hameln pharma is a finished-dose manufacturer based in Germany. It appears in 502 regulatory filings across 14 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, MHRA (UK) and AIFA (IT). Its GMP standing is certified by ZLG (DE) and EMA.
| Site | FDA FEI |
|---|---|
| Niedersachsen, Germany | Not on file |
| Lower Saxony, Germany | Not on file |
| Hameln, Germany | Not on file |
| Hameln, Germany | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | 164 | 3 |
| MHRA (UK) | 116 | None |
| AIFA (IT) | 77 | None |
| MPA (SE) | 35 | None |
| DKMA (DK) | 31 | None |
| INFARMED (PT) | 21 | None |
| ZLG (DE) | None | 18 |
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