| 1 | SAI PHARMACEUTICALS LTD | 12938 | Telminorm-80 | Human | Foreign | "Telmisartan USP " | Telmisartan USP 80mg | H2021/CTD6643/12938 | Tablet | ORAL | Recommended | 24 months | | C09CA07 | telmisartan | | | | Ipca Laboratories Limited, Ratlam | Ipca Laboratories Limited, Ratlam | Registered | Valid |
| 2 | DAWA LTD | 13198 | TGT-20M EXTENDED-RELEASE TABLETS | Human | Foreign | Teneligliptin Hydrobromide Hydrate & Metformin… | Teneligliptin Hydrobromide Hydrate equivalent to… | H2021/CTD6861/13198 | Tablet | ORAL | Recommended | 24 months | | A10BD07 | metformin and sitagliptin | | | | CORONA REMEDIES PVT LTD | Village: Jatoli Post Office Oachgat. Tehsil Solan… | Registered | Valid |
| 3 | SYNER-MED PHARMACEUTICALS (K)LTD | 14836 | I- FREE DUAL | Human | Foreign | Levonorgestrel BP | 0.75 mg | H2021/CTD7622/14836 | Film-Coated Tablet | ORAL | Recommended | 24 months | Pink, round, biconvex, plain on both sides, film… | G03AD01 | levonorgestrel | Synokem Pharmaceuticals Limited | Corporate Office: Synokem House, 14/486, Sunder… | pankaj@synokempharma.com | Synokem Pharmaceuticals Ltd | Plot 35-36 Sector-6A, Integrated Industrial… | Registered | Valid |
| 4 | PHARMACO HEALTHCARE LTD | 12298 | CEFDIA | Human | Foreign | Cefixime Trihydrate | 447.63 mg Cefixime Trihydrate equivalent to 400… | H2021/CTD6357/12298 | Film-Coated Tablet | ORAL | Recommended | 24 months | | J01DD | Beta-lactamantibacterials: Third-generation… | İlko İlaç Sanayi ve Ticaret A. Ş., Turkey | İlko İlaç San. Tic. A.S. Veysel Karani Mah.… | Tel: (0216) 564 80 00 Fax: (0216) 564 80 99 | Nobel Ilaç San. Ve Tic. A.S | Sancaklar 81100 Düzce –Turkey | Registered | Valid |
| 5 | GOODMAN AGENCIES LTD | 13090 | Colistin - 600 | Vet | Foreign | Colistin Sulphate | Colistin Sulphate 6,000,000 I.U./Gm | V2021/CTD6743/13090 | Powder For Syrup | ORAL | Recommended | 36 months | A white creamy fine powder | QA07AA | Antibiotics | Goodman Agencies Ltd. | 6th Floor, Goodman Tower, Waiyaki Way, Westlands,… | mgubara@goodman.co.ke;rgubara@goodman.co.ke | Vapco (Veterinary and Agricultural Products Mfg.… | Vapco (Veterinary and Agricultural Products Mfg.… | Registered | Valid |
| 6 | KRISHNA CHEMISTS LTD | 15000 | MONTYFEX | Human | Foreign | FEXOFENADINE HYDROCHLORIDE AND MONTELUKAST TABLETS | FEXOFENADINE HYDROCHLORIDE 120 MG MONTELUKAST 10… | H2021/CTD7844/15000 | Film-Coated Tablet | ORAL | Recommended | 36 months | A light yellow colour round shaped biconvex film… | R06AX26 | fexofenadine | KRISHNA CHEMISTS LTD | 3rd Floor Metrix Hardware, Lusaka Road,… | regulatory@krishnachemists.com | RELAX BIOTECH PVT LTD | 862/1, GIDC, MAKARPURA, VADODARA-390010, GUJARAT,… | Registered | Valid |
| 7 | TRIDEM PHARMA KENYA LTD | 12448 | GUTAXIME | Human | Foreign | CEFOTAXIME SODIUM | EACH VIAL CONTAINS CEFOTAXIME SODIUM EQUIVALENT… | H2021/CTD6389/12448 | Powder And Solvent For Solution For Injection | INTRAVENOUS | Recommended | 36 months | | J01DD | Beta-lactamantibacterials: Third-generation… | Guilin Pharmaceutical Co.,Ltd | PLOT NO. 43, QILIDIAN RD, GUILIN-541004, CHINA | n.zhou@tridem-pharma.com | REYOUNG PHARMACEUTICALS Co LTD | No.1 Ruiyang Road, Yiyuan County, Shandong… | Registered | Valid |
| 8 | PHILLIPS THERAPEUTICS LIMITED | 12932 | OVUROL OVULES | Human | Foreign | ticonazole, Tinidazole Lidono caise Hl | 200mg.300mg,123.36mg | H2021/CTD6706/12932 | Pessary | VAGINAL | Recommended | 36 months | | P01AB02 | tinidazole | | | | EXELTIS IIAC SAN VE TIC A.S | 100000000000311
| Registered | Valid |
| 9 | SYNER-MED PHARMACEUTICALS (K)LTD | 14831 | SYNCORT- 30 | Human | Foreign | Deflazacort | 30 mg | H2021/CTD7618/14831 | Tablet | ORAL | Recommended | 24 months | White coloured, round, flat, scored on one side,… | H02AB13 | deflazacort | Synokem Pharmaceuticals Limited | Synokem House, 14/486, Sunder Vihar, Outer ring… | synokem@airtelmail.in | Synokem Pharmaceuticals Ltd | Plot 35-36 Sector-6A, Integrated Industrial… | Registered | Valid |
| 10 | GOODMAN AGENCIES LTD | 13092 | Theilacide 50mg/ml injection | Vet | Foreign | Buparvaquone | Buparvaquone 50mg/ml | V2021/CTD6745/13092 | Solution For Injection | INTRAMUSCULAR | Recommended | 36 months | A deep brown to red clear liquid | QP51AG | Sulfonamides plain and in combinations | Goodman Agencies Ltd. | Goodman Tower, 6th Floor, Waiyaki way, Westlands,… | mgubara@goodman.co.ke Rgubara@goodman.co.ke | Vapco (Veterinary and Agricultural Products Mfg.… | Vapco (Veterinary and Agricultural Products Mfg.… | Registered | Valid |