Hanmi Pharm is a finished-dose manufacturer based in South Korea. It appears in 13 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), INVIMA (CO) and MINSA (CR). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 2 August 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| HWASEONG, South Korea | Not on file |
| South, South Korea | 3009350213 |
| Regulator | Filings | GMP certificates |
|---|---|---|
| ARCSA (EC) | 5 | None |
| INVIMA (CO) | 2 | None |
| MINSA (CR) | 2 | None |
| NMPA (CN) | 2 | None |
| NPRA (MY) | 2 | None |
| US FDA | None | 1 |
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