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-2352 Z-COT 15 RIVAROXABAN TABLETS BP 15MG TABLETS 3X10 TABLETS 10 TABLETS IN ALUMINUM – PVC/PVDC BLISTER PACK, 3 BLISTERS IN A PRINTED CARTON ALONG WITH PACK INSERT 24 MONTHS AJANTA PHARMA LIMITED MIRZA-PALASHBARI ROAD, VILL-KOKJHAR, KAMRUP (R), GUWAHATI, ASSAM- 781128, INDIA INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2025-10-09 2030-10-08

Registered

2 Rwanda FDA-HBP-MA-0010 ZABDENO SUSPENSION FOR INJECTION. EBOLA VACCINE (AD26.ZEBOV-GP [RECOMBINANT]) AND MVABEA SUSPENSION FOR INJECTION. EBOLA VACCINE (MVA-BN-FILO [RECOMBINANT]) Ad26.ZEBOV, MVA-BN-Filo, 0.5 mL, NLT 0.7x108 Infectious units 0.5 mL, NLT 0.7x108 Infectious units Suspension for Injection Single dose Type I glass Vial, with a rubber stopper, aluminium crimp and red plastic cap for Zabdeno and with yellow plastic cap for Mvabea 48 Months IDT BIOLOGIKA GmbH, Am Pharmapark 06861 Dessau-Rosslau, Germany GERMANY JANSSEN-CILAG INTERNATIONAL NV, BELGIUM KIPHARMA LTD 2023-03-13 2028-03-12

3 Rwanda FDA-HMP-MA-1742 ZABITERON-250 Abiraterone Acetate USP 250 mg Tablets 120 Tablets HDPE BOTTLE WITH 1 SILICA GEL PUCH AND COTTON 24 Months ZUVIUS LIFESCIENCES PVT. LTD. B/108,109 & 111, Kanara Business Centre, Near Everest Garden, Link Road, Ghatkopar East), Mumbai-400075, India. Tel. No.: + 91 22 67653561 / +91 22 67653562 E-Mail: info@zuviuslifesciences.in INDIA ZUVIUS LIFESCIENCES PVT. LTD. KIPHARMA LTD 2024-08-17 2029-08-16

4 Rwanda FDA-HMP-MA-0855 ZAHA ORAL SUSPENSION Azithromycin Dihydrate USP, 200 mg/5 mL 200 mg/5 mL Suspension 15 ml Bottle Amber colored glass bottle along with a pack insert 24 Months AJANTA PHARMA LIMITED, 31-O, M.I.D.C, Area Chikalthana-431 210, Aurangabad, Maharashtra, India. INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-02-09 2029-02-08

5 Rwanda FDA-HMP-MA-0387 Zalain 300 mg ovule Each ovule contains 300mg of sertaconazole nitrate 300mg Ovule One ovule Carton box with one ovule in thermo PVC/PE 60 months, FERRER INTERNACIONAL, S.A., Gran Vía Carlos III, 94, 08028 Barcelona, Spain SPAIN FERRER INTERNACIONAL, S.A., SPAIN GOMHS LIMITED 2024-01-08 2029-01-07

6 RWANDA-FDA25/HM/0287/0007 Zapacid 30 LANSOPRAZOLE 30MG Hard Gelatin Capsules 24 Months Smilax Laboratories Ltd India Win-Medicare Private Limited Surgipharm Rwanda Ltd. 2026-02-05 2031-02-04

7 Rwanda FDA-HBP-MA- 0013 ZARZIO 30 MU/0.5 ML SOLUTION FOR INJECTION OR INFUSION IN PRE-FILLED SYRINGE Filgrastim 30 MU/0.5 mL 30 MU/0.5 mL Solution for injection or infusion 1, 3, 5 or 10 pre-filled syringes containing 0.5 ml solution 1, 3, 5 or 10 pre-filled syringes (type I glass) with injection needle (stainless steel), with or without a needle safety guard, containing 0.5 ml solution 36 Months SANDOZ GmbH Biochemiestr 10 A-6336 Langkampfen Austria AUSTRIA SANDOZ PHARMACEUTICALS D.D. SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

8 Rwanda FDA-HBP-MA- 0014 ZARZIO 48 MU/0.5 ML SOLUTION FOR INJECTION OR INFUSION IN PRE-FILLED SYRINGE Filgrastim 48 MU/0.5 mL 48 MU/0.5 mL Solution for injection or infusion 1, 3, 5 or 10 pre-filled syringes containing 0.5 ml solution 1, 3, 5 or 10 pre-filled syringes (type I glass) with injection needle (stainless steel), with or without a needle safety guard, containing 0.5 ml solution 36 Months SANDOZ GmbH Biochemiestr 10 A-6336 Langkampfen Austria AUSTRIA SANDOZ PHARMACEUTICALS D.D. SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

9 Rwanda FDA-HMP-MA-0595 ZEDCAL ORAL SUSPENSION Zinc Sulphate Monohydrate (2 mg), Calcium Carbonate (150 mg), Magnesium Hydroxide (25 mg), Vitamin D3 (200IU) 2 mg, 150 mg, 25 mg, 200IU Oral Suspension 200 ml Bottle PET bottle 36 Months MEYER ORGANICS PVT. LTD, 10 D, 2nd Phase, Peenya Ind. Area, Bangalore- 560 058, India INDIA MEYER ORGANICS PVT. LTD SUN ENTERPRISES LTD 2023-10-13 2028-10-12

10 Rwanda FDA-HMP-MA-1513 ZEE-1 LEVONORGESTREL BP 1.5MG TABLET 1X1 TABLET Alu/PVC Blister pack 36 Months CORONA REMEDIES PRIVATE LIMITED Village Jatoli, Post Office– Oachgha, Tehsil Solan, Dist. Solan Himachal Pradesh – 173223, India INDIA CORONA REMEDIES PRIVATE LIMITED SUN ENTERPRISES LTD 2024-07-27 2029-07-26

11 Rwanda FDA-HMP-MA-0626 ZEFCOLIN Dextromethorphan Hydrobromide 10mg, Phenylephrine Hydrochloride 5mg, Cetirizine Hydrochloride 5mg and Menthol 1.5mg 10mg, 5mg, 5mg and 1.5mg Syrup 100 ml Bottle Amber colour glass bottle with Aluminium ROPP Cap, Measuring Cup and with pack insert in a carton 24 Months 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

12 Rwanda FDA-HMP-MA-1077 ZEFONE-1000 Ceftriaxone Sodium 1000mg 1000 mg Dry powder for injection 10 ml glass vial Moulded clear glass vial, sealed with grey colored butyl rubber plugs with colored flip off seal 24 Months INJECT CARE PARENTERALS PVT. LTD, Plot. No. 130, Silvassa Road, G.I.D.C., Vapi-396195, India INDIA CADILA HEALTHCARE LTD ABACUS PHARMA (A) LTD 2024-04-20 2029-04-19

13 Rwanda FDA-HMP-MA-1524 ZENSALBU NEBULES 2.5 SALBUTAMOL SULFATE 2.5MG/2.5ML 2.5MG/2.5ML Solution for inhalation via a nebulizer 10, 20, 50 plastic ampoules of 2.5ml Plastic ampoule in aluminum bag. 36 Months HA NOI CPC1 PHARMACEUTICAL JOINT STOCK COMPANY Ha Binh Phuong Industrial Zone, Thuong Tin District, Hanoi City, Vietnam Vietnam AFRIPHARMA LTD AFRIPHARM LTD 2024-07-27 2029-07-26

14 RwandaFDA-HMP-MA-0524 ZENTEL SUSPENSION Albendazole 4% w/v 4% w/v Suspension 10 ml bottle HDPE bottles 24 Months ASPEN BAD OLDESLOE GmbH, Industriestrasse 32–36 23843 Bad Oldesloe, Germany. GERMANY GLAXOSMITHKLINE PHARMACEUTICAL KENYA LIMITED KIPHARMA LTD 2023-10-05 2028-10-04

15 Rwanda FDA-HMP-MA-1022 ZEPIN SYRUP Carbamazepine BP 100mg 100 mg Syrup 250 ml Bottle PET amber-coloured bottle packed in a carton box 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 LIMITED, INDIA SUN ENTERPRISES LTD 2024-02-28 2029-02-27

16 Rwanda FDA-HMP-MA-0748 ZEPIN-200 Carbamazepine BP 200 mg 200 mg Uncoated tablets 10 x 10 Tablets Blister Packs 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 2024-01-08 2029-01-07

17 Rwanda FDA-HMP-MA-1020 ZEPIN-400 Carbamazepine BP 400mg 400 mg Film-coated tablets 100 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 LIMITED, INDIA SUN ENTERPRISES LTD 2024-02-28 2029-02-27

18 RWANDA-FDA25/HM/0132/0037 ZERCYM ESOMEPRAZOLE 40 mg Lyophilized injection white powder or cake 24 Months EVEREST ORGANICS LIMITED India MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) Ltd 2025-10-16 2030-10-15

19 Rwanda FDA-HMP-MA-0217 ZIDOVUDINE ORAL SOLUTION USP 50 MG/5ML Zidovudine USP 50mg/5ml 50mg/5ml Colourless to pale yellow, strawberry flavoured liquid 240 ml HDPE Container HDPE Container 24 Months AUROBINDO PHARMA LIMITED Unit III, Sy. No. 313 & 314, Bachupally, Bachupally Mandal, Medchal-Malkajgiri District, Telangana State, India INDIA AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2023-01-25 2028-01-24

20 Rwanda FDA-HMP-MA-1949 ZIMAGRA -50 SILDENAFIL CITRATE 50MG TABLETS 1x4 Tablets ALU/PVC BLISTER 36 Months ZIM LABORATORIES LIMITED B-21/22, MIDC Area,Kalmeshwar, Nagpur 441501, Maharashtra State, India INDIA ZIM LABORATORIES LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

21 Rwanda FDA-HMP-MA-0906 ZIMAGRA 100 Sildenafil Tablet USP 100mg 100mg Film coated tablets 1 x 4 Tablets Alu-PVC Blister packed in carton along with pack insert 36 Months ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar, Nagpur 441501, Maharashtra State, India INDIA ZIM LABORATORIES LIMITED, INDIA SUN ENTERPRISES LTD 2024-02-22 2029-02-21

22 Rwanda FDA-HMP-MA-0100 ZIMAGRA ODS-50 Sildenafil Citrate 50 mg Oral Disintegrating Strips. 10 Sachets Pack In Carton. EACH STRIP PACKED IN ALUMINUM SACHET AND SUCH 24 Months ZIM LABORATORIES LIMITED. B-21/22, MIDC Area, Kalmeshwar, Nagpur 441501, Maharashtra State, India. INDIA ZIM LABORATORIES LIMITED/INDIA SUN ENTERPRISES LTD 2021-08-05 2026-08-05

23 Rwanda FDA-HMP-MA-1391 ZINC OXIDE OINTMENT Zinc Oxide USP 20% w/w 20% w/w Topical ointment 500gm jar 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 2024-05-18 2029-05-17

24 Rwanda FDA-HMP-MA-0224 ZINC SULFATE TABLETS USP 20MG Zinc Sulfate Monohydrate 20 mg 20 mg Uncoated Tablets 10x10 Tablets PVC/PVdC-Alu blister of 10 tablets, such 10 blisters in a carton along with the pack insert 48 Months MACLEODS PHARMACEUTICALS LIMITED Block N-2, Village: Theda, Post Office: Lodhimajra, Tehsil Baddi, Dist: Solan, Himachal Pradesh – 174 101, India INDIA MACLEODS PHARMACEUTICALS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

25 Rwanda FDA-HMP-MA-1842 ZINC SULPHATE DISPERSIBLE TABLETTS Zinc Sulfate Monohydrate 20mg Tablets 10x10 Tablets PVC/PRINTED ALUMINIUM FOIL 24 Months LABORATORY & ALLIED LIMITED Plot No. 209/10349, Opposite Sameer Business Park, Next to Libra House, Mombasa Road, P.O. Box 42875 GPO 00100, Nairobi, KENYA KENYA LABORATORY & ALLIED LIMITED DEPOT PHARMACEUTIQUE LE MEDICAL 2024-08-17 2029-08-16

26 Rwanda FDA-HMP-MA-1070 ZINCOL TABLETS Zinc (as sulphate), 20mg 20 mg Dispersible Tablets 10 × 10 tablets PVC/Aluminium blisters packed in dispenser carton 24 Months VARICHEM PHARMACEUTICALS (PVT) LTD, 194 Gleneagles Road, Willowvale, Harare, Zimbabwe ZIMBABWE VARICHEM PHARMACEUTICALS (PVT) LTD ACTIVIS PHARMA 2024-04-20 2029-04-19

27 Rwanda FDA-HMP-MA-1706 ZINCOS DISPERSIBLE TABLETS Zinc Sulfate Monohydrate 20 MG TABLETS 1X10 PVC/ALU blister 36 month Cosmos Limited Rangwe Road; Off Lunga Lunga Road, Industrial Area, P. O. Box 41433, GPO 00100 - Nairobi Kenya COSMOS LIMITED,Address: RANGWE ROAD; OFF LUNGA LUNGA ROAD, INDUSTRIAL AREA, P. O. BOX 41433, GPO 00100 - NAIROBI,Country: KENYA.Telephone: +(254-20) 8042200/2/3/4/5 +254(0) 709864000Telefax: +(254-20)8096280/1E-Mail: registration@cosmos-pharm.com SUN ENTERPRISES LTD 2024-08-17 2029-08-16

28 Rwanda FDA-HMP-MA-0422 ZINNAT GRANULES Cefuroxime Axetil, 125mg/5ml 125mg/5ml Granules for Oral Suspension 40 ml and 80 ml bottles Amber glass bottles with a closure containing a heat-seal induction membrane and a re-seal liner 24 Months GLAXO OPERATIONS UK LIMITED, Harmire Road, Barnard Castle, County Durham DL12 8DT, United Kingdom UNITED KINGDOM GLAXO SMITHKLINE PHARMACEUTICAL KENYA LIMITED KIPHARMA LTD 2023-08-24 2028-08-23

29 Rwanda FDA-HMP-MA-0641 ZINNAT TABLETS Cefuroxime Axetil, 250 mg 250 mg Film coated tablets 1X8’s Tablets Double foil blister pack comprising of a cold formed aluminium laminate base material and a hard tempered aluminium foil/heat seal lacquer lid 36 Months GLAXO OPERATIONS UK LIMITED (TRADING AS GLAXO WELLCOME OPERATIONS), Harmire Road, Barnard Castle, Durham, Dl12 8dt, United Kingdom UNITED KINGDOM GLAXOSMITHKLINE PHARMACEUTICAL KENYA LTD KIPHARMA LTD 2023-12-02 2028-12-01

30 Rwanda FDA-HMP-MA-0573 ZINNIA F Levonorgestrel 0.15 mcg and Ethinyl oestradiol 0.03 mcg Tablets with ferrous fumarate tablets 75 mg 0.15 mcg and 0.03 mcg, 75 mg Tablet 28 tablets PVC film blister coated with PVDC and foil made of Aluminum. 36 Months MYLAN LABORATORIES LIMITED, Plot No: 1606-1609, G.I.D.C, Sarigam, Tal-Umergam, Dist-Valsad_396155, Gujarat, India INDIA MYLAN LABORATORIES LIMITED PYRAMID PHARMA LTD 2023-10-05 2028-10-04

31 Rwanda FDA-HMP-MA-2217 ZINNIA P Levonorgestrel 0.15mg + Ethinylestradiol 0.03mg 150mcg + 30mcg tablets 28 Tablets Clear transparent PVC/PVdC-Alu blister cards 36 Months MYLAN LABORATORIES LIMITED Mylan Laboratories Limited Plot No. 1606-1609, G. I. D.C. Sarigam, Dist. Valsad, Gujrat, India.396155 India MYLAN LABORATORIES LIMITED Pyramid Pharma Limited 2025-02-04 2030-02-03

32 RWANDA-FDA24/HM/0140/0027 ZINRO ORNIDAZOLE 0.5%W/V Solution for infusion. 100 ml 36 Months Zhejiang Supour Pharmaceutical Co. Ltd China Abacus Parenteral Drugs Limited ABACUS PHARMA (A) Ltd 2025-10-16 2030-10-15

33 Rwanda FDA-HMP-MA-1818 ZIQUANTA Praziquantel USP 600mg Tablets 1x6’s and 10x10’s , 6’s, 100’s, 500’s, 1000’s Tablets ALU-ALU BLISTERS, AND HDPE CONTAINER PACK 24 Months HETERO LABS LIMITED (Unit -V) Survey No. 439, 440, 441 & 458, TSIIC-Formulation SEZ, Polepally (Village), Jadcherla (Mandal), Mahaboob Nagar (Dist) Telangana State, India – 509301 Manufacturing location/Block - VA INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

34 Rwanda FDA-HMP-MA-0308 ZIRIN Cetirizine Dihydrochloride 10mg 10mg Soft gelatin capsules 5 x 10 softgel capsules Alu-PVC/PVDC blisters packed in a catch cover, contained in a unit carton with a leaflet 24 Months, MEGA LIFESCIENCES PUBLIC COMPANY LIMITED, 384 MOO 4, SOI 6, BANG POO Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280. Thailand THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED GOMHS LTD 2023-05-12 2028-05-11

35 Rwanda FDA-HMP-MA-1782 ZIROMIN Azithromycin dehydrate 500mg Tablets 3 Tablets ALU-PVC/PVDC BLISTER 36 Months WORLD MEDICINE ILAC SAN. VE TIC.A.S 15 Temmuz Mah. Cami Yolu Cad. No:50, Güne?li, Ba?c?lar Post code: 34212, ?stanbul ,TURKEY TURKEY WORLD MEDICINE ILAC SAN. VE TIC.A.S GOODMAN INTERNATIONAL (R) LTD 2024-08-17 2029-08-16

36 Rwanda FDA-HMP-MA-1850 ZIROMIN POWDER FOR ORAL SUSPENSION Azithromycin dehydrate 200mg/5ml Powder for oral suspension 60ml Bottle HDPE BOTTLE 36 Months WORLD MEDICINE ILAC SAN. VE TIC.A.S . 15 Temmuz Mah. Cami Yolu Cad. No:50, Güne?li, Ba?c?lar Post code: 34212, ?stanbul ,TURKEY TURKEY WORLD MEDICINE ILAC SAN. VE TIC.A.S . GOODMAN INTERNATIONAL (R) LTD 2024-08-17 2029-08-16

37 Rwanda FDA-HMP-MA-0704 ZITHROCARE 500 Azithromycin dehydrate 500mg 500mg Film coated tablets 3x10’s tablets Alu/Alu blister pack of 3x10’s tablets in a carton 36 Months MEYER ORGANICS PVT. LTD, A-177, Road No: 16-Z, Wagle Estate, Thane-400604(Mumbai), INDIA INDIA MEYER ORGANICS PVT. LTD SUN ENTERPRISES LTD 2023-12-30 2028-12-29

38 Rwanda FDA-HMP-MA-1059 ZITHROCARE-200 SUSPENSION Azithromycin USP 200 mg 200 mg Suspension 15 ml Bottle Amber Coloured Glass Bottle with pilfer proof cap and EPE liner packed with a printed carton 36 Months MEYER ORGANICS PVT. LTD, 10 D, IInd Phase, Peenya Industrial Area, Bangalore, 560 058, A-303, Road No.32, Wagle Estate, Thane 400604 (Mumbai), India. INDIA MEYER ORGANICS PVT. LTD SUN ENTERPRISES LTD 2024-02-23 2029-02-22

39 Rwanda FDA-HMP-MA-1065 ZITHROX 500MG Azithromycin 500mg 500mg Film Coated Tablet 3 Tablets PVDC/Aluminium Blister packed in a carton 48 Months COSMOS LIMITED, Rangwe Road; Off Lunga Lunga Road, Industrial Area, Nairobi, Kenya KENYA COSMOS LIMITED, KENYA SUN ENTERPRISES LTD 2024-02-23 2029-02-22

40 Rwanda FDA-HMP-MA-0940 ZITHROX DRY POWDER FOR SUSPENSION Azithromycin 200mg/5ml 200mg/5ml Granular powder 60mL Bottle Amber Glass Bottle, with a 15ml plastic measuring cup, in a carton box 48 Months COSMOS LIMITED, Rangwe Road, Off Lunga Lunga Road, Industrial Area, P. O. Box 41433, GPO 00100 Nairobi, Kenya KENYA COSMOS LIMITED, KENYA SUN ENTERPRISES LTD 2024-02-21 2029-02-20

41 Rwanda FDA-HMP-MA-0077 ZITO SUSPENSION Azithromycin Dihydrate 200mg Powder For Oral Suspension 15 Ml HDPE BOTTLE 36 Months ZIM LABORATORIES LIMITED B-21/22, MIDC Area, Kalmeshwar, Nagpur 441501, Maharashtra State, India. INDIA ZIM LABORATORIES LIMITED/INDIA SUN ENTERPRISES LTD 2021-08-05 2026-08-05

42 Rwanda FDA-HMP-MA-0076 ZITO-500 Azithromycin 500 mg Film Coated Tablets 1x3 Tablets ALU-PVC BLISTER PACK. 36 Months ZIM LABORATORIES LIMITED B-21/22, MIDC Area, Kalmeshwar, Nagpur 441501, Maharashtra State, India. INDIA ZIM LABORATORIES LIMITED/INDIA SUN ENTERPRISES LTD 2021-08-05 2026-08-05

43 20-4363-DGC&PHS-2018-R1 ZOEGAS-20 Esomeprazole 20 mg Capsules Box/7, Box/14, Box/28 ALU/PVC FILM BLISTER PACK/CARTON 36 Months LABORATOIRES COOPER PHARMA Route 107km 2,5 Douar Ouled Sidi Abbou Tit Mellil , CASABLANCA-MOROCCO -MOROCCO MOROCCO LABORATOIRES COOPER PHARMA MD CONSEIL MEDICAL SUPPLY LTD 2024-08-17 2029-08-16

44 20-4364-DGC&PHS-2018-R1 ZOEGAS-40 Esomeprazole 40 mg Capsules Box/7, Box/14, Box/28 ALU/PVC/ALU BLISTER 24 Months LABORATOIRES COOPER PHARMA Route 107km 2,5 Douar Ouled Sidi Abbou Tit Mellil , CASABLANCA-MOROCCO MOROCCO LABORATOIRES COOPER PHARMA MD CONSEIL MEDICAL SUPPLY LTD 2024-08-17 2029-08-16

45 Rwanda FDA-HMP-MA-0451 ZOLADEX 10.8 MG Goserelin Acetate 10.8 mg 10.8 mg Implant 1 prefilled syringe Prefilled syringe per carton 36 Months AstraZeneca UK Limited, Silk road business Park Macclesfield, Cheshire, SK10 2NA United Kingdom UNITED KINGDOM AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2023-12-02 2028-12-01

46 Rwanda FDA-HMP-MA-0452 ZOLADEX 3.6 MG Goserelin Acetate 3.6 mg 3.6 mg Implant 1 prefilled syringe Prefilled syringe per carton 36 Months AstraZeneca UK Limited, Silk road business Park Macclesfield, Cheshire, SK10 2NA United Kingdom UNITED KINGDOM AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2023-12-02 2028-12-01

47 Rwanda FDA-HMP-MA-0309 ZOLCER KIT Omeprazole USP 20mg, Tinidazole BP 500mg, Clarithromycin USP 250mg 20mg, 500mg, 250mg Capsules, tablets, 7x 2 capsules of omeprazole /2 tablets each of Tinidazole & Clarithromycin Blister pack & 7 such kit in a Carton 24 Months AUROCHEM LABORATORIES (INDIA) PVT. LTD. Plot No.8, Palghar Taluka, Industrial Co.-op. Estate Ltd. Palghar – 401 404, District Thane, Maharashtra, INDIA INDIA AUROCHEM LABORATORIES (INDIA) PVT. LTD MULTIPHAR UBIPHARM-RWANDA LTD 2023-05-12 2028-05-11

48 Rwanda FDA-HMP-MA-1994 ZOLDRO Zoledronic Acid monohydrate for Injection 4 mg/vial Injection 1’s Pack: 12 ml tubular vial 4 mg/Vial tubular vial 4 mg/Vial 24 months Aspiro Pharma Limited Aspiro Pharma Limited Address: Survey No.321, Biotech Park, Phase III, Karkapatla, Markook Mandal, Siddipet District, Telangana (S)- 5002281, INDIA INDIA Aspiro Pharma Limited BION PHARMA GROUP LTD 2024-08-17 2029-08-16

49 Rwanda FDA-HMP-MA-0777 ZOLEDRA Zoledronic Acid monohydrate 4.26mg (4mg on Anhydrous) 4mg Powder for solution for infusion 1 vial of 15ml Type I glass vial of 15 ml, Unit pack containing 1 vial 24 Months LES LABORATOIRES MÉDIS, Km 7 route de Tunis, BP 206 8000 Nabeul, Tunisia TUNISIA LES LABORATOIRES MÉDIS, TUNISIA KIPHARMA LTD 2023-12-30 2028-12-29

50 Rwanda FDA-HMP-MA-2255 ZOLID Linezolid 600 mg Tablets 1x10 Tablets Alu- Alu 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 2025-02-04 2030-02-03

51 Rwanda FDA-HMP-MA-1825 ZOSEC CAPSULES Omeprazole 20mg Capsules 1X10 & 10X10 Capsules ALUMINIUM STRIP 24 Months EMCURE PHARMACEUTICAL LIMITED Lane No. 3, Phase-II, SIDCO Industrial Complex, Bari-Brahmana, Jammu – 181 133, India INDIA EMCURE PHARMACEUTICAL LIMITED ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

52 Rwanda FDA-HMP-MA-0103 ZYCEL 100 Celecoxib 100mg Capsule 1x10 Hard Gelatin Capsules ALU/ALU BLISTER PACK 36 Months CADILA HEALTHCARE LIMITED Kundaim Industrial Estate, Plot 203-213, Kundaim, GOA – 403 115, India. INDIA CADILA HEALTHCARE LIMITED ABACUS PHARMA (A) LTD 2022-03-22 2027-03-22

53 Rwanda FDA-HMP-MA-0102 ZYCEL 200 Celecoxib 200mg Capsule 1x10 Hard Gelatin Capsules ALU/ALU BLISTER PACK 36 Months CADILA HEALTHCARE LIMITED Kundaim Industrial Estate, Plot 203-213, Kundaim, GOA – 403 115, India. INDIA CADILA HEALTHCARE LIMITED ABACUS PHARMA (A) LTD 2022-03-22 2027-03-22

54 Rwanda FDA-HMP-MA-2127 ZYFORGE 10/160 Amlodipine and Valsartan USP 10mg / 160mg Tablets 3x10 tablets Alu-Alu Blisters pack 24 Months ZYDUS LIFESCIENCES LIMITED Kundaim Industrial Estate, Plot No.203-213, Kundaim, Goa 403 115, India India ZYDUS LIFESCIENCES LIMITED ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

55 Rwanda FDA-HMP-MA-2126 ZYFORGE 5/160 Amlodipine and Valsartan USP 5mg / 160mg Tablets 3x10 Tablets Alu-Alu Blisters pack 24 Months ZYDUS LIFESCIENCES LIMITED Kundaim Industrial Estate, Plot No.203-213, Kundaim, Goa 403 115, India India ZYDUS LIFESCIENCES LIMITED ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

56 Rwanda FDA-HMP-MA-2125 ZYFORGE 5/80 Amlodipine and Valsartan Tablets USP 5mg / 80mg Tablets 10’s (3x10 Tablets) Alu-Alu blisters 24 Months ZYDUS LIFESCIENCES LIMITED Kundaim Industrial Estate, Plot No.203-213, Kundaim, Goa 403 115, India India ZYDUS LIFESCIENCES LIMITED ABACUS PHARMA (A) LTD 2024-10-18 2029-10-17

57 Rwanda FDA-HMP-MA-0932 ZYLORIC TABLETS Allopurinol 100mg 100 mg Tablets 28 Tablets PVC/aluminium foil blister pack 60 Months ASPEN BAD OLDESLOE GmbH, Industriestrasse 32-36, D-23843 bad oldesloe, Germany GERMANY BETA HEALTHCARE INTERNATIONAL LTD SURGIPHARM (RWANDA) LIMITED 2024-02-21 2029-02-20

58 Rwanda FDA-HMP-MA-2161 ZYLORIC-200 ALLOPURINOL 200MG TABLET 28 Tablets polyvinyl chloride (PVC)/aluminium foil blister 60 Months Aspen Bad Oldesloe GmbH Industriestrasse 32-36 Physical Address: D-23843 Bad Oldesloe Germany Beta Healthcare International, Plot No. L.R 209/6554 Mogadishu Road, Industrial Area, Nairobi, Kenya SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16

59 Rwanda FDA-HMP-MA-0105 ZYROVA 10 Rosuvastatin Calcium Ph. Eur. 10mg Biconvex Beveled Edged Film Coated Tablets 3 X 10 Tablets ALU-ALU BLISTER PACK 24 Months CADILA HEALTHCARE LIMITED Kundaim Industrial Estate, Plot 203-213, Kundaim, GOA – 403 115, India. INDIA CADILA HEALTHCARE LIMITED ABACUS PHARMA (A) LTD 2022-03-22 2027-03-22

60 Rwanda FDA-HMP-MA-0104 ZYROVA 20 Rosuvastatin Calcium Ph. Eur. 20mg Biconvex Beveled Edged Film Coated Tablets 3 X 10 Tablets ALU-ALU BLISTER PACK 24 Months CADILA HEALTHCARE LIMITED Kundaim Industrial Estate, Plot 203-213, Kundaim, GOA – 403 115, India. INDIA CADILA HEALTHCARE LIMITED ABACUS PHARMA (A) LTD 2022-03-22 2027-03-22

61 Rwanda FDA-HMP-MA-0995 ZYRTEC TABLETS Cetirizine dihydrochloride 10 mg 10 mg Film coated tablet 10 tablets PVC/Aluminium blister packs 60 Months UCB FARCHIM SA, Z.I. de Planchy, 10, Chemin de Croix Blanche, 1630 Bulle Switzerland. SWITZERLAND GLAXOSMITHKLINE PHARMACEUTICAL KENYA LIMITED KIPHARMA LTD 2024-02-26 2029-02-25