Sichuan Kelun Pharmaceutical is an API and finished-dose manufacturer based in China. It holds 17 active US drug master files across a filed portfolio of 17 molecules. Its filings concentrate with ARCSA (EC), UZPHARM (UZ) and NAFDAC (NG). Its GMP standing is certified by NAFDAC (NG), UZPHARM (UZ) and ANVISA (Brazil), among 4 authorities.
| Site | FDA FEI |
|---|---|
| Qionglai, China | Not on file |
| SICHUAN, China | Not on file |
| China, China | 3026331762 |
| Hunan Province, Nigeria | Not on file |
| P.R. CHINA, Nigeria | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Apalutamide | US FDA | 1 |
| Aprepitant | US FDA | 1 |
| Empagliflozin | US FDA | 1 |
| Enzalutamide | US FDA | 1 |
| Finerenone | US FDA | 1 |
| Ibrutinib | US FDA | 1 |
| Neratinib | US FDA | 1 |
| Netupitant | US FDA | 1 |
| Nintedanib | US FDA | 1 |
| Olaparib | US FDA | 1 |
| Omadacycline | US FDA | 1 |
| Pemafibrate | US FDA | 1 |
| Posaconazole | US FDA | 1 |
| Regorafenib | US FDA | 1 |
| Sacubitril | US FDA | 1 |
| Sildenafil | US FDA | 1 |
| Siponimod | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| ARCSA (EC) | 16 | None |
| UZPHARM (UZ) | 11 | 1 |
| NAFDAC (NG) | 6 | 2 |
| ANVISA (Brazil) | None | 1 |
| NCELS (KZ) | None | 1 |
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