Wuxi Fortune Pharmaceutical is an API manufacturer based in China. It holds 8 active US drug master files across a filed portfolio of 8 molecules. Its filings concentrate with US FDA and MINSA (CR). Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 22 November 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| China, China | 3005968356 |
| Molecule | Regulators | Docs |
|---|---|---|
| Mitomycin | SFDA (Saudi Arabia), US FDA | 2 |
| Cantharidin | US FDA | 1 |
| Doxercalciferol | US FDA | 1 |
| Mycophenolate Mofetil | US FDA | 1 |
| Mycophenolic Acid | US FDA | 1 |
| Rifapentine | US FDA | 1 |
| Rivastigmine | US FDA | 1 |
| Tacrolimus | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 1 | 1 |
| MINSA (CR) | 1 | None |
| MFDS (Korea) | None | 2 |
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