Fujian South Pharmaceutical is an API manufacturer based in China. It holds 5 active US drug master files across a filed portfolio of 8 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 11 October 2024 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| China, China | 3008467694 |
| Molecule | Regulators | Docs |
|---|---|---|
| Paclitaxel | SFDA (Saudi Arabia), US FDA | 3 |
| Acetylcysteine | US FDA | 1 |
| Bendamustine | SFDA (Saudi Arabia) | 1 |
| Cytarabine | US FDA | 1 |
| Docetaxel | US FDA | 1 |
| Fluorouracil | US FDA | 1 |
| Pemetrexed Disodium Hemipentahydrate | SFDA (Saudi Arabia) | 1 |
| Sodium Thiosulfate | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 2 | None |
| US FDA | None | 1 |
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