Thymoorgan Pharmazie is a finished-dose manufacturer based in Germany. It appears in 13 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with JFDA (JO), ARCSA (EC) and INVIMA (CO). Its GMP standing is certified by ZLG (DE) and EMA. Its most recent recorded inspection, by US FDA, closed on 25 April 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Goslar, United Arab Emirates | Not on file |
| Fuerth, Germany | Not on file |
| Bavaria, Germany | Not on file |
| Germany, Germany | 3002320821 |
| VIENENBURG, Germany | Not on file |
| Lower Saxony, Germany | Not on file |
1 further sites are on record.
| Regulator | Filings | GMP certificates |
|---|---|---|
| JFDA (JO) | 7 | None |
| ARCSA (EC) | 2 | None |
| INVIMA (CO) | 1 | None |
| MINSA (CR) | 1 | None |
| UZPHARM (UZ) | 1 | None |
| EDE (AE) | 1 | None |
| ZLG (DE) | None | 12 |
| EMA | None | 3 |
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