Public View of Electronically Registered Products
Certificates issued on 21-Jul-2021
Electronically Registered Product Details
Electronically Registered Product Details
| # | Local Technical Representative | Application Number | Product Trade Name | Human Vet | Local Foreign | Inn Of Api | Api Strength Per Dosage | Product Registration No | Dosage Form Name | Routes Name | Evaluated | Shelf Life Name | Product Visual Desc | Atc Code Name | Pharmacotherapeutic Group | Mah Company Name | Mah Company Address | Mah Company Email | Site Name | Site Address | Status Name | Status Description |
|---|
| 1 | SAI PHARMACEUTICALS LTD | 16634 | Santocyn Injection | Human | Foreign | Oxytocin | 10 IU/ml | H2021/CTD8075/16634 | Solution For Injection | INTRAVENOUS | Recommended | 24 months | | H01BB02 | oxytocin | Pt Sanbe Farma | Jl. Taman Sari No. 10 Bandung West Java, Bandung,… | ikhsan@sanbe-farma.com | Pt Sanbe Farma ( Unit 3) | | Registered | Valid |
| 2 | JOHNSON & JOHNSON MIDDLE EAST FZ LLC | 20203 | COVID-19 vaccine Janssen (Ad26.COV2-S… | Human | Foreign | COVID-19 vaccine (Ad26.COV2-S [recombinant]) | One dose (0.5 mL) contains: Adenovirus type 26… | H2021/CTD8692/20203EUA | Suspension For Injection | INTRAMUSCULAR | Recommended | 24 months | | J07BX | Other viral vaccines | | | | Janssen Pharmaceutica NV, | Turnhoutseweg 30 B-2340 Beerse Belgium | Authorized | Done by the regulator |
| 3 | GLAD HEALTHCARE KENYA LIMITED | 16451 | GLANAC | Human | Foreign | Diclofenac sodium | 75mg/3ml | H2021/CTD8227/16451 | Solution For Injection | SUBCUTANEOUS | Recommended | 36 months | Almost colorless and clear liquid. | M01AB05 | diclofenac | Reyoung Pharmaceutical Co., Ltd. | : No.1, Ruiyang Road Yiyuan county, Shandong… | xie.manyi@reyoungh.com | REYOUNG PHARMACEUTICAL Co LTD | at No. 6, Erlangshan Road, Yiyuan county,… | Registered | Valid |
| 4 | ZENGENTA PHARMACEUTICALS LIMITED | 18049 | CEFXONE 1GM INJECTION | Human | Foreign | Ceftriaxone Sodium USP | Ceftriaxone 1gm | H2021/CTD8221/18049 | Powder For Injection | INTRAVASCULAR | Recommended | 24 months | | J01DD04 | ceftriaxone | | | | Kilitch Drugs (India) Ltd | C-301/2 M.I.D.C T.T.C Industrial Area, Pawane… | Registered | Valid |