Solupharm Pharmazeutische Erzeugnisse is a finished-dose manufacturer based in Germany. It appears in 92 regulatory filings across 15 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, DIGEMAPS (DO) and EDE (AE). Its GMP standing is certified by ZLG (DE), EMA and EAEU_EEC, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 29 July 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Ismaning, United Arab Emirates | Not on file |
| Melsungen, United Arab Emirates | Not on file |
| 34212 Melsungen, United Arab Emirates | Not on file |
| Ismaning, Germany | Not on file |
| Bavaria, Germany | Not on file |
| MELSUNGEN, Germany | Not on file |
2 further sites are on record.
| Regulator | Filings | GMP certificates |
|---|---|---|
| EMA | 30 | 3 |
| DIGEMAPS (DO) | 17 | None |
| EDE (AE) | 10 | None |
| ARCSA (EC) | 5 | None |
| NPRA (MY) | 5 | None |
| MINSA (CR) | 5 | None |
| ZLG (DE) | None | 18 |
| EAEU_EEC | None | 3 |
| ANVISA (Brazil) | None | 2 |
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