Bracco Imaging is an API and finished-dose manufacturer based in Italy. It holds one active US drug master file and one valid CEP across a filed portfolio of 2 molecules. Its filings concentrate with AIFA (IT), FAMHP (BE) and NMPA (CN). Its GMP standing is certified by EMA, MFDS (Korea) and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 24 March 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Milano, United Arab Emirates | Not on file |
| Milano, Italy | Not on file |
| COLLERETTO GIACOSA, Italy | Not on file |
| CERIANO LAGHETTO, Italy | Not on file |
| COLLERETTO GIACOSA (TO), Italy | Not on file |
| Italy, Italy | 3005604782 |
1 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Iopamidol | US FDA | 1 |
| Levothyroxine Sodium | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 106 | None |
| FAMHP (BE) | 57 | None |
| NMPA (CN) | 43 | None |
| EMA | 33 | 2 |
| Health Canada | 26 | None |
| DKMA (DK) | 22 | None |
| MFDS (Korea) | None | 2 |
| ANVISA (Brazil) | None | 1 |
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