| 1 | DAWA LTD | 13114 | NITAXAN 500MG TABLETS | Human | Local | NITAZOXANIDE | EACH FILM COATED TABLET CONTAINS:NITAZOXANIDE… | H2020/CTD6753/13114 | Film-Coated Tablet | ORAL | Recommended | 36 months | | P01AX11 | nitazoxanide | DAWA LIMITED | 16633 - 00620 NAIROBI | LMUTETI@DAWALIMITED.COM | DAWA LTD | PLOT NO. 7879/8, BABA DOGO RD, RUARAKA, NAIROBI | Registered | Valid |
| 2 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | 13302 | INVEL | Human | Foreign | Metronidazole , Miconazole Nitrate | Metronidazole 500mg , Miconazole Nitrate 100mg | H2020/CTD6975/13302 | Vaginal Tablet | VAGINAL | Recommended | 24 months | Off White to brown bullet shaped suppository | G01AF20 | combinations of imidazole derivatives | Mega Lifesciences Public Company Ltd | 384,Soi 6, Pattana 3 Road, Bangpoo Industrial… | snehal@megawecare.com | Bliss GVS Pharma Ltd | Plot 10, 11, and 12 Dewan Udyong Nagahar, Aliyali… | Registered | Valid |
| 3 | REGAL PHARMACEUTICALS LTD | 13820 | SONATEC MOUTHWASH COOL PEPPERMINT (ALCOHOL FREE) | Human | Local | Cetylpyridinium Chloride BP 0.05% w/v | 0.05% w/v | H2020/CTD7121/13820 | Oral Liquid | ORAL | Recommended | 24 months | | R02AA06 | cetylpyridinium | REGAL PHARMACEUTICALS LIMITED | P.o Box 44421-00100 | info@regalpharmaceuticals.com | REGAL PHARMACEUTICALS LTD | BABA DOGO RD, RUARAKA | Registered | Valid |
| 4 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | 14617 | URSOLIV 250 | Human | Foreign | Ursodeoxycholic acid | 250mg | H2020/CTD7525/14617 | Capsule, Hard | ORAL | Recommended | 24 months | White to off- white powder filled in size 'o'… | A05AA02 | ursodeoxycholic acid | Mega Lifesciences Public Company Limited | 515/1 MOO.4 Soi 8, Bangpoo Industrial Estate,… | info@megawecare.com | Mega Lifesciences Public Company Limited at Mega… | 515/1 Soi 8, Pattana 3rd Road, Bangpoo Industrial… | Registered | Valid |
| 5 | KRISHNA CHEMISTS LTD | 14974 | CEREGARD PLUS | Human | Foreign | CEREBROPROTEIN HYDROLYSATE AND CITICOLINE TABLETS | Cerebroprotein hydrolysate = 60 mg Citicoline… | H2020/CTD7821/14974 | Film-Coated Tablet | ORAL | Recommended | 36 months | A Brown Coloured, oblong shaped, biconvex film… | N06BX06 | citicoline | 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 |
| 6 | HARLEYS LTD-NAIROBI | 14976 | Treviamet 50mg + 850mg Tablets | Human | Foreign | Sitagliptin and Metformin | Sitagliptin 50mg and Metformin 850mg | H2020/CTD7823/14976 | Film-Coated Tablet | ORAL | Recommended | 24 months | | A10BD07 | metformin and sitagliptin | Getz Pharma (Private) Limited | Getz Pharma (Private) Limited 29-30/27, Korangi… | info@getzpharma.com | GETZ PHARMA (PVT) LTD | 29-30 SECTOR 27,KORANGI INDUSTRIAL AREA… | Registered | Valid |
| 7 | KRISHNA CHEMISTS LTD | 14984 | HITKIT | Human | Foreign | COMBIKIT OF (A) Rabeprazole Sodium Tablets (B)… | COMBIKIT OF (A) Rabeprazole sodium tablets 20 mg… | H2020/CTD7830/14984 | Tablet | ORAL | Recommended | 36 months | A-Rabeprazole tablets 20 mg-A yellow coloured,… | J01CA04 | amoxicillin | KRISHNA CHEMISTS LTD | 3rd Floor Metrix Hardware, Lusaka Road,… | regulatory@krishnachemists.com | Health Care Formulations Pvt. Ltd | C/8, Sarder Estate ,Ajwa Road, Vadodara-390019 , | Registered | Valid |
| 8 | KRISHNA CHEMISTS LTD | 14985 | GEMKIT | Human | Foreign | COMBIKIT OF (A) Rabeprazole Sodium Tablets (B)… | COMBIKIT OF (A) Rabeprazole sodium tablets 20 mg… | H2020/CTD7831/14985 | Tablet | ORAL | Recommended | 36 months | A-Rabeprazole tablets 20 mg-A yellow coloured,… | J01CA04 | amoxicillin | KRISHNA CHEMISTS LTD | 3rd Floor Metrix Hardware, Lusaka Road,… | regulatory@krishnachemists.com | HEALTHCARE FORMULATIONS PVT LTD | AJWA ROAD, 390019 VADODARA, INDIA | Registered | Valid |
| 9 | KRISHNA CHEMISTS LTD | 14986 | FLODART | Human | Foreign | DUTASTERIDE | DUTASTERIDE TABLETS 0.5MG | H2020/CTD7832/14986 | Film-Coated Tablet | ORAL | Recommended | 36 months | A white colour, round shaped, biconvex, film… | G04CB02 | dutasteride | 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 |
| 10 | MEGA LIFESCIENCES PUBLIC COMPANY LIMITED | 15033 | INVEL FORTE | Human | Foreign | Metronidazole , Minconazole Nitrate , Lidocaine | Metronidazole BP 750mg , Miconazole Nitrate BP… | H2020/CTD7861/15033 | Suppository | VAGINAL | Recommended | 24 months | White opaque bullet shaped Vaginal suppositories | G01AF20 | combinations of imidazole derivatives | Mega Lifesciences Public Company Ltd | 384, Soi 6, Pattana 3 Road, Bangpoo Industrial… | info@megawecare.com | BLISS GVS PHARMA LTD | PLOT NO. 10, 11 & 12 DEWAN UDYONG NAGAHAR,… | Registered | Valid |