Changzhou Syntheall Pharmaceutical is a finished-dose manufacturer based in China. It appears in 5 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with MINSA (CR) and ARCSA (EC). Its GMP standing is certified by MFDS (Korea), US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 7 March 2025 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| China, China | 3012897823 |
| Changzhou, China | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Fedratinib | SFDA (Saudi Arabia) | 1 |
| Ibrutinib | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 4 | None |
| ARCSA (EC) | 1 | None |
| MFDS (Korea) | None | 2 |
| US FDA | None | 1 |
| EMA | None | 1 |
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