Zhejiang Apeloa Jiayuan Pharmaceutical is an API manufacturer based in China. It holds 22 active US drug master files and 7 valid CEPs across a filed portfolio of 19 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 11 April 2025 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Dongyang City, China | Not on file |
| Dongyang, China | Not on file |
| Hengdian, China | Not on file |
| China, China | 3004944662 |
| Molecule | Regulators | Docs |
|---|---|---|
| Metoprolol | EDQM, US FDA | 4 |
| Clopidogrel | EDQM, US FDA | 3 |
| Bupropion | US FDA | 2 |
| Irbesartan | SFDA (Saudi Arabia), US FDA | 2 |
| Levetiracetam | EDQM, US FDA | 2 |
| Quetiapine | EDQM, US FDA | 2 |
| Sacubitril | US FDA | 2 |
| Telmisartan | SFDA (Saudi Arabia), US FDA | 2 |
| Venlafaxine | EDQM, US FDA | 2 |
| Brivaracetam | US FDA | 1 |
| Desvenlafaxine | US FDA | 1 |
| Gabapentin | US FDA | 1 |
| Iron Dextran | US FDA | 1 |
| Laropiprant | US FDA | 1 |
| Levosalbutamol | US FDA | 1 |
| Metaxalone | US FDA | 1 |
| Methocarbamol | US FDA | 1 |
| Pregabalin | US FDA | 1 |
| Sitagliptin | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | None | 1 |
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