The public registers hold a second record for Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory. The fuller profile, with 9 active US DMFs and 8 valid CEPs, is at Zhejiang Medicine. Figures on this page cover only this record.
Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory is an API manufacturer based in China. It holds 8 active US drug master files across a filed portfolio of 8 molecules. Its GMP standing is certified by MFDS (Korea), MHRA (UK) and US FDA. Its most recent recorded inspection, by US FDA, closed on 7 March 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Xinchang, China | Not on file |
| Shaoxing, China | Not on file |
| XINCHANG, China | Not on file |
| China, China | 3003631275 |
| Molecule | Regulators | Docs |
|---|---|---|
| Bosentan | US FDA | 1 |
| Daptomycin | US FDA | 1 |
| Icosapent Ethyl | US FDA | 1 |
| Levofloxacin | US FDA | 1 |
| Miglitol | US FDA | 1 |
| Minocycline | US FDA | 1 |
| Rifaximin | US FDA | 1 |
| Vancomycin | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| NMPA (CN) | 7 | None |
| MFDS (Korea) | None | 2 |
| MHRA (UK) | None | 1 |
| US FDA | None | 1 |
Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.
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