Delpharm Milano is a finished-dose manufacturer based in Italy. It appears in 89 regulatory filings across 7 regulators, without an active US DMF or CEP on file. Its filings concentrate with DIGEMAPS (DO), MINSA (CR) and INVIMA (CO). Its GMP standing is certified by ANVISA (Brazil), EMA and MFDS (Korea), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 18 February 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| (MI), United Arab Emirates | Not on file |
| MILANO (MILAO), Italy | Not on file |
| Segrate, Italy | Not on file |
| Italy, Italy | 3003716872 |
| Regulator | Filings | GMP certificates |
|---|---|---|
| DIGEMAPS (DO) | 43 | None |
| MINSA (CR) | 19 | None |
| INVIMA (CO) | 12 | None |
| ARCSA (EC) | 8 | None |
| EDE (AE) | 5 | None |
| FDA (GH) | 1 | None |
| ANVISA (Brazil) | None | 6 |
| EMA | None | 3 |
| MFDS (Korea) | None | 2 |
| EAEU_EEC | None | 1 |
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