STADA Arzneimittel is a finished-dose manufacturer based in Germany. It appears in 2,256 regulatory filings across 16 regulators, without an active US DMF or CEP on file. Its filings concentrate with MPA (SE), EMA and INFARMED (PT). Its GMP standing is certified by ZLG (DE), EMA and EAEU_EEC, among 4 authorities.
| Site | FDA FEI |
|---|---|
| Bad Vilbel, United Arab Emirates | Not on file |
| Vienna, Austria | Not on file |
| Hassia, Germany | Not on file |
| Bad Vilbel, Germany | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| MPA (SE) | 953 | None |
| EMA | 754 | 2 |
| INFARMED (PT) | 139 | None |
| URPL (PL) | 125 | None |
| FAMHP (BE) | 100 | None |
| AIFA (IT) | 40 | None |
| ZLG (DE) | None | 4 |
| EAEU_EEC | None | 1 |
| NCELS (KZ) | None | 1 |
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