Daewoong Bio is an API manufacturer based in South Korea. It holds 2 active US drug master files and 4 valid CEPs across a filed portfolio of 3 molecules. Its filings concentrate with DAV (Vietnam) and MINSA (CR).
| Site | FDA FEI |
|---|---|
| Hwaseong-Si, South Korea | Not on file |
| Hwasung-City, South Korea | Not on file |
| South, South Korea | 3011083160 |
| Molecule | Regulators | Docs |
|---|---|---|
| Ursodeoxycholic Acid | EDQM, US FDA | 5 |
| Cefuroxime Axetil | EDQM | 1 |
| Fexuprazan | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| DAV (Vietnam) | 15 | None |
| MINSA (CR) | 1 | None |
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