Jiangsu Nhwa Pharmaceutical is an API manufacturer based in China. It holds 3 active US drug master files and 2 valid CEPs across a filed portfolio of 4 molecules. Its filings concentrate with MINSA (CR) and ARCSA (EC). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 1 September 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Xuzhou City, China | Not on file |
| China, China | 3005619485 |
| Molecule | Regulators | Docs |
|---|---|---|
| Fenofibrate | EDQM, US FDA | 2 |
| Buspirone | US FDA | 1 |
| Lithium Carbonate | EDQM | 1 |
| Lithium Cation | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 3 | None |
| ARCSA (EC) | 1 | None |
| US FDA | None | 1 |
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