| 1 | MEDFO KENYA LIMITED | 14638 | CARDIPIN-40/2.5H | Human | Foreign | TELMISARTAN, (s)-AMLODIPINE BESYLATE &… | Telmisartan USP 40 mg, Amlodipine Besylate USP… | H2021/CTD7491/14638 | Tablet | ORAL | Recommended | 36 months | | C09DX | Agents acting on the renin-angiotensin system:… | | | | RELAX BIOTECH PVT. LIMITED | 862/1, GIDC, MAKARPURA, VADODARA - 390010,… | Registered | Valid |
| 2 | GALAXY PHARMACEUTICAL LIMITED-DOCTORS PARK | 18672 | GLIFEMPA M 10/500 TABLETS | Human | Foreign | EMPAGLIFLOZIN AND METFORMIN HCL TABLETS | - Empagliflozin 10 mg - Metformin Hydrochloride… | H2021/CTD8466/18672 | Film-Coated Tablet | ORAL | Recommended | 36 months | | A10BD20 | metformin and empagliflozin | GALAXY PHARMACEUTICAL LTD | 1st floor, doctors' park, 3rd Parklands Avenue,… | info@galaxypharma.co.ke | FREDUN PHARMACEUTICAL LIMITED | 14, 15, 16, Zorabian industrial complex , Vevoor,… | Registered | Valid |
| 3 | SAI PHARMACEUTICALS LTD | 18621 | Rotavirus Vaccine, Live Attenuated (Oral)… | Human | Foreign | Live Attenuated Rotavirus Vaccine (Oral) | Each dose of 2.5 mL contains: Live Attenuated… | H2021/CTD8690/18621 | Oral Drops, Liquid | ORAL | Recommended | 24 months | | J07BH02 | rota virus pentavalent live reassorted | | | | Serum Institute of India Pvt Limited | | Registered | Valid |
| 4 | PROLINE HEALTHCARE LIMITED | 14046 | Sevoprane Inhalation Solution | Human | Foreign | Sevoflurane | Each 100ml contains Sevoflurane USP 100ml | H2021/CTD7142/14046 | Inhalation Vapour, Liquid | RESPIRATORY (INHALATION) | Recommended | 36 months | | N01AB08 | sevoflurane | | | | ILSUNG PHARMACEUTICAL CO.LTD | 349,Sandan-ro,Danwon-gu,Ansan-Si,Gyeonggi-Do,repul… | Registered | Valid |
| 5 | TIBA HEALTHCARE LIMITED | 18403 | DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL… | Human | Foreign | DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL… | Each tablet cotains DOLUTEGRAVIR 50MG, LAMIVUDINE… | H2021/CTD8566/18403 | Tablet | ORAL | Recommended | 24 months | | J05AR | Antivirals for systemic use: Combinations of… | | | | CELLTRION PHARM, INC. CHEONGJU PLANT | | Registered | Valid |
| 6 | GLAD HEALTHCARE KENYA LIMITED | 16456 | GLAMOXY | Human | Foreign | Amoxicillin trihydrate | 500mg | H2021/CTD8012/16456 | Capsule, Hard | ORAL | Recommended | 36 months | While granules filled in 0# red & black capsules | J01CA04 | amoxicillin | Reyoung Pharmaceutical Co., Ltd. | No.1 Ruiyang Road Yiyuan county, Shandong… | xie.manyi@reyoungh.com | REYOUNG PHARMACEUTICAL Co LTD | at No. 6, Erlangshan Road, Yiyuan county,… | Registered | Valid |
| 7 | HARLEYS LTD-NAIROBI | 18497 | Fastil Gel | Human | Foreign | Ketoprofen Bp | Eacg gram contains Ketoprofen Bp 25mg | H2021/CTD8444/18497 | Gel | TOPICAL | Recommended | 36 months | | M01AE03 | ketoprofen | Unisel Pharma (K) Ltd | Apricot Suites, 1st Floor, 4th Parkland Avenue,… | regulatory@uniselpharma.com | Coral Laboratories Ltd 2 | Plot No. 27-28, Pharmacity, Selaqui, Dehradun… | Registered | Valid |
| 8 | DAWA LTD | 18475 | Dapaflo 10mg Tablet | Human | Local | Dapagliflozin propanediol monohydrate | Each film coated tablet contains: Dapagliflozin… | H2021/CTD8528/18475 | Film-Coated Tablet | ORAL | Recommended | 36 months | Yellow ,biconvex film coated tablet plain on both… | A10BK01 | Dapagliflozin | DAWA LIMITED | PLOT NO 7879/8,BABA DOGO ROAD,RUARAKA-P.O BOX… | admin@dawalimited.com | Dawa Limited | 16633 | Registered | Valid |
| 9 | MEDCURE HEALTHCARE LTD | 14696 | PRODOM CAPSULES | Human | Foreign | Enteric Coated Rabeprazole Sodium and Sustained… | Rabeprazole Sodium AND Domperidone BP | H2021/CTD7782/14696 | Capsule | ORAL | Recommended | 24 months | Green/ Green colored size “2” capsule | A03FA03 | domperidone | MEDCURE HEALTHCARE LTD | Address: P.O. Box 14609-00400 – Nairobi-Kenya… | medcurepharmaceuticalskenya@gmail.com | Saga Laboratories Ltd | Survey no. 198/2 & 198/3, Chachrawadi, NR Claris,… | Registered | Valid |