Zhejiang Huayi Pharmaceutical is an API manufacturer based in China. It holds 10 active US drug master files and 4 valid CEPs across a filed portfolio of 13 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 18 April 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Yiwu, China | Not on file |
| Jinhua, China | Not on file |
| China, China | 3003657871 |
| Molecule | Regulators | Docs |
|---|---|---|
| Mirabegron | EDQM, US FDA | 2 |
| Apremilast | US FDA | 1 |
| Canagliflozin | US FDA | 1 |
| Ciprofloxacin | US FDA | 1 |
| Clarithromycin | EDQM | 1 |
| Empagliflozin | US FDA | 1 |
| Ibrutinib | US FDA | 1 |
| Levetiracetam | EDQM | 1 |
| Macitentan | US FDA | 1 |
| Omeprazole | EDQM | 1 |
| Pioglitazone | US FDA | 1 |
| Regorafenib | US FDA | 1 |
| Selexipag | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | None | 1 |
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