AOP Orphan Pharmaceuticals is a finished-dose manufacturer based in Austria. It appears in 121 regulatory filings across 13 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, MHRA (UK) and AEMPS (ES). Its GMP standing is certified by EMA.
| Site | FDA FEI |
|---|---|
| Vienna, United Arab Emirates | Not on file |
| Vienna, Austria | Not on file |
| Vialonga, Portugal | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | 40 | 1 |
| MHRA (UK) | 29 | None |
| AEMPS (ES) | 12 | None |
| URPL (PL) | 8 | None |
| MPA (SE) | 7 | None |
| AIFA (IT) | 5 | None |
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