HUMAN MEDICINAL PRODUCTS REGISTER

HUMAN MEDICINE REGISTERED PRODUCTS

Search Box: A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z| All




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-2055 A-CERUMEN EAR HYGIENE SOLUTION IN SPRAY SOLUTION OF SODIUM ACYL SARCOSINATE SUCROSE LAURATE SOLUTION 15%, 5% EAR DROPS 40 ml Bottle HDPE Bottle 36 Months LABORATOIRES GILBERT 928 avenue du General de Gaulle, France, Tel. +33608663386Fax. +33231439500E-mail: ar-exp-dossier@labogilbert.fr FRANCE LABORATOIRES GILBERT GOMHS Ltd 2024-09-30 2029-09-29

2 Rwanda FDA-HMP-MA-2054 A-CERUMEN EAR HYGIENE SOLUTION IN UNIDOSE SOLUTION OF SODIUM ACYL SARCOSINATE, SUCROSE LAURATE SOLUTION 15%, 5% EAR DROPS 10x2ml Doses Polyethylene low density unidose bottelpack container 36 Months LABORATOIRES GILBERT Avenue du general de gaulle 14200 Herouville Saint- Clair France FRANCE LABORATOIRES GILBERT GOHMS LTD 2024-09-30 2029-09-29

3 RWANDA-FDA25/HM/0134/0017 Aarciflox-500 Ciprofloxacin USP 500 mg Film-coated tablets, 36 Months AARTI DRUGS LIMITED. India. PINNACLE LIFESCIENCES PVT. LTD. ABACUS PHARMA (A) Ltd 2026-02-05 2031-02-04

4 Rwanda FDA-HMP-MA-0070 ABACAVIR (AS SULFATE) AND LAMIVUDINE Abacavir, Lamivudine 120 mg, 60 mg Tablet 30 Tablets, 60 Tablets 50CC HDPE CONTAINER, 85CC HDPE CONTAINER 36 Months CIPLA LTD Plot No A – 33, A – 2 (Unit – I), MIDC, Patalganga District Raigad, Maharashtra and Plot No A - 42 (Unit-II), MIDC, Patalganga, District Raigad, India INDIA CIPLA LTD PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2021-06-01 2026-06-01

5 Rwanda FDA-HMP-MA-0134 ABACAVIR (AS SULFATE)/LAMIVUDINE 120MG/60MG DISPERSIBLE TABLETS. Abacavir Sulfate USP 120mg/Lamivudine USP 60mg 120mg/60mg Biconvex tablets 30’s tablets HDPE bottle 36 Months MYLAN LABORATORIES LIMITED, F-4 & F-12, MIDC, Malegaon, Sinnar, Nashik-422 113, Maharashtra, India and Plot No. 11,12 & 13 Indore SEZ, Phase-II, Sector-III, Pithampur-454775, Dist.-Dhar, M.P., India INDIA MYLAN LABORATORIES LIMITED, INDIA PYRAMID PHARMA LIMITED 2022-12-19 2027-12-18

6 Rwanda FDA-HMP-MA-1105 ABACAVIR 600 MG AND LAMIVUDINE 300 MG TABLETS Abacavir Sulfate USP 600mg, Lamivudine USP 300mg 600 mg and 300 mg Film-coated tablets 30 tablets HDPE container 24 Months MACLEODS PHARMACEUTICALS LTD. Block N-2, Village Theda, Post Office Lodhimajra, Tehsil Baddi, Dist. Solan, Himachal Pradesh – 174101 India INDIA MACLEODS PHARMACEUTICALS LTD AIVEEN RWANDA LIMITED 2024-04-20 2029-04-19

7 Rwanda FDA-HMP-MA-1848 ABACAVIR AND LAMIVUDINE DISPERSIBLE TABLETS Abacavir sulphate USP , Lamivudine USP 120mg/60mg Tablets 30 Tablets HDPE BOTTLE 24 Months MICRO LABS LIMITED Plot No. S-155 to S-159 & N1, Phase III & IV, Verna. Industrial Estate, Verna Salcette Goa - 403722 INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS RWANDA LTD 2024-08-17 2029-08-16

8 Rwanda FDA-HMP-MA-0936 ABACAVIR AND LAMIVUDINE TABLETS 600MG/300MG Abacavir Sulphate and Lamivudine USP 600mg/300mg 600mg/300mg Film-Coated Tablets 30 Tablets, 90 Tablets and 180 Tablets HDPE Bottles 24 Months LAURUS LABS LIMITED, (Unit-II), Plot No: 19, 20 & 21, Western Sector, APSEZ, Atchutapuram Mandal, Visakhapatnam District, Andhra Pradesh, 531011 India. INDIA LAURUS LABS LIMITED CAPITAL PHARMACEUTICAL SUPPLIES LIMITED 2024-02-26 2029-02-25

9 Rwanda FDA-HMP-MA-0339 ABACAVIR SULFATE AND LAMIVUDINE Abacavir Sulfate 60mg and Lamivudine 30mg 60mg and 30mg Uncoated tablets 60 tablets HDPE container 36 Months CIPLA LIMITED, Patalganga Plot No A - 42 (UnitII), MIDC, Patalganga, District Raigad, India INDIA CIPLA LTD, INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2023-06-26 2028-06-25

10 Rwanda FDA-HMP-MA-1910 Abacavir Sulfate and Lamivudine Tablets 600/300mg Abacavir Sulfate and Lamivudine 600mg/300mg Tablets 30\\\'s HDPE Container 24 months Hetero Labs Limited Hetero Labs Limited Address : TSIIC Formulation SEZ, S.No 439, 440, 441 & 458 Polepally village, Jadcherla Mandal, Mahaboob Nagar (Dist) –509301, Telangana. Country : India Telephone : +91-8542-238400 Telefax: +91-8542 238404 INDIA Hetero Labs Limited Address : Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad – 500 018, Telangana. SUN ENTREPRISE LTD 2024-08-17 2029-08-16

11 Rwanda FDA-HMP-MA-0122 ABACAVIR SULFATE/LAMIVUDINE TABLETS USP 600 MG/300 MG Abacavir Sulfate 600 mg/Lamivudine 300 mg 600 mg/ 300 mg Film Coated Tablets 30’s Tablets HDPE BOTTLE 48 Months MYLAN LABORATORIES LIMITED, F-4 & F-12, MIDC, Malegaon, Sinnar, Nashik-422 113, Maharashtra, India and Mylan Laboratories Limited, Plot No. 11,12 & 13 Indore SEZ, Phase-II, Sector-III, Pithampur-454775, Dist.-Dhar, M.P., India INDIA MYLAN LABORATORIES LIMITED, INDIA PYRAMID PHARMA LIMITED 2022-12-19 2027-12-18

12 RWANDA-FDA25/HM/0312/0045 Abacavir, Dolutegravir and Lamivudine Abacavir, Dolutegravir and Lamivudine tablets 60/5/30 mg Dispersible tablet 30 tablets and 90 tablets 24 Months Laurus Labs Limited, India CIPLA LTD INDIA Phillips Pharmaceuticals Rwanda 2025-12-12 2030-12-11

13 RWANDA-FDA25/HM/0051/0041 Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension 60mg/5mg/30mg Abacavir, Dolutegravir and Lamivudine 60mg/5mg/30mg TABLET FOR ORAL SUSPENSION 30's; 60's; 90's; 120's and 180's 36 Months Laurus Labs Limited, India Lupin Limited AIVEEN (R) LTD 2025-12-12 2030-12-11

14 Rwanda FDA-HMP-MA-2018 ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE 60/5/30MG TABLETS 30 tablets & 90 Tablets HDPE Bottle 24 Months CIPLA LTD Unit IV, Plot No. 9 & 10, Pharma Zone, Phase-II, Indore Special Economic Zone, Pithampur, Sector – III, District Dhar, Indore, Madya Pradesh, 454775 INDIA CIPLA LTD Phillips Pharmaceuticals (Rwanda) Ltd 2024-08-17 2029-08-16

15 Rwanda FDA-HMP-MA-1453 ABACAVIR,DOLUTEGRAVIR AND LAMUVIDINE ABACAVIR,DOLUTEGRAVIR AND LAMUVIDINE 600MG/50MG/300MG Film Coated Tablets 30 Tablets HDPE Bottle of 30’s count Container (120 CC) ii) 38 mm – 400 CR Closure with Tekniplex HS 123 induction sealing wad iii) 3 numbers of 1g molecular sieve canister 24 Months LAURUS LABS LIMITED (Unit-II), Plot No: 19, 20 & 21, Western Sector, APSEZ, Atchutapuram Mandal, Visakhapatnam District 531011, Andhra Pradesh, India INDIA LAURUS LABS LIMITED CAPITAL PHARMACEUTICALS SUPPLIES LTD 2024-07-27 2029-07-26

16 1073-Rwanda FDA-2019-R1 ABACAVIR/LAMIVUDINE-600/300 Abacavir, Lamivudine 600, 300mg Tablets 30 Tablets HDPE BOTTLE 36 Months AUROBINDO PHARMA LIMITED Unit-III, Survey No. 313, Bachupally village, Bachupallapur Mandal, Ranga Reddy District (A.P), INDIA INDIA AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16

17 Rwanda FDA-HMP-MA-0541 ABACOFF COUGH SYRUP Diphenhydramine Hydrochloride BP, Ammonium Chloride BP, Sodium Citrate BP & Menthol USP 14.08mg, 138mg, 57.03mg, 0.900mg Syrup 100 ml Bottle Amber bottle having 25 mm "LPL" logo Printed Aluminium P.P. Cap & 10 ml measuring cup 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12

18 Rwanda FDA-HMP-MA-0413 ABAGYL Metronidazole Intravenous Infusion 0.5 % w/v B.P. 0.5 % w/v Solution for Infusion 100 ml Bottle LDPE (Low Density Polyethylene) bottles of 100 ml which are flow wrapped in BOPP (Polypropylene bags). The final product is packed in corrugated boxes 24 Months ABACUS PARENTERAL DRUGS LTD (APDL) BLOCK 191, PLOT NO.114, KINGA MUKONO, P.O.BOX 31376, KAMPALA, UGANDA UGANDA ABACUS PARENTERAL DRUGS LTD (APDL), UGANDA ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

19 Rwanda FDA-HMP-MA-1186 ABBORI EAR DROPS Boric acid B.P equivalent to Boric acid 1.83%w/v Otic Solution 5ml & 10ml ampoules Sealed transparent low density polyethylene plastic ampoules, packed in mono baby cartons ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O.Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2024-05-06 2029-05-05

20 Rwanda FDA-HMP-MA-0455 ABCHLOR EAR DROPS Chloramphenicol B.P 0.5% W/V + Phenyl mercuric Nitrate B.P 0.002%W/V 0.5% W/V + 0.002%W/V Ophthalmic solution 5 ml and 10 ml vial LDPE vial and in carton 36 Months, 28 days after opening ABACUS PARENTERAL DRUGS LTD (APDL) Block 191, Plot NO.114, Kinga Mukono Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL)/ UGANDA ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

21 Rwanda FDA-HMP-MA-0454 ABCHLOR EYE DROPS Chloramphenicol B.P 0.5% W/V + Phenyl mercuric Nitrate B.P 0.002%W/V 0.5% W/V + 0.002%W/V Eye drop solution 5ml and 10ml LDPE container and in carton 36 months ABACUS PARENTERAL DRUGS LTD (APDL) Block 191, Plot No.114, Kinga Mukono Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL)/ UGANDA ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

22 Rwanda FDA-HMP-MA-0522 ABCROM EYE DROPS Sodium Cromoglicate eye drops 2.0%w/v 2.0%w/v Ophthalmic solution 5ml & 10ml Vials Clear colourless LDPE vials 24 Months ABACUS PARENTERAL DRUGS LTD (APDL) Block 191, Plot No.114, Kinga Mukono P.O Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12

23 Rwanda FDA-HMP-MA-1791 ABDOL-500 Paracetamol 500 mg Tablets 10x10 Tablets ALUMINIUM FOIL PVC 36 Months JIANGSU PENGYAO PHARMACEUTICALS Co LTD No.10, Chaquan road, Yixing city, Jiangsu Province, P.R CHINA FARMASINO Co LTD ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

24 Rwanda FDA-HMP-MA-0419 ABGENTA Eye/Ear drops Gentamicin sulphate Eye/Ear drops 0.3% w/v BP 0.3% w/v Ophthalmic and otic clear, faintly yellow solution 10 ml bottles LDPE bottles with a screw cap which is then packed in a mono-carton 36 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot no.114, Kinga Mukono, P.O.BOX 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-09-06 2028-09-05

25 Rwanda FDA-HMP-MA-1766 ABIRAT 500 Abiraterone Acetate USP 500mg Tablets 60 Tablets HDPE CONTAINER 24 Months M/S 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

26 Rwanda FDA-HMP-MA-2060 ABIRAT 250 Abiraterone Acetate Tablets USP 250 mg TABLETS 120 Tablets HDPE container pack 24 Months HETERO LABS LIMITED Hetero Labs Limited, Unit V Address: 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 2024-09-30 2029-09-29

27 Rwanda FDA-HMP-MA-2249 ABLADO Abacavir sulfate, Dolutegravir sodium and Lamivudine 600 mg /50 mg /300 mg Tablets 30 Tablets HDPE Container 36 Months APL HEALTHCARE LIMITED (SUBSIDIARY OF AUROBINDO PHARMA LTD) Unit-IV, Plot No 16, APIIC, Multi Products SEZ, Menakuru Village, Naidupeta Mandal, Tirupati District, Andhra Pradesh, India INDIA AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2025-02-04 2030-02-03

28 Rwanda FDA-HMP-MA-2145 ABLADO DT ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM AND LAMIVUDINE 60 MG / 5 MG / 30 MG TABLETS 90\'s & 180’s HDPE Container 24 Months APL Healthcare Limited Unit-IV, Plot No 16, APIIC, Multi Products SEZ, Menakuru Village, Naidupeta Mandal, Tirupati District, Andhra Pradesh, India INDIA AUROBINDO PHARMA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-10-18 2029-10-17

29 Rwanda FDA-HMP-MA-2185 ABLEPT-300 GABAPENTINE 300MG CAPSULES 3x10 Capsules Alu/Alu Blister pack 36 Months MICRO LABS LIMITED 92, Sipcot, Industrial Complex, Hosur-635126, Tamil Nadu, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2025-01-09 2030-01-08

30 Rwanda FDA-HMP-MA-1286 ABLEVOX Levofloxacin Hemihydrate 0.5 %w/v 0.5 %w/v Solution for infusion 100ml bottles LDPE (Low Density Polyethylene) bottles 24 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL), UGANDA ABACUS PHARMA (A) LTD 2024-05-07 2029-05-06

31 Rwanda FDA-HMP-MA-1548 ABLOL-5 Timolol maleate 0.5% W/V EYE DROPS 10ml Bottle LDPE bottles packed in a printed carton 36 Months ABACUS PARENTERAL DRUGS LTD (APDL) Block 191, Plot No. 114, Kinga Mukono P. O. Box 31376, Kampala, Uganda Uganda ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2024-07-27 2029-07-26

32 Rwanda FDA-HMP-MA-0481 ABNAL NASAL DROPS Sodium Chloride 0.9 % w/v 0.9 % w/v A clear colourless solution 1x10 ml bottle LDPE bottle 24 Months ABACUS PARENTERAL DRUGS LTD (APDL) Address: Block 191, Plot No.114, Kinga Mukono P.O.Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

33 Rwanda FDA-HMP-MA-0506 ABPARA Paracetamol 1.0% W/V 1.0% W/V Solution for infusion 100ml Bottles LDPE Bottles 24 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O. Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-10-05 2028-10-04

34 Rwanda FDA-HMP-MA-0707 ABTOL Mannitol 20% w/v 20% w/v Solution 100ml Bottles LDPE Bottles 36 Months ABACUS PARENTERAL DRUGS LTD (APDL), Block 191, Plot No.114, Kinga Mukono P.O.Box 31376, Kampala, Uganda UGANDA ABACUS PARENTERAL DRUGS LTD (APDL) ABACUS PHARMA (A) LTD 2023-12-30 2028-12-29

35 Rwanda FDA-HMP-MA-0492 ACEFORCE SP Aceclofenac 100mg, Paracetamol 325mg & Serratiopeptidase 15mg Tablets 100mg, 325mg & 15mg Film-coated tablets 10x10 tablets Alu/Alu blister, and such 10 blisters are packed in a printed carton 24 Months AKUMS DRUGS & PHARMACEUTICALS LTD. 19, 20 & 21 Sector 6A, IIE, SIDCUL, Ranipur, Haridwar-249403, Uttarakhand, India INDIA UNOSOURCE PHARMA LTD, INDIA ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12

36 Rwanda FDA-HMP-MA-1927 ACEM-500 CLARITHROMYCIN USP 500MG TABLETS 1x10 Tablets ALU/PVC BLISTER 24 Months EMCURE PHARMACETICALS LTD Lane No. 3. Phase-II, SIDCO Industrial Complex, Bari – Brahmana, Jammu (J&K) – 181133 INDIA INDIA EMCURE PHARMACETICALS LTD ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

37 Rwanda FDA-HMP-MA-1037 ACEPAR CAPLETS Paracetamol BP 500mg and Aceclofenac BP 100mg 500mg/100mg Tablets 1x10s Tablets ALU–ALU Blister Pack and Carton 36 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Road, Ruaraka. P.O. Box 16633-00620, Nairobi, Kenya. KENYA DAWA LIMITED, KENYA. SUN ENTERPRISE LTD 2024-02-28 2029-02-27

38 Rwanda FDA-HMP-MA-1036 ACEPAR MR CAPLETS Paracetamol 500 mg, Aceclofenac 100 mg and Chlorzoxazone 375 mg 500mg/100mg/375mg Film Coated Caplets 1x10 Caplets Alu–Alu Blister Pack 36 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Road, Ruaraka. P.O. Box 16633-00620, Nairobi, Kenya. KENYA DAWA LIMITED, KENYA SUN ENTERPRISE LTD 2024-02-28 2029-02-27

39 Rwanda FDA-HMP-MA-0433 ACICLOVIR 200MG Aciclovir 200mg 200mg Tablets 25 tablets PVC/PVDC/Aluminium blisters 48 Months DENK PHARMA GmbH & Co. KG Göllstr. 184529 Tittmoning, Germany GERMANY Denk Pharma GmbH & Co. KG ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-08-24 2028-08-23

40 Rwanda FDA-HMP-MA-1658 ACINET 625 Amoxicillin Trihydrate USP and Clavulanate Potassium USP 500mg/125mg TABLETS 10 tablets Alu-Alu blister 24 Months INDCHEMIE HEALTH SPECIALITIES PVT. LTD Village -Than, Tehsil – Baddi, Dist. – Solan, Himachal Pradesh – 173 205, India INDIA CACHET PHARMACEUTICALS PVT. LTD Wessex Pharmaceutical (Rwanda) Ltd 2024-08-17 2029-08-16

41 Rwanda FDA-HMP-MA-1227 ACINET DRY SYRUP 156.25 MG/ML Amoxicillin 125 mg and Clavulanate Potassium 156.25 mg/ml Powder for Oral Suspension 100 ml Bottle Amber glass bottle 24 Months INDCHEMIE HEALTH SPECIALITIES PVT. LTD. Village – Than, Tehsil –Baddi, Dist. – Solan, Himachal Pradesh – 173 205, India INDIA CACHET PHARMACEUTICALS PVT. LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LIMITED 2024-05-06 2029-05-05

42 Rwanda FDA-HMP-MA-0368 ACNESOL CREAM Tretinoin 0.5mg 0.5mg Cream 25gm Collapsible aluminium tube which are then packed in unit boxes 36 Months M/s UNIVERSAL CORPORATION LIMITED Address: P.O. Box 1748-00902, Kikuyu - Kenya. KENYA UNIVERSAL CORPORATION LIMITED SUN ENTERPRISES LTD 2023-07-08 2028-07-07

43 Rwanda FDA-HMP-MA-0123 ACNOTIN 20 Isotretinoin 20 mg 20 mg Soft Gelatin Shell Capsules 3 X 10 Soft Gel Capsules ALU-ALU Aluminum Foil Blisters 24 Months MEGA LIFESCIENCES PUBLIC COMPANY LIMITED, 384 Moo 4, Soi 6, Bangpoo Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280, Thailand THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

44 Rwanda FDA-HMP-MA-0215 ACNOTIN-10 Isotretinoin 10mg 10mg Soft gelatin capsules 3 x 10 soft gelatin capsules ALU-ALU Aluminum foil blisters 24 Months MEGA LIFESCIENCES Public Company Ltd. Address: 384 Moo 4, Soi 6, Bangpoo Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280, Thailand THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LTD ABACUS PHARMA (A) LTD 2023-01-25 2028-01-24

45 Rwanda FDA-HMP-MA-0410 ACRIPTEGA Lamivudine, Tenofovir disoproxil fumarate and Dolutegravir Tablets 300 mg/300 mg/50 mg 300 mg/300 mg/50 mg Tablets 30's, 90's and 180's Tablets HDPE Bottle pack 24 Months MYLAN LABORATORIES LIMITED. Plot No.1l, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase-ll, Sector-lll, Pithampur -45477 5. Dist. Dhar, Madhya Pradesh, India INDIA MYLAN LABORATORIES LIMITED. INDIA PYRAMID PHARMA LIMITED 2023-10-13 2028-10-12

46 RwandaFDA-HMP-MA-1870 ACTILOR SYRUP DESLORATADINE SYRUP 2.5MG/5ML SYRUP 150ML 150ML Amber Glass Bottle with CR Cap 36 Months NEOPHARMA Address: Plot No. A-1, 89-95, Industrial City of Abu Dhabi (ICAD), P. O Box 72900, Mussafah, Abu Dhabi, UAE Country: United Arab Emirates UNITED ARAB EMIRATES NEOPHARMA PHILIPS PHARMACEUTICALS RWANDA LTD 2024-08-17 2029-08-16

47 Rwanda FDA-HMP-MA-1647 ACTIMAG MAGNESIUM PIDOLATE 0.4G/ML ORAL SOLUTION 100ml Bottle Glass amber bottle 60 Months Faes Farma, S.A, Máximo Aguirre, 14-48940 Leioa (Vizcaya) Spain SPAIN FAES FARMA/ SPAIN UBIPHARM-RWANDA LTD 2024-08-17 2029-08-16

48 Rwanda FDA-HMP-MA-1133 ACTINAC ER 200 Aceclofenac Extended release tablets, 200 mg 200 mg Film Coated Tablets 2x10 Tablets Alu-Alu blister pack, such 2 blisters in a printed carton along with Pack Insert 24 Months AJANTA PHARMA LIMITED, Mirza - Palashbhari Road, Vill. – Kokhjar, Kamrup (R), Guwahati, Assam – 781128, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-04-21 2029-04-20

49 Rwanda FDA-HMP-MA-0406 ACTION TABLETS Aspirin 600mg, Paracetamol 300mg and Caffeine 50mg 600mg, 300mg and 50mg Tablets 20’s and 100’s Tablets Polypaper on a unit carton made of chipboard 60 Months BETA HEALTHCARE INTERNATIONAL LTD, Plot No. L.R 209/6554 Mogadishu Road, Industrial Area, Nairobi, Kenya KENYA BETA HEALTHCARE INTERNATIONAL LTD SURGIPHARM (RWANDA) LTD 2023-08-24 2028-08-23

50 Rwanda FDA-HBP-MA- 0017 ACTRAPID®100IU/ML ,10 ML VIAL Human Insulin(rDNA) 100UI/ml 100UI/ml Aqueous solution 1 and 5 vials of 10ml Vial 10HN 30 Months NOVO NORDISK A/S, NOVO ALLE, Novo Nordisk Production SAS, DK-2880 Bagsvaerd, Denmark, 45 Avenue d’Orléans, F-28000 Chartres, France DENMARK , FRANCE NOVO NORDISK PHARMA GULF FZ-LLC/DUBAI, UAE WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

51 Rwanda FDA-HMP-MA-1880 ACUDOL 15 INJ KETOTOLAC TROMETHAMANE 15MG/ML IV INJECTION 21’s count 2R,2ml Amber Color Tubular glass vial,USP Type-I with 13mm serum grey bromo butyl rubber stopper (RS) and 13mm orange color flip of seal 24 months ASPIRO PHARMA LIMITED Sy. No. 321, Biotech Park, Phase-III, Karkapatla Village,Markook Mandal. Siddipet District,Telangana, India. India ASPIRO PHARMA LIMITED H.No.8-3-166/7/1,3rd Floor, Erragadda,Hyderabad-18, Telangana State, IndiaTelephone: +91-40-23704925,Fax: +91-40-23704926Web: www.aspiropharma.com E-mail: vinodkumar.u@aspiropharma.com SUN ENTEPRISES LTD 2024-08-17 2029-08-16

52 Rwanda FDA-HMP-MA-1881 ACUDOL 30 INJ KETOTOLAC TROMETHAMANE 30MG/ML IV INJECTION 21’s count 2R,2ml Amber Color Tubular glass vial,USP Type-I with 13mm serum grey bromo butyl rubber stopper (RS) and 13mm orange color flip of seal 24 months ASPIRO PHARMA LIMITED Sy. No. 321, Biotech Park, Phase-III, Karkapatla Village,Markook Mandal. Siddipet District,Telangana, India. India ASPIRO PHARMA LIMITED H.No.8-3-166/7/1,3rd Floor, Erragadda,Hyderabad-18, Telangana State, IndiaTelephone: +91-40-23704925,Fax: +91-40-23704926Web: www.aspiropharma.com E-mail: vinodkumar.u@aspiropharma.com SUN ENTEPRISES LTD 2024-08-17 2029-08-16

53 Rwanda FDA-HMP-MA-1631 ACUPAN NEFOPAM 20MG/2ML SOLUTION FOR INJECTION 2ml Ampoules Type I colourless glass, bottle-shaped ampoules with a sealed neck 36 Months BIOCODEX 1 avenue Blaise Pascal, 60000 Beauvais, France France BIOCODEX, FRANCE FORTILAB RWANDA 2024-08-17 2029-08-16

54 Rwanda FDA-HBP-MA-0115 ACURIN 5000I.U/ML Heparin sodium BP 5000I.U/ml 5000I.U/ml Solution for injection 5 ml vial Amber Glass Vial USP Type I closed with grey bromobutyl rubber stopper sealed with flip off seal 24 Months ACULIFE HEALTHCARE PRIVATE LTD, Village- Sachana, Tal-Viramgam, City: Sachana–382 150, Dist: Ahmedabad Gujarat State, India INDIA ACULIFE HEALTHCARE PRIVATE LTD, INDIA SUN ENTERPRISES LTD 2024-02-26 2029-02-25

55 Rwanda FDA-HMP-MA-1679 ACYCLOVIR DENK ACYCLOVIR 5% CREAM 7 g Tube Aluminium tube 36 Months RubiePharm Arzneimittel GmbH Brüder-Grimm-Str. 62 36396 Steinau an der Straße, Germany Germany DENK PHARMA GmbH & Co. KG, Germany ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2024-08-17 2029-08-16

56 Rwanda FDA-HMP-MA-1134 ADACIN Adapalene 0.1% w/w and Clindamycin Phosphate 1.0% w/w 0.1% w/w and 1.0% w/w Gel 15 g Tube A laminated tube packed in a unit carton along with the information insert 24 Months AJANTA PHARMA LIMITED, Mirza - Palashbhari Road, Vill. – Kokhjar, Kamrup (R), Guwahati, Assam – 781128, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2024-04-21 2029-04-20

57 Rwanda FDA-HMP-MA-2011 ADDAVEN FERRIC CHLORIDE/ ZINC CHLORIDE/ MANGANESE CHLORIDE TETRAHYDRATE/ COPPER CHLORIDE DIHYDRATE/ SODIUM SELENITE ANHYDROUS/ POTASSIUM IODIDE/ CHROMIC CHLORIDE HEXAHYDRATE/ SODIUM FLUORIDE/ SODIUM MONHYDRATE DEHYDRATE 53.3 mcg,1.02 mg, 5.40 mg, 198 mcg, 166 mcg, 2.10 mg, 48.5 mcg, 173 mcg, 10.5 mg in 10 ml Concentrate for solution for infusion 20 x 10 ml ampoules Ampoule (polypropylene) 36 months Fresenius Kabi Norge AS NORWAYS vinesundsveien 80NO - 1788 Halden Norway Norway FRESENIUS KABI SOUTH AFRICA PTY SURGIPHARM RWANDA LTD 2024-08-17 2029-08-15

58 Rwanda FDA-HMP-MA-2266 ADRENALINE AGUETTANT ADRENALINE TARTRATE 1MG/ML SOLUTION FOR INJECTION Box of 1 or 10 syringes of 5ml Polypropylene pre-filled syringes 24 Months LABORATOIRE AGUETTANT 1, rue Alexander Fleming 69007 LYON France Laboratoire AguettantAdress: 1, rue Alexander Fleming-69007 LyonCounty: France Telephone: +33(0)478615141Email: regulatory.export-dm@aguettant.fr PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2025-01-09 2030-01-08

59 Rwanda FDA-HMP-MA-0149 ADRENALINE AGUETTANT 0.1MG/ML SULPHITE FREE, SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Adrenaline tartrate 0.1 mg/ml 0.1mg/ml Solution for injection Box of 10 pre-filled syringes of 10ml Polypropylene pre-filled syringes 18 Months LABORATOIRE AGUETTANT Address: 1, rue Alexander Fleming-69007 Lyon, France FRANCE LABORATOIRE AGUETTANT PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2022-12-21 2027-12-20

60 Rwanda FDA-HMP-MA-0536 ADRENALINE INJECTION BP 0.1% Adrenaline acid tartrate BP 1 mg/ ml 1 mg/ml Liquid Injection 5 Ampoules Blister Pack Using “LPLl” Logo Paper Foil, such 1 Blister is Packed in Printed Carton with Packing Insert 18 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khantraj, Taluka: Kalol, District: Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED. INDIA ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12

61 Rwanda FDA-HBP-MA-0103 ADSORBED TETANUS VACCINE B.P TETANUS TOXOID 1 DOSE Tetanus Toxoid, Each single 0.5 ml human dose contains: Tetanus Toxoid ?5 Lf (? 40 IU) Adsorbed onto Aluminium Phosphate, Al3+? 1.25 mg 0.5ml/1 dose ? 40 IU, +? 1.25 mg 0.5ml/1 dose Suspension for Injection 1 blister containing 10 ampoules 1 blister containing 10 OPC Type I glass ampoules (Single dose) packed in a corrugated box 36 Months SERUM INSTITUTE OF INDIA PRIVATE LIMITED, 212/2, Hadapsar Pune- 411028, India INDIA SERUM INSTITUTE OF INDIA LTD, INDIA SUN ENTERPRISE LTD 2023-12-30 2028-12-29

62 Rwanda FDA-HMP-MA-2203 AEROTROPA NEBULIZER SOLUTION Ipratropium Bromide Monohydrate 500.000 mcg & Salbutamol Sulphate 2.500 mg 500 mcg & 2.500 mg Nebulizer Solution 10 x 2.5 ml Ampoules Type I glass ampoules 36 Months PHARCO B INTERNATIONAL New Borg El Arab City, 3rd Industrial Zone, Alexandria, Egypt EGYPT EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES HELIOS PHARMA Ltd 2025-02-04 2030-02-03

63 Rwanda FDA-HMP-MA-0792 AGO SCRUB PLUS Chlorhexidine Gluconate 1.5% w/v, and Cetrimide 15% w/v 1.5% w/v, and 15% w/v Topical Liquid 1 Litre Bottle HDPE Bottle 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 2024-01-15 2029-01-14

64 Rwanda FDA-HMP-MA-0671 AGO-AMIN TABLET Aminophylline Tablets BP 100 mg 100 mg Uncoated tablets 10X10 tablets Printed Aluminium foil/PVC foil blister. Such 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

65 Rwanda FDA-HMP-MA-1526 AGO-C 500 TABLET ASCORBIC ACID BP 500MG TABLET 10x10 Tablets and 100 Tablets in jar Strip Pack of 10 x 10 Tablets or HDPE jar pack of 100 tablets 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 SUN ENTERPRISES LTD 2024-07-27 2029-07-26

66 Rwanda FDA-HMP-MA-1399 AGO-CPM Chlorphenamine Maleate BP 2mg/5ml 2mg/5ml Syrup 60ml Bottle PET Amber Bottles 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 SUN ENTERPRISES LTD 2024-07-18 2029-07-17

67 Rwanda FDA-HMP-MA- 1393 AGOBATE CREAM Clobetasol Propionate BP 0.05 % w/w 0.05 % w/w Cream 30gm Tube 30gm packed in one tube such tube packed in unit printe carton 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 SUN ENTERPRISES LTD 2024-05-18 2029-05-17

68 Rwanda FDA-HMP-MA-1152 AGOBEN SUSPENSION Mebendazole Oral Suspension 100 mg/5 ml 100 mg/5 ml Suspension 30 ml Bottle Amber coloured round plastic bottles 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 2024-04-27 2029-04-26

69 Rwanda FDA-HMP-MA-0694 AGOBEX TABLETS Mebendazole USP 100mg 100mg Uncoated tablets 1000’s Tablets HDPE 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 2024-01-08 2029-01-07

70 Rwanda FDA-HMP-MA-1379 AGOBIS TABLETS Bisacodyl BP 5 mg 5 mg Enteric coated tablets 10x 10 tablets Blister Pack of 10x10 Tablets 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 SUN ENTERPRISES LTD 2024-05-18 2029-05-17

71 Rwanda FDA-HMP-MA-1151 AGOBURN CREAM Silver Sulfadiazine USP 1%w/w 1%w/w Cream 15 gram tube and 100gm Laminated tube and flower pot type white HDPE cap 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 2024-04-27 2029-04-26

72 Rwanda FDA-HMP-MA- 0760 AGOCAL TABLETS Calcium Lactate BP 300mg 300mg Uncoated tablets 1000 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 2024-01-08 2029-01-07

73 Rwanda FDA-HMP-MA-0753 AGOCARB TABLET Activated Charcoal tablets 0.25 g 0.25 g Uncoated 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 LTD, INDIA SUN ENTERPRISES LTD 2024-01-08 2029-01-07

74 Rwanda FDA-HMP-MA-0726 AGOCARB-500 TABLETS Activated Charcoal Tablets 500 mg 500 mg Uncoated 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 LTD, INDIA SUN ENTERPRISES LTD 2024-01-15 2029-01-14

75 Rwanda FDA-HMP-MA-0638 AGOCIM-200 Cimetidine BP, 200 mg 200 mg Film coated tablets 10x10’s Tablets Printed Alu/PVC foil blister 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 2023-12-02 2028-12-01

76 Rwanda FDA-HMP-MA-0639 AGOCIM-400 Cimetidine BP, 400 mg 400 mg Film coated tablets 10x10’s Tablets Printed Alu/PVC foil blister 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 2023-12-02 2028-12-01

77 Rwanda FDA-HMP-MA-1104 AGODAPS-100 TABLETS Dapsone tablets BP 100mg 100mg Uncoated Tablets 10x10 Tablets Blister 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 2024-04-20 2029-04-19

78 Rwanda FDA-HMP-MA-1652 AGODIC GEL DICLOFENAC BP 1% W/W GEL 30 gram Tube Lami tube, flower pot type white HDPE cap 36 Months AGOG PHARMA LTD Plot No. 33, Section II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

79 Rwanda FDA-HMP-MA-1358 AGODIC-50 TABLETS Diclofenac BP 50mg 50 mg Enteric Coated Tablets 10 tablets Printed Aluminum foil/PVC in a carton 36 Months AGOG PHARMA LTD. Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-05-18 2029-05-17

80 Rwanda FDA-HMP-MA-1933 AGODINE -TS POVIDONE IODINE USP 10% W/V TOPICAL SOLUTION 120ml Bottle Amber colour PET Bottle 36 Months AGOG PHARMA LTD Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane, Country: India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

81 Rwanda FDA-HMP-MA-1273 AGODOX CAPSULES Doxycycline hydrochloride 100 mg 100 mg Hard Gelatin Capsules 10 x 10 capsules 1000 Capsules Printed Aluminum foil/PVC foil Blister in unit printed duplex board carton and HDPE Jar 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 SUN ENTERPRISES LTD 2024-05-07 2029-05-06

82 Rwanda FDA-HMP-MA-1815 AGOFEN SUSPENSION Ibuprofen BP 100 mg/5ml Suspension 60ml and 100ml Bottle PET AMBER COLOUR BOTTLE 36 Months AGOG PHARMA LTD Plot No. 33, Section II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai(E), Dist.Thane, India. INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

83 Rwanda FDA-HMP-MA-0693 AGOFEN-200 TABLET Ibuprofen 200 mg tablet 200 mg Film coated tablets 1000’s Tablets HDPE 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 2024-01-08 2029-01-07

84 Rwanda FDA-HMP-MA-1302 AGOFORMIN TABLETS Metformin Tablets BP 500mg 500 mg Film coated tablet 10X10 tablets Blister 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 SUN ENTERPRISES LTD 2024-05-07 2029-05-06

85 Rwanda FDA-HMP-MA-0665 AGOFULVIN-125 Griseofulvin 125mg 125mg Uncoated tablets 10X10 tablets Printed Aluminium foil/PVC foil blister. Such 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

86 Rwanda FDA-HMP-MA-0666 AGOFULVIN-250 Griseofulvin 250 mg 250 mg Uncoated tablets 10X10 tablets Printed Aluminium foil/PVC foil blister. Such 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

87 Rwanda FDA-HMP-MA-1150 AGOFULVIN-500 TABLETS Griseofulvin BP 500 mg 500 mg Uncoated Tablets 10x10 Tablets Aluminum foil/PVC foil blisters packed in a unit printed duplex board carton 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 2024-04-27 2029-04-26

88 Rwanda FDA-HMP-MA-0756 AGOHAL-5 Haloperidol BP 5 mg 5 mg Uncoated tablets 1000 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 2024-01-08 2029-01-07

89 Rwanda FDA-HMP-MA-1574 AGOLACTONE-25 Spironolactone BP 25 mg Tablets 10 Tablets ALU/PVC BLISTER 36 Months AGOG PHARMA LTD Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

90 Rwanda FDA-HMP-MA-0810 AGOLITHO TABLET Lithium Carbonate Tablets BP 400mg 400mg 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 LTD, INDIA SUN ENTERPRISES LTD 2024-01-15 2029-01-14

91 Rwanda FDA-HMP-MA-1127 AGOMETHASONE TABLETS Dexamethasone tablets BP 0.5 mg 0.5 mg Tablets 10x10 tablets and 1000 tablets Alu/PVC Blister Pack and HDPE Jar pack for 1000 tablets 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane-401208, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-04-21 2029-04-20

92 Rwanda FDA-HMP-MA-0628 AGOMETROL SUSPENSION Metronidazole benzoate BP 125 mg/5 ml 125 mg/5 ml Suspension 100 ml Bottle Amber coloured PET bottle with PP cap packed in a carton along with its package insert. 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane-401208, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-10 2028-12-09

93 Rwanda FDA-HMP-MA-1527 AGOMIDE TABLET Furosemide BP 40MG TABLETS 28s, 30s, 50s, 56s, 60s, 84s, 90s, 100s and 1000 tablets Alu/PVC blister pack for 28s, 30s, 50s, 56s, 60s, 84s, 90s, 100s and HDPE jar Pack for1000 tablets 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 SUN ENTERPRISES LTD 2024-07-27 2029-07-26

94 Rwanda FDA-HMP-MA-0664 AGOMOL SUSPENSION Paracetamol BP 125 mg/5ml 125 mg/5ml Oral Suspension 60 ml bottle & 100 ml bottle PET bottle with PP cap and measuring cup are packed in export worthy 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

95 Rwanda FDA-HMP-MA-0745 AGOMOL TABLET Paracetamol BP 500 mg 500 mg Uncoated tablet 10 x 10 Tablets Blister 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 2024-01-08 2029-01-07

96 Rwanda FDA-HMP-MA-1640 AGOMOL-100 TABLETS PARACETAMOL BP 100MG TABLETS 10 x 10 Tablets and 1000 tablets Blister Pack and 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 SUN ENTERPRISES LTD 2024-08-17 2029-08-16

97 Rwanda FDA-HMP-MA-1143 AGOMYCIN SUSPENSION Erythromycin Estolate 125mg/5ml 125mg/5ml Suspension 100 ml Bottle PET Amber Colour 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 INDIAA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-04-27 2029-04-26

98 Rwanda FDA-HMP-MA-1275 AGONAL TABLETS Nalidixic Acid BP 500 mg 500 mg Uncoated tablets 1000 Tablets and 10x10 tablets Jar pack & Blister 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 SUN ENTERPRISES LTD 2024-05-07 2029-05-06

99 Rwanda FDA-HMP-MA-1544 AGONOR NORFLOXACIN BP 400MG FILM COATED TABLETS 10x10 Tablets Alu-Pvc blister 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 SUN ENTERPRISES LTD 2024-07-27 2029-07-26

100 Rwanda FDA-HMP-MA-0627 AGOPHENOL CAPSULES Chloramphenicol BP 250 mg 250 mg Capsules 10 Capsules Alu foil Blister. Such blister packed in unit carton along with its package insert 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane-401208, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-10 2028-12-09

101 Rwanda FDA-HMP-MA-1244 AGOPHENOL SUSPENSION Chloramphenicol Palmitate BP eq. to 125 mg of Chloramphenicol/5ml 125 mg/5ml Oral suspension 100 ml Bottle Polythene Bags 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 SUN ENTERPRISES LTD 2024-05-06 2029-05-05

102 Rwanda FDA-HMP-MA-2357 AGOPINE SR TABLETS NIFEDIPINE SUSTAINED RELEASED TABLETS BP 20MG TABLETS 10X10 TABLETS ALU/ALU BLISTER PACK 24 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 SUN ENTERPRISES LTD 2025-10-17 2030-10-16

Registered

103 Rwanda FDA-HMP-MA-1131 AGOPRED TABLETS Prednisolone BP 5 mg 5 mg Uncoated Tablets 10x10 tablets & 1000 tablets Alu/PVC Blister Pack and jar pack for 1000 tablets 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane-401208, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-04-21 2029-04-20

104 Rwanda FDA-HMP-MA-1274 AGOPRED-10 TABLETS Prednisolone BP 10mg 10mg Uncoated tablets 1000 Tablets and 10x10 tablets Jar pack & Blister 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 SUN ENTERPRISES LTD 2024-05-07 2029-05-06

105 Rwanda FDA-HMP-MA-1289 AGOPRIL TABLETS Captopril Tablets BP 25 mg 25 mg Un coated Tablets 10x10 tablets and 1000 tablets Alu-Alu blister and Jar pack of 1000 tablets 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 SUN ENTERPRISES LTD 2024-05-07 2029-05-06

106 Rwanda FDA-HMP-MA-0630 AGOSCAB Benzyl Benzoate Application BP 25% W/V 25% W/V Emulsion 100 ml Bottle PET Clear Bottle 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane-401208, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2023-12-10 2028-12-09

107 Rwanda FDA-HMP-MA-1290 AGOSPIRIN-100 TABLETS Aspirin BP 100 mg 100 mg Un coated Tablets 1000 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 SUN ENTERPRISES LTD 2024-05-07 2029-05-06

108 Rwanda FDA-HMP-MA-1291 AGOSPIRIN-500 TABLETS Aspirin BP 500 mg 500 mg Un coated Tablets 1000 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 SUN ENTERPRISES LTD 2024-05-07 2029-05-06

109 Rwanda FDA-HMP-MA-1292 AGOTHIAZIDE TABLETS Hydrochlorothiazide BP 50 mg 50 mg Un coated Tablets 10x10 tablets and 1000 tablets Alu-Alu blister and Jar pack of 1000 tablets 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane-401208, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-05-07 2029-05-06

110 Rwanda FDA-HMP-MA-1359 AGOTOIN TABLETS Nitrofurantoin tablets BP 100mg 100 mg Uncoated Tablets 10 tablets Printed Aluminum foil/PVC in a carton 36 Months AGOG PHARMA LTD. Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, India INDIA AGOG PHARMA LTD, INDIA SUN ENTERPRISES LTD 2024-05-18 2029-05-17

111 Rwanda FDA-HMP-MA-0670 AGOVIR-200 Aciclovir BP, 200 mg 200 mg Uncoated tablets 10 x 10 Tablets Printed Aluminum foil/PVC foil blister. Such 10 blisters are packed in unit printed duplex board 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

112 Rwanda FDA-HMP-MA-1952 AGOVIR-400 TABLETS ACICLOVIR BP 400MG 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, Country: India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

113 Rwanda FDA-HMP-MA-1388 AGOVIT-6 TABLETS Pyridoxine Hydrochloride BP 25mg 25mg Uncoated Tablets 1000 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 SUN ENTERPRISES LTD 2024-05-18 2029-05-17

114 Rwanda FDA-HMP-MA-1981 AGYCIN SUSPENSION AZYTHROMYCIN 40MG/ML SUSPENSION 15 ml HDPE bottle 24 months Bliss GVS Pharma Ltd, Plot No. 10, 11A, 12, Survey No. 38/1, Dewan Udyog Nagar, Aliyali Village, Palghar, Thane – 401404, Maharashtra State, India. India BLISS GVS PHARMA LTD Address: 102, Hyde Park, Saki-Vihar Road, Andheri (East). Mumbai-400072Country: IndiaTelephone: +91-22-42160000Telefax: +91-22-28563930E-Mail: info@blissgvs.com SURYA DEPOT PHARMACY LTD 2024-08-17 2029-08-16

115 Rwanda FDA-HMP-MA-0913 AGYCIN-250 Azithromycin Dihydrate USP 250 mg 250 mg Film coated tablets 6 tablets Blister of Aluminium/PVC foil in monocarton along with insert 36 Months BLISS GVS PHARMA LIMITED. Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal- Palghar, District-Thane 401404 INDIA BLISS GVS PHARMA LTD SURYA DEPOT PHARMACY LTD 2024-02-22 2029-02-21

116 Rwanda FDA-HMP-MA-0715 AGYCIN-500 Azithromycin Dihydrate USP 500mg 500mg Film coated tablets 3 Tablets Blisters (Alu-PVC foil) of 3 tablets packed in a mono carton along with a pack insert 36 Months BLISS GVS PHARMA Ltd, Plot No. 10, 11A, 12, Survey No. 38/1, Dewan Udyog Nagar, Aliyali Village, Palghar, Thane – 401404, Maharashtra State, India INDIA BLISS GVS PHARMA LTD, INDIA SURYA DEPOT PHARMACY LTD 2024-01-15 2029-01-14

117 Rwanda FDA-HMP-MA-0790 AIRTAL-100 Aceclofenac 100mg 100mg Film coated tablets 2x10 Tablets or 4x10 Tablets 10’s tablets are packed in Alu/Alu blister. Such 2 or 4 blisters are packed in cardboard box with the patient information leaflet 48 Months INDUSTRIAS FARMACÉUTICAS ALMIRALL, S.A. Ctra. de Martorell 41-61, E-08740 Sant Andreu de la Barca Barcelone, Spain SPAIN ALMIRALL, S.A, SPAIN UBIPHARM-RWANDA LTD 2024-01-08 2029-01-07

118 Rwanda FDA-HBP-MA-0046 AKEROL Desloratadine 5mg Tablets Blister Pack ALU/ALU PACK BLISTER 36 Months WEST-COAST PHARMACEUTICAL WORKS LTD F.P. No. 17 & 16/5, Meldi Estate, B/s Meldi Mata Temple, Near Gota Railway Crossing, At & Post Gota, Ahmedabad, – 382481. Gujarat State. INDIA BEKRA PHARMA UK LTD MULTIPHAR UBIPHARM-RWANDA LTD 2021-01-18 2026-01-18

Grace Period

119 Rwanda FDA-HMP-MA-1017 AKEROL SYRUP 2.5MG/5ML Desloratadine 2.5mg/5ml 2.5mg/5ml Syrup 60 ml Bottle Amber PET bottle, in printed and laminated carton 36 Months WEST-COAST PHARMACEUTICAL WORKS LTD F.P. No. 17 & 16/5, Meldi Estate, B/s Meldi Mata Temple, Near Gota Railway Crossing, At & Post Gota, Ahmedabad – 382481. Gujarat State, India INDIA BEKRA PHARMA UK LTD UBIPHARM RWANDA LTD 2024-02-28 2029-02-27

120 Rwanda FDA-HMP-MA-0071 AKURIT Rifampin, Isoniazid 150 mg, 75 mg Tablets Pack 24 X 28 Tablets ALU-ALU BLISTER 36 Months LUPIN LIMITED Block - 1, extended area of Block 1, A-28/1, M.I.D.C., Chikalthana, Aurangabad – 431 210, INDIA INDIA LUPIN LIMITED, INDIA AIVEEN (R) LTD 2021-06-01 2026-06-01

121 Rwanda FDA-HMP-MA-0072 AKURIT-3 Rifampin, Isoniazid, Ethambutol Hydrochloride 150 mg, 75 mg, 275 mg Tablets 24x14 Tablets ALU-ALU BLISTER PACK 36 Months LUPIN LIMITED Block - 1, extended area of Block 1, A-28/1, M.I.D.C., Chikalthana, Aurangabad – 431 210, INDIA INDIA LUPIN LIMITED, INDIA AIVEEN (R) LTD 2021-06-01 2026-06-01

122 Rwanda FDA-HMP-MA-0073 AKURIT-4 Rifampin, Isoniazid, Pyrazinamide And Ethambutol Hydrochloride 150mg, 75mg, 400 mg, 275 mg Tablets Pack 15 X 6 Tablets And 14x28 Tablets ALU-ALU BLISTER 36 Months LUPIN LIMITED Block - 1, A-28/1, M.I.D.C., Chikalthana, Aurangabad – 431 210. INDIA and EPIP, SIDCO Industrial Complex Kartholi, Bari Brahmana Jammu (J&K)- 181133, India INDIA LUPIN LIMITED, INDIA AIVEEN (R) LTD 2021-06-01 2026-06-01

123 Rwanda FDA-HMP-MA-2168 AKUROSE Iron Sucrose Injection USP 20 mg/ml Injection 5ml Amber glass coloured glass ampoule USP type I 36 months AKUMS DRUGS & PHARMACEUTICALS LTD Plot No. 2,3,4,5, Sector 6B, IIE, SIDCUL, Ranipur, Haridwar – 249403, Uttarakhand INDIA UNOSOURCE PHARMA LTD AIVEEN (R) LTD 2025-01-09 2030-01-08

124 Rwanda FDA-HMP-MA-1657 ALBENDAZOLE 400mg ALBENDAZOLE 400MG CHEWABLE TABLETS 100 tablets HDPE bottle 36 Months Mepro Pharmaceuticals Pvt. Ltd Unit-II, Q Road, Phase-IV, G.I.D.C, Wadhwan City–363 035, Gujarat, India India MEPRO PHARMACEUTICALS PVT. LTD Depot Pharmaceutique Ubumwe Ltd 2024-08-17 2029-08-16

125 Rwanda FDA-HMP-MA-1911 ALBUREL HUMAN ALBUMIN SOLUTION BP 20% INTRAVENOUS INFUSION 50ML AND 100ML Glass vial 36 months Reliance Life Sciences Pvt. Ltd Reliance Life Sciences Pvt. Ltd Address: Plant 4B, Dhirubhai Ambani Life Sciences Centre (DALC), Plant 4B, R-282, TTC Area of MIDC, Thane Belapur Road, Rabale, Navi- Mumbai, India INDIA Reliance Life Sciences Pvt. Ltd, Dhirubhai Ambani Life Sciences Centre (DALC), Plant 4B, R-282, TTC Area of MIDC, Thane Belapur Road, Rabale, Navi- Mumbai, India. STAR BIOTECH RWANDA 2024-08-17 2029-08-16

126 Rwanda FDA-HMP-MA-1668 ALCOF-C Dextromethorphan Hydrochloride BP, Cetrizine Hydrochloride BP, Phenylepherine Hydrochloride BP, Levomenthol BP 10mg, 5mg, 5mg, 1.5 mg SYRUP 100ml Bottle Amber PET Bottles 36 Months Aurochem Laboratories (India) Pvt. Ltd 8, Palghar Taluka, Industrial Co.-op. Estate Ltd, Palghar-401 404, District Thane, Maharashtra, India India Aurochem Laboratories (India) Pvt. Ltd UBIPHARM RWANDA LTD 2024-08-17 2029-08-16

127 Rwanda FDA-HMP-MA-0761 ALDAZ-400 Albendazole, 400 mg 400 mg Chewable uncoated tablets 50 × 1 x 1 Chewable uncoated 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 2023-12-30 2028-12-29

128 Rwanda FDA-HMP-MA-2213 ALERBIX BILASTINE 2.5 MG/ML ORAL SOLUTION 120ml Bottle An amber glass bottle (Type III glass), sealed with an aluminium screw cap, with tamper-proof closure system and LDPE liner 36 Months FAES FARMA, S.A Máximo Aguirre, 14; 48940 Leioa Spain SPAIN LABORATORIOS VITORIA S.A/ PORTUGAL UBIPHARM-RWANDA LTD 2025-02-04 2030-02-03

129 Rwanda FDA-HMP-MA-2212 ALEVE NAPROXEN SODIUM 220 MG TABLETS 1x12 tablets PVC Blisters 36 Months Bayer Bitterfeld GmbH Salegaster Chaussee 1, OT Greppin, Bitterfeld-Wolfen, Saxony-Anhalt 06803, Germany Germany Bayer East Africa Limited Surgipharm (Rwanda) Ltd 2025-02-04 2030-02-03

130 Rwanda FDA-HMP-MA- 1052 ALLERBAN SYRUP Chlorpheniramine Maleate 2mg/5ml 2mg/5ml Syrup 100ml Bottle HDPE round bottle with polypropylene screw cap 24 Months VARICHEM PHARMACEUTICALS (PVT.) LTD, 194 Gleneagles road, Willow vale, Harare, Zimbabwe ZIMBABWE VARICHEM PHARMACEUTICALS (PVT.) LTD ACTIVIS PHARMA 2024-02-28 2029-02-27

131 Rwanda FDA-HMP-MA-1983 ALLERCET M MONTELUKAST/ LEVOCETRIZINE DIHYROCHLORIDE 10MG/5MG TABLET 1x10\\\'s Alu/Alu blister 36 month Micro Labs Limited 92, SIPCOT, Hosur-635 126, Tamil Nadu India MICRO LABS LTD/INDIA WESSEX PHARMACEUTICALS RWANDA LTD 2024-08-17 2029-08-16

132 Rwanda FDA-HMP-MA-0409 ALLTERA 50 Lopinavir/Ritonavir Granules Oral 40mg/10mg 40mg/10mg Creamish granular powder 120 sachets Sachet Pack comprises of printed triple laminated roll with AL foil, soft, dull side PET and bright side laminated to PE film 24 Months MYLAN LABORATORIES LIMITED, F- 4 & F-12, MIDC, Malegaon, Sinnar, Nashik -422 113, Maharashtra, India INDIA MYLAN LABORATORIES LIMITED/INDIA PYRAMID PHARMA LIMITED 2023-08-24 2028-08-23

133 Rwanda FDA-HMP-MA-0472 ALMAX ORAL SUSPENSION Almagate 1g/7.5ml 1g/7.5ml Oral Suspension 225 ml bottle Amber glass bottle 60 Months INDUSTRIAS FARMACÉUTICAS ALMIRALL, S.A. (IFA, S.A.), Ctra. Nacional II, km 593 E-08740 Sant Andreu de la Barca Barcelona, Spain SPAIN ALMIRALL, S.A, SPAIN MULTIPHAR-UBIPHARM-RWANDA LTD 2023-08-24 2028-08-23

134 Rwanda FDA-HMP-MA-0466 ALMAX® FORTE ORAL SUSPENSION Almagate, 1.5g 1.5 g Oral Suspension 30 Sachets Paper/aluminium foil/polyethylene complex sachets consisting of heat sealing aluminium foil (20 ?m) and polyethylene 60 Months INDUSTRIAS FARMACÉUTICAS ALMIRALL, S.A. (IFA, S.A.), Ctra. Nacional II, km 593 E-08740 Sant Andreu de la Barca Barcelona Spain SPAIN ALMIRALL, S.A, SPAIN ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2023-08-24 2028-08-23

135 Rwanda FDA-HMP-MA-1720 ALTOA SUSPENSION Albendazole 200mg/5ml Suspension 10ml Bottles GLASS/PET BOTTLE 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 2024-08-17 2029-08-16

136 Rwanda FDA-HMP-MA-1711 ALTOA TABLETS Albendazole 400mg Tablets 1 x 1 Tablets PVC/ALUMINIUM FOIL 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 2024-08-17 2029-08-16

137 Rwanda FDA-HMP-MA-1023 ALUCID TABLETS Aluminium hydroxide BP 500mg 500mg Tablets 1000’s Tablets JAR PACK 36 Months AGOG PHARMA LIMITED, 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

138 Rwanda FDA-HMP-MA-0568 ALUKON® 10MG Montelukast 10 mg 10 mg Film-coated tablet 14 tablets Alu/Alu blister, 36 Months BILIM ILAÇ SAN.VE TIC. A.?, and Dafra Pharma GmbH S, GOSB 1900 Sokak, N° 1904, 41480 Gebze, Kocaeli, Turkey and Dafra Pharma GmbH, Site address: Mühlenberg 7, 4052 Basel, Switzerland TURKEY AND SWITZERLAND DAFRA PHARMA GmbH SUN ENTREPRISES LTD 2023-10-05 2028-10-04

139 Rwanda FDA-HMP-MA-0605 ALUKON® 4 MG, GRANULES Montelukast, 4 mg 4 mg Granular (powder) 14 sachets Polyester-Al-PE foil, 14 sachets in the carton box 36 Months BILIM ILAÇ SAN.VE TIC. A.?, S, and DAFRA PHARMA GmbH, GOSB 1900 Sokak, N° 1904, 41480 Gebze, Kocaeli, Turkey and DAFRA PHARMA GmbH, Site address: Mühlenberg 7, 4052 Basel, Switzerland TURKEY AND SWITZERLAND DAFRA PHARMA GmbH SUN ENTREPRISES LTD 2023-10-13 2028-10-12

140 Rwanda FDA-HMP-MA-0622 ALUKON® 5 MG Montelukast 5 mg 5 mg Pink chewable tablet 28 tablets Alu/Alu blistes 36 Months BILIM ILAÇ SAN.VE TIC. A.?, GOSB 1900 Sokak, N° 1904, 41480 Gebze, Kocaeli, Turkey and DAFRA PHARMA GmbH, Site address: Mühlenberg 7, 4052 Basel, Switzerland TURKEY AND SWITZERLAND DAFRA PHARMA GmbH, Switzerland SUN ENTERPRISES LTD 2023-12-10 2028-12-09

141 Rwanda FDA-HBP-MA-0134 ALVEOFACT-108 108 mg/ml (One vial of 108 mg contains 101.52 – 120.00 mg phospholipid fraction from bovine lung (dried mass), equivalent to a content of 66 ?mol or 108 mg total phospholipids as lyophilized powder 108 mg/ml Powder and solvent for suspension 1 glass vial Type I white glass vial with grey rubber stopper and aluminium cuff with a purple (54 mg) or blue (108 mg) tear-off seal. Solvent in a pre-filled white glass syringe with rubber plunger containing 1.2 ml or 2.4 ml. 36 Months BAG HEALTH CARE GmbH, Amtsgerichtsstr. 1-5 35423 Lich, Germany GERMANY BAG HEALTH CARE GmbH, India PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-07-18 2029-07-17

142 Rwanda FDA-HBP-MA-0133 ALVEOFACT-54 One vial of 54 mg contains 50.76 – 60.00 mg phospholipid fraction from bovine lung (dried mass), equivalent to a content of 66 ?mol or 54 mg total phospholipids as lyophilised powder 54 mg/ml Powder and solvent for suspension 1 glass vial Type I white glass vial with grey rubber stopper and aluminium cuff with a purple (54 mg). Solvent in a pre-filled white glass syringe with rubber plunger containing 1.2 ml 36 Months BAG HEALTH CARE GmbH, Amtsgerichtsstr. 1-5 35423 Lich, Germany GERMANY BHARAT SERUMS & VACCINES LTD, INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-07-18 2029-07-17

143 Rwanda FDA-HMP-MA-1179 ALVITE SYRUP Ferrous Sulphate 166.70mg, Thiamine Hydrochloride 0.67mg, Riboflavin 0.67mg, Pyridoxine Hydrochloride 0.50mg, Nicotinamide 7.50mg, Cyanocobalamin 0.5mcg, Dexpanthenol 1.33mg, Flavoured syrup base q.s. 166.70mg, 0.67mg, 0.67mg, 0.50mg, 7.50mg, 0.5mcg, 1.33mg Syrup 200ml Bottle Amber colored brute shaped glass bottle and each bottle is packed in a mono carton 24 Months BLISS GVS PHARMA LIMITED, 10, Dewan Udyog Nagar, Aliyali, Palghar, Maharashtra – 401 404, India INDIA BLISS GVS PHARMA LIMITED SURYA DEPOT PHARMACY LTD 2024-05-06 2029-05-05

144 Rwanda FDA-HMP-MA-1154 AMADAY PL 10/4 Amlodipine 10 mg and Perindopril Erbumine BP 4 mg 10 mg and 4 mg Uncoated Tablets 3x 10 Tablets Alu/Alu Blisters packed in a carton. 24 Months AJANTA PHARMA LIMITED, Mirza-Palashbari Road, Village Kokjhar, Kamrup (R), Guwahati, Assam - 781128, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-27 2029-04-26

145 Rwanda FDA-HMP-MA-1155 AMADAY PL 10/8 Amlodipine 10 mg and Perindopril Erbumine BP 8 mg 10 mg and 8 mg Uncoated Tablets 3x 10 Tablets Alu/Alu Blisters packed in a carton. 24 Months AJANTA PHARMA LIMITED, Mirza-Palashbari Road, Village Kokjhar, Kamrup (R), Guwahati, Assam - 781128, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-27 2029-04-26

146 Rwanda FDA-HMP-MA-1107 AMADAY PL 5/4 Amlodipine 5mg and Perindopril Erbumine BP 4mg 5mg, 4mg Uncoated tablets 3x 10 tablets Alu-PVC/Alu blisters packed in a carton box 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

147 Rwanda FDA-HMP-MA-1156 AMADAY PL 5/8 Amlodipine 5mg and Perindopril Erbumine BP 8mg 5mg and 8mg Uncoated Tablets 3x 10 Tablets Alu/Alu Blisters packed in a carton. 24 Months AJANTA PHARMA LIMITED, Mirza-Palashbari Road, Village Kokjhar, Kamrup (R), Guwahati, Assam - 781128, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-04-27 2029-04-26

148 Rwanda FDA-HMP-MA-1341 AMAREL - 1 Glimepiride 1mg 1 mg Tablets 3 x 10 tablets PVC/ALU Blister packed in a carton 36 Months SANOFI S.PA – SCOPPITO, Strada Statale 17, Km 22, 67019 Scoppito (AQ), Italy ITALY SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2024-05-18 2029-05-17

149 Rwanda FDA-HMP-MA-1342 AMAREL - 2 Glimepiride 2mg 2 mg Tablets 3 x 10 tablets PVC/ALU Blister packed in a carton 36 Months SANOFI S.PA – SCOPPITO, Strada Statale 17, Km 22, 67019 Scoppito (AQ), Italy ITALY SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2024-05-18 2029-05-17

150 Rwanda FDA-HMP-MA-1343 AMAREL - 3 Glimepiride 3mg 3 mg Tablets 3 x 10 tablets PVC/ALU Blister packed in a carton 36 Months SANOFI S.PA – SCOPPITO, Strada Statale 17, Km 22, 67019 Scoppito (AQ), Italy ITALY SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2024-05-18 2029-05-17

151 Rwanda FDA-HMP-MA-1344 AMAREL - 4 Glimepiride 4mg 4 mg Tablets 3 x 10 tablets PVC/ALU Blister packed in a carton 36 Months SANOFI S.PA – SCOPPITO, Strada Statale 17, Km 22, 67019 Scoppito (AQ), Italy ITALY SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2024-05-18 2029-05-17

152 Rwanda FDA-HMP-MA- 1373 AMARYL M SR Glimepiride 2mg and Metformin Hydrochloride 500mg 2mg, 500 mg Film Coated Tablets 3x10 Tablets Blisters packed in a carton 36 Months HANDOK INC., 78, Daepungsandan-ro, Daeso-myeon, Eumseong-gun, Chungcheongbuk-do, Korea KOREA SANOFI AVENTIS KENYA LIMITED KIPHARMA LTD 2024-05-18 2029-05-17

153 Rwanda FDA-HMP-MA-1562 AMARYL-M 2/500 IR GLIMEPIRIDE +METFORMIN 2MG+ 500MG FILM COATED TABLETS 60 & 100 tablets or Blister packs of 3x10 Tablets Low density polyethylene film bags are used as primary packaging. Blister packs 36 Months HANDOK INC KOREA Handok Inc., 78, Daepungsandan-ro, Daeso-myeon, Eumseong-gun, Chungcheongbuk-do, KOREA KOREA Sanofi Aventis Kenya Limited KIPHARMA LTD 2024-08-17 2029-08-16

154 Rwanda FDA-HMP-MA-0868 AMATRIX PLUS Glibenclamide BP 5 mg and Metformin Hydrochloride BP 500mg 5mg and 500mg Uncoated Tablets 3 x10 Tablets Alu/Alu Blister Pack 36 Months BAROQUE PHARMACEUTICALS PVT. LTD, Address: Sokhada-388 620, Ta-Khambhat, Dist-Anand (Gujarat), India INDIA BEKRA PHARMA UK LTD UBIPHARM RWANDA LTD 2024-02-17 2029-02-16

155 20-4360-DGC&PHS-2018-R1 AMEP-10 Amlodipine 10 mg Tablets Box/7, Box/14, Box/28 PACK/CARTON 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

156 20-4359-DGC&PHS-2018-R1 AMEP-5 Amlodipine 5 mg Tablets Box/7, Box/14, Box/28 PVC/ALUMINIUM BLISTER 36 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

157 Rwanda FDA-HMP-MA-2198 AMEROPEM Meropenem Trihydrate and Sodium Carbonate anhydrous/ 1140.95 mg (Eq to Meropenem 1 g 1G Powder for Solution for IV Injection/Infusion 1 vial/box Colorless transparent glass vial closed with a bromobutyl rubber stopper and sealed with an aluminium/polypropylene plastic cap fitted with detachable flip top. 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

158 RWANDA-FDA25/HM/0239/0019 Ameropem 0.5g Meropenem Trihydrate USP 500mg POWDER FOR SOLUTION FOR INJECTION OR INFUSION 1x 1Vial 24 Months PHARCO B INTERNATIONAL New Borg El-Arab 3rd Industrial Zone, Alexandria, Egypt Egypt Pharco B International LE MEDICAL LTD 2025-09-30 2030-09-29

159 Rwanda FDA-HMP-MA-0078 AMIFER JUNIOR SYRUP Iron Hydroxide Polymaltose Complex 50 mg/5 ml Syrup 150ml GLASS BOTTLE, CLOSED WITH PILFER PROOF PLASTIC CAP PACKED IN A CARDBOARD 36 Months SANTA FARMA ILAÇ SAN. A. S. Gebkim Tesisi, Gebkim Organize Sanayi Bölgesi Çerkesli Yolu Üzeri Erol Kiresepi Cad. No: 8, 41455 Dilovas? - Kocaeli, TURKEY DAFRA PHARMA GMBH SURGIPHARM (RWANDA) LTD 2021-08-05 2026-08-05

160 Rwanda FDA-HMP-MA-1322 AMIFER SYRUP Ferric ammonium citrate 172.41 mg equivalent to iron 30mg,folic acid (hydrate) 2.5mg and cyanocobalamin 0.02mg per 5ml 172.41 mg equivalent to 30 mg, 2.5mg, 0.02 mg per 5ml Syrup 200ml bottle Amber coloured glass bottle, closed with a white plastic screw-cap, and a plastic graduated measuring cup 24 Months SOFARIMEX - LNDÉSTRIA QUÍMICA E FARMACÊUTICA, S.A., Av. Das lndÍstrias - Alto do Colaride, Cacém, 2735-213, Portugal PORTUGAL DAFRA PHARMA GMBH SUN ENTERPRISES LTD 2024-05-18 2029-05-17

161 Rwanda FDA-HMP-MA-1135 AMILINE TABLET Amitriptyline BP 25 mg 25 mg Film Coated Tablets 10x10 tablets and 1000 tablets Jar pack (1000 tablets) & blister pack (10x10 tablets) 36 Months AGOG PHARMA LTD, Plot No. 33, Sector II, The Vasai Taluka Industrial Co-Op. Estate Ltd., Gauraipada, Vasai (E), Dist. Thane-401208, India INDIA AGOG PHARMA LTD SUN ENTERPRISES LTD 2024-04-21 2029-04-20

162 Rwanda FDA-HMP-MA-2064 AMINOPHYLINE TABLETS BP 100MG Aminophylline 100mg TABLETS 1000 Tablets HDEP jar 36 Months ANGEL BIOGENICS PVT. LTD Tirupati complex, First floor, Shapar-Veraval, Rajkot - 360024, Gujarat INDIA ANGEL BIOGENICS PVT. LTD SUN ENTERPRISES LTD 2024-09-30 2029-09-29

163 Rwanda FDA-HMP-MA-0448 AMINOPHYLLINE Aminophylline Hydrate BP 250 mg/10ml 250 mg/10ml Solution for Injection 5x10 ml Ampoules Clear Glass Ampoules (Such 5 Labeled Ampoules are packed in a HIPS Tray Pack. Such 1 Tray is packed in a Printed Carton with Packing Insert. 24 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal-Kalol, Gandhinagar Gujarat, India. INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

164 Rwanda FDA-HMP-MA-0117 AMITRIP 25MG TABLETS Amitriptyline Hydrochloride 25mg Film Coated 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

165 Rwanda FDA-HMP-MA-0743 AMITRYP-25 Amitriptyline HCl 25mg 25mg Film coated tablets 10x10 Tablets Alu-PVC Blister Pack and Such 10 Blisters are packed in a printed Carton with Packing Insert 36 Months LINCOLN PHARMACEUTICALS LIMITED; Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat; India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2024-01-05 2029-01-04

166 Rwanda FDA-HMP-MA-0200 AMLIN-10 Amlodipine Besylate USP 10mg 10mg Uncoated Tablets 10 tablets ALU-PVC blister pack 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat. India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

167 Rwanda FDA-HMP-MA-0369 AMLIN-5 Amlodipine Besylate USP 5 mg 5 mg Uncoated tablets 10 tablets ALU-PVC blister pack 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat. India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-07-08 2028-07-07

168 Rwanda FDA-HMP-MA-0143 AMLO-DENK 10 Amlodipine 10mg 10mg Round, biconvex and scored on one side tablets 50 tablets PVC/PE/PVDC- Aluminium film blisters 24 Months DENK PHARMA GmbH & Co. KG, Göllstr1. , 84529 Tittmoning, Germany GERMANY DENK PHARMA GmbH & Co. KG, Germany ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2022-12-14 2027-12-13

169 Rwanda FDA-HMP-MA-0144 AMLO-DENK 5 Amlodipine 5mg 5mg Round, biconvex and scored on one side tablets 50 tablets PVC/PE/PVDC- Aluminium film blisters 24 Months DENK PHARMA GmbH & Co. KG, Göllstr1. , 84529 Tittmoning, Germany GERMANY DENK PHARMA GmbH & Co. KG, Germany ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2022-12-14 2027-12-13

170 Rwanda FDA-HMP-MA-0740 AMLODIPINE 10MG TABLETS Amlodipine besylate 10mg 10mg Tablets 10 x 10 Tablets 10 Alu-Alu blisters of 10 tablets (10 x 10) packed in a carton box 36 Months LEK PHARMACEUTICALS D.D., Verovškova 57 SI-1526 Ljubljana, Slovenia SLOVENIA SANDOZ GmbH, KUNDL SURGIPHARM (RWANDA) LTD 2024-01-08 2029-01-07

171 Rwanda FDA-HMP-0384 AMLODIPINE 5 MG Amlodipine besilate 5mg 5mg Tablets 30 Tablets AL/OPA/Al/PVC Blister park and in carton along with the leaflet 36 Months LEK PHARMACEUTICALS D.D. Verovškova 57 SI - 1526 Ljubljana, Slovenia SLOVENIA Sandoz GmbH/ Austria SURGIPHARM (RWANDA) LTD 2023-07-08 2028-07-07

172 Rwanda FDA-HMP-MA-0649 AMLODIPINE GP 10 Amlodipine 10mg 10mg Tablets 60 Tablets PVC-PVDC/Al Blisters 36 Months FARMALABOR- PRODUTOS FARMACEUTICOS, S.A. Zona Industrial de condeixa-a-Nova 3150-194 condeixa-a-Nova, Portugal PORTUGAL GP- GENERICOS PORTUGUESES, LDA UBIPHARM-RWANDA LTD 2023-12-10 2028-12-09

173 Rwanda FDA-HMP-MA-0648 AMLODIPINE GP 5MG Amlodipine 5mg 5mg Tablets 60 Tablets PVC-PVDC/Al Blisters 36 Months FARMALABOR- PRODUTOS FARMACEUTICOS, S.A. Zona Industrial de condeixa-a-Nova 3150-194 condeixa-a-Nova, Portugal PORTUGAL GP- GENERICOS PORTUGUESES, LDA UBIPHARM-RWANDA LTD 2023-12-10 2028-12-09

174 Rwanda FDA-HMP-MA-2335 AMLOLAAN LOSARTAN POTASSIUM +AMLODIPINE BESILATE 50MG/5MG TABLETS 3x10 Tablets ALU -ALU BLISTER PACK 36 MONTHS STALLION LABORATORIES PVT. LTD C-1B 305/2, 3, 4 & 5, G.I.D.C, KERALA (BAVLA), DIST. AHMEDABAD, GUJARAT, INDIA INDIA STALLION LABORATORIES PVT. LTD GLAXO PHARMA WHOLESALE LTD 2025-07-11 2030-07-10

Registered

175 Rwanda FDA-HMP-MA-1999 AMLOSIN 10 Amlodipine Besylate USP 10 mg Tablets 3 × 10 Tablets Alu–Alu PVC Blister 36 months Hetero Labs Ltd Unit- I Vill. Kalyanpur, Chakkan Road, Baddi, Distt. Solan [H.P.], India INDIA Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

176 Rwanda FDA-HMP-MA-1998 AMLOSIN 5 Amlodipine Besylate USP 5 mg Tablets 3 × 10 Tablets Alu– Alu Blister 36 months Hetero Labs Ltd Hetero Labs Ltd. Unit- I, Vill. Kalyanpur, Chakkan Road, Baddi, Distt. Solan [H.P.], India INDIA Hetero Labs Limited Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

177 Rwanda FDA-HMP-MA-0758 AMLOZAAR Amlodipine 50mg and Losartan potassium 50 mg 50mg and 50 mg Film coated tablets 3 X 10’s Tablets Alu/Alu blister pack 36 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-30 2028-12-29

178 Rwanda FDA-HMP-MA- 1427 AMLOZAAR-H Amlodipine 50 mg, Losartan Potassium 50 mg, Hydrochlorothiazide 12.5 mg 50 mg, 50 mg, 12.5 mg Film-coated tablets 3x10 Tablets Alu/Alu blister pack. Three of such blisters are packed in a printed outer carton 24 Months MICRO LABS LIMITED, 92 Sipcot Industrial Complex Hosur-635 126 India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-07-18 2029-07-17

179 Rwanda FDA-HMP-MA-1462 AMOLAB-5 TABLETS Amlodipine Besilate PB equivalent to Amlodipine 5mg 5mg Tablets 3x10 and 10x10 Tablets Aluminum foil/PVC blister packs of 3x10’s and 10x10’s in a unit box along with a literature insert 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 DEPOT PHARMACEUTIQUE LE MEDICAL 2024-07-20 2029-07-19

180 Rwanda FDA-HMP-MA-1912 AMOXI-DENK 1000 AMOXICILLIN TRIHYDRATE 1000 MG TABLETS 10 tablets PVC/PVDC aluminium blister strips 36 months PenCef Pharma GmbH PenCef Pharma GmbH Breitenbachstr. 13 - 14, 13509 Berlin GERMANY DENK PHARMA GmbH & Co. KG, Prinzregentenstr. 79, 81675 München, Germany, E-Mail: pharma@denkpharma.de ETS CONTINENTAL 2024-08-17 2029-08-16

181 Rwanda FDA-HMP-MA-1913 AMOXI-DENK 500 AMOXICILLIN TRIHYDRATE 500MG TABLETS 20 TABLETS PVC/PVDC aluminium blister strips 36 months Pencef Pharma GmbH PenCef Pharma GmbH Address: Breitenbachstr. 13-14 13509 Berlin, Germany GERMANY DENK PHARMA GmbH & Co. KG, Prinzregentenstr. 79, 81675 München Country: Germany Telephone: +49 89 - 23 00 29 – 0 Telefax: +49 89 - 23 00 29 – 480 E-Mail: pharma@denkpharma.de ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2024-08-17 2029-08-16

182 Rwanda FDA-HMP-MA-0427 AMOXICILLIN 250MG DISPERSIBLE TABLETS Amoxicillin Trihydrate, 250mg 250mg Dispersible tablets 10, 20, 30 and 100 tablets PVC/PVDC-Alu blister PVC/ACLAR/ALU blisters then packed in box 30 Months SANDOZ GmbH, Biochemiestr. 10, A-6250 Kundl, Austria AUSTRIA SANDOZ GmbH, KUNDL Biochemiestrasse 106250. Austria. SURGIPHARM (RWANDA) LTD 2023-08-24 2028-08-23

183 Rwanda FDA-HMP-MA-2138 AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN AND CLAVULANATE POTASSIUM 625 MG TABLETS 10 tablets ALU/PVC 36 Months REYOUNG PHARMACEUTICAL CO., LTD No. 1. Ruiyang Road, Yiyuan County, Shandong Province, P. R. China CHINA REYOUNG PHARMACEUTICAL CO., LTD SUN ENTERPRISES LTD 2024-10-18 2029-10-17

184 Rwanda FDA-HMP-MA-1075 AMOXICILLIN CAPSULE 250MG Amoxicillin trihydrate 250mg 250 mg Hard Gelatin Capsules 10×10 capsules Aluminum foil and PVC blisters packed in box. Amber PET coloured bottle in a unit carton with a literature insert 36 Months REYOUNG PHARMACEUTICAL CO., LTD, No.1, Ruiyang Road, Yiyuan County, Shandong Province, P.R. China CHINA REYOUNG PHARMACEUTICAL CO., LTD SUN ENTREPRISES LTD 2024-04-20 2029-04-19

185 Rwanda FDA-HMP-MA-2314 AMOXICLAV-DENK 1000/125 Amoxicillin and Clavulanic acid 1000 mg/125mg Powder for oral suspension 8 or 12 sachets in a carton Sachets with a foil structure consisting of paper, polyethylene, aluminum, and Surlyn layers 36 Months PENCEF PHARMA GmbH Breitenbachstrasse 13 - 14 D-13509 Berlin GERMANY DENK PHARMA GmbH & Co. KG HERILY-AGENCE DE MARKETING LTD 2025-05-12 2030-05-11

186 Rwanda FDA-HMP-MA-0813 AMOXICLAV-DENK 500/62.5 One film-coated tablet contains 574 mg amoxicillin trihydrate, equivalent to 500 mg amoxicillin and 74.45 mg potassium clavulanate, equivalent to 62.5 mg clavulanic acid 500mg/62.5mg Film coated tablets 16 film-coated tablets Aluminium/Aluminium blister 24 Months PENCEF PHARMA GmbH, Breitenbachstrasse 13 – 14 D-13509 Berlin, Germany GERMANY DENK PHARMA GmbH & Co. KG HERILY – AGENCE DE MARKETING LTD 2024-01-30 2029-01-29

187 Rwanda FDA-HMP-MA-1419 AMOXIMED Amoxicillin 250 mg capsules 250 mg Hard capsules 10x10 capsules PVC/Aluminum blister foil 36 Months CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. No.88, Yangzi Road, Shijiazhuang City, Hebei province, China CHINA MEDISEL (K) LTD SUN ENTERPRISES LTD 2024-07-18 2029-07-17

188 Rwanda FDA-HMP-MA-1931 AMOXIMED AMOXICILLIN 500MG Capsules 10x10 Capsules and 500 Capsules ALU/PVC BLISTER and HDPE bottle 36 Months CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) Co., Ltd No.88, Yangzi Road, Shijiazhuang City, Hebei province, China.Corporate Office address: Not applicableManufacturing site Address: No.88, Yangzi Road, Shijiazhuang City, Hebei province, China.Country : China CHINA MEDISEL (K) LTD SUN ENTEPRISES LTD 2024-08-17 2029-08-16

189 Rwanda FDA-HMP-MA-1941 AMOXIREN Amoxicillin trihydrate BP 250 MG CAPSULES 10x10 Capsules Aluminium/PVC Blister Strip 24 Months RENE INDUSTRIES LTD Plot No 680,Kamuli, Kireka, Kampala, Uganda. Uganda RENE INDUSTRIES LTD, UGANDA RENE PHARMACY (R) LTD 2024-08-17 2029-08-16

190 Rwanda FDA-HBP-MA-0029 AMPHONEX-50 Amphotericin B 50mg/vial Lyophilized Powder for injection 50mg/vial Lyophilized powder for injection 20ml Vial 20ml clear, colorless, USP-Type I (Neutral Borosilicate) Tubular Vial 36 Months BHARAT SERUMS & VACCINES LTD, Plot No. K-27, K-27 Part and K-27/1, Anand Nagar, Jambivili Village, Additional MIDC, Ambernath East, Thane 421506, Maharashtra, India INDIA BHARAT SERUMS & VACCINES LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-08-24 2028-08-23

191 Rwanda FDA-HMP-MA-0736 AMPICILLIN FOR INJECTION Ampicillin Sodium, 1000mg 1000mg Powder for injection 50 Vials 7ml Type II glass vial, sealed with aluminum 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 2024-02-09 2029-02-08

192 Rwanda FDA-HMP-MA-1119 AMPICLO-DAWA Ampicillin trihydrate BP 125mg/5ml and Cloxacillin Sodium BP 125mg/5mL 125mg/5ml and 125mg/5mL Powder for suspension 60 ml and 100 ml Bottles High Density Polyethylene (HDPE) bottles 36 Months DAWA LIMITED. Plot No. 7879/8, Baba Dogo Rd, Ruaraka. P.O. Box 16633-00620. Nairobi. Kenya KENYA DAWA LIMITED, KENYA SUN ENTERPRISES LTD 2024-04-20 2029-04-19

193 Rwanda FDA-HMP-MA-1089 AMPIKARE 1G INJECTION Ampicillin Sodium 1g 1g Solution for injection 50’s x 7mL glass vials Mould vials glass containers, Non flip off cap, butyl rubber stopper, with adhesive label in box 36 Months REYOUNG PHARMACEUTICAL CO., LTD. No.1 Ruiyang Road, Yiyuan county, Shandong Province, P. R. China CHINA KAREMAX INDUSTRIAL LTD, INDIA SUN ENTERPRISES LTD 2024-04-20 2029-04-19

194 Rwanda FDA-HMP-MA-1542 AMVA DENK 10/160MG AMLODIPINE/ VALSARTAN 10/160MG FILM COATED TABLET 28 Tablets PVC/PVDC-Aluminium blisters 36 Months BALKAN PHARMA DUPNITSA AD 3 Samokovsko Shosse Str., Dupnitsa, 2600 Bulgaria Bulgaria Denk Pharma Gmbh & CO. KG, Germany ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2024-07-27 2029-07-26

195 Rwanda FDA-HMP-MA-1543 AMVA DENK 5/160MG AMLODIPINE/ VALSARTAN 5/160MG Film Coated Tablets 28 Tablets PVC/PVDC-Aluminium blisters packed in Printed carton containing package leaflet 36 Months BALKAN PHARMA DUPNITSA AD 3 Samokovsko Shosse Str., Dupnitsa, 2600 Bulgaria Bulgaria Denk Pharma Gmbh & CO. KG, Germany ETS CONTINENTAL 2024-07-27 2029-07-26

196 Rwanda FDA-HMP-MA-0832 AMYN DT 125 Amoxicillin Trihydrate USP 125 mg 125 mg Tablets 10x10 Tablets Alu/Alu blister 24 Months KOPRAN LIMITED, Village Savroli, Taluka Khalapur, District Raigad – 410202, India INDIA KOPRAN LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LIMITED 2024-02-09 2029-02-08

197 Rwanda FDA-HMP-MA-1267 AMYN DT 250 Amoxicillin Trihydrate USP 250 mg 250 mg Dispersible tablets 3x 15 tablets, 2x 10 tablets Alu/Alu strips packed in a carton 24 Months KOPRAN LIMITED, Village Savroli, Taluka Khalapur, District Raigad – 410202, India INDIA KOPRAN LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-07 2029-05-06

198 Rwanda FDA-HMP-MA-1327 AMYN-250 Amoxicillin Trihydrate BP 250mg 250mg Capsules 10x10 Capsules Blister of Alu/PVC 36 Months KOPRAN LIMITED, Village Savroli Khalapur, Dist-Raigad, Maharashtra, India INDIA KOPRAN LIMITED, INDIA PHILIPS PHARMACEUTICALS LTD 2024-05-18 2029-05-17

199 Rwanda FDA-HMP-MA-1366 ANASICA 2% Lidocaine Hydrochloride BP 21.330mg/ml 21.330mg/ml Solution for Injection 10 x 30 ml glass vials Amber colored glass vials packed in a carton 36 Months BHARAT PARENTERALS LIMITED, Survey No. 144& 146, Jarod Samlaya Rod, Vill. Haripura, Tal. Savli, Dist. Vadodara 391520, India INDIA ASENCE PHARMA PRIVATE LIMITED, INDIA SUN ENTERPRISES LTD 2024-05-18 2029-05-17

200 Rwanda FDA-HMP-MA-0252 ANASTROZOLE 1 MG FILM-COATED TABLETS Anastrozole 1 mg 1 mg Film-coated tablets 1x30 tablets PVC/Aluminium blister 60 Months SALUTAS PHARMA GmbH, Otto-von-Guericke-Allee 1 39179 Barleben, Germany Germany SANDOZ GmbH, KUNDL SURGIPHARM (RWANDA) LTD 2023-05-12 2028-05-11

201 Rwanda FDA-HMP-MA-2023 ANASTROZOLE NEAPOLIS ANASTROZOLE 1MG TABLETS 3x10 Tablets ALU/PVC BLISTER 24 Months NEAPOLIS PHARMA Road of Tunis Km7 BP 206 Nabeul 8000, Tunisia. TUNISIA NEAPOLIS PHARMA KIPHARMA LTD 2024-08-17 2029-08-16

202 Rwanda FDA-HMP-MA-1823 ANATERO Anastrozole 1mg Tablets 30 Tablets HDPE CONTAINER PACK 36 Months HETERO LABS LIMITED Unit-V, TSIIC Formulation SEZ, Survey No. 411, 425, 435 & 458, Polepally village, Jadcherla Mandal, Mahaboob Nagar (Dist) – 509301, Telangana. India. INDIA HETERO DRUGS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

203 Rwanda FDA-HMP-MA-0727 ANAWIN Bupivacaine Hydrochloride BP 2.5mg/mL 2.5mg/mL Solution for Injection 20mL Vial 1 glass vial packed in Unit Carton 24 Months NEON LABORATORIES LIMITED; Plot No.29, 30, 31, 32, 57&60. The Palghar Taluka-Co-op Estate Ltd., Boisar Road, Palghar, Dist: Thane 401404, Maharashtra, India INDIA NEON LABORATORIES LIMITED SUN ENTERPRISE LTD 2024-01-08 2029-01-07

204 Rwanda FDA-HMP-MA-0800 ANAWIN HEAVY Bupivacaine Hydrochloride equivalent to anhydrous Bupivacaine Hydrochloride 20mg/4mL 20mg/4mL Solution for injection 5×1 ampoules 5×1 ampoule of 4mL flint with black dotted ‘snap off’ OPC 18 Months NEON LABORATORIES LIMITED, Plot No. 29, 30, 31, 32, 57 & 60, The Palghar Taluka-Co-Op Estate Ltd, Boisar Road, Palghar, Thane 401404, Maharashtra, India INDIA NEON LABORATORIES LIMITED SUN ENTERPRISES LTD 2024-01-08 2029-01-07

205 20-4362-DGC&PHS-2018-R1 ANDOL-1000 Paracetamol 1000 mg Tablets Box/8 PVC/ALUMINIUM BLISTER 36 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

206 20-4361-DGC&PHS-2018-R1 ANDOL-500 Paracetamol 500 mg Tablets Box/16 PP TUBE WITH PE STOPPER 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

207 Rwanda FDA-HMP-MA-1958 ANDROGEL TESTOSTERONE 16.2MG/G GEL Boxes of 1, 2, 3 or 6 containers Multi-dose polypropylene canister, containing a pouch, with a metered dose airless pump 36 Months Besins Healthcare Benelux Sa. Groot Bijgaardenstraat 128 1620 Drogenbos, Belgium Belgium BESINS HEALTHCARE BENELUX SA SURGIPHARM (RWANDA) LTD 2024-08-17 2029-08-16

208 Rwanda FDA-HMP-MA-0439 ANGINOVAG Dequalinium chloride 1mg, Tyrothricin 4mg, ? -glycyrrhetinic acid (Enoxolone) 0.6mg & Hydrocortisone acetate 0.6mg and Lidocaine hydrochloride 1mg 1mg, 4mg, 0.6mg, 0.6mg and 1mg Oromucosal spray solution 20 ml Bottle Plastic bottle sealed with a plastic metered dose pump containing 10 or 20 ml 48 Months FERRER INTERNACIONAL, S.A. Joan Buscalla, 1-9 08173 Sant Cugat Del Vallés Barcelona, Spain SPAIN FERRER INTERNACIONAL, S.A. GOMHS LTD 2023-08-24 2028-08-23

209 Rwanda FDA-HMP-MA-0292 ANOL-100 Atenolol BP, 100mg 100mg Uncoated tablets 10x10 tablets Alu-Alu blister pack. Such 10 blisters are packed in printed carton with pack insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist.- Gandhinagar, Gujarat. India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

210 Rwanda FDA-HMP-MA-0298 ANOL-50 Atenolol BP, 50mg 50mg Uncoated tablets 10x10 tablets Alu-Alu blister pack. Such 10 blisters are packed in printed carton with pack insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist.- Gandhinagar, Gujarat. India INDIA LINCOLN PHARMACEUTICALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

211 Rwanda FDA-HMP-MA-1467 ANOMEX Hydrocortisone Acetate BP, Lidocaine USP, Zinc Oxide USP and Allantoin BP 0.25 % w/w, 3.0 % w/w, 5.0 % w/w and 0.5 % w/w SUPPOSITORIES 2 Strips of 5 Suppositories PVC/PE foil packed in a carton along pack insert 24 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 2024-07-27 2029-07-26

212 Rwanda FDA-HMP-MA-0370 ANTALGEX T® Paracetamol BP & Tramadol hydrochloride BP 325 mg/37.5 mg 325 mg/37.5 mg Hard gelatin capsule 2X10 capsules PVC-Aluminium blisters 24 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 2023-07-08 2028-07-07

213 Rwanda FDA-HMP-MA-0807 ANTHEL Albendazole USP 200mg/5ml 200mg/5ml Oral suspension 20 ml Amber PET Bottle Amber PET Bottle with 25 mm “LPL” logo Printed Aluminium P.P. Cap & 10 ml Measuring Plastic Cup. Such Labelled Bottle is packed in a Printed Carton with Packing Insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Taluka: Kalol, Gandhinagar Gujarat District, India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LIMITED 2024-01-15 2029-01-14

214 Rwanda FDA-HMP-MA-0174 ANTHEL Albendazole USP, 400mg, Tablet 400mg Uncoated chewable tablets, 1Tablet Packed PVC blister, Aluminium foil 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2022-12-14 2027-12-13

215 Rwanda FDA-HMP-MA-1370 ANTI-COUGH SYRUP Ambroxol HCL 50mg, Guaiphenesin 15mg, Terbutaline Sulphate1.5mg, Chlorpheniramine Maleate 2mg, Menthol 1mg 50mg/15mg/1.5mg/2mg/1mg syrup 100 ml Glass bottle Amber Glass Heam up bottle and a primary carton 36 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

216 Rwanda FDA-HMP-MA-1145 ANTI-HIST CREAM Mepyramine maleate BP 2% w/w 2% w/w Cream 20 gm Tube Collapsible aluminium tube with extended nozzle and polythene cap 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 2024-04-27 2029-04-26

217 Rwanda FDA-HMP-MA-0079 ANZAVIR-R Atazanavir Sulfate & Ritonavir 300mg, 100mg Biconvex Tablet, Debossed With ‘M777’ 30 Tablets HDPE BOTTLE WITH WHITE OPAQUE CAP 36 Months MYLAN LABORATORIES LIMITED F- 4 & F-12, MIDC, Malegaon, Sinnar, Nashik -422 113, Maharashtra, India INDIA MYLAN LABORATORIES LIMITED PYRAMID PHARMA LIMITED 2021-08-05 2026-08-05

218 Rwanda FDA-HMP-MA-0162 APCALIS-SX 20 Tadalafil Tablets USP 20mg 20mg Film coated tablets 2X2 Tablets Alu- PVC blister pack, 2 such blisters are packed in a carton along with PIL 36 Months AJANTA PHARMA LIMITED, B-4/5/6, M.I.D.C. Area, Paithan, Dist. Aurangabad, Maharashtra-India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

219 Rwanda FDA-HMP-MA-1609 APDROPS Moxifloxacin Hydrochloride Eye Drops 0.5% w/v Eye Drops 3 mL or 5 mL LDPE vial 36 Months Ajanta Pharma Limited Mirza - Palashbhari Road, Vill. – Kokhjar, Kamrup (R), Guwahati, Assam -781128, India. India Ajanta Pharma Ltd, India Abacus Pharma (A) Ltd 2024-08-17 2029-08-16

220 Rwanda FDA-HMP-MA-1047 APEXIME® 200MG/5ML Azithromycin 200mg/5ml 200mg/5ml Suspension 15ml Bottle PET Bottle, packed in a carton 24 Months THE MADRAS PHARMACEUTICALS, 137-B Old Mahabalipuram Road, Karappakkam, Chennai, Tamilnadu – 603 103, India. INDIA CROSS PHARM SA, SUISSE. GOMHS LTD 2024-02-28 2029-02-27

221 Rwanda FDA-HMP-MA-1048 APEXIME® 500 MG TABLETS Azithromycin 500mg 500mg Film-coated tablet 3 Tablets ALU/PVC blister, and in a printed carton 36 Months THE MADRAS PHARMACEUTICALS, 137-B Old Mahabalipuram Road, Karappakkam, Chennai, Tamilnadu – 603 103, India. INDIA CROSS PHARM SA, SUISSE GOMHS LTD 2024-02-28 2029-02-27

222 Rwanda FDA-HMP-MA-1374 APFLU Paracetamol 500mg, Pheniramine Maleate 25mg, Ascorbic Acid 200mg 500 mg, 25 mg, 200 mg Granular powder 10 sachets of 13.0g Aluminium sachets in a carton 24 Months AJANTA PHARMA LIMITED. Gut No.11/12/13/14/15, Paithan Road, Chitegaon, Aurangabad 431105 Taluka Paithaan, India INDIA AJANTA PHARMA LIMITED, INDIA ABACUS PHARMA (A) LTD 2024-05-18 2029-05-17

223 Rwanda FDA-HMP-MA-0163 APFLU SYRUP Chlorphenamine Maleate BP 0.5mg, Paracetamol BP 120mg & Vitamin C BP 50mg 0.5mg, 120mg & 50mg SYRUP 100 ml bottle Amber Glass bottle in a carton along with pack insert 24 Months AJANTA PHARMA LIMITED, 31-0, M.I.D.C Area Chikalthana Aurangabad, 431 210 India. INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

224 Rwanda FDA-HMP-MA-2258 APIBAN 5 Apixaban 5 mg Tablets 1x10\'s, 3x10\'s & 10x10 Tablets Alu-PVC/PVDC Blister Packs 36 Months MSN LABORATORIES PRIVATE LIMITED MSN House Plot No.: C – 24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, Pincode: 500 018, India. INDIA MSN LABORATORIES PRIVATE LIMITED ABACUS PHARMA (A) LTD 2025-02-04 2030-02-03

225 Rwanda FDA-HMP-MA-2354 APMALT IRON (III) HYDROXIDE POLYMALTOSE 100MG TABLETS 12 TABLETS 12’S TABLETS IN A PP TUBE WITH 0.125 GM COTTON POLYESTER BALL, 1 SUCH PP TUBE IN A PRINTED CARTON WITH INSERT 24 MONTHS AJANTA PHARMA LIMITED GUT. NO. 11/12/14/15, CHITEGAON, PAITHAN ROAD. AURANGABAD 431105, MAHARASHTRA STATE, INDIA INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2025-10-09 2030-10-08

Registered

226 Rwanda FDA-HMP-MA-2062 APRETUDE CABOTEGRAVIR 30MG Film Coated Tablets 30 tablets HDPE Container 36 Months Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) Priory Street Ware Hertfordshire SG12 0DJ United Kingdom ViiV Healthcare Pty Ltd KIPHARMA LTD 2024-09-30 2029-09-29

227 Rwanda FDA-HMP-MA-1504 APRETUDE PROLONGED RELEASE SUSPENSION FOR INJECTION Cabotegravir Sodium 600MG/3ML Prolonged release suspension for injection 3ml Vial Type I clear glass vial, sealed with bromobutyl rubber stopper and an aluminum Overseal with a removable plastic cap 36 Months GLAXO OPERATIONS UK LIMITED Harmire Road, Barnard Castle, County Durham DL12 8DT, United Kingdom United Kingdom ViiV Healthcare Pty Ltd KIPHARMA LTD 2024-07-27 2029-07-26

228 Rwanda FDA-HMP-MA-0539 ARBITEL 80MG Telmisartan 80mg 80mg Tablets 3x10’s tablets Alu/Alu blister pack 36 Months MICRO LABS LIMITED, API – Division (ML-15) Plot No.43-45, KIADB Jigani – Bommasandra Link Road Anekal Taluk, Bangalore – 560 10 Karnataka, India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-10-13 2028-10-12

229 Rwanda FDA-HMP-MA-1890 ARBITEL H-80 TELMISARTAN AND HYDRCHLOROTHIAZIDE 80MG/12.5MG Tablets 3x10\'s Alu-Alu 24 Months MICROLABS LTD 92. SIPCOT, industrial complex, HOSUR-635126, TAMIL NADU, INDIA India MICRO LABS LIMITED Wessex Pharmaceuticals Rwanda Ltd 2024-08-17 2029-08-16

230 Rwanda FDA-HMP-MA-0904 ARBITEL –AM Telmisartan BP 40mg and Amlodipine Besilate 5mg 40mg and 5mg Film coated tablets 3x10 tablets Alu/Alu blisters. Such 3 blisters are packed in a printed outer carton along with a pack insert 36 Months MICRO LABS LIMITED, 92 SIPCOT Industrial Complex, Hosur-635 126, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-22 2029-02-21

231 Rwanda FDA-HMP-MA-0975 ARBITEL-40 Telmisartan BP 40 mg 40 mg Tablets 3x10 Tablets Alu/ Alu Blister. Such 10 blisters are packed in a carton along with a pack insert 36 Months MICRO LABS LIMITED, 92 SIPCOT Industrial Complex, Hosur-635 126, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-26 2029-02-25

232 Rwanda FDA-HMP-MA-0722 ARBITEL-H Telmisartan 40 mg and Hydrochlorothiazide 12.5 mg 40 mg and 12.5 mg Uncoated tablets 3 x 10's Tablets Alu/Alu blister pack of 3 x 10's tablets Packed in outer carton 24 Months MICRO LABS LIMITED, 92 SIPCOT Industrial Complex Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-01-15 2029-01-14

233 Rwanda FDA-HMP-MA-1050 ARIMIDEX® 1 MG TABLETS Anastrozole 1mg 1mg Film Coated Tablet 14*2 (28) Tablets PVC/Aluminium Blister 60 Months ASTRAZENECA UK LTD, Silk Road Business Park, Macclesfield, SK10 2NA, United Kingdom UNITED KINGDOM ASTRAZENECA UK LIMITED SURGIPHARM (RWANDA) LTD 2024-02-28 2029-02-27

234 RWANDA-FDA23/HM/0414/0013 ARMEZA 80/480 Artemether and Lumefantrine 80 mg / 480 mg ORAL TABLET 36 Months Vital Laboratories Pvt Ltd India UNIZA LIFECARE PVT. LTD. ABACUS PHARMA (A) Ltd 2026-02-05 2031-02-04

235 Rwanda FDA-HMP-MA-0784 ARPREL 10 Prasugrel 10mg 10mg Film coated tablets 3x10’s Tablets Alu/ Alu blisters. Such 3 blisters are packed in a printed carton along with a package insert 24 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-01-08 2029-01-07

236 Rwanda FDA-HMP-MA-0783 ARPREL 5 Prasugrel 5mg 5mg Film coated tablets 3x10’s tablets Alu/ Alu blisters. Such 3 blisters are packed in a printed carton along with a package insert 24 Months MICRO LABS LIMITED, 92, Sipcot Industrial Complex, Hosur-635 126, Tamil Nadu, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-01-08 2029-01-07

237 Rwanda FDA-HMP-MA-0164 ARTEFAN 20/120 Artemether and Lumefantrine, 20/120mg tablets 20/120mg Dispersible tablets 1x6’s, 1x12’s, 30x6’s, 30x12’s tablets PVC-PVdC/ Aluminium blister packs 24 Months AJANTA PHARMA LIMITED, B-4/5/6, M.I.D.C. Area, Paithan, Dist. Aurangabad, 431148 Maharashtra-India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

238 Rwanda FDA-HMP-MA-0980 ARTEFAN 20MG/120MG Artemether/Lumefantrine 20mg/120mg 20mg/120mg Uncoated Tablets 1x 6’s, 1x12’s, 1x18’s, 1x24’s, 30x6’s, 30x12’s, 30x18’s, 30x24’s, 30x8’s Tablets PVC-PVdC/Aluminium Blister packs, packed in a carton along with pack insert 24 Months AJANTA PHARMA LIMITED, B-4/5/6, M.I.D.C. Area, Paithan, Dist. Aurangabad,431148 Maharashtra, India INDIA AJANTA PHARMA LTD, INDIA ABACUS PHARMA (A) LTD 2024-02-26 2029-02-25

239 Rwanda FDA-HMP-MA-0165 ARTEFAN 40/240 Artemether and Lumefantrine 40/240mg tablets 40/240mg Uncoated tablets 6 tablets ALU/PVC-PVdC blister Pack 24 Months AJANTA PHARMA LIMITED, B-4/5/6, M.I.D.C. Area, Paithan, Dist. Aurangabad, 431148 Maharashtra-India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

240 Rwanda FDA-HMP-MA-0166 ARTEFAN 80/480 Artemether and Lumefantrine, 80/480mg tablets 80/480mg Uncoated tablets 6 tablets ALU/PVC-PVdC Blister Pack 24 Months AJANTA PHARMA LIMITED, B-4/5/6, M.I.D.C. Area, Paithan, Dist. Aurangabad, Maharashtra-India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

241 Rwanda FDA-HMP-MA-1614 ARTEMETHER 20MG & LUMEFANTRINE 120MG TABLETS Artemether 20mg & Lumefantrine 120mg tablets 20mg/120mg Tablets 30 x 1 x 6’s, 30 x 1 x 12’s, 30 x 1 x 18’s, 30 x 1 x 24’s Tablets PVC/PRINTED ALUMINIUM FOIL 36 Months Ipca laboratories limited, Ipca laboratories limited, Plot No. 255/1 Village Athal, Silvassa-396230, Union Territory of Dadra and Nagar Haveli and Daman and Diu, India INDIA IPCA LABORATORIES LIMITED SUN ENTEPRISES LTD 2024-08-17 2029-08-16

242 Rwanda FDA-HMP-MA-1776 ARTEMETHER AND LUMEFANTRINE Artemether and Lumefantrine 80mg/480 mg Tablets 1x6 Tablets Alu-PVC blister 36 Months AURA LIFECARE PVT. LTD. Address: Survey No 254/ 14/1, Jarod ,Savli Road, P.O. Karachiya, Tal-Savli , Dist : Vadodara-391520. Gujarat State. INDIA AURA LIFECARE PVT. LTD. SUN ENTERPRISES LTD 2024-08-17 2029-08-16

243 Rwanda FDA-HMP-MA-2061 ARTENAM BETA-ARTEMETHER 10MG/1ML INJECTION 7 Ampules Glass Ampoules 48 Months SOLUPHARM GmbH Industriestra?e3 34212, Melsungen Germany Germany ARENCO PHARMACEUTICA N.V KIPHARMA LTD 2024-09-30 2029-09-29

244 Rwanda FDA-HMP-MA-1214 ARTHRIX CAPSULE 100 MG Colecoxib 100mg 100 mg Hard gelatin capsules 2×10’s blister Alu/Alu Blisters packed in a printed carton along with a pack insert 36 Months NEOPHARMA. Plot No. A1, 89-95, Industrial City of Abu Dhabi (ICAD), P.O. Box 72900, Mussafah, Abu Dhabi UAE, United Arab Emirates UNITED ARAB EMIRATES NEOPHARMA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05

245 Rwanda FDA-HMP-MA-1211 ARTHRIX CAPSULE 200 MG Celecoxib 200mg 200 mg Hard gelatin capsules 1×10 capsules Alu/Alu Blisters packed in a carton along with a pack insert 36 Months NEOPHARMA. Plot No. A-1, 89-95, Industrial City of Abu Dhabi (ICAD), P.O Box 72900, Mussafah, Abu Dhabi, UAE UNITED ARAB EMIRATES NEOPHARMA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05

246 Rwanda FDA-HMP-MA-1612 ARTIM Artemether 80mg/ml 800mg/ml Injection 6x1ml Ampoules USP TYPE I AMBER AMPOULE 24 Months Kilitch Drugs (India) Ltd Kilitch Drugs (India) Ltd, Plot no-C-301/2, M.I.D.C T.T.C, Industrial Area Pawane, Navi, Mumbai-400705, Maharashtra, India INDIA KILITCH DRUGS (INDIA) LIMITED WESSEX PHARMACEUTICAL (RWANDA) LTD 2024-08-17 2029-08-16

247 Rwanda FDA-HMP-MA-1222 ASCIPRAM 10 Escitalopram Oxalate, 10mg 10mg Film Coated Tablets 3x10 Tablets Alu/PVC Blisters pack 36 Months MICRO LABS LIMITED, No.92, Sipcot Industrial Complex, Hosur – 635 126, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICAL (RWANDA) LIMITED 2024-05-06 2029-05-05

248 Rwanda FDA-HMP-MA-1223 ASCIPRAM 20 Escitalopram Oxalate, 20mg 20mg Film Coated Tablets 3x10 Tablets Alu/PVC Blister pack 36 Months MICRO LABS LIMITED, No.92, Sipcot Industrial Complex, Hosur – 635 126, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICAL (RWANDA) LIMITED 2024-05-06 2029-05-05

249 Rwanda FDA-HMP-MA- 1375 ASCORIL EXPECTORANT Bromohexine Hydrochloride BP 4mg, Salbutamol sulphate 2mg, Guaifenesin USP 100mg 4mg, 2mg, 100mg Syrup 100mL bottle Amber coloured labelled PET bottle sealed with aluminium PP cap with “G” logo 10 mL HDPE & measuring cup 24 Months GLENMARK PHARMACEUTICALS LTD., Village Kishanpura, Baddi-Nalagarh Road, Teshsil Baddi, Dist. Solan, Himachal Pradesh-173 205 India INDIA GLENMARK PHARMACEUTICALS LTD., INDIA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-18 2029-05-17

250 Rwanda FDA-HMP-MA-0967 ASOMEX 2.5 S (-) Amlodipine Besilate 2.5 mg 2.5 mg Uncoated Tablets 3x10 tablets, or 5x10 tablets, PVDC Coated PVC Film and Aluminium Foil. 3 or 5 such blister strips are packed in a carton along with a package insert 36 Months EMCURE PHARMACEUTICALS LIMITED, Lane no. 03, Phase II, SIDCO industrial Complex, Bari-Brahmana, Jammu (J&K) – 181133, India INDIA EMCURE PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2024-02-26 2029-02-25

251 Rwanda FDA-HMP-MA-0861 ASOMEX 5 S (-) Amlodipine besilate equivalent to S (-) Amlodipine 5mg 5mg Uncoated tablets 3x10 Tablets PVDC coated PVC/ Aluminium Foil. Such blisters of 10 tablets each are packed in a carton along with pack insert 36 Months EMCURE PHARMACEUTICALS LIMITED, Lane No.3, Phase-II, SIDCO Industrial Complex, Bari-Brahmana, Jammu – 181 133, India. INDIA EMCURE PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2024-02-09 2029-02-08

252 Rwanda FDA-HMP-MA-0721 ASOMEX LT S (-) Amlodipine Besilate 2.5mg & Losartan Potassium 50 mg USP 2.5mg & 50 mg Uncoated tablets 3×10 tablets 2 composite blister strips of PVC/PVDC 24 Months EMCURE PHARMACEUTICALS LTD, SIDCO Industrial complex, Lane No. 03Phase-II, Bari-Brahmana, Jammu (J & K)- 181133, India INDIA EMCURE PHARMACEUTICALS LTD ABACUS PHARMA (A) LTD 2024-02-09 2029-02-08

253 Rwanda FDA-HMP-MA-1534 ASOMEX-D S (-) Amlodipine 2.5mg and Hydrochlorothiazide 12.5mg 2.5mg/12.5 mg TABLETS 3x10 Tablets Blister pack of 3 x 10 tablets in a carton along with pack insert 36 Months EMCURE PHARMACEUTICALS LIMITED SIDCO Industrial Complex, Lane -3, Phase II, Bari-Brahmana-Jammu 181133, India INDIA EMCURE PHARMACEUTICALS LIMITED BION PHARMA GROUP LTD 2024-07-27 2029-07-26

254 Rwanda FDA-HMP-MA-1459 ASPIRIN 300MG TABLETS Aspirin BP 300mg 300g Tablets 20x10 tablets and 1000 tablets Alu/PVDC blisters of 20 x 10 tablets packed in a unit carton with a literature insert and in 1000’s in HDPE container 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 DEPOT PHARMACEUTIQUE LE MEDICAL 2024-07-20 2029-07-19

255 Rwanda FDA-HMP-MA-1530 ASPIRIN CARDIO 100MG ACETYLSALICYLIC ACID 10MG Film Coated Tablets 3x10 Tablets Alu/Alu Blister packs 36 Months BAYER AG Leverkusen, Kaiser-Wilhelm-Allee, 51368 Leverkusen, Germany Germany Bayer (Switzerland) AG SURGIPHARM (RWANDA) LTD 2024-07-24 2029-07-26

256 Rwanda FDA-HMP-MA-0785 ASPIRINE UPSA- 1000 Acetylsalicylic Acid 1000 mg 1000 mg Effervescent tablets 1x10’s effervescent tablets Polypropylene tube with a polyethylene stopper containing a desiccant (molecular sieve) 24 Months UPSA, 979, Avenue des Pyrénées, 47520 Le Passage – France FRANCE UPSA, FRANCE UBIPHARM RWANDA LTD 2024-01-08 2029-01-07

257 Rwanda FDA-HMP-MA-1978 ASPOCAN Posaconazole 100 mg Tablets 3x10 Tablets PVC/ALU Blister pack 24 Months M/s. Hetero Labs Limited Unit-III Address: 22-110,IDA,Jeedimetla,Hyderaba,Telangana, India India HETERO LABS LIMITED Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

258 Rwanda FDA-HMP-MA-2041 ASTHAREN TABLETS Salbutamol Sulphate 4mg Tablets 10×10 Tablets Aluminium/Pvc Blister Strip And Carton 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. Telephone: +256 414236595, +256 414341416 E-Mail: info@rene.co.ug, rishi@rene.co.ug UGANDA RENE INDUSTRIES LTD RENE PHARMACY (R) LTD 2024-09-30 2029-09-29

259 Rwanda FDA-HMP-MA-0125 ATACAND 16 MG 16mg Candesartan Cilexetil 16mg Biconvex Tablets 2x14’s Tablets PVC-PVDC/Al Blister Pack 36 Months AstraZeneca AB, Gartunavagen, SE-151 85, Sodertalje, Sweden SWEDEN AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2022-12-19 2027-12-18

260 Rwanda FDA-HMP-MA-0126 ATACAND 8 MG 8 mg Candesartan Cilexetil 8 mg Biconvex Tablets 2x14’s Tablets PVC-PVDC/Al Blister Pack 36 Months AstraZeneca AB, Gartunavagen, SE-151 85, Sodertalje, Sweden SWEDEN AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2022-12-19 2027-12-18

261 Rwanda FDA-HMP-MA-0124 ATACAND PLUS 16/12.5 MG 16mg Candesartan Cilexetil and 12.5mg Hydrochlorothiazide 16mg and 12.5mg Biconvex Tablets 2x14’s Tablets PVC-PVDC/Al Blister Pack 36 Months AstraZeneca AB, Gartunavagen, SE-151 85, Sodertalje, Sweden SWEDEN AstraZeneca UK Limited SURGIPHARM (RWANDA) LTD 2022-12-19 2027-12-18

262 Rwanda FDA-HMP-MA-0332 ATAZANAVIR (AS SULFATE) AND RITONAVIR TABLETS 300MG AND 100MG Atazanavir Sulfate equivalent to Atazanavir 300 mg, Ritonavir USP 100 mg 300 mg and 100 mg Film coated tablets 30 Tablets 120CC HDPE Bottle 24 Months LUPIN LIMITED, Plot No. 6A, Sector-17, Special Economic Zone, MIHAN notified Area, Nagpur, Maharashtra-4411 08, India INDIA LUPIN LIMITED AIVEEN (R) LTD 2023-06-26 2028-06-25

263 Rwanda FDA-HMP-MA-1888 ATAZOR-R-300/100 ATANAVIR SULPHATE/RITONAVIR 300/100MG TABLETS 30’s count, 90’s count and 180’s count HDPE container pack 36 months. EMCUREPHARMACEUTICALSLTD Plot No. P-1 & P-2, I.T.B.T. Park, Phase II, MIDC, Hinjwadi, Pune-411 057 Maharashtra, India India EMCUREPHARMACEUTICALSLTD,Plot No. P-1&P-2. I.T.B.TPark, Phase II, M.I.D.C,Hinjwadi, Pune – 411 057,India Bion Pharma Group (BPG) Limited 2024-08-17 2029-08-16

264 Rwanda FDA-HMP-MA-0127 ATENOLOL DENK 50 Atenolol 50 mg 50 mg Film-Coated Tablet 100 Film-Coated Tablets BLISTER PACKS 36 Months ARTESAN PHARMA GmbH & Co. KG, Wendlandstraße 1 29439 Lüchow, Germany GERMANY DENK PHARMA GmbH & Co. KG ETS CONTINENTAL DEPOT PHARMACEUTIQUE 2022-12-19 2027-12-18

265 RWANDA-FDA24/HM/0876/0050 Atosar Losartan Potassium BP 50 mg Film-coated tablets, 24 Months Vasudha Pharma Chem Limited (Unit-II) India CORONA REMEDIES PVT LTD SUN ENTERPRISES LTD 2025-12-12 2030-12-11

266 Rwanda FDA-HMP-MA-1512 ATOSAR-H Losartan Potassium BP & Hydrochlorothiazide BP 50MG/12.5MG TABLET 3x10 Tablets Alu/Alu Blister pack, such 3 Blisters are packed in carton along with insert 24 Months CORONA REMEDIES PRIVATE LIMITED Village Jatoli, Post Office– Oachgha, Tehsil Solan, Dist. Solan Himachal Pradesh – 173223, India INDIA CORONA REMEDIES PRIVATE LIMITED SUN ENTERPRIESES LTD 2024-07-27 2029-07-26

267 Rwanda FDA-HMP-MA-1318 ATRACURIUM MÉDIS 25MG, INJECTION SOLUTION Atracurium Besylate 25mg 25mg Solution for injection 2.5ml ×50 vials Type I white neutral stretched vial 2R blow back of diameter 16 mm closed with Grey chlorobutyl flat rubber stopper Ø13 mm and Aluminum plat green Capsule Ø 13 mm 24 Months LES LABORATOIRES MÉDIS, Road of Tunis Km7 BP 206 Nabeul 8000 Tunisia TUNISIA LES LABORATOIRES MÉDIS, TUNISIA KIPHARMA LTD 2024-05-16 2029-05-15

268 Rwanda FDA-HMP-MA-1319 ATRACURIUM MÉDIS 50MG, INJECTION SOLUTION Atracurium Besylate 50mg 50mg Solution for injection 2.5ml ×50 vials Type I white neutral stretched vial 2R blow back of diameter 16 mm closed with Grey chlorobutyl flat rubber stopper Ø13 mm and Aluminum plat green Capsule Ø 13 mm 24 Months LES LABORATOIRES MÉDIS, Road of Tunis Km7 BP 206 Nabeul 8000 Tunisia TUNISIA LES LABORATOIRES MÉDIS, TUNISIA KIPHARMA LTD 2024-05-16 2029-05-15

269 Rwanda FDA-HMP-MA-2058 ATRONA-40 ATORVASTATIN CALCIUM 40 mg Tablets 3x10 Tablets Alu-Alu Blister pack 36 Months ZOTA HEALTHCARE LTD Zota Healthcare Ltd. plot no 169, Surat Special Economic Zone, Near Sachin Railway Station, Sachin, Surat-394 230, Gujart, India. INDIA ZOTA HEALTHCARE LTD Taha Healthcare Ltd 2024-09-30 2029-09-29

270 Rwanda FDA-HMP-MA-0942 ATROP OPHTHALMIC SOLUTION Atropine Sulfate 1.0 % w/v 1.0 % w/v Ophthalmic Solution 10 ml Bottle Low Density Polyethylene (LDPE) container with HDPE cap and noozle 24 Months AUROLAB, No.1 Sivagangai Main Road, Veerapanjan, Madurai, 625020, India INDIA AUROLAB, INDIA DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-21 2029-02-20

271 Rwanda FDA-HMP-MA-0148 ATROPINE SULFATE AGUETTANT 0.1 MG/ML, SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Atropine sulfate 0.1 mg/ml 0.1mg/ml Solution for injection Box of 10 polypropylene pre-filled syringes of a capacity of 5 ml Polypropylene pre-filled syringes 36 Months LABORATOIRE AGUETTANT Address: 1, rue Alexander Fleming-69007 Lyon, France FRANCE LABORATOIRE AGUETTANT PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2022-12-21 2027-12-20

272 Rwanda FDA-HMP-MA-1984 ATROZEMB 10-10MG ATORVASTATIN/EZETIMIBE 10MG+10MG FILM COATED TABLET 10 tablets Alu/Alu blister 24 month Liptis for Pharmaceutical and Medical Products (S.A.E) Plot no. B/2, 6th industrial zone, 6th of October City Egypt Liptis for Pharmaceuticals & Medical Products (S.A.E).Plot No. B/2, 6th Industrial zone, 6th of October City, Egypt.mahmoud.elaila@liptispharma.com GOODMAN INTERNATIONAL ® LTD 2024-08-17 2029-08-16

273 Rwanda FDA-HMP-MA-1985 ATROZEMB 20-10MG ATORVASTATIN/EZETIMIBE 20MG+10MG FILM COATED TABLET 10 tablets Alu/Alu blister 24 month Liptis for Pharmaceutical and Medical Products (S.A.E) Plot no. B/2, 6th industrial zone, 6th of October City Egypt Liptis for Pharmaceuticals & Medical Products (S.A.E).Plot No. B/2, 6th Industrial zone, 6th of October City, Egypt.mahmoud.elaila@liptispharma.com GOODMAN INTERNATIONAL ® LTD 2024-08-17 2029-08-16

274 RWANDA-FDA24/HM/0725/0029 ATSTAT 10 ATORVASTATIN CALCIUM TRIHYDRATE PH. EUR Film Coated Tablets 24 Synthimed Labs Private Limited India Ind-Swift Limited LOTUS MEDICAL GROUP Ltd 2026-03-14 2031-03-13

275 Rwanda FDA-HMP-MA-2082 AUGMENTIN 500/62.5MG AMOXICILLIN /CLAVULANIC ACID 500MG/62.5MG TABLETS 2x8 tablets PVC/Aluminium/Polyamide Cold Formed blister 24 Months Glaxo Wellcome Production ZI de la Peyenniere 53100 Mayenne FRANCE GlaxoSmithKline Pharmaceutical Kenya Limited KIPHARMA LTD 2024-08-17 2029-08-16

276 Rwanda FDA-HMP-MA-1062 AUGMENTIN PDR 112.5 MG/5 ML 100 mg of Amoxycillin (as trihydrate) and 12.5mg Potassium Clavulanate 100 mg + 12.5mg Powder for Oral Suspension 30 ml & 60 ml Bottles Glass Bottles 24 Months GLAXO WELLCOME PRODUCTION, ZI de la Peyenniere 53100 Mayenn, France FRANCE GLAXOSMITHKLINE PHARMACEUTICAL KENYA LIMITED KIPHARMA LTD 2024-02-23 2029-02-22

277 Rwanda FDA-HMP-MA-0873 AUROCAINE Proparacaine Hydrochloride Ophthalmic solution USP 0.5% w/v 0.5% w/v Ophthalmic Eye Drops 10 ml Bottle Low Density Polyethylene Container with HDPE cap and nozzle packed in a monocarton with pack insert 12 Months AUROLAB, No.1 Sivagangai Main Road, Veerapanjan, Madurai, India. INDIA AUROLAB DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-17 2029-02-16

278 Rwanda FDA-HMP-MA-0996 AUROCARPINE Pilocarpine Nitrate USP 0.5%w/v 0.5%w/v Eye drops solution 1ml Bottle Amber glass vial with grey bromo butyl rubber wad and flip off seals 24 Months AUROLAB, No.1, Sivagangai Main Road, Veerapanjan, Madurai – 625 020, India INDIA AUROLAB, INDIA DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-26 2029-02-25

279 Rwanda FDA-HMP-MA-0944 AUROCORT Triamcinolone Acetonide 40mg/ml 40mg/ml Intraocular injection 5 vials of 1 mL of a 40 mg/Ml glass vial, are packed in a carton Flint type I single use glass vial with a grey rubber stopper and an open target seal 24 Months AUROLAB, No.1 Sivagangai Main Road, Veerapanjan, Madurai, India INDIA AUROLAB DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-26 2029-02-25

280 Rwanda FDA-HMP-MA-0900 AUROCROME Cromolyn sodium ophthalmic solution 2%w/v 2%w/v Ophthalmic Eye Drop 5ml Bottle 10ml LDPE container with HDPE cap and Nozzle. Such LDPE container is packed in a monocarton with package insert 24 Months AUROLAB, No.1 Sivagangai Main Road, Veerapanjan, Madurai, India INDIA AUROLAB, INDIA DEPOT PHARMACEUTICAL LE MEDICAL 2024-02-22 2029-02-21

281 Rwanda FDA-HMP-MA-0957 AUROFLOX Ofloxacin,0.3% w/v 0.3% w/v Ophthalmic eye drop 10 ml Bottle Low density polyethylene container with HDPE cap and Nozzle 24 Months AUROLAB, No.1.Sivagangai Main Road, Veerapanjan, Madurai 625020, India INDIA AUROLAB DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-26 2029-02-25

282 Rwanda FDA-HMP-MA-0847 AUROFORT Prednisolone acetate Ophthalmic suspension 1%w/v. 1%w/v Ophthalmic Eye Drops 5 ml Bottle 10 ml LDPE container with HDPE cap and Nozzle. Such LDPE container is packed in a monocarton with package insert 24 Months AUROLAB, No.1, Sivagangai Main Road, Veerapanjan, Madurai – 625 020, India INDIA AUROLAB DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-09 2029-02-08

283 Rwanda FDA-HMP-MA-0899 AUROMIDE PLUS Tropicamide 0.8% w/v and Phenylephrine HCl 5% w/v 0.8% w/v and 5% w/v Ophthalmic Eye Drop 5ml Bottle Packed in 10ml LDPE container with HDPE cap and Nozzle. Such LDPE container is packed in a monocarton with package insert 24 Months AUROLAB, No.1 Sivagangai Main Road, Veerapanjan, Madurai, India INDIA AUROLAB, INDIA DEPOT PHARMACEUTICAL LE MEDICAL 2024-02-22 2029-02-21

284 Rwanda FDA-HMP-MA-0845 AUROPENT Cyclopentolate Hydrochloride BP 1% w/v 1% w/v Ophthalmic Eye Drops 5 ml Bottle 10 ml LDPE container with HDPE cap and Nozzle. Such LDPE container is packed in a monocarton with package insert 24 Months AUROLAB, No.1, Sivagangai Main Road, Veerapanjan, Madurai – 625 020, India INDIA AUROLAB DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-09 2029-02-08

285 Rwanda FDA-HMP-MA-0846 AUROPRED Prednisolone sodium Phosphate BP 0.5%w/v. 0.5%w/v Ophthalmic Eye Drops 5 ml Bottle 10 ml LDPE container with HDPE cap and Nozzle. Such LDPE container is packed in a monocarton with package insert 24 Months AUROLAB, No.1, Sivagangai Main Road, Veerapanjan, Madurai – 625 020, India INDIA AUROLAB DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-09 2029-02-08

286 Rwanda FDA-HMP-MA-0849 AUROPROST RT Latanoprost USP 0.005% w/v 0.005% w/v Ophthalmic Eye Drops 2.5 ml Bottle 5 ml LDPE container with HDPE cap and Nozzle. Such LDPE container is packed in a monocarton with package insert 24 Months AUROLAB, No.1, Sivagangai Main Road, Veerapanjan, Madurai – 625 020, India INDIA AUROLAB DEPOT PHARMACEUTIQUE LE MEDICAL 2024-02-09 2029-02-08

287 Rwanda FDA-HMP-MA-1136 AUROTIM Timolol Maleate BP 0.5% w/v 0.5% w/v Eye Drops 5ml filled in a 10ml bottle Low Density Polyethylene (LDPE) container with HDPE 24 Months AUROLAB, No.1 Sivagangai Main Road, Veerapanjan, Madurai, India INDIA AUROLAB DEPOT PHARMACEUTIQUE LE MEDICAL 2024-04-21 2029-04-20

288 Rwanda FDA-HMP-MA-0128 AVAMYS NASAL SPRAY Each Spray Actuation Delivers 27.5 Micrograms of Fluticasone Furoate 27.5 micrograms Nasal Spray White Suspension 1 Bottle Of 30, 60 Or 120 Sprays TYPE III AMBER GLASS BOTTLE 36 Months GLAXO OPERATIONS UK LIMITED (TRADING AS GLAXO WELLCOME OPERATIONS), GLAXO WELLCOME S.A., Harmire Road Barnard Castle Co. Durham, DL12 8DT, United Kingdom and/or Avenida De Extremadura 3, 09400 Aranda De Duero Burgos, Spain UNITED KINGDOM AND SPAIN GLAXOSMITHKLINE PHARMACEUTICAL KENYA LIMITED KIPHARMA LTD 2022-12-19 2027-12-18

289 Rwanda FDA-HMP-MA-0601 AVARIN Simethicone 300mg and Alverine Citrate 60mg 300mg and 60mg Soft Gelatin Capsule 5 x 10 Tablets PVC/PVDC–Aluminium blister-packed softgel capsules packed in a catch covers and contained in unit cartons 24 Months MEGA LIFESCIENCES PUBLIC COMPANY LIMITED. 384 MOO 4, SOI 6, Bangpoo Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280, Thailand THAILAND MEGA LIFESCIENCES PUBLIC COMPANY LIMITED ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12

290 Rwanda FDA-HMP-MA-2070 AVAS 40 ATORVASTATIN 40MG TABLETS 3x10 Tablets ALU-ALU Blisters 36 Months MICRO LABS LIMITED 27, Race Course Road, Bangalore 560 001, Karnataka, India INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16

291 Rwanda FDA-HMP-MA-1187 AVASTIN Bevacizumab 400mg/16ml 400mg/16ml Concentrate for solution for infusion 16 ml vial (Type I glass) with a stopper (butyl rubber) 36 Months ROCHE PHARMA AG, Emil-Barrell-Str. 1, D-79639 GrenzachWyhlen, Germany GERMANY F. HOFFMANN-LA ROCHE LTD. KIPHARMA LTD 2024-05-06 2029-05-05

292 Rwanda FDA-HMP-MA-2044 AVASTIN Bevacizumab 100mg/4ml CONCENTRATE FOR SOLUTION FOR INFUSION 4ML VIAL RUBBER-STOPPERED VIAL. 24 Months Roche Diagnostics GmbH and F. Hoffmann-La Roche Ltd Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim Germany, and F. Hoffmann-La Roche Ltd Wurmisweg CH-4303 Kaiseraugst Switzerland Germany and SWITZERLAND Roche Registration GmbH KIPHARMA LTD 2024-09-30 2029-09-29

293 Rwanda FDA-HMP-MA-1188 AVAZIR Tobramycin 0.3% (3mg/ml) 0.3% (3mg/ml) Ophthalmic Solution 10 ml bottle LDPE white plastic dropper bottle 24 Months ORCHIDIA PHARMACEUTICAL INDUSTRIES, Al-Obour City, North Industrial zone, Area 14, 15, Block no. 12011 Cairo, Egypt, P.O Box 11341 Cairo, Egypt EGYPT ORCHIDIA PHARMACEUTICAL INDUSTRIES ETS CONTINENTAL 2024-05-06 2029-05-05

294 Rwanda FDA-HMP-MA-0111 AVIBELA Levonorgestrel 52mg (20?g/24hrs) Ius 1 Sterile Unit POLYESTER BLISTER WITH A PEELABLE LID (TYVEK POLYETHYLENE) 60 Months ODYSSEA PHARMA S.A. Rue du travail, 16 B-4460 Grace-Hollogne-Belgium BELGIUM IMPACT RH360/USA PROLINE HEALTCARE AND SYSTEMS 2022-07-18 2027-07-17

295 Rwanda FDA-HMP-MA-0311 AVIR-200 Acyclovir USP, 200 mg 200 mg Uncoated tablets 10 Tablets Alu-PVC Blister Pack, packed in a printed Carton with Packing Insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Trimul Estate, Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat-India INDIA LINCOLN PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

296 RWANDA-FDA24/HM/0530/0011 AVIRAX Aciclovir BP 5% w/w Cream 36 Months Great Pacific Exports Pvt. Ltd India S KANT HEALTHCARE LTD ABACUS PHARMA (A) Ltd 2026-02-05 2031-02-04

297 Rwanda FDA-HMP-MA-2116 AVIRAX Aciclovir Tablets BP 200 mg Tablets 10 tablets Alu-PVDC blister 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

298 Rwanda FDA-HMP-MA-0157 AVONZA Efavirenz/Lamivudine/ Tenofovir Disoproxil Fumarate Tablets/400 mg/300 mg/300 mg 400mg/300mg/300mg Film coated tablets 30 tablets and 90 tablets 30 tablets in white HDPE bottle and 90 tablets in blue HDPE bottle 24 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 PYRAMID PHARMA LIMITED 2022-12-21 2027-12-20

299 Rwanda FDA-HMP-MA-0135 AXA AQUA Sterile Water for Injection USP 10ml Solvent for parenteral use 48x10ml ampoules LDPE ampoules packed in a unit carton 36 Months AXA PARENTERALS LIMITED, Plot No 936, 937& 939, Vill. Kishanpur, Jamalpur, Roorkee-247667, Distt. Haridwar (Uttarakhand), India INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

300 Rwanda FDA-HMP-MA-0136 AXACIP Ciprofloxacin USP 200mg/100ml 200mg/100ml Solution for infusion 100 ml ampoules LDPE ampoules packed in a unit carton 36 Months AXA PARENTERALS LIMITED, Plot No 936, 937& 939, Vill. Kishanpur, Jamalpur, Roorkee-247667, Distt. Haridwar (Uttarakhand), India INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

301 Rwanda FDA-HMP-MA-0188 AXACOMOCATE Sodium Cromoglicate BP, 2% w/v 2% w/v Eye Drops 10 ml vial LPDE vial packed in a unit carton along with pack insert 24 Months AXA PARENTERALS LIMITED, Plot No.936, 937 & 939, Vill. Kishanpur, Jamalpur, Roorkee 247667, Distt. Haridwar (uttarakhand), India INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2022-12-21 2027-12-20

302 Rwanda FDA-HMP-MA-0137 AXADEX D10 Glucose Intravenous Infusion BP 10% w/v 10% w/v Intravenous infusion 1X250ml bottle 300ml LDPE bottle 36 Months Axa Parenterals Limited, Plot No 936, 937& 939, Vill. Kishanpur, Jamalpur, Roorkee-247667, Distt. Haridwar (Uttarakhand), India. INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2022-12-19 2027-12-18

303 Rwanda FDA-HMP-MA-0296 AXADEX D5 Glucose Anhydrous Intravenous Infusion BP 5% w/v 5% w/v Solution for Intravenous Infusion 1x500ml bottle LDPE bottle 36 Months AXA PARENTERALS LIMITED, Plot No.936, 937 & 939, Vill. Kishanpur, Jamalpur, Roorkee 247667, Distt. Haridwar (uttarakhand), India. INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

304 Rwanda FDA-HMP-MA-0297 AXADEX D50 Glucose Anhydrous Intravenous Infusion BP 50% w/v 50% w/v Solution for Intravenous Infusion 1x500ml bottle LDPE bottle 24 Months AXA PARENTERALS LIMITED, Plot No.936, 937 & 939, Vill. Kishanpur, Jamalpur, Roorkee 247667, Distt. Haridwar (uttarakhand), India INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

305 Rwanda FDA-HMP-MA-0353 AXAGYL Metronidazole USP 500mg/100ml 500mg/100ml Intravenous Injection 100 ml bottle LDPE bottle 36 Months AXA PARENTERALS LIMITED, Address: Plot No.936, 937 & 939, Vill. Kishanpur, Jamalpur, Roorkee247667, Distt. Haridwar (Uttarakhand), India INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-07-08 2028-07-07

306 Rwanda FDA-HMP-MA-0578 AXALINE-N Sodium Chloride BP 0.9%w/v 0.9%w/v Nasal Drops 10ml Vial LDPE vial packed in a unit carton a long with pack insert 24 Months AXA PARENTERALS LIMITED, Plot No.936, 937 & 939, Vill. Kishanpur, Jamalpur, Roorkee247667, Distt. Haridwar (Uttarakhand), India. INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-09-11 2028-09-10

307 Rwanda FDA-HMP-MA-0480 AXAMOL Salbutamol Sulfate BP, 2.5mg/2.5ml 2.5mg/2.5ml Respules, A clear colourless solution 4x5x2.5ml LDPE respule. LDPE respule wraped in a foil pouch packed in a unit carton. 24 Months AXA PARENTERALS LIMITED, Plot No.936,937&939 Vill. Kishanpur,Jamalpur,Roorkee 247667, Distt. Haridwar(Uttarakhand), India INDIA AXA PARENTERALS LIMITED ABACUS PHARMA (A) LTD 2023-08-24 2028-08-23

308 Rwanda FDA-HMP-MA-0280 AXAPARA Paracetamol Intravenous Infusion BP 1.0%w/v 1.0%w/v Intravenous infusion 100 ml bottle LDPE bottle packed in a Unit Carton, along with the pack insert 24 Months AXA PARENTERALS LIMITED, Plot No.936, 937 & 939, Vill. Kishanpur, Jamalpur, Roorkee 247667, Distt. Haridwar (Uttarkhand) India INDIA AXA PARENTERALS LIMITED, INDIA ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

309 Rwanda FDA-HMP-MA-1982 AZACITIDINE NEAPOLIS AZACITIDINE 100MG/VIAL SOLUTION FOR INJECTION 10 vial Type I glass vial 24 month NEAPOLIS PHARMA Route de Tunis, Km7- B.P. 206, 8000 Nabeul Tunisia Neapolis Pharma, route de Tunis, Km7-B.P.206, 8000 Nabeul, Tunisia. KIPHARMA Ltd 2024-08-17 2029-08-16

310 Rwanda FDA-HMP-MA-1531 AZAL- 500MG Azithromycin Dihydrate USP 500MG Film Coated Tablets 3x10 Tablets Alu-Pvc blister pack 36 Months STALLION LABORATORIES PVT. LTD C-1B, 305/2, 3, 4 & 5, G.I.D.C. Kerala (Bavla), Dist. Ahmedabad-382 220, Gujarat, India INDIA STALLION LABORATORIES PVT. LTD SUN ENTERPRISES LTD 2024-07-27 2029-07-26

311 Rwanda FDA-HMP-MA-0364 AZARGA® 10 mg/mL brinzolamide / 5 mg/mL timolol 10 mg/mL / 5 mg/mL Eye Drops 5ml Droptainer Plastic Droptainer 24 Months S.A. ALCON-COUVREUR N.V., Rijksweg 14, B-2870 Puurs, Belgium BELGIUM NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-07-08 2028-07-07

312 Rwanda FDA-HMP-MA-0926 AZBACT SUSPENSION AZITHROMYCIN 200mg/5ml Oral Suspension 30 ml Bottle HDPE Bottles with a PP/ PE 36 Months GLOBELA PHARMA PVT. LTD. 357-358, G.I.D.C, Sachin, Surat – 394 230, Gujarat, India INDIA GLOBELA PHARMA PVT. LIMITED AFRIPHARM LTD 2024-02-21 2029-02-20

313 Rwanda FDA-HMP-MA-0625 AZINOWEL 500 Azithromycin Dihydrate USP, 500 mg 500 mg Film Coated Tablets 1X3 tablets Alu-PVC blister; such 1 blister packed in a printed carton with pack insert 36 Months AKUMS DRUGS AND PHARMACEUTICALS LTD, Plot No. 19,20 & 21, Sector-6A, IIE., SidcuL, Ranipur, Haridwar-249403, Uttarakhand, India INDIA UNOSOURCE PHARMA LTD, INDIA AIVEEN RWANDA LTD 2023-12-10 2028-12-09

314 Rwanda FDA-HMP-MA-2075 AZITAR-500 Azithromycin (Dihydrate) USP 500MG TABLETS 1x3 Tablets Alu-Alu Blister 36 Months MAXTAR BIO-GENICS K.NO. 705, NALAGARH ROAD, MALKU MAZRA, (Baddi), TEHSIL NALARH, DISTT. SOLAN, H.P. India INDIA MAXTAR BIO-GENICS SUN ENTERPRISES LTD 2024-08-17 2029-08-16

315 Rwanda FDA-HMP-MA-1282 AZITHROMIL -500 Azithromycin 500mg 500 mg Film coated tablet 1 X 3 tablets Alu/Alu Blister pack, in carton 36 Months BAROQUE PHARMACEUTICALS PRIVATE LIMITED, Address: 192/2&3, 190/1 & 202/9, Sokhada-388 620 Tal: Khambhat, Dist. Anand, Gujarat, India INDIA BEKRA PHARMA UK LTD UBIPHARM-RWANDA LTD 2024-05-16 2029-05-15

316 Rwanda FDA-HMP-MA-1851 AZITHROMYCIN Azithromycin dehydrate USP 500mg Tablets 3 tablets ALU/PVC BLISTER 24 Months AURA LIFECARE PVT. LTD. Survey No 254/ 14/1,Jarod ,Savli Road, P.O. Karachiya, Tal-Savli ,Dist : Vadodara-391520. Gujarat State, INDIA INDIA AURA LIFECARE PVT. LTD SUN ENTERPRISES LTD 2024-08-17 2029-08-16

317 Rwanda FDA-HMP-MA-1226 AZITHROSAFE SUSPENSION Azithromycin Suspension 200 mg/5 ml 200 mg/5 ml Suspension 15 ml Bottle Amber coloured pet bottle 24 Months ENICAR PHARMACEUTICALS PVT. LTD. J-214, 215, 216, M.I.D.C, Tarapur Industrial Area, Boisar, Taluka Palghar, Dist. Palghar401 506, Maharashtra, India INDIA PHARMA LIFE SCIENCE LTD, KENYA STAR BIOTECH LIMITED 2024-05-06 2029-05-05

318 Rwanda FDA-HMP-MA-1986 AZITRINE AZITHROMYCIN 40MG SUSPENSION 15ml HDPE bottle 24 month Bliss GVS Pharma Limited Plot 10, 11A, 12, Survey No. 37/1, Dewan Udyog Nagar, Aliyali, Palghar, DistrictThane – 401404, India IMEX PHARMA, Rose Belle building, unit 3- Rose Belle, Business Park, Maurice, Email: audrene.rouxel@imex-sf.com MEDIASOL PHARMACEUTICAL Ltd 2024-08-17 2029-08-16

319 Rwanda FDA-HMP-MA-1778 AZITRINE -500 Azithromycin (as dihydrate) USP 500 mg Film Coated Tablets 3 Tablets Alu-PVC foil 36 Months BLISS GVS PHARMA LIMITED Plot 10, 11-A, 12; Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Palghar, District- Thane – 401404 INDIA BLISS GVS PHARMA LIMITED MEDIASOL PHARMACEUTICAL DEPOT LTD 2024-08-17 2029-08-16

320 Rwanda FDA-HMP-MA-0170 AZITRINE-250 AZITHROMYCIN 250MG TABLETS 6 Tablets Alu-PVC foil 36 Months BLISS GVS PHARMA LTD Plot 10, 11-A, 12 Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Tal. - Palghar, District-Thane – 401404. INDIA IMEX PHARMA, Maurice Mediasol Pharmaceutical Depot Ltd 2024-08-17 2029-08-16

321 Rwanda FDA-HMP-MA-1253 AZIWIN 500 Azithromycin USP 500mg 500mg Film Coated Tablets 3 Tablets Aluminium/PVC blister 36 Months BAL PHARMA LIMITED, 21 & 22 - Bommasandra Industrial Area Bangalore, India INDIA BAL PHARMA LIMITED, INDIA SUN ENTERPRISES LTD 2024-05-06 2029-05-05

322 Rwanda FDA-HMP-MA-0464 AZOPT EYE DROPS Brinzolamide 10 mg/ml Eye Drops, Suspension 10 mg/ml Eye Drops Suspension 5 ml Bottle LDPE bottle with a dispensing plug / carton 24 Months S.A. ALCON-COUVREUR N.V., Rijksweg 14 B-2870 Puurs, Belgium BELGIUM NVS KENYA LIMITED SURGIPHARM (RWANDA) LTD 2023-08-24 2028-08-23

323 Rwanda FDA-HMP-MA-1651 AZUNATE Artesunate Ph. Int. 60MG POWDER FOR INJECTION 1 VIAL A carton containing one vial of artesunate powder for injection, one ampoule of sodium bicarbonate injection, one ampoule of sodium chloride injection placed in a plastic tray along with a package insert. Artesunate powder for injection is filled in a 10ml clear glass vial (USP Type III.) The filled vial is closed with 20mm grey bromobutyl rubber plug and sealed with 20mm chocolate brown flip off aluminum seal. Sodium bicarbonate injection is filled in a 1ml clear glass ampoule (USP Type I) with a green snap off ring. Diluent: Sodium chloride injection is filled in a 5ml clear glass ampoule (USP Type I) 24 Months MACLEODS PHARMACEUTICALS LIMITED Phase I, Unit II Plot No. 25 – 27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman – 396210, India INDIA MACLEODS PHARMACEUTICALS LIMITED AIVEEN RWANDA LTD 2024-08-17 2029-08-16