| 1 | COSMOS LIMITED | 15275 | ES-OMECOS 40MG ENTERIC COATED TABLETS | Human | Local | ESOMEPRAZOLE USP | 40MG | H2020/CTD7890/15275 | Tablet | ORAL | Recommended | 24 months | SALMON RED, ROUND SHAPED ENTERIC COATED TABLETS… | A02BC05 | esomeprazole | COSMOS LIMITED | RANGWE ROAD; OFF LUNGA LUNGA ROAD, INDUSTRIAL… | -8096046 | COSMOS LIMITED | P.O. BOX 41433 GPO 00100-NAIROBI KENYA | Registered | Valid |
| 2 | MEDISEL KENYA LTD | 17358 | OLAPIN-5 TABLETS | Human | Foreign | Olanzapine USP | Olanzapine USP 5 mg | H2020/CTD5503/1188ER | Tablet | ORAL | Recommended | 36 months | | N05AH03 | olanzapine | MEDISEL KENYA LIMITED | P.O BOX 540-01000 THIKA, KENYA | regulatory@mediselkenya.com | Aurochem Pharmaceuticals (I) Private Limited | 58, Palghar Taluka Industrial Co-operative Estate… | Registered | Valid |
| 3 | OPERA PHARMA (K) LTD | 19528 | SPAMCIL ORAL SUSPENSION | Human | Foreign | AMPICILLIN ORAL SUSPENSION B.P. | 125MG | H2020/CTD5882/1593ER | Powder And Solvent For Oral Suspension | ORAL | Recommended | 24 months | | J01CA04 | amoxicillin | | | | SPARSH BIO-TECH (PVT) LTD | PLOT NO. 1 SURVEY NO. 242/243/244 VILLAGE… | Registered | Valid |
| 4 | HARLEYS LTD-NAIROBI | 17345 | Xtrazid Injection 1gm | Human | Foreign | Ceftazidime (as pentahydrate) | Each vial contains: Ceftazidime (as… | H2020/CTD5666/1553ER | Injection | INTRAVENOUS | Recommended | 24 months | | J01DD02 | ceftazidime | | | | SURGE LABORATORIES LTD | PLOT NO. 10 KM FAISALABAD ROAD, BIKHI DIST.… | Registered | Valid |
| 5 | MEDISEL KENYA LTD | 17359 | OLAPIN-10 TABLETS | Human | Foreign | Olanzapine USP | Olanzapine USP 10 mg | H2020/CTD5504/1189ER | Tablet | ORAL | Recommended | 36 months | | N05AH03 | olanzapine | MEDISEL KENYA LIMITED | P.O BOX 540-01000 THIKA, KENYA | regulatory@mediselkenya.com | Aurochem Pharmaceuticals (I) Private Limited | 58, Palghar Taluka Industrial Co-operative Estate… | Registered | Valid |
| 6 | SAI PHARMACEUTICALS LTD | 17510 | Bunase 200mcg | Human | Foreign | Budesonide 200mcg ......suspended in Propellant… | 200mcg | H2020/CTD5199/1262ER | Inhalation Vapour | ORAL | Recommended | 24 months | | R01AD05 | budesonide | | | | OXALIS LABS | VILLAGE THEDA, P.O LODHI MAJRA TEHSIL BADDI,… | Registered | Valid |
| 7 | SUNPAR PHARMACEUTICALS LTD | 17513 | ARCHIFAR 1G POWDER FOR SOLUTION FOR INJECTION | Human | Foreign | Meropenem | Each vial contains Meropenem 1g | H2020/CTD5555/1254ER | Powder For Solution For Injection | INTRAVENOUS | Recommended | 24 months | | J01DH02 | meropenem | | | | MEDOCHEMIE LTD., FACTORY AZ | 2, MICHEAL ERAKLEOUS STREET, AGIOS ATHANASSIOS… | Registered | Valid |
| 8 | ABACUS PHARMA (A) LTD | 19413 | PRAZIKANT TABLETS | Human | Foreign | Praziquantel USP | 600 mg | H2020/CTD5018/924ER | Tablet | ORAL | Recommended | 36 months | | P02BA01 | praziquantel | | | | SKANT HEALTHCARE LTD | Plot no. 1802 - 1805, GIDC, phase III, Vapi… | Registered | Valid |
| 9 | MEDISEL KENYA LTD | 19458 | ENMED SOLUTION FOR INJECTION | Vet | Foreign | ENROFLOXACIN | ENROFLOXACIN 100MG | V2020/6261/1169ER | Solution For Injection | PARENTERAL | Recommended | 36 months | | QJ01MA | Fluoroquinolones | | | | MEDISEL KENYA LTD | GENERAL KAGO RD, P.O. BOX 540-01000, THIKA | Registered | Valid |
| 10 | PHILLIPS THERAPEUTICS LIMITED | 12280 | Brintellix 10 mg | Human | Foreign | Vortioxetine (as hydrobromide) | 10 mg per tablet | H2019/CTD6340/12280 | Film-Coated Tablet | ORAL | Recommended | 36 months | Yellow, almond-shaped film-coated tablet engraved… | N06AX | Other Antidepressants | H. Lundbeck A/S | Ottiliavej 9, DK-2500, Valby-Copenhagen, Denmark | information@ lundbeck.com | H.LUNDBECK A/S | OTTILIAVEJ 9,DK-2500 VALBY-COPENHAGEN, DENMARK | Registered | Valid |