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-1772 Wellness Paracetamol Pseudoephedrine HCl Dextromethorphan HBr 325 mg/30 mg/4.5 mg Film Coated Tablets 10x10 Tablets Carton box containing 1 0r 2 (AL / transparent PVC/PVDC ) 36 Months LIPTIS FOR PHARMACEUTICALS & MEDICAL PRODUCTS (S.A.E). Plot no. B/2, 6th industrial zone, 6th of October City. EGYPT LIPTIS FOR PHARMACEUTICALS & MEDICAL PRODUCTS GOODMAN INTERNATIONAL LTD (R) 2024-08-17 2029-08-16

2 Rwanda FDA-HMP-MA-1041 WHITFIELD’S OINTMENT Benzoic Acid BP 6% w/w and Salicylic Acid BP 3% w/w 6% w/w- 3% w/w Ointment 25mg Aluminium tubes in unit carton with leaflet 36 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 2024-02-28 2029-02-27

3 Rwanda FDA-HMP-MA-1754 WHITFIELD’S SKIN OINTMENT Benzoic Acid and Salicylic Acid 6.0%w/w / 3.0%w/w Skin Ointment 20 Grams Tubes ALUMINIUM TUBE 36 Months DAWA LIMITED Plot No.7879/8, Baba Dogo Road, Ruaraka. P.O. BOX 16633-00620 Nairobi, Kenya. KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

4 Rwanda FDA-HMP-MA-0494 WILCREAS-50 Vildagliptin 50 mg 50 mg Tablets 3 x 10 Tablets Alu/Alu Blisters which are packed in a printed outer carton 24 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur - 635 126 (Tamilnadu), India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICAL (RWANDA) LTD 2023-10-13 2028-10-12

5 Rwanda FDA-HMP-MA-2196 WILLGO CR Aceclofenac 200MG TABLETS 5x2x10 Tablets /10x10 Tablets Alu-Alu blister pack 36 Months PANACEA BIOTEC PHARMA Ltd Wholly-owned Subsidiary of Panacea Biotec Ltd. Malpur, Baddi, Distt. Solan (H.P.) - 173 205, India. INDIA PANACEA BIOTEC PHARMA LIMITED AIVEEN (R) LTD 2025-01-09 2030-01-08

6 Rwanda FDA-HMP-MA-1537 WOMNIL SUSPENSION ALBENDAZOLE BP 200MG/5ML SUSPENSION 10ml Bottle Amber coloured glass bottle contained in a unit box 36 Months DAWA LIMITED Plot No. 7879/8, Baba Dogo Road, Ruaraka. P.O Box 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTEPRISES LTD 2024-07-27 2029-07-26

7 Rwanda FDA-HBP-MA-0136 WOSULIN -N-100 IU/ML Neutral Insulin Injection 100 IU/ml 100 IU/ml Injection 10ml Vial GLASS VIAL WITH FLUORINTED POLYMER COATED BROMOBUTYL RUBBER STOPPER (OMMIFLEX) AND FLIP OFF SEAL 24 Months Wockhardt Limited Wockhardt Limited, Biotech Park, H-14/2, M.I.D.C, Waluj, Aurangabad – 431 136, Maharashtra, India INDIA Wockhardt Limited, SURGIPHARM RWANDA LIMITED 2024-08-17 2029-08-16

8 Rwanda FDA-HBP-MA-0126 WOSULIN 30/70 100 IU/ML Biphasic Isophane Insulin Injection BP-100IU/ml 100IU/ml Suspension for Injection 3ml and 10ml Vials Cartridge and Dispopen in Type-I glass vials and carton. 36 Months WOCKHARDT LIMITED, Biotech Park, H-14/2, M.I.D.C, Waluj, Aurangabad – 431 136, Maharashtra, India. INDIA WOCKHARDT LIMITED SURGIPHARM (RWANDA) LIMITED 2024-05-06 2029-05-05

9 Rwanda FDA-HBP-MA-0120 WOSULIN-R 100IU/ML Human Recombinant (r-DNA) Insulin Regular (Soluble/Neutral) 100IU/ml 100IU/ml Injectable 10ml Vial Glass vial packed in a printed carton with literature insert, 24 Months WOCKHARDT LIMITED, Biotech Park, H-14/2, M.I.D.C, Waluj, Aurangabad – 431 136, Maharashtra-India INDIA WOCKHARDT LIMITED ABACUS PHARMA (A) LTD 2024-04-27 2029-04-26

10 Rwanda FDA-HMP-MA-1009 WOXHEAL Diperoxochloric Acid Concentrate 1.16 mg 1.16 mg Topical Solution 7.5 ml Bottle HDPE Bottles 24 Months CENTAUR PHARMACEUTICAL PVT.LTD, Plant-I, Plot No.3,5B,2C, Tivim Industrial Estate, Karaswada, Mapusa, Goa-403 526, India. INDIA CENTAUR PHARMACEUTICAL PVT. LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-23 2029-02-22