Anhui Poly Pharm is an API manufacturer based in China. It holds 12 active US drug master files and 5 valid CEPs across a filed portfolio of 14 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 27 February 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Anqing, China | Not on file |
| China, China | 3020871572 |
| Molecule | Regulators | Docs |
|---|---|---|
| Cyclophosphamide | EDQM, US FDA | 2 |
| Gadobutrol | EDQM, US FDA | 2 |
| Voriconazole | EDQM, US FDA | 2 |
| Allopurinol | US FDA | 1 |
| Apremilast | US FDA | 1 |
| Crisaborole | US FDA | 1 |
| Gadoteric Acid | US FDA | 1 |
| Gadoteridol | US FDA | 1 |
| Ioversol | US FDA | 1 |
| Magnesium | US FDA | 1 |
| Magnesium Hydroxide | EDQM | 1 |
| Semaglutide | US FDA | 1 |
| Sodium Nitroprusside | EDQM | 1 |
| Tecovirimat | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 2 | None |
| US FDA | None | 1 |
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