| 1 | SAI PHARMACEUTICALS LTD | 16433 | Isoniazid 300mg and Rifapentine 300mg coated… | Human | Foreign | Isoniazid BP and Rifapentine | 300mg and 300mg | H2020/CTD7981/16433 | Coated Tablet | ORAL | Recommended | 24 months | | J04AB05 | rifapentine | Macleods Pharmaceuticals Limited | 304 Atlanta Arcade, Marol Church Road, Andheri… | ajay@macleodspharma.com | OXALIS LABS | VILLAGE THEDA, P.O LODHI MAJRA TEHSIL BADDI,… | Registered | Valid |
| 2 | UNIVERSAL CORPORATION LTD | 17179 | Tenofovir Disoproxil… | Human | Foreign | Tenofovir Disoproxil… | Tenofovir Disoproxil Fumarate - 300mg/Lamivudine… | H2020/CTD8181/17179 | Film-Coated Tablet | ORAL | Recommended | 24 months | White opaque HDPE containers | J05AR12 | lamivudine and tenofovir disoproxil | STRIDES PHARMA SCIENCE LIMITED(Formerly Strides… | Strides House, Opp. IIMB,… | info@strides.com | Strides Pharma Science Limited (Formerly Strides… | Strides Pharma Science Limited (Formerly Strides… | Registered | Valid |
| 3 | SAI PHARMACEUTICALS LTD | 12270 | Repoitin 5000 PFS | Human | Foreign | Erythropoietin concentrated solution BP (… | Each 0.5ml contains Erythropoietin concentrated… | H2020/CTD7700/12270 | Solution For Injection | SUBCUTANEOUS | Recommended | 24 months | | B03XA | Other antianemic preparations | Serum Institute of India Pvt Limited | 212/2, Hadapsar, Pune-411028, India | vijay.patil@seruminstitute.com | Serum Institute of India Pvt Limited | Serum Institute of India Pvt Limited | Registered | Valid |
| 4 | DAWA LTD | 12624 | FEXMONT-120 | Human | Foreign | Montelukast sodium & Fexofenadine hydrochloride | Montelukast sodium 10mg & Fexofenadine… | H2020/CTD6473/12624 | Film-Coated Tablet | ORAL | Recommended | 36 months | | R06AK | Combinations of Antihistamines for systemic use: | Medisel Kenya Ltd | P.O. Box 540-01000 Thika | regulatory@mediselkenya.com | East African India Overseas | 14449
| Registered | Valid |
| 5 | MEDFO KENYA LIMITED | 14649 | MEPIN | Human | Foreign | METHYLDOPA & NIFEDIPINE USP TABLETS | Methyldopa USP 250 mg Nifedipine USP 20 mg | H2020/CTD7494/14649 | Tablet | ORAL | Recommended | 36 months | | C02A | Antihypertensives: Antiadrenergic agents… | MEDFO KENYA LTD | P.O. BOx 104425-00101, Nairobi, Kenya | regulatory.medfo@gmail.com | RELAX BIOTECH PVT. LIMITED | 862/1, GIDC, MAKARPURA, VADODARA - 390010,… | Registered | Valid |