Hainan Poly Pharm is an API and finished-dose manufacturer based in China. It holds 7 active US drug master files across a filed portfolio of 9 molecules. Its filings concentrate with NMPA (CN), US FDA and SFDA (Saudi Arabia). Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 30 June 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Hainan Province, United Arab Emirates | Not on file |
| Haikou, China | Not on file |
| China, China | 3005115952 |
| Molecule | Regulators | Docs |
|---|---|---|
| Acyclovir | US FDA | 1 |
| Amiodarone | US FDA | 1 |
| Bumetanide | US FDA | 1 |
| Dobutamine | US FDA | 1 |
| Esomeprazole | US FDA | 1 |
| Ganciclovir | SFDA (Saudi Arabia) | 1 |
| Glycopyrronium | US FDA | 1 |
| Sodium Nitroprusside | SFDA (Saudi Arabia) | 1 |
| Trimebutine | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| NMPA (CN) | 49 | None |
| US FDA | 17 | 1 |
| SFDA (Saudi Arabia) | 9 | None |
| MINSA (CR) | 6 | None |
| EDE (AE) | 2 | None |
| NPRA (MY) | 2 | None |
| EMA | None | 1 |
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