| 1 | DAWA LTD | 12276 | ONDATON 2MG/5ML SYRUP | Human | Local | Ondansetron Hydrochloride | Each 5ml of Ondaton syrup contains: Ondansetron… | H2020/CTD6399/12276 | Syrup | ORAL | Recommended | 24 months | An orange coloured syrup,free from visible… | A04AA | Antiemetics and antinauseants: Serotonin (5-HT3)… | Dawa Limited | P.O. Box 16633 - 00620 Nairobi | lmuteti@dawalimited.com | DAWA LTD | PLOT NO. 7879/8, BABA DOGO RD, RUARAKA, NAIROBI | Registered | Valid |
| 2 | 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 |
| 3 | PRUNUS PHARMA LIMITED | 12508 | MICNIT CREAM | Human | Foreign | Miconazole Nitrate | Miconazole Nitrate BP 2.0 % w/w | H2020/CTD6384/12508 | Cream | TOPICAL | Recommended | 36 months | A white to off-white smooth cream. | D01AC02 | miconazole | Kremoint Pharma Pvt. Ltd | Plot No, B-8,Additional Ambernath M.I.D.C.,… | info@kremointpharma.com | KREMOINT PHARMA PRIVATE LIMITED | B-8, ADDITIONAL AMBERNATH MIDC,… | Registered | Valid |
| 4 | DAWA LTD | 13164 | Rosuat-10 | Human | Local | Rosuvastatin Calcium | Rosuvastatin (as Calcium) 10mg. | H2020/CTD6851/13164 | Film-Coated Tablet | ORAL | Recommended | 24 months | Pale pink, Round biconvex film coated tablets,… | C10AA07 | rosuvastatin | DAWA LIMITED | P.O BOX 16633-00620 | admin@dawalimited.com | DAWA LTD | PLOT NO. 7879/8, BABA DOGO RD, RUARAKA, NAIROBI | Registered | Valid |
| 5 | DAWA LTD | 13461 | NIBEPIN TABLETS | Human | Local | Amlodipine Besylate and Nebivolol Hydrochloride | Amlodipine (as Besilate)5mg and nebivolol (as… | H2020/CTD7042/13461 | Tablet | ORAL | Recommended | 24 months | Circular biconvex plain tablets, with Yellow… | C07FB12 | nebivolol and other antihypertensives | DAWA LIMITED | P.O. BOX 16633-00620 | admin@dawalimited.com | DAWA LTD | PLOT NO. 7879/8, BABA DOGO RD, RUARAKA, NAIROBI | Registered | Valid |
| 6 | SURGIPHARM LTD | 14083 | Jardiance 10 mg Tablets | Human | Foreign | Empagliflozin | 10mg Empagliflozin/tablet | H2019/CTD7286/14083 | Film-Coated Tablet | ORAL | Recommended | 36 months | Film-coated tablet (tablet). Jardiance 10 mg… | A10 | DRUGS USED IN DIABETES | Boeheringer Ingelheim | Binger Strasse 173 55216 Ingelheim am Rhein | nada.abdelwahab@boehringer-ingelheim.com | Boehringer Ingelheim Pharma GmbH & Co. KG, | 173 Binger Strasse, 55216, Ingelheim am Rhein,… | Registered | Valid |
| 7 | DAWA LTD | 14154 | Dawasolone oral solution | Human | Local | Prednisolone sodium phosphate | Each 5ml contains: Prednisolone sodium phosphate… | H2020/CTD7287/14154 | Oral Liquid | ORAL | Recommended | 36 months | A Clear pink solution free from visible evidence… | H02AB06 | prednisolone | DAWA LIMITED | P.O BOX 16630-00620 NAIROBI | admin@dawalimited.com | Dawa Limited | 16633 | Registered | Valid |
| 8 | SURGIPHARM LTD | 14170 | Jardiance 25 mg Tablets | Human | Foreign | Empagliflozin | 25mg Empagliflozin/tablet | H2019/CTD7291/14170 | Film-Coated Tablet | ORAL | Recommended | 36 months | Film-coated tablet (tablet). Jardiance 25 mg… | A10 | DRUGS USED IN DIABETES | Boeheringer Ingelheim | Binger Strasse 173 55216 Ingelheim am Rhein | nada.abdelwahab@boehringer-ingelheim.com | Boehringer Ingelheim Pharma GmbH & Co. KG, | 173 Binger Strasse, 55216, Ingelheim am Rhein,… | Registered | Valid |
| 9 | SAI PHARMACEUTICALS LTD | 14303 | Efavirenz 400mg , Lamivudine 300mg and Tenofovir… | Human | Foreign | Efavirenz USP,Lamivudine USP, Tenofovir … | 400 mg+300mg+300mg | H2019/CTD7299/14303 | Film-Coated Tablet | ORAL | Recommended | 24 months | | J05AR11 | lamivudine tenofovir disoproxil and efavirenz | Macleods Pharmaceuticals Limited | 304 Atlanta Arcade, Marol Church road Andheri (… | ajay@macleodspharma.com | MACLEODS PHARMACEUTICALS LTD | BLOCK N-1, N-2, N-3 VILLAGE THEDA, PO:… | Registered | Valid |
| 10 | HARLEYS LTD-NAIROBI | 14333 | BETMIGA 25 | Human | Foreign | Mirabegron | Each Film Coated Tablet contains: Mirabegron… | H2020/CTD7392/14333 | Prolonged-Release Tablet | ORAL | Recommended | 36 months | Oval, brown film-coated tablet, debossed with… | G04BD12 | mirabegron | ASTELLAS PHARMA (PTY) LTD | : 5 OSBORNE LANE, BEDFORDVIEW SOUTH AFRICA | shamima.rashid@astellas.com | ASTELLAS PHARMA EUROPE BV | HOGERMAAT 2 7942JG MEPPEL, NETHERLANDS | Registered | Valid |