Haupt Pharma Amareg is a finished-dose manufacturer based in Germany. It appears in 26 regulatory filings across 8 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), NAFDAC (NG) and INVIMA (CO). Its GMP standing is certified by ZLG (DE), EAEU_EEC and ANVISA (Brazil), among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 26 July 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Regensburg, United Arab Emirates | Not on file |
| REGENSBURG, Germany | Not on file |
| Germany, Germany | 3008293991 |
| Bavaria, Germany | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| ARCSA (EC) | 8 | None |
| NAFDAC (NG) | 4 | None |
| INVIMA (CO) | 4 | None |
| NPRA (MY) | 4 | None |
| JFDA (JO) | 2 | None |
| EDE (AE) | 2 | None |
| ZLG (DE) | None | 10 |
| EAEU_EEC | None | 4 |
| ANVISA (Brazil) | None | 2 |
| EMA | None | 2 |
| US FDA | None | 1 |
| NCELS (KZ) | None | 1 |
Choose your molecules and target markets. Haupt Pharma Amareg comes back tiered against every other supplier able to file there.
Start for free