Sinopep-Allsino Biopharmaceutical is an API manufacturer based in China. It holds 22 active US drug master files across a filed portfolio of 18 molecules. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 20 September 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| China, China | 3005460102 |
| Molecule | Regulators | Docs |
|---|---|---|
| Fulvestrant | PMDA (Japan), SFDA (Saudi Arabia), US FDA | 4 |
| Semaglutide | SFDA (Saudi Arabia), US FDA | 4 |
| Cetrorelix | SFDA (Saudi Arabia), US FDA | 2 |
| Liraglutide | SFDA (Saudi Arabia), US FDA | 2 |
| Oseltamivir | US FDA | 2 |
| Risdiplam | US FDA | 2 |
| Baloxavir Marboxil | US FDA | 1 |
| Bivalirudin | US FDA | 1 |
| Cagrilintide | US FDA | 1 |
| Desmopressin | US FDA | 1 |
| Elacestrant | US FDA | 1 |
| Eptifibatide | SFDA (Saudi Arabia) | 1 |
| Icotrokinra | US FDA | 1 |
| Lanreotide | US FDA | 1 |
| Octreotide | US FDA | 1 |
| Orforglipron | US FDA | 1 |
| Retatrutide | US FDA | 1 |
| Tirzepatide | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MFDS (Korea) | None | 2 |
| US FDA | None | 1 |
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