Zhejiang Changhai Pharmaceuticals is an API manufacturer based in China. It holds 3 active US drug master files across a filed portfolio of 3 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 26 May 2023 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Shaoxing, China | Not on file |
| China, China | 3013591876 |
| Molecule | Regulators | Docs |
|---|---|---|
| Linezolid | US FDA | 1 |
| Minocycline | US FDA | 1 |
| Rifamycin | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | None | 2 |
| US FDA | None | 1 |
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