AESICA Pharmaceuticals is a finished-dose manufacturer based in Germany. It appears in 43 regulatory filings across 8 regulators, without an active US DMF or CEP on file. Its filings concentrate with MINSA (CR), ARCSA (EC) and INVIMA (CO). Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and EMA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 12 September 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Monheim, United Arab Emirates | Not on file |
| Pianezza, United Arab Emirates | Not on file |
| WESTPHALIA, Germany | Not on file |
| Zwickau, Germany | Not on file |
| Germany, Germany | 3002948883 |
| Saxony, Germany | Not on file |
2 further sites are on record.
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 18 | None |
| ARCSA (EC) | 7 | None |
| INVIMA (CO) | 6 | None |
| EDE (AE) | 6 | None |
| UZPHARM (UZ) | 3 | None |
| NPRA (MY) | 1 | None |
| ZLG (DE) | None | 18 |
| ANVISA (Brazil) | None | 8 |
| EMA | None | 3 |
| MFDS (Korea) | None | 2 |
| US FDA | None | 2 |
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