CSPC Ouyi Pharmaceutical is an API and finished-dose manufacturer based in China. It holds 3 active US drug master files across a filed portfolio of 3 molecules. Its filings concentrate with DIGEMAPS (DO), ARCSA (EC) and US FDA. Its GMP standing is certified by NAFDAC (NG) and US FDA. Its most recent recorded inspection, by US FDA, closed on 5 September 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Shijiazhuang, United Arab Emirates | Not on file |
| China, China | 2000021110 |
| Shijiazhuang City, Nigeria | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Azithromycin | SFDA (Saudi Arabia), US FDA | 2 |
| Indomethacin | US FDA | 1 |
| Tramadol | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| DIGEMAPS (DO) | 35 | None |
| ARCSA (EC) | 24 | None |
| US FDA | 9 | 1 |
| EFDA (ET) | 8 | None |
| UZPHARM (UZ) | 6 | None |
| MINSA (CR) | 4 | None |
| NAFDAC (NG) | None | 1 |
Choose your molecules and target markets. CSPC Ouyi Pharmaceutical comes back tiered against every other supplier able to file there.
Start for free