HUMAN MEDICINAL PRODUCTS REGISTER

HUMAN MEDICINE REGISTERED PRODUCTS

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No. Registration No. Product Brand Name Generic Name Dosage Strength Dosage Form Pack Size Packaging Type Shelf Life Manufacturer's Name Manufacturer's Address Manufacturer Country Marketing Authorization Holder(MAH) Local Technical Representative(LTR) Registration Date Expiry Date
1 Rwanda FDA-HMP-MA-0680 EASCOF EXPECTORANT Bromhexine Hydrochloride BP 4 mg, Salbutamol Sulphate BP equivalent to Salbutamol 2mg, Guaifenesin BP 100 mg and Menthol BP 1 mg 4 mg, 2mg, 100 mg and 1 mg Syrup 100 ml Bottle Orange colored PET Bottle sealed with 25 mm EPE WAD Cap 24 Months CACHET PHARMACEUTICALS. PVT. LTD, Village-Thana, Near Baddi, Tehsil- Nalagarh, Dist.- Solan, Himachal Pradesh -173205, India INDIA CACHET PHARMACEUTICALS. PVT. LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-10 2028-12-09

2 Rwanda FDA-HMP-MA-1771 EASCOF-D Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride & Chlorpheniramine Maleate Syrup 10mg/5mg/2mg Syrup 100 ml Bottles Bottle in one carton along with its pack insert. 24 Months CACHET PHARMACEUTICALS PVT LTD Village - Thana, Near Baddi, Tehsil- Nalagarh, Dist.- Solan, Himachal Pradesh - 173205, INDIA CACHET PHARMACEUTICALS PVT SURGIPHARM RWANDA LIMITED 2024-08-17 2029-08-16

3 Rwanda FDA-HMP-MA-2048 EASCOF-LS SYRUP LEVOSALBUTAMOL SULPHATE/ AMBROXOL HYDROCHLORIDE/ GUAIPHENESIN 1MG/30MG/50MG/5ML SYRUP 100 ml round Pet Bottle 24 Months CACHET PHARMACEUTICALS PVT. LTD 415, Shah Nahar Industrial Estate, Dr. E. Moses Road, Worli, Mumbai-400 018 INDIA CACHET PHARMACEUTICALS PVT. LTD/INDIA SUN ENTERPRISES LTD 2024-09-30 2029-09-29

4 Rwanda FDA-HMP-MA-0315 EDURANTTM 25 MG FILM-COATED TABLETS Rilpivirine hydrochloride equivalent to 25 mg rilpivirine 25 mg Film coated tablets 30 tablets HDPE bottle with a polypropylene (PP) child resistant closure and induction seal liner 36 Months JANSSEN-CILAG S.p. A Via C. Janssen Borgo S. Michele 04100 Latina, Italy ITALY JANSSEN CILAG INTERNATIONAL NV KIPHARMA LTD 2023-05-12 2028-05-11

5 Rwanda FDA-HMP-MA-1582 EFAVIRENZ 400 MG, LAMIVUDINE 300 MG AND TENOFOVIR DISOPROXIL FUMARATE 300 MG TABLETS Efavirenz USP, Lamivudine USP and Tenofovir Disoproxil fumarate 400 mg/ 300 mg/300mg equivalent to 245 mg Tablets 30 Tablets HDPE CONTAINER 24 Months MACLEODS PHARMACEUTICALS LIMITED Block n2, Theda, P.O Lodhimjra, Tehsil Baddi, Dist. Solan, Himachal Pradesh-174101 INDIA MACLEODS PHARMACEUTICALS LIMITED CAPITAL PHARM SUPPLIES LTD 2024-08-17 2029-08-16

6 Rwanda FDA-HMP-MA-0378 EFAVIRENZ 400MG, LAMIVUDINE 300MG AND TENOFOVIR DISOPROXIL FUMARATE 300MG Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 400 mg / 300 mg / 300 mg 400 mg / 300 mg / 300 mg Film coated tablets 30, 90, 180’s tablets HDPE Bottle 24 Months MACLEODS PHARMACEUTICALS LIMITED, Block N 2, Village Theda, P.O. Lodhi Majra, Tehsil Baddi Dist.: Solan, Himachal Pradesh, 174101, India INDIA MACLEODS PHARMACEUTICALS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-07-08 2028-07-07

7 Rwanda FDA-HMP-MA-0253 EFAVIRENZ TABLETS 600MG Efavirenz USP 600mg 600mg Film-coated tablets 1x30’s Tablets White opaque HDPE container 36 Months STRIDES SHASUN LIMITED, No 36/7, Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore-562 106, India INDIA STRIDES SHASUN LIMITED, INDIA SUN ENTERPRISES LTD 2023-05-12 2028-05-11

8 Rwanda FDA-HMP-MA-0059 EFAVIRENZ, LAMIVUDINE & TENOFOVIR DISOPROXIL FUMARATE Efavirenz, Lamivudine & Tenofovir Disoproxil Fumarate 600mg, 300mg, 300mg Tablets 30 Tablets HDPE BOTTLE 24 Months CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED Plot 1-7, 1st Ring Road, Luzira Industrial Park, UGANDA UGANDA CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED SURGIPHARM (RWANDA) LTD 2021-06-01 2026-06-01

9 Rwanda FDA-HMP-MA-1173 EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE Efavirenz 600 mg, Lamivudine 300 mg, and Tenofovir Disoproxil Fumarate 600 mg 600 mg, 300 mg, 600 mg Film coated tablets 30 tablets and 90 tablets White opaque HDPE bottle 24 Months LAURUS LABS LIMITED, (Unit-2), Plot No. 19, 20 & 21, Western Sector, APSEZ, Atchutapuram Mandal, Visakhapatnam-531011. Andhra Pradesh, India INDIA LAURUS LABS LIMITED CAPITAL PHARMACEUTICAL SUPPLIES LTD 2024-05-06 2029-05-05

10 Rwanda-FDA-HM-1856 EFAVIRENZ,LAMIVUDINE,TENOFOVIR FUMARATE EFAVIRENZ,LAMIVUDINE,TENOFOVIR FUMARATE 600MG/300MG/300MG TABLETS 30’s HDPE container 24 Months Hetero Labs Limited (Unit-III) Address: Industrial Development Area (IDA), : Jeedimetla : Hyderabad-500 055 : Telangana. Country: India Telephone : 91-40-23096171/72/73/74 Telefax : 91-40-23095105, 23097756, 23140376 E-Mail: contact@heterodrugs.com India HETERO LAB LTD BION PHARMA GROUP LTD 2024-08-17 2029-08-16

11 Rwanda FDA-HMP-MA-2085 EFFERALGAN 1000 MG FRUITS ROUGES COMPRIME EFFERVESCENT PARACETAMOL 1000MG EFFERVESCENT TABLETS 8 effervescent tablets The polyethylene stopper and Polypropylene Tube 36 Months UPSA SAS 304, Avenue du Docteur Jean Bru 47000 Agen – France FRANCE UPSA SAS UBIPHARM-RWANDA LTD 2024-08-17 2029-08-16

12 Rwanda FDA-HMP-MA-0786 EFFERALGAN 150 MG POWDER Paracetamol 150 mg 150 mg Crystalline Powder 10 Sachets Sachets per box are made of paper/aluminium/polyethylene complex 36 months UPSA SAS 979, Avenue des Pyrénées 47520 Le Passage, France FRANCE PROPHARMED INTERNATIONAL UBIPHARM RWANDA LTD 2024-01-08 2029-01-07

13 Rwanda FDA-HMP-MA-0787 EFFERALGAN 250 MG POWDER Paracetamol 250 mg 250 mg Crystalline Powder 10 Sachets Sachets per box are made of paper/aluminium/polyethylene complex 36 months UPSA SAS 979, Avenue des Pyrénées 47520 Le Passage, France FRANCE UPSA, FRANCE UBIPHARM RWANDA LTD 2024-01-08 2029-01-07

14 Rwanda FDA-HMP-MA-1607 EFFERALGAN 300 SUPPOSITORY Paracetamol 300 mg Suppositories 10 Suppositories PVC/PE Blisters 36 Months UPSA 979 and UPSA 304 Avenue des Pyrénées 47520 Le Passage – France and avenue du Docteur Jean Bru 47000 agents – France France UPSA SAS, France Kipharma Ltd 2024-08-17 2029-08-16

15 Rwanda FDA-HMP-MA-1628 EFFERALGAN 500 MG TABLETS Paracetamol Ph Eur, 500mg, tablets 500mg TABLETS 2x8 Tablets ALU/PVC or PVDC 36 months UPSA SAS 304 UPSA SAS 304, Avenue du Docteur Jean Bru 47000 Agen – France FRANCE UPSA SAS UBIPHARM RWANDA LTD 2024-08-17 2029-08-16

16 Rwanda FDA-HMP-MA-1618 EFFERALGAN 500 MG, EFFERVESCENT SECABLE Paracetamol 500mg effervescent tablet 500mg Efervescent secable tablets 16 tablets HEAT-SEALED BLISTER PACK (ALUMINIUM /PE)/16 TABLETS IN POLYPROPYLENE TUBE 36 Months UPSA 979, UPSA 979, Avenue des Pyrénées, 47520 Le Passage - France FRANCE UPSA SAS UBIPHARM RWANDA LTD 2024-08-17 2029-08-16

17 Rwanda FDA-HMP-MA-1044 EFFERALGAN 80 MG SUPPOSITORY Acetaminophen, 80mg 80mg Suppository 2x5’s suppositories Heat-Sealed Sachets, consisting of a Paper/Aluminium/Polyethylene Complex. 36 Months UPSA 304, Avenue du Docteur Jean Bru 47000 Agen – France FRANCE UPSA SAS, FRANCE UBIPHARMA RWANDA LTD 2024-02-28 2029-02-27

18 Rwanda FDA-HMP-MA-1004 EFFERALGAN CODEINE 500 MG Paracetamol 500 mg and Codeine phosphate hemihydrate 30 mg 500 mg+30 mg Effervescent tablets 8 Effervescent tablets Opaque Polypropylene Tube closed with a polyethylene stopper containing molecular sieve as desiccant packed in a carton 36 Months UPSA, 979, Avenue des Pyrenees, 47520 Le Passage– France. FRANCE UPSA SAS UBIPHARM RWANDA LIMITED 2024-02-23 2029-02-22

19 Rwanda FDA-HMP-MA-1918 EFFERALGAN PEDIATRIC-3 PARACETAMOL 3G SYRUP 90 ml Polyethylene terephtalate brown bottle 36 month UPSA SAS 304, Avenue du Docteur Jean Bru 47000 Agen France UPSA SAS/FRANCE Address: 304, Avenue du Docteur Jean Bru 47000 Agen –France UBIPHARM-RWANDA LTD 2024-08-17 2029-08-16

20 Rwanda FDA-HMP-MA-1451 EFFERALGAN-600 Acetaminophen (Paracetamol) 600MG SUPPOSITOR 10 Suppositories Opaque PVC/PE complex 36 months UPSA SAS 304, Avenue du Docteur Jean Bru 47000 Agen – France. France UPSA SAS Ubipharma Rwanda Ltd 2024-07-27 2029-07-26

21 Rwanda FDA-HMP-MA-0856 EFLARON 125MG ORAL SUSPENSION Metronidazole (as Benzoate) BP 125mg/5ml 125mg/5ml Oral Suspension 60ml and 100ml bottles Amber Colored PET Bottles in unit box 36 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Rd, Ruaraka, Kenya. KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-02-09 2029-02-08

22 Rwanda FDA-HMP-MA-1138 EFLARON 250MG TABLETS Metronidazole 250mg 250mg Tablets 1000 tablets HDPE container along with literature insert 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 2024-04-21 2029-04-20

23 Rwanda FDA-HMP-MA-1475 ELMOX 250 Amoxicillin trihydrate BP 250MG hHard Gelatin Capsules 10x10 Capsules Alu-Pvc blister pack 36 Months YELURI FORMULATIONS PVT LTD Sy. No 296/7/6, I.D.A Bollaram, Sangareddy District-502 325, Telangana-India INDIA YELURI FORMULATIONS PVT LTD SURGIPHARM (RWANDA) LTD 2024-07-27 2029-07-26

24 Rwanda FDA-HMP-MA-0921 ELMOX CAPSULES Amoxicillin trihydrate BP 500 mg 500 mg Hard Gelatin Capsules 10x10 Capsules Alu-PVC blister pack 36 Months YELURI FORMULATIONS PVT. LTD, Sy. No. 296 / 7 / 6, IDA Bollaram, Sangareddy Dist. – 502 325, Telangana, India INDIA YELURI FORMULATIONS PVT. LTD SUN ENTERPRISES LTD 2024-02-21 2029-02-20

25 Rwanda FDA-HMP-MA-1092 ELMOX- CV 625 Amoxicillin and Clavulanate Potassium Tablets USP 625mg 625 mg Film coated tablets 2x10 tablets Alu-Alu Blisters packed in one Aluminium Pouch, this pouch is kept in one monocarton along with pack insert and silica gel bag 24 Months YELURI FORMULATIONS PVT LTD, Sy. No. 296 / 7 / 6, IDA Bollaram, Sanga reddy Dist. – 502 325, Telangana, India INDIA YELURI FORMULATIONS PVT LTD SUN ENTERPRISES LTD 2024-04-20 2029-04-19

26 Rwanda FDA-HMP-MA-0961 EMBRACOTRIM 960 Sulphamethoxazole BP 800mg and Trimethoprim BP 160mg 800mg, 160mg Uncoated Tablets 10x10 Tablets Blister pack 36 Months MERIT ORGANICS LTD, Plot No. 2104/2/A, G.I.D.C., Sarigam, Bhilad, Dist. Valsad - 396 155, Gujarat, India INDIA MERIT ORGANICS LTD SUN ENTERPRISES LTD 2024-02-26 2029-02-25

27 Rwanda FDA-HMP-MA-0830 EMETON SYRUP Metoclopramide Hydrochloride BP 5.0mg/ml 5.0mg/ml Syrup 60 ml Bottles Amber coloured (Glass/PET) bottles, 25 mm Aluminium caps, Emeton Syrup 60ml unit boxes 36 Months BIODEAL LABORATORIES LTD, 123, Lunga Lunga road, Industrial area, P.O BOX 32040-00600, Nairobi, Kenya KENYA BIODEAL LABORATORIES LTD CAPITAL PHARMACEUTICAL SUPPLIES LIMITED 2024-02-09 2029-02-08

28 Rwanda FDA-HMP-MA-0066 EMITINO Ondansetron 2mg/5ml Oral Solution 30 Ml AMBER COLOR PET BOTTLE 24 Months CACHET PHARMACEUTICALS PVT. LTD Village: Thana, Baddi, Himachal Pradesh-173 205, India INDIA CACHET PHARMACEUTICALS PVT. LTD STAR BIOTECH LIMITED 2021-06-01 2026-06-01

29 Rwanda FDA-HMP-MA-1589 EMITINO Ondansetron USP 8 mg Tablets 10 Tablets ALU/ALU BLISTER 24 Months CACHET PHARMACEUTIVAL Pvt.LTD Village-Thana, Baddi, Dist. Solan, Himachal Pradesh-173 205 INDIA CACHET PHARMACEUTICALS Pvt LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16

30 Rwanda FDA-HMP-MA-0067 EMITINO TABLETS Ondansetron 4mg Tablets 10 Tablets ALU-ALU BLISTER 24 Months CACHET PHARMACEUTICALS PVT. LTD Village: Thana, Baddi, Himachal Pradesh-173 205, India INDIA CACHET PHARMACEUTICALS PVT. LTD, INDIA STAR BIOTECH LIMITED 2021-06-01 2026-06-01

31 Rwanda FDA-HMP-MA-2328 EMITOSS INJECTION ONDANSENTRON HYDROCHLORIDE DIHYDRATE 4MG/2ML SOLUTION FOR INJECTION AMPOULE OF 2 ML USP TYPE I GLASS AMPOULE 24 MONTHS STERIL-GENE LIFE SCIENCES (P) LTD NO. 45, MANGALAM MAIN ROAD, MANGALAM VILLAGE, VILLIANUR COMMUNE, PUDUCHERRY-605110. INDIA INDIA GALAXY PHARMACEUTICALS LTD STAR BIOTECH LTD 2025-07-11 2030-07-10

Registered

32 Rwanda FDA-HMP-MA-2194 EMITOSS SOLUTION ONDANSENTRON HYDROCHLORIDE DIHYDRATE 2MG/5ML Oral Solution 30 ml PET Bottle 36 Months ENICAR PHARMACEUTICALS PVT. LTD J-214, 215, 216,M.I.D.C, TARAPUR INDUSTRIAL AREA, BOISAR, TALUKA PALGHAR, DIST. PALGHAR 401 506, MAHARASHTRA, INDIA INDIA GALAXY PHARMACEUTICALS LTD, KENYA STAR BIOTECH LIMITED 2025-01-09 2030-01-08

33 Rwanda FDA-HMP-MA-2260 EMPADIL-M 12.5/1000 EMPAGLIFLOZIN USP + METFORMIN HCL USP 12.5/1000 MG TABLETS 3x10 Tablets Alu-Alu Blisters 24 Months AJANTA PHARMA LIMITED Z/103/A, Dahej SEZ II, Bharuch – 392 130, Gujarat State, India INDIA AJANTA PHARMA LIMITED ABACUS PHARMA (A) LTD 2025-02-04 2030-02-03

34 Rwanda FDA-HMP-MA-1437 EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE Empagliflozin 5mg/ Metformin Hydrochloride 1000mg 5mg/ 1000mg Film Coated Tablets 60 Tablets White HDPE container of 60 tablets each packed in carton unit 24 Months CIPLA LIMITED, Unit III Plot No. L-139 to L-146 Verna Industrial Estate, Verna, Salcette, Goa-403 722. India INDIA CIPLA LTD, INDIA KIPHARMA LTD 2024-07-20 2029-07-19

35 Rwanda FDA-HMP-MA-1438 EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE Empagliflozin 25mg/ Metformin Hydrochloride 1000mg 25mg/ 1000mg Film Coated Tablets 30 Tablets White HDPE container of 30 tablets each packed in carton unit 24 Months CIPLA LIMITED, Unit III Plot No. L-139 to L-146 Verna Industrial Estate, Verna, Salcette, Goa-403 722. India INDIA CIPLA LTD, INDIA KIPHARMA LTD 2024-07-20 2029-07-19

36 Rwanda FDA-HMP-MA-1408 EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG/1000MG Empagliflozin and Metformin Hydrochloride, 10 mg/1000 10mg/1000mg Film coated extendedrelease tablet 30 Tablets HDPE container with a 38mm blue child resistant cap 24 Months CIPLA LTD, Cipla house, Peninsula business park, Ganpatrao kadam marg, Lower parel, Mumbai INDIA CIPLA LTD PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-07-18 2029-07-17

37 Rwanda FDA-HMP-MA-1317 EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS 12.5 MG/1000 MG Empagliflozin 12.5mg and Metformin Hydrochloride 1000mg 12.5mg, 1000 mg Extended Release Tablets 60 tablets White HDPE container 24 Months CIPLA LIMITED, Unit III Plot No. L-139 to L-146, Verna Industrial Estate, Verna-Goa 403 722-India INDIA CIPLA LIMITED, INDIA KIPHARMA LTD 2024-05-16 2029-05-15

38 Rwanda FDA-HMP-MA-1858 EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE 200/300MG TABLET HDPE Bottle of 30’s count, 90\\\'s count. HDPE Bottle 36 months. Laurus Labs Limited (Unit-II) Plot No: 19, 20 & 21, Western Sector, APSEZ, Gurajapalem village, Rambilli Mandal Anakapalli District, Andhra Pradesh, India. 531011, India India LAURUS LABS Limited, 2ND Floor, Serene Chambers, Road No.-7, Banjara Hills, Hydrabad, Telangana. Post Code: 500034, India, Email: info@lauruslabs.com CAPITAL PHARMACEUTICALS SUPPLIES 2024-08-17 2029-08-16

39 RWANDA-FDA24/HM/0087/0028 Emtricitabine and Tenofovir Alafenamide Tablets 200 mg/25 mg EMTRICITABINE AND TENOFOVIR ALAFENAMIDE 200 mg/25 mg ORAL TABLET 30's, 90's and 180's 24 Months Mylan Laboratories Limited Plot no: 11, 12 & 13, Indore SEZ, Pharma Zone, Phase-II, Sector-III, Pithampur – 454775, Dist. Dhar (MP) India India Mylan Laboratories Limited PYRAMID PHARMA LIMITED 2026-02-06 2031-02-05

40 Rwanda FDA-HMP-MA-2089 Emtricitabine and Tenofovir Disoproxil fumarate Tablets 200mg /300 mg Emtricitabine and Tenofovir Disoproxil fumarate 200/300MG TABLETS 30 Tablets HDPE container 24 Months HETERO LABS LIMITED (Unit-III) Hetero Labs Limited Industrial Development Area (IDA) Jeedimetla Hyderabad-500 055 Telangana India HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

41 Rwanda FDA-HMP-MA-0075 EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE 200MG/300MG TABLETS Emtricitabine, Tenofovir Disoproxil Fumarate 200mg, 300mg Film Coated Tablets 30 Tablets HDPE CONTAINER WITH 5G MOLECULAR SIEVE DESICCANT SACHET 24 Months LUPIN LIMITED Plot No. 6A1, 6A2, Sector-17, Special Economic Zone, MIHAN, Nagpur, Maharashtra-4411 08, India INDIA LUPIN LIMITED, INDIA AIVEEN (R) LTD 2021-06-01 2026-06-01

42 Rwanda FDA-HMP-MA-0724 EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE FILM COATED TABLETS 200 MG/300 MG Emtricitabine/Tenofovir Disoproxil Fumarate, 200 mg/300 mg 200 mg/300 mg Film-coated tablets 30’s Tablets HDPE bottles packed in outer carton 36 Months MYLAN LABORATORIES LIMITED, F-4 & F-12, Malegaon MIDC, Sinnar, Nashik - 422 113, Maharashtra State, India INDIA MYLAN LABORATORIES LIMITED, INDIA PYRAMID PHARMA LIMITED 2024-01-15 2029-01-14

43 Rwanda FDA-HMP-MA-0860 ENCIFER INJECTION Iron Sucrose 100mg/5ml (20mg/ml) 100mg/5ml (20mg/ml) Solution for Injection 5 Ampoules of 5ml Alu/PVC blister. One such blister packed in carton 24 Months EMCURE PHARMACEUTICALS LIMITED, Plot No. J-174, J-168 & J-168/1, MIDC, Tarapur, Boisar, Dist Thane-401506, Maharashtra, India. INDIA EMCURE PHARMACEUTICALS LIMITED ABACUS PHARMA (A) LTD 2024-02-09 2029-02-08

44 Rwanda FDA-HMP-MA-0330 ENDOPROST 125MCG Carboprost Tromethamine Injection USP 125 mcg 125 mcg Solution for injection 2ml vial USP type I (Neutral borosilcate) tubular glass vial with concave bottom 24 Months BHARAT SERUMS AND VACCINES LIMITED, K-27, K-27 PART and K-27/1, Jambivili village, Anand Nagar, Additional M.I.D.C, Thane 421506 Maharashtra State INDIA BHARAT SERUMS & VACCINES LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

45 Rwanda FDA-HMP-MA-0329 ENDOPROST 250MCG Carboprost Tromethamine Injection USP 250 mcg 250 mcg Solution for injection 2ml vial USP type I (Neutral borosilcate) tubular glass vial with concave bottom 24 Months BHARAT SERUMS AND VACCINES LIMITED, K-27, K-27 PART and K-27/1, Jambivili village, Anand Nagar, Additional M.I.D.C, Thane 421506 Maharashtra State INDIA BHARAT SERUMS & VACCINES LTD WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-05-12 2028-05-11

46 Rwanda FDA-HMP-MA-0184 ENEAS Enalapril maleate 10mg and Nitrendipine 20mg 10mg and 20mg Biconvex tablets 30 tablets Alu/Alu blister. PA/AL/PVC foil and Al foil 36 Months FERRER INTERNACIONAL, S.A Joan Buscallà 1-908173-Sant Cugat del Vallès (Barcelona), Spain SPAIN FERRER INTERNACIONAL, S.A. SPAIN GOMHS LTD 2022-12-21 2027-12-20

47 Rwanda FDA-HMP-MA-0293 ENOXA 2000 UI, ANTI-XA/0.2ML Enoxaparin Sodium 20mg/0.2ml Solution for Injection Box of 2 pre-filled syringes of 0.2 ml Pre-filled syringes 24 Months LES LABORATOIRES MÉDIS, Km 7 route de Tunis, BP 206 8000 Nabeul, TUNISIA TUNISIA LES LABORATOIRES MÉDIS, TUNISIA KIPHARMA LTD 2023-05-12 2028-05-11

48 Rwanda FDA-HMP-MA-0300 ENOXA 4000 UI, ANTI-XA/0.4ML Enoxaparin Sodium 4000 UI/0.4ml 4000 UI/0.4ml Solution for injection 2 pre-filled syringes of 0.4 ml Box of 2 pre-filled syringes of 0.4 ml 24 Months LES LABORATOIRES MEDIS, Km 7 route de Tunis, BP 206, 8000 Nabeul, TUNISIA TUNISIA LES LABORATOIRES MEDIS. KIPHARMA LTD 2023-05-12 2028-05-11

49 Rwanda FDA-HMP-MA-0310 ENOXA 6000 UI, ANTI-XA/0.6ML Enoxaparin sodium 60mg/0.6ml Solution for Injection Box of 2 pre-filled syringes of 0.6 ml Pre-filled syringes 24 Months LES LABORATOIRES MÉDIS, Km 7 route de Tunis, BP 206 8000 Nabeul, TUNISIA TUNISIA LES LABORATOIRES MÉDIS, TUNISIA KIPHARMA LTD 2023-05-12 2028-05-11

50 Rwanda FDA-HMP-MA-0294 ENOXA 8000 UI, ANTI-XA/0.8ML Enoxaparin sodium 80mg/0.8ml Solution for Injection Box of 2 pre-filled syringes of 0.8 ml Pre-filled syringes 24 Months LES LABORATOIRES MÉDIS, Km 7 route de Tunis, BP 206 8000 Nabeul, TUNISIA TUNISIA LES LABORATOIRES MÉDIS, TUNISIA KIPHARMA LTD 2023-05-12 2028-05-11

51 Rwanda FDA-HMP-MA-0998 ENTEZMA OINTMENT Betamethasone (as Dipropionate BP) 0.5 mg and salicylic acid BP 30mg 0.5 mg and 30mg Ointment 1 Tube Aluminum collapsible tubes, which are packed in well labeled cartons 36 Months CENTAUR PHARMACEUTICAL PVT. LTD., Plant-I, Plot No.3,5B,2C, Tivim Industrial Estate, Karaswada, Mapusa, Goa-403 526, India INDIA CENTAUR PHARMACEUTICALS PVT. LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-26 2029-02-25

52 Rwanda FDA-HMP-MA-0087 EPCLUSA™ 400/100 Sofosbuvir, Velpatasvir 400mg, 100mg Tablets, Debossed With "Gsi" On One Side And "7916" On The Other Side. 28 Tablets POLYESTER PACKING MATERIAL. 24 Months GILEAD SCIENCES INC 333 Lakeside Drive Foster City, CA, 94404, United States. USA GILEAD SCIENCES INC/USA PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2021-08-05 2026-08-05

53 Rwanda FDA-HMP-MA-0146 EPHEDRINE AGUETTANT 3 MG/ML, SOLUTION FOR INJECTION IN PREFILLED SYRINGE Ephedrine hydrochloride 3 mg/ml 3 mg/ml Solution for injection Box of 10 polypropylene pre-filled syringes of a capacity of 10 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

54 Rwanda FDA-HMP-MA-1294 EPHEVER Ephedrine hydrochloride injection BP, 50mg/ml 50mg/ml Solution for Injection 10 ml ampoule Amber USP Type-1 glass ampoules 24 Months VERVE HUMAN CARE LABORATORIES, Plot no. 15-A, Pharmacity, Selaqui, Dehradun, Uttarakhand, India INDIA VERVE HUMAN CARE LABORATORIES ABACUS PHARMA (A) LTD 2024-05-07 2029-05-06

55 Rwanda FDA-HMP-MA-1975 Epibalin 25 Pregabalin USP 25 mg Capsules 1 x 10 Capsules & 3x10 Capsules Aluminium Blister foil -178 36 Months MSN LABORATORIES PRIVATE LIMITED Plot No.: 42, Anrich Industrial Estate, Bollaram, Sangareddy District, Pin Code - 502 325, Telangana, INDIA India MSN LABORATORIES PRIVATE LIMITED ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

56 Rwanda FDA-HMP-MA-2238 EPIBALIN 50 Pregabalin USP 50 mg Capsules 1x10 Capsules & 3x10 Capsules ALU-PVC/PVdC Blisters 36 Months MSN LABORATORIES PRIVATE LIMITED (Formulations Division) Plot No.: C – 24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, Pincode: 500 018 INDIA MSN LABORATORIES PRIVATE LIMITED ABACUS PHARMA (A) LTD 2025-02-04 2030-02-03

57 RWANDA-FDA24/HM/0066/0003 Epibalin 75 Pregabalin 75mg Capsule 1 x 10's or 3 x 10's 36 Months MSN LABORATORIES PRIVATE LIMITED PLOT NO.: 42, ANRICH INDUSTRIAL ESTATE, BOLLARAM, SANGAREDDY DISTRICT, PIN CODE. 502325, TELANGANA, INDIA India MSN Laboratories Private Limited SUN ENTERPRISES LTD 2026-02-05 2031-02-04

58 RWANDA-FDA25/HM/0531/0038 EPOFIT 4000IU Recombinant Human Erythropoietin INJECTION USP 24 Intas Pharmaceutical Ltd. India Intas Pharmaceuticals Limited BION PHARMA GROUP (BPG) Ltd 2026-03-14 2031-03-13

59 Rwanda FDA-HMP-MA-0371 EQUIRAB 1000IU Rabies Antiserum Equine 1000 I.U. 1000 I.U. Solution for injection 5ml Vial Clear colorless Glass USP Type I Moulded flint Vial covered a Rubber Bung 20mm clotted chlorobutyl and a 20mm Aluminium Flip off seal Violet 36 Months BHARAT SERUMS AND VACCINES LIMITED, Plot No. K-27, K-27 Part and K-27/1, Anand Nagar, Jambivili Village, Additional MIDC, Ambernath East, Thane 421506, Maharashtra, India INDIA BHARAT SERUMS & VACCINES LTD, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-07-08 2028-07-07

60 Rwanda FDA-HMP-MA-1662 ERLOCIP 100 Erlotinib hydrochloride 100MG TABLETS 10 Tablets Plain Aluminium Foil (Blister) PVC film strip 24 Months CIPLA LTD Unit X. S-103 to S-105, S-107 to S-112, L-138, L-147 to L-147/1, L-147/3 & L147/A, Verna Industrial Estate, Verna, Salcette, Goa 403 722 India India CIPLA LTD KIPHARMA LTD 2024-08-15 2029-08-15

61 Rwanda FDA-HMP-MA-1633 ERLOCIP 150 Erlotinib hydrochloride 150MG TABLETS 10 tablets Plain Aluminium Foil (Blister) PVC film strip 24 Months CIPLA LTD Unit X. S-103 to S-105, S-107 to S-112, L-138, L-147 to L-147/1, L-147/3 & L147/A, Verna Industrial Estate, Verna, Salcette, Goa 403 722 India India CIPLA LTD KIPHARMA LTD 2024-08-17 2029-08-16

62 Rwanda FDA-HMP-MA-1656 ERLOCIP 25 Erlotinib Hydrochloride, 25 mg 25 mg Film coated tablets 10 Tablets Aluminium blister foil and PVC Film 24 Months CIPLA LIMITED, Goa Unit X, Plot No. S-103 to S-105, S-107 S-112, L-138, L-147 to L-147/1 to L-147/3 & L147/A, Verna Industrial Estate, Verna Goa-403 722, India INDIA CIPLA LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-07-18 2029-07-17

63 Rwanda FDA-HMP-MA-1820 ERLOZ 150 Erlotinib 150mg Tablets 30 Tablets HDPE BOTTLE 24 Months HETERO LABS LIMITED Unit-V, Address: TSIIC Formulation SEZ, No. 439,440,441 & 458, Polepally Village, Jadcherla, Mahaboob Nagar- 509301, Telangana State, India. INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

64 Rwanda FDA-HMP-MA- 0892 ERO-125 DRY SYRUP Erythromycin Estolate USP 125 mg / 5ml 125 mg / 5ml Powder for suspension 100 ml Bottle Amber Coloured PET Bottle with PP Cap packed in a unit printed duplex board 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, India. INDIA AGOG PHARMA LTD SUN ENTERPRISE LTD 2024-02-17 2029-02-16

65 Rwanda FDA-HMP-MA-0977 ERO-250 TABLETS Erythromycin Stearate Tablets BP 250 mg 250 mg Film Coated tablets 1000 Tablets and 10x10 tablets Jar pack for 1000 tablets and Blister Pack for 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 2024-02-26 2029-02-25

66 Rwanda FDA-HMP-MA-2143 EROCIN DRY MIXTURE ERYTHROMYCIN STEARATE 125mg / 5mL Dry Powder for Oral Suspension 100mL / 60mL Amber glass / HDPE bottles 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 2024-10-18 2029-10-17

67 Rwanda FDA-HMP-MA-0710 EROCIN-250 EURTHROMYCIN STREATE BP 250MG TABLETS 10x10 Tablets Alu-PVC blisters packed in a unit carton 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 2024-08-17 2029-08-16

68 Rwanda FDA-HMP-MA-1671 EROCIN-500 ERYTHROMYCINE 500MG TABLET 10x10 Tablets Alu/PVC blister 36 Months MAXTAR BIO-GENICS K. No. 705, Nalagarh road, Malku Majra, (Baddi), Tehsil Nalagarh, Distt. Solan, Himachal Pradesh – 173205, India INDIA MAXTAR BIO-GENICS SUN ENTEPRISES LTD 2024-08-17 2029-08-16

69 Rwanda FDA-HMP-MA-1573 EROCIN250 Erythromycin stearate BP 250 mg Tablets 10x10 Tablets ALU/PVC BLISTER 36 Months MAXTAR BIO-GENECS K No. 705, Nalagarh road, Malku Majra, (Baddi), Tehsil Nalagarh, Distt. Solan, Himachal Pradesh-1732205 INDIA MAXTAR BIO-GENICS SUN ENTERPRISES LTD 2024-08-17 2029-08-16

70 Rwanda FDA-HMP-MA-1581 EROSTIN-20 Ebastine 20 mg Tablets 1x10 Tablets ALU/ALU BLISTER 36 Months MICRO LABS LIMITED 92, Sipcot, hour-635 126 INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-08-17 2029-08-16

71 Rwanda FDA-HMP-MA-1483 EROSTINE SUSPENSION Ebastine 5mg/5ml 5mg/5ml Suspension 60ml Bottle Amber glass Bottles 24 Months MICRO LABS LIMITED, At KNM Pharma Pvt. Ltd, No 13, Mahagujrat Industrial Estate, Opp. Nova Petrochem, Sanand Bavla Road, Changodar, Dist: Ahmedabad Gujarat, India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-07-20 2029-07-19

72 Rwanda FDA-HMP-MA-1200 ERYKO -250 Erythromycin Stearate BP 250mg 250mg Film Coated Tablet 10 x 10 tablets and 1000 Tablets Alu/PVC & HDPE Jar pack for 1000 tablets 36 Months KOPRAN LIMITED, Village Savroli Khalapur, Dist-Raigad, Maharashtra, District Raigad – 410202, India INDIA KOPRAN LIMITED PHILLIPS PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05

73 Rwanda FDA-HMP-MA-1755 ERYTHROKANT Erythromycin Stearate BP 125 mg/5 ml Suspension 100 ml Bottles PET BOTTLE 36 Months S KANT HEALTHCARE LTD Plot No. 1802-1805, G.I.D.C. Phase III,Vapi 396 195. Gujarat, India INDIA S KANT HEALTHCARE LTD. ABACUS PHARMA (A) LTD 2024-08-17 2029-08-16

74 Rwanda FDA-HMP-MA-0588 ERYTHROKANT-250 Erythromycin Stearate, 250mg 250mg Film coated tablets 10x10 Tablets 10 blisters along with the insert are packed in the Carton 36 Months S KANT HEALTHCARE LTD. Plot No. 1802-1805, G.I.D.C. Phase III, Vapi 396 195. Gujarat, India INDIA S KANT HEALTHCARE LTD ABACUS PHARMA (A) LTD 2023-10-13 2028-10-12

75 Rwanda FDA-HMP-MA-0875 ERYTHROMYCIN TABLETS BP 250 MG Erythromycin stearate 250mg 250mg Film Coated Caplet 10x10 Tablets and 1000 Tablets Blisters and P.P. Bag packed in a HDPE Container (for 1000 tablets) 36 Months MILAN LABORATORIES (INDIA) PVT LTD, Plot no. 35/36/63/64/65/67/87, J.C.I.E. Ltd., Kamothe, Panvel, Navi Mumbai, India INDIA MILAN LABORATORIES (INDIA) PVT LTD, INDIA. SIGMA PHARMA RWANDA LIMITED 2024-02-17 2029-02-16

76 Rwanda FDA-HMP-MA-1606 ERYTHROREN Erythromycin 250 mg Tablets 10x10 Tablets Aluminium/PVC blister strips 24 Months Rene Industries Ltd Plot No 680, PO Box 6034, Kamuli, Kireka, Kampala, Uganda. Uganda Rene Industries Ltd Rene Pharmacy (R) Ltd 2024-08-17 2029-08-16

77 Rwanda FDA-HMP-MA-1768 Erythrox Erythromycin 125mg/5mL Powder for oral suspension 100mL Bottles HDPE bottles 36 Months DAWA LIMITED Plot No. 7879/8, Baba Dogo Rd, Ruaraka. Address: P.O. BOX 16633-00620 City: Nairobi KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

78 Rwanda FDA-HMP-MA-1265 ERYTHROX 500MG Erythromycin Stearate 500mg 500mg Film-coated tablets 10 x 10 tablets & 1000 tablets Alu/PVC & HDPE Jar 36 Months DAWA LIMITED, Plot No. 7879/8, Baba Dogo Rd, Ruaraka, P.O. BOX 16633-00620. Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-05-07 2029-05-06

79 Rwanda FDA-HMP-MA-1515 ERYTHROX TABLETS Erythromycin Stearate 250mg 250MG TABLET 10x10 Tablets and 1000 Tablets Blisters packed in a unit box and bulk packs of 1000s in HDPE along with literature insert 36 Months DAWA LIMITED Plot No. 7879/8, Baba Dogo Rd, Ruaraka, P.O. BOX 16633-00620, Nairobi, Kenya KENYA DAWA LIMITED SUN ENTERPRISES LTD 2024-07-27 2029-07-26

80 Rwanda FDA-HMP-MA-0496 ES-LOPROT 40MG IV INJECTION Esomeprazole Sodium, 40mg 40mg Injection 1 Vial + 1 Ampoule of 10ml Sodium Chloride 0.9% Vial + Ampoule of 10ml Sodium Chloride 0.9% Injection in transparent tubular glasses 24 Months NABIQASIM INDUSTRIES (PVT) LTD, 17/24, Korangi Industrial Area, Korangi, Karachi-Pakistan PAKISTAN NABIQASIM INDUSTRIES (PVT) LTD AFRI HEALTH CARE LTD 2023-10-13 2028-10-12

81 Rwanda FDA-HMP-MA-1767 Es-Omecos Esomeprazole 40 mg Tablets 30 Tablets ALU-ALU BLISTERS 24 Months COSMOS LIMITED rangwe road; off lunga lunga road, industrial area, p. o. box 41433, gpo 00100 - nairobi KENYA. COSMOS LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

82 Rwanda FDA-HMP-MA-1482 ESLOTIN 2.5MG/ML SYRUP Desloratidine 2.5mg/ml 2.5mg/ml Syrup 100ml Bottle Amber colored Type III glass bottle and closed by white PE cap 36 Months WORLD MEDICINE ?LAÇ SAN. VE TIC. A.?. 15 Temmuz Mahallesi, Cami Yolu Caddesi, No:50 k:4 WM Plaza, Güne?li, Ba?c?lar, Istanbul, Turkey TURKEY WORLD MEDICINE ?LAÇ SAN. VE TIC. A.?. GOODMAN INTERNATIONAL LTD (R) 2024-07-20 2029-07-19

83 Rwanda FDA-HMP-MA-1260 ESLOTIN 5MG FILM COATED TABLETS Desloratidine 5mg 5mg Film Coated Tablets 10, 20 & 30 Tablets Alu-PVC/Aclar foil blister 36 Months WORLD MEDICINE ?LAÇ SAN. VE TIC. A.?. 15 Temmuz Mah. Cami Yolu Cad. No:50, Güne?li, Ba?c?lar, Istanbul, Turkey TURKEY WORLD MEDICINE ?LAÇ SAN. VE TIC. ?., TURKEY GOODMAN INTERNATIONAL LTD (R) 2024-05-06 2029-05-05

84 Rwanda FDA-HMP-MA-1806 ESMA - 40 Esomeprazole Magnesium Trihydrate 40 mg Tablets 10x10 Tablets alu/alu blister 30 Months MAXTAR BIO-GENICS no. 705, Vill. Malkumajra, Nalagarh Road, Baddi, Distt. Solan (H.P.) INDIA MAXTAR BIO-GENICS SUN ENTERPRISES LTD 2024-08-17 2029-08-16

85 Rwanda FDA-HMP-MA-1804 ESMA-20 Esomeprazole Magnesium Trihydrate 20 mg Tablets 10 Tablets ALU-ALU blister 30 Months MAXTAR BIO-GENICS K.No.705, Nalagarh road, Malku Majra, (Baddi), Tehsil Nalagarh, Distt. Solan, Himachal Pradesh-173205 INDIA MAXTAR BIO-GENICS SUN ENTERPRISES LTD 2024-08-17 2029-08-16

86 Rwanda FDA-HMP-MA-1312 ESOCOR 20 Esomeprazole Magnesium Trihydrate BP 20mg 20mg Enteric coated tablet 3×10 Tablets Alu/Alu Blisters packed in carton along with insert 24 Months CORONA REMEDIES PRIVATE LIMITED, Village Jatoli,Post Office - Oachghat,Tehsil Solan, Dist. Solan Himachal Pradesh – 173223, India INDIA CORONA REMEDIES PRIVATE LIMITED, INDIA SUN ENTERPRISES LTD 2024-05-16 2029-05-15

87 Rwanda FDA-HMP-MA-1268 ESOCOR 40 Esomeprazole Magnesium Trihydrate 40mg 40mg Tablets 3 x10 Tablets Alu/Alu Blister packed in carton along with insert 24 Months CORONA REMEDIES PRIVATE LIMITED, Village Jatoli, Post Office - Oachghat, Tehsil Solan, Dist. Solan, Himachal Pradesh – 173223, India INDIA CORONA REMEDIES PRIVATE LIMITED SUN ENTERPRISES LTD 2024-05-07 2029-05-06

88 Rwanda FDA-HMP-MA-1058 ESOFAG- 40 Esomeprazole magnesium trihydrate BP 40 mg 40 mg Enteric Coated Tablet 3X10 Tablets Alu/ Alu Blisters in a carton along with pack insert 36 Months MICRO LABS LIMITED, 92, SIPCOT Industrial Complex, Hosur – 635 126, India. INDIA MICRO LABS LIMITED WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-02-23 2029-02-22

89 Rwanda FDA-HMP-MA-0673 ESOFAG-20 Esomeprazole Magnesium Trihydrate BP 20mg 20mg Enteric coated tablets 3X10 tablets Alu-Alu blister, such 3blister is packed in a printed outer carton along with a pack insert. 36 Months MICRO LABS LIMITED, 92, SIPCOT, Hosur- 635 126, Tamil Nadu India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-02 2028-12-01

90 Rwanda FDA-HMP-MA-0652 ESOFAG-D Esomeprazole 40mg and Domperidone 30mg 40mg and 30mg Hard gelatin capsules 3 x 10’s capsules Alu-Alu strip pack of 3 x 10’s capsules 24 Months MICRO LABS LIMITED, 92, SIPCOT, Hosur- 635 126, Tamil Nadu India INDIA MICRO LABS LIMITED, INDIA WESSEX PHARMACEUTICALS (RWANDA) LTD 2023-12-10 2028-12-09

91 RwandaFDA-HMP-MA-1863 ESOMAC 20 ESOMEPRASOLE MAGNESIUM DEHYDRATE 20MG TABLETS Carton containing 2 Alu-Alu blister strip of 7 tablets. ? - Carton containing 3 Alu-Alu blister strip of 10 tablets. ALU/PVC BLISTER 24 Months CIPLA LTD Address: Cipla Goa, Unit IV, Plot No. L-139 to L-146, Verna Industrial Estate, Verna Salcette, Goa 403722, India Telephone: +91 832 2889000 /2889199 /2889101 Telefax: + 91 832 2782479 / 2782598 / 2782805 E-mail: ciplagoa@cipla.com INDIA CIPLA LTD/INDIACipla house, peninsula business park, Ganpatrao Kadam Marg lower Parel, Mumbai, India Telephone: 91 22 25756558 Telefax: 91 22 24826120 E-mail: globalra@cipla.com KIPHARMA LTD 2024-08-17 2029-08-16

92 Rwanda FDA-HMP-MA-1350 ESOMAC 40 MUPS Esomeprazole Magnesium Dehydrate 40mg 40 mg Film Coated Tablets 3x 10 tablets & 2x7 tablets Alu-Alu blister strips 24 Months CIPLA LIMITED, Cipla Goa, Unit IV, Plot No. L-139 to L-146, Verna Industrial Estate, Verna Salcette, Goa 403722, India INDIA CIPLA LIMITED, INDIA KIPHARMA LTD 2024-05-18 2029-05-17

93 RWANDA-FDA24/HM/0228/0023 ESOMEPRAZOLE 40 MG, GASTRO-RESISTANT CAPSULE, HARD Esomeprazole Magnesium dihydrate 40MG Capsule 28 24 Months CIPLA LTD India Ethypharm KIPHARMA Ltd 2026-02-06 2031-02-05

94 Rwanda FDA-HMP-MA-0350 ESOMEX-40 Esomeprazole Magnesium Tri-hydrate BP 40mg 40mg Enteric Coated Tablets 3X10 Tablets Alu-Alu Blister Pack. Such 3 Alu-Alu Blisters are packed in a printed Carton with Packing Insert 36 Months LINCOLN PHARMACEUTICALS LIMITED, Address: Trimul Estate, Khantraj, Taluka: Kalol, District: Gandhinagar, Gujarat, India INDIA LINCOLN PHARMACEUTICALS LIMITED/ INDIA ABACUS PHARMA (A) LTD 2023-07-08 2028-07-07

95 Rwanda FDA-HMP-MA-1632 ESOPRAZOLE-40 Esomeprazole Magnesium 40mg TABLETS 1x10 Tablets Alu-Alu Blister 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 SUN ENTERPRISES LTD 2024-08-17 2029-08-16

96 Rwanda FDA-HMP-MA-0728 ESOZIM-20 Esomeprazole Magnesium DelayedRelease Capsules USP 20 mg 20 mg Hard Gelatin Capsule 10 × 10 Hard Gelatin Capsules Alu-Alu blister pack 30 Months ZIM LABORATORIES LIMITED, B-21/22, MIDC Area, Kalmeshwar, Nagpur 441 501, Maharashtra State, India INDIA ZIM LABORATORIES LIMITED SUN ENTERPRISE LTD 2024-01-08 2029-01-07

97 Rwanda FDA-HMP-MA-1587 ESOZIM-40 Esomeprazole magnesium trihyrate 40 mg per unit Capsules 10x10 Hard gelatin capsule ALU/ALU BLISTER 30 Months ZIM LABORATORIES LIMITED B-21/22, MIDC Area, Kalmeshwar, Nagpur 441 501, Maharashtra State INDIA ZIM LABORATORIES LIMITED SUN ENTERPRISES LTD 2024-08-17 2029-08-16

98 Rwanda FDA-HMP-MA-1241 ETROBAX 60 Etoricoxib Tablets 60mg 60mg Film Coated Tablets 3x 10 Tablets Alu-Alu blisters 36 Months HETERO LABS LIMITED, (Unit-III), survey No.: 51 22-110, Industrial Development Area (IDA), Jeedimetla, Hyderabad- PIN-500 055, Telangana, India INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-05-06 2029-05-05

99 Rwanda FDA-HMP-MA-1839 ETROBAX 90 Etoricoxib 90 mg Tablets 3x10 Tablets ALU-ALU BLISTER PACK 36 Months HETERO LABS LIMITED Unit – III IDA, #22-110, Jeedimetla, Hyderabad – 500 055, Telangana, India. INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-08-17 2029-08-16

100 Rwanda FDA-HMP-MA-1518 ETROBAX 90 Etoricoxib Tablets 90 mg Film Coated Tablets 3x10 Tablets Alu/Alu Blisters packed in printed carton 36 Months HETERO LABS LIMITED (Unit-III), Survey No.: 51, 22-110, Industrial Development Area (IDA), Jeedimetla, Hyderabad, PIN-500 055, Telangana. India INDIA HETERO LABS LIMITED BION PHARMA GROUP LTD 2024-07-27 2029-07-26

101 Rwanda FDA-HMP-MA-0271 EUGLIM-2 Glimepiride USP 2mg 2mg Uncoated tablets 10x10 tablets Alu-Alu Blister pack 24 Months CADILA HEALTHCARE LIMITED, Kundaim industrial estate, Plot No.203-213, Kundaim, Goa 403 115, India INDIA CADILA HEALTHCARE LIMITED ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

102 Rwanda FDA-HMP-MA-0272 EUGLIM-4 Glimepiride USP 4mg 4mg Uncoated tablets 10x10 tablets Alu-Alu Blister pack 24 Months CADILA HEALTHCARE LIMITED, Kundaim industrial estate, Plot No.203-213, Kundaim, Goa 403 115, India INDIA CADILA HEALTHCARE LIMITED ABACUS PHARMA (A) LTD 2023-05-12 2028-05-11

103 Rwanda FDA-HMP-MA-2318 EUTHYROX 100 LEVOTHYROXINE SODIUM 100 µG TABLETS 30 Tablets ALU/ALU BLISTER 36 MONTHS MERCK HEALTHCARE KGAA Frankfurter Straße 250 64293 Darmstadt Germany GERMANY MERCK (PTY) LTD SURGIPHARM RWANDA LTD 2025-06-19 2030-06-18

Registered

104 Rwanda FDA-HMP-MA-2317 EUTHYROX 50 LEVOTHYROXINE SODIUM 50 µG Tablets 100 Tablets ALU/ALU BLISTER 36 MONTHS MERCK HEALTHCARE KGAA Frankfurter Strasse 250 64293 Darmstadt, Germany GERMANY MERCK (PTY) LTD SURGIPHARM RWANDA LTD 2025-06-18 2030-06-18

Registered

105 Rwanda FDA-HMP-MA-1124 EVA VIT 400 Vitamin E USP 400 IU 400 IU Soft Gelatin Capsules 3× 10’s Blister Pack Alu/Aluminium/Colourless PVDC coated PVC film- Blister pack 24 Months SOFTGEL HEALTHCARE PVT LIMITED, Survey No. 20/1, vandalur kelambakkam road, Pudupakkam, Kancheepuram– 603 103, Tamilnadu.India INDIA SOFTGEL HEALTHCARE PVT LIMITED DOLIPHARM LTD 2024-04-21 2029-04-20

106 Rwanda FDA-HMP-MA-0119 EVAC SOLUTION Lactulose Concentrate USP Equivalent To Lactulose 3.35g/5ml Yellow Coloured Solution 100ml AMBER COLOURED PET BOTTLE WITH A MEASUREMENT CUP AND UNIT BOX 24 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

107 Rwanda FDA-HMP-MA-0689 EVATOCIN Oxytocin 5 I.U./ ml 5 I.U./ ml Solution for Injection 2x5 ampoules 2 aluminium blisters containing 5 flint USP type I ampoule, 1ml each; packed in a carton box 24 Months M/S NEON LABORATORIES LIMITED, Plot no. 29 to 32 & 57, 60, The Palghar Taluka Industrial Estate Co-Op Estate Ltd., Boisar road, Palghar -401404 Maharashtra State, India. INDIA M/S NEON LABORATORIES LIMITED, INDIA SUN ENTERPRISES LTD 2023-12-30 2028-12-29

108 Rwanda FDA-HMP-MA-0088 EVOKE-100 Sildenafil Citrate 100 mg Tablets 4 Tabets ALU/PVC 36 Months LABORATORY AND 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 AND ALLIED LIMITED/KENYA DEPOT PHARMACEUTIQUE LE MEDICAL 2021-08-05 2026-08-05

109 Rwanda FDA-HMP-MA-0092 EXFORGE HCT-10/160/12.5 Amlodipine, Valsartan, Hydrochlorothiazide 10 mg, 160mg, 12.5 mg Film-Coated Tablet, Debossed “Nvr” On One Side And “Vdl” On The Other Side. 28 Film-Coated Tablets PVC/PVDC BLISTER PACK 36 Months NOVARTIS FARMACÉUTICA SA RONDA DE SANTA MARIA, NOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE 158 08210 Barberà del Vallès (Barcelona)Spain, 4332 Stein Switzerland SPAIN, SWITZERLAND NVS KENYA LIMITED/KENYA SURGIPHARM (RWANDA) LTD 2021-08-05 2026-08-05

110 Rwanda FDA-HMP-MA-0089 EXFORGE HCT-5/160/12.5 Amlodipine, Valsartan, Hydrochlorothiazide 5mg, 160mg, 12.5mg Film-Coated Tablet, With Debossing “Nvr” On One Side And “Vcl” On The Other Side. 28 Film-Coated Tablets PVC/PVDC BLISTER PACK 24 Months NOVARTIS FARMACÉUTICA SA RONDA DE SANTA MARIA, NOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE 158 08210 Barberà del Vallès (Barcelona)Spain, 4332 Stein Switzerland SPAIN, SWITZERLAND NVS KENYA LIMITED/KENYA SURGIPHARM (RWANDA) LTD 2021-08-05 2026-08-05

111 Rwanda FDA-HMP-MA-0091 EXFORGE-10/160 Amlodipine, Valsartan 10 mg, 160mg Film-Coated Tablet, Debossed “Nvr” On One Side And “Uic” On The Other Side. 28 Film-Coated Tablets PVC/PVDC BLISTER PACK 36 Months NOVARTIS FARMACÉUTICA SA RONDA DE SANTA MARIA, NOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE 158 08210 Barberà del Vallès (Barcelona)Spain, 4332 Stein Switzerland SPAIN, SWITZERLAND NVS KENYA LIMITED/KENYA SURGIPHARM (RWANDA) LTD 2021-08-05 2026-08-05

112 Rwanda FDA-HMP-MA-0090 EXFORGE-5/160 Amlodipine, Valsartan 5 mg, 160mg Film-Coated Tablet Debossed With “Nvr” On One Side And “Ece” On The Other Side. 28 Tablets PVC/PVDC BLISTER PACK. 36 Months NOVARTIS FARMACÉUTICA SA RONDA DE SANTA MARIA, NOVARTIS PHARMA STEIN AG SCHAFFHAUSERSTRASSE 158 08210 Barberà del Vallès (Barcelona)Spain, 4332 Stein Switzerland SPAIN, SWITZERLAND NVS KENYA LIMITED/KENYA SURGIPHARM (RWANDA) LTD 2021-08-05 2026-08-05

113 Rwanda FDA-HMP-MA-1180 EXTRACEF 200 DT TABLETS Cefixime trihydrate USP 200mg 200mg Dispersible tablets 1×10 Tablets Printed aluminium strip packed in a printed mono carton 30 Months BLUE CROSS LABORATORIES PVT. LTD. A - 12, M.I.D.C., Ambad, Nashik – 422 010.Maharashtra, India INDIA BLUE CROSS LABORATORIES PVT. LTD. WESSEX PHARMACEUTICALS (RWANDA) LTD 2024-05-06 2029-05-05

114 Rwanda FDA-HMP-MA-0700 EXXIB TABLET Celecoxib 200mg 200mg Tablets 10 Tablets Blister (PVC/PVdC-Aluminium) of 10 tablets in a cardboard box 36 Months GRACURE PHARMACEUTICALS LIMITED, E-1105, Industrial Area, Phase-III Bhiwadi, PIN-301019, Dist. Alwar. Rajasthan, India INDIA EXPHAR S.A, BELGIUM H&H PHARMA LTD 2023-12-30 2028-12-29

115 Rwanda FDA-HMP-MA-1316 EZPAIN TABLETS Paracetamol 450mg, Codeine Phosphate 10mg, Doxylamine Succinate 5mg & Caffeine 50mg 450mg, 10mg, 5mg 50mg Uncoated tablet 2 x 9 tablets Aluminum-PVC strip packed in a carton 36 Months KWALITY PHARMACEUTICALS LTD. Vill. Nag Kalan, Majitha Road, Amritsar– 143601. India INDIA SUN ENTERPRISES LTD SUN ENTERPRISES LTD 2024-05-16 2029-05-15