KinOmega Biopharm is an API manufacturer based in China. It holds 3 active US drug master files and 3 valid CEPs across a filed portfolio of 4 molecules. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 24 January 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Deyang City, China | Not on file |
| China, China | 3009754809 |
| Molecule | Regulators | Docs |
|---|---|---|
| Omega-3-Acid Ethyl Esters 90 | EDQM | 3 |
| Icosapent | US FDA | 1 |
| Icosapent Ethyl | US FDA | 1 |
| Omega-3-Acid Ethyl Esters | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MFDS (Korea) | None | 2 |
| US FDA | None | 1 |
Choose your molecules and target markets. KinOmega Biopharm comes back tiered against every other supplier able to file there.
Start for free