 HEPARIN MEDIS Heparin Sodium, 25000 UI 25000 UI Injectable solution Box of 10 vials of 5ml Transparent glass vial type I of 8 ml, gray chlorobutyl flat cap, blue aluminium /PVC capsule 36 Months LES LABORATOIRES MEDIS, Km 7 route de Tunis, BP 206, 8000 Nabeul, Tunisia TUNISIA LES LABORATOIRES MÉDIS KIPHARMA LTD 2024-01-15 2029-01-14
17 Rwanda FDA-HMP-MA-2170 Heparin Sodium Injection BP Heparin Sodium Injection BP 25000IU/5ml Injection 5 mL USP type I clear glass vial 36 months M/s. Gland Pharma Limited Survey No. 143 to 148, 150 & 151, Near Gandimaisamma Cross Roads, D.P. Pally, Dundigal Post, Dundigal - Gandimaisamma Mandal, Medchal-Malkajgiri District, Hyderabad - 500 043, Telangana INDIA M/s. Gland Pharma Limited Africa Healthcare Network Rwanda Ltd 2025-01-09 2030-01-08
18 Rwanda FDA-HBP-MA-0111 HEPATITIS B VACCINE (rDNA) (ADULT) 1 DOSE Hepatitis B Surface Antigen (Aqueous), 20mcg/1ml 20mcg/1ml Suspension for injection Box of 50 vials of 4ml Tubular Flint Vial (Type I Glass) with a gray plain bromobutyl rubber stopper and aluminium flip off cap 36 Months SERUM INSTITUTE OF INDIA PVT. LTD 2122, Hadapsar, Pune411028, India INDIA SERUM INSTITUTE OF INDIA PVT. LTD SUN ENTERPRISES LTD 2024-02-17 2029-02-16
19 Rwanda FDA-HMP-MA-0346 HepBest Tenofovir Alafenamide Fumarate 25mg 25mg Film-Coated Tablets 30’s and 90’s tablets HDPE bottle 36 Months MYLAN LABORATORIES LIMITED, Plot No.11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase-II, Sector-III, Pithampur-454775. Dist. Dhar, Madhya Pradesh, India INDIA MYLAN LABORATORIES LIMITED, India PYRAMID PHARMA LIMITED 2023-07-08 2028-07-07
20 Rwanda FDA-HMP-MA-0027 HERCEPTIN SOLUTION FOR INJECTION 600MG/5ML Trastuzumab 600mg/5ml 600mg/5ml Solution for injection 6 mL glass vial Glass vial (type 1 glass) closed by means of a rubber. Stopper (rubber laminated with fluoro-resin) and an aluminum Overseal with flip-off disk 21 months F. HOFFMANN-LA ROCHE LTD, Wurmisweg, 4303 Kaiseraugst, Switzerland SWITZERLAND F. HOFFMANN-LA ROCHE LTD KIPHARMA LTD 2023-07-08 2028-07-07
21 Rwanda FDA-HMP-MA-2005 HETSOLID 110 Dabigatran Etexilate 110mg Capsules 1 x10 Tablets Alu–Alu PVC Blister 24 months M/s Hetero Labs Limited Unit-IIIAddress: 22-110, IDA, Jeedimetla, Hyderabad, Telangana, INDIACountry: INDIA India Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16
22 Rwanda FDA-HMP-MA-2006 HETSOLID 150 Dabigatran Etexilate 150 mg CAPSULES 1 x10 Tablets Alu-Alu blister pack 24 months M/s Hetero Labs Limited Unit-IIIAddress: 22-110, IDA, Jeedimetla, Hyderabad, Telangana, INDIA India Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16
23 Rwanda FDA-HMP-MA-2004 HETSOLID 75 Dabigatran Etexilate 75 mg Capsules 1 x10 Tablets Alu–Alu PVC Blister 24 months M/s Hetero Labs Limited Unit-IIIAddress: 22-110, IDA, Jeedimetla, Hyderabad, Telangana, INDIACountry: INDIA Telephone: +91-40-23096171/172/173/174 India M/s Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16
24 RWANDA-FDA24/HM/1081/0035 HIDROFEROL 0.266MG SOFT CAPSULES Calcifediol Monohydrate 266MCG Soft Capsules 48 Months CARBOGEN AMCIS B.V. Netherlands FAES FARMA, S.A. UBIPHARM-RWANDA LTD 2025-10-16 2030-10-15
25 Rwanda FDA-HMP-MA-0735 HISTALIN COUGH EXPECTORANT Chlorpheniramine Maleate BP 1.0mg, Promethazine HCl BP 2.5mg, Diphenhydramine HCl BP 5.0mg, Ephedrine HCl BP 7.5mg, Ammonium Chloride BP 90.0mg, Sodium Citrate BP 45.0mg 1.0mg, 2.5mg, 5.0mg, 7.5mg, 90.0mg, 45.0mg Viscous free flowing liquid 60ml Bottle Amber glass bottles 36 Months REGAL PHARMACEUTICALS LTD, Plot No: 7879/18, off Baba Dogo Road Ruaraka, Kenya KENYA REGAL PHARMACEUTICALS LTD, KENYA ABACUS PHARMA (RWANDA) LTD 2024-01-05 2029-01-04
26 Rwanda FDA-HBP-MA-0146 HUCOG-5000 HP CHORIONIC GONADOTROPHIN 5000HP INJECTION 2ml Ampoules GLASS Vials 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 2025-05-12 2030-05-11
27 Rwanda FDA-HMP-MA-0456 HYCORUM CREAM HYDROCORTISONE BP 1%w/w 1%w/w CREAM 1X15G Tube Collapsible Aluminium collapsible Tubes 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, KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2023-08-24 2028-08-23
28 Rwanda FDA-HMP-MA-0677 HYDROCHLOROTHIAZIDE TABLETS USP 25MG Hydrochlorothiazide USP 25 mg 25 mg Uncoated tablets 10x10 tablets Alu-PVC Blister Pack. Such 10 Alu-PVC Blisters are packed in a printed carton along with package insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, District: Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-12-10 2028-12-09
29 Rwanda FDA-HMP-MA-0537 HYDROCHLOROTHIAZIDE TABLETS USP 50 MG Hydrochlorothiazide 50mg 50mg Uncoated tablets 10x10 Tablets PVC Aluminum foil blister. 10 blisters are packed in a carton box 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-10-05 2028-10-04
30 Rwanda FDA-HMP-MA-0656 HYDROCHLOROTHIAZIDE-25 Hydrochlorothiazide 25mg 25mg Tablets 30 tablets Packed in blister and carton along with a pack insert 36 Months SALUTAS PHARMA GmbH, & LEK S.A. Otto-von-Guericke-Allee 1 D-39179 Barleben, Germany, and Podlipie 16, 95-010 Strykow Poland GERMANY AND POLAND SANDOZ GmbH, AUSTRIA SURGIPHARM (RWANDA) LTD 2023-12-02 2028-12-01
31 RWANDA-FDA24/HM/0910/0016 Hydrocortisone Sodium Succinate For Injection BP 100 mg Hydrocortisone Sodium succinate Eq.to Hydrocortisone 100 mg Dry Powder for injection or infusion 36 Months SYMBIOTEC PHARMALAB LIMITED India Lincoln Pharmaceuticals Limited ABACUS PHARMA (A) Ltd 2026-02-05 2031-02-04
32 Rwanda FDA-HMP-MA-0943 HYDROXYCARBAMIDE 500MG CAPSULES, HARD Hydroxycarbamide 500mg 500mg Hard capsules 100 Capsules PVC/PVDC/Aluminium-Blisters packed in a carton box 24 Months HAUPT PHARMA AMAREG GMBH, Donaustaufer Strasse 378 D-93055 Regensburg, Germany GERMANY SANDOZ GmbH KUNDL SURGIPHARM (RWANDA) LTD 2024-02-26 2029-02-25
33 Rwanda FDA-HMP-MA-2103 Hydroxyurea 100 HGC Hydroxyurea 100 mg TABLETS 60, 90 and 120 Tablets High density polyethylene (HDPE) 24 Months Haupt Pharma Amareg GmbH Haupt Pharma Amareg GmbH Address: Donaustaufer Strasse 378 D-93055 Regensburg Germany Sandoz Pharmaceutical d.d SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16
34 RwandaFDA-HMP-MA-1899 Hydroxyurea 1000 HGC Hydroxyurea 1000 mg 1000 mg Tablet 3x10’s HDPE 24 Months Haupt Pharma Amareg GmbH Donaustaufer Strasse 378 D-93055 Regensburg Germany Sandoz Pharmaceutical d.dAddress: Donaustaufer Strasse 378, 93055 Regensburg, GermanyCountry: GermanyTelephone:+254 711592940Telefax: N/A E-Mail: david.odhiambo@novartis.com Surgipharm Rwanda Address: P.O Box 2414 CCOAIB Building, KN 5 Rd 18 Boulevard de l’Umuganda Country: Rwanda 2024-08-17 2029-08-16
35 Rwanda FDA-HMP-MA-0120 HYMET TABLETS Hydrochlorothiazide BP 50mg Tablets 10x10’s ALU-PVC BLISTER 36 Months LABORATORY & ALLIED LTD Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa road, P.O. Box 42875 GPO 00100, Nairobi, Kenya KENYA LABORATORY & ALLIED LTD DEPOT PHARMACEUTIQUE LE MEDICAL 2022-10-24 2027-10-23
36 Rwanda FDA-HMP-MA-1183 HYOCE Hyoscine Butylbromide 20mg/ml 20mg/ml Solution for injection 1ml×10 ampoules Amber colored glass ampoules with white ring at constriction 24 Months KILITCH DRUGS (INDIA) LIMITED. Plot no. C-301/2, M.I.D.C T.T.C, Industrial Area, Pawane Village, Navi Mumbai - 400 705, Maharashtra, India INDIA KILITCH DRUGS (INDIA) LIMITED SUN ENTERPRISES LTD 2024-05-06 2029-05-05
37 Rwanda FDA-HMP-MA-1929 HYORTH injection Sodium Hyaluronate Sterile Solution 10 mg/1mL Injection 1’s x 2 mL USP type I glass syringe 36 Months VIRCHOW BIOTECH PVT LTD Survey No.172 Part, Gagillapur (V), Dundigal Gandimaisamma (M), Medchal-Malkajgiri (D),Telangana (State) - 500 043, India. INDIA VIRCHOW BIOTECH PVT LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16
38 Rwanda FDA-HMP-MA-2235 HYOSCINE BUTYLBROMIDE Hyoscine Butylbromide 10 mg TABLETS 10x10 Capsules PVC/Aluminium 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
39 Rwanda FDA-HMP-MA-2063 Hyoscine Butylbromide Tablets BP 10mg Hyoscine Butylbromide 10 mg Tablets 1000 tablets HDPE jar 36 Months ANGEL BIOGENICS PVT. LTD angelpharma3511@gmail.com INDIA ANGEL BIOGENICS PVT. LTD SUN ENTERPRISES LTD 2024-09-30 2029-09-29
40 Rwanda FDA-HMP-MA-1525 HYOSPAN SYRUP HYOSCINE BUTYL BROMIDE BP 5MG SYRUP 60ml Bottle Amber glass bottle packed in a carton 36 Months BIODEAL LABORATORIES LTD Plot No.123, Lunga Lunga P.O Box 32040-00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LTD BIODEAL LABORATORIES LTD 2024-07-27 2029-07-26
41 Rwanda FDA-HMP-MA-2305 HYOSWISS HYOSCINE BUTYLBROMIDE 20mg/ml Solution for Injection 10 X 1 ml Ampoules A clear glass ampoule is packed in a carton along with an insert 36 Months SWISS PARENTERALS LTD 808, 809 & 810, Kerala Industrial Estate, Nr. Bavla, Dist. Ahmedabad - 382 220, Gujarat, India INDIA SWISS PARENTERALS LTD Pharmaceutical and Medical Supplies Society Limited 2025-05-12 2030-05-11
42 Rwanda FDA-HMP-MA-1061 HYTAN-40 Termisartan USP 40mg 40mg Uncoated Tablets 3x10 Tablets Alu/Alu Pack (Alu/Alu Printed Aluminium foil with Alu/Alu Base Foil) 24 Months BAFNA PHARMACEUTICALS LTD., No.147, Madhavaram Redhills High Road, Grantlyon, Vadakarai Post, Chennai – 600 052, India. INDIA PRISMA PHARMA FZE PRAFIN RWANDA LTD 2024-02-23 2029-02-22
43 Rwanda FDA-HMP-MA-1057 HYTAN-80 TABLETS Telmisartan USP 80mg 80mg Uncoated Tablets 3x10 Tablets Alu/Alu Blister. Such Blister packed in a carton along with product insert 24 Months BAFNA PHARMACEUTICALS LTD., No.147, Madhavaram Redhills High Road, Grantlyon, Vadakarai Post, Chennai – 600 052, India INDIA PRISMA PHARMA FZE, DUBAI, U.A.E. PRAFIN RWANDA LTD 2024-02-28 2029-02-27