R-Pharm Germany is a finished-dose manufacturer based in Germany. It appears in 65 regulatory filings across 10 regulators, without an active US DMF or CEP on file. Its filings concentrate with DAV (Vietnam), EEC_EAEU and MINSA (CR). Its GMP standing is certified by ZLG (DE), EMA and MHRA (UK), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 28 February 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Illertissen, United Arab Emirates | Not on file |
| ILLERTISSEN, Germany | Not on file |
| Germany, Germany | 3002807165 |
| HWASEONG-SI, South Korea | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| DAV (Vietnam) | 26 | None |
| EEC_EAEU | 10 | None |
| MINSA (CR) | 9 | None |
| UZPHARM (UZ) | 8 | 1 |
| NPRA (MY) | 3 | None |
| ARCSA (EC) | 3 | None |
| ZLG (DE) | None | 4 |
| EMA | None | 1 |
| MHRA (UK) | None | 1 |
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