1 | MEDOX PHARMACEUTICALS LIMITED | 19482 | Epimate 25 | Human | Foreign | Topiramate | 25 mg/Tablet | H2020/CTD1519/1337ER | Tablet | ORAL | Recommended | 24 months | | N03AX11 | topiramate | | | | Torrent Pharmaceuticals Limited | Indrad â 382721, Dist. Mehsana, India | Registered | Valid |
2 | SIMBA PHARMACEUTICALS LTD | 19551 | OROZART A | Human | Foreign | Losartan Potassium/ Amlodipine Besylate | Losartan Potassium USP 50MG/ Amlodipine Besylate
| H2020/CTD5664/1742ER | Film-Coated Tablet | ORAL | Recommended | 24 months | | C09DB06 | losartan and amlodipine | | | | SWISS GARNIER LIFE SCIENCES | NO. 21-23 INDUSTRIAL AREA, MEHATPUR, DIST. UNA,
| Registered | Valid |
3 | PHARMAMED SOLUTION LIMITED | 14853 | Cledomox 312.5 DT | Human | Foreign | Amoxicillin Trihydrate B.P. equivalent to 250mg
| 250+ 62.5mg | H2020/CTD7670/14853 | Dispersible Tablet | ORAL | Recommended | 24 months | Yellow to light yellow colour flat circular
| J01CR02 | amoxicillin and enzyme inhibitor | MEDOPHARM PVT LTD C/O MEDOX PHARMACEUTICALS LTD | P.o. Box 52771 - 00200, Nairobi | medoxpharmaceuticalsltd@gmail.com | MEDOPHARM PVT LTD | NO. 50, KAYARAMBEDU VILLAGE, GUDUVANCHERY-603203,
| Registered | Valid |
4 | KRISHNA CHEMISTS LTD | 14978 | RIZAPTAN TABLETS | Human | Foreign | RIZATRIPTAN TABLETS | RIZATRIPTAN TABLETS 10 MG | H2020/CTD7825/14978 | Tablet | ORAL | Recommended | 36 months | A White colour, round shape, flat bevelled edged,
| N02CC04 | rizatriptan | 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 |
5 | UNISEL LTD | 19407 | LARTEM DS TABLETS | Human | Foreign | Artemether ph & Lumefantrine ph | Artemether 40mg & Lumefantrine 240mg | H2020/CTD5023/906ER | Tablet | ORAL | Recommended | 24 months | | P01BF01 | artemether and lumefantrine | | | | SKANT HEALTHCARE LTD | Plot no. 1802 - 1805, GIDC, phase III, Vapi
| Registered | Valid |
6 | KRISHNA CHEMISTS LTD | 14989 | FUNGISIL | Human | Foreign | TERBINAFINE TABLETS USP | TERBINAFINE TABLETS USP 250MG | H2020/CTD7835/14989 | Film-Coated Tablet | ORAL | Recommended | 36 months | A white colour round shaped biconvex film coated
| D01AE15 | terbinafine | 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 | SURGILINKS LTD | 16651 | XENGLU TABLETS 25mg | Human | Foreign | EMPAGLIFLOZIN | Each film coated tablet contains: Empagliflozin
| H2020/CTD7973/16651 | Film-Coated Tablet | ORAL | Recommended | 24 months | White rectangular biconvex coated tablet, having
| A10BX12 | empagliflozin | Hilton Pharma (Pvt.) Ltd. | Plot No. 13-14, Sector 15, Korangi Industrial
| hilton@hiltonpharma.com | Hilton Pharma Pvt Ltd | Plot No 13-14 Sector 15, Korangi Industrial Area,
| Registered | Valid |
8 | NEXTGEN PHARMACEUTICALS (K) LTD | 19660 | ROXETIL CAPSULE | Human | Foreign | Cefpodoxime Proxetil | Each hard gelatin capsule contains: Cefpodoxime
| H2020/CTD3853/1821ER | Capsule, Hard | ORAL | Recommended | 24 months | | J01DD13 | cefpodoxime | | | | HEALTHCARE PHARMACEUTICALS LTD | GAZARIAPARA, P.O. MIRZAPUR BAZAR, RAJENDRAPUR,
| Registered | Valid |
9 | OPERA PHARMA (K) LTD | 19472 | ROSUVAX 10 | Human | Foreign | ROSUVASTATIN 10MG | 10MG | H2020/5581/1277ER | Tablet | ORAL | Recommended | 24 months | | C01AA07 | deslanoside | | | | Astra Lifecare (India) Pvt Ltd | Survey No. 57/P, Sarkhej Bavla Highway,
| Registered | Valid |
10 | SURGILINKS LTD | 16739 | XENGLU-MET 12.5/1000mg Tablets | Human | Foreign | Empagliflozin + Metformin HCl | Empagliflozin 12.5mg + Metformin HCl 1000mg per
| H2020/CTD7975/16739 | Film-Coated Tablet | ORAL | Recommended | 24 months | White oblong biconvex coated tablet engraved âTâ
| A10BD20 | metformin and empagliflozin | Hilton Pharma (Pvt.) Ltd. | Plot# 13-14, Sector 15, Korangi Industrial Area,
| hilton@hiltonpharma.com | Hilton Pharma Pvt Ltd | Plot No 13-14 Sector 15, Korangi Industrial Area,
| Registered | Valid |