Bsp Pharmaceuticals is a finished-dose manufacturer based in Italy. It appears in 36 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with INVIMA (CO), ARCSA (EC) and NPRA (MY). Its GMP standing is certified by ANVISA (Brazil), EAEU_EEC and MFDS (Korea), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 12 November 2021 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| LATINA (LT), Italy | Not on file |
| LATINA, Italy | Not on file |
| LATINA, Italy | Not on file |
| Italy, Italy | 3007255826 |
| Regulator | Filings | GMP certificates |
|---|---|---|
| INVIMA (CO) | 12 | None |
| ARCSA (EC) | 11 | None |
| NPRA (MY) | 6 | None |
| MINSA (CR) | 4 | None |
| JFDA (JO) | 2 | None |
| US FDA | 1 | None |
| ANVISA (Brazil) | None | 13 |
| EAEU_EEC | None | 4 |
| MFDS (Korea) | None | 2 |
| EMA | None | 2 |
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