B. Braun Melsungen is a finished-dose manufacturer based in Germany. It appears in 894 regulatory filings across 25 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), EMA and FAMHP (BE). Its GMP standing is certified by ZLG (DE), EMA and ANVISA (Brazil), among 6 authorities.
| Site | FDA FEI |
|---|---|
| Berlin, United Arab Emirates | Not on file |
| MELSUNGEN, Germany | Not on file |
| Berlin, Germany | Not on file |
| Hassia, Germany | Not on file |
| Hesse, Germany | Not on file |
| Hessen, Germany | Not on file |
1 further sites are on record.
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 282 | None |
| EMA | 156 | 13 |
| FAMHP (BE) | 135 | None |
| MPA (SE) | 82 | None |
| INFARMED (PT) | 74 | None |
| DMP (NO) | 49 | None |
| ZLG (DE) | None | 32 |
| ANVISA (Brazil) | None | 5 |
| MFDS (Korea) | None | 2 |
| EAEU_EEC | None | 1 |
| NAFDAC (NG) | None | 1 |
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