Sichuan Xieli Pharmaceutical is an API manufacturer based in China. It holds 11 active US drug master files and 5 valid CEPs across a filed portfolio of 12 molecules. Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 26 September 2025 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Pengzhou, China | Not on file |
| China, China | 3007432586 |
| Molecule | Regulators | Docs |
|---|---|---|
| Diosmin | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Irinotecan | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Cytisine | US FDA | 2 |
| Troxerutin | EDQM, US FDA | 2 |
| Anastrozole | EDQM | 1 |
| Berberine | US FDA | 1 |
| Cabazitaxel | US FDA | 1 |
| Erlotinib | US FDA | 1 |
| Gefitinib | US FDA | 1 |
| Hesperidin | SFDA (Saudi Arabia) | 1 |
| Ingenol Mebutate | US FDA | 1 |
| Ursodeoxycholic Acid | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | None | 1 |
| EMA | None | 1 |
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