Kyongbo Pharmaceutical is an API and finished-dose manufacturer based in South Korea. It holds one active US drug master file and 3 valid CEPs across a filed portfolio of 6 molecules. Its filings concentrate with DAV (Vietnam) and ARCSA (EC). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 11 November 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Asan-Si, South Korea | Not on file |
| South, South Korea | 3003773799 |
| Molecule | Regulators | Docs |
|---|---|---|
| Cefotaxime | EDQM | 1 |
| Ceftriaxone | EDQM | 1 |
| Lenalidomide | US FDA | 1 |
| Pemetrexed Disodium Hemipentahydrate | SFDA (Saudi Arabia) | 1 |
| Polmacoxib | SFDA (Saudi Arabia) | 1 |
| Tiotropium | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| DAV (Vietnam) | 76 | None |
| ARCSA (EC) | 1 | None |
| US FDA | None | 1 |
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