Lts Lohmann Therapie-Systeme is a finished-dose manufacturer based in Germany. It appears in 48 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with EDE (AE), ARCSA (EC) and DIGEMAPS (DO). Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and EMA. Its most recent recorded inspection, by US FDA, closed on 18 May 2022 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Andernach, United Arab Emirates | Not on file |
| 56626 Andernach, United Arab Emirates | Not on file |
| ANDERNACH, Germany | Not on file |
| Rhineland-Palatinate, Germany | Not on file |
| Germany, Germany | 3003387535 |
| Regulator | Filings | GMP certificates |
|---|---|---|
| EDE (AE) | 15 | None |
| ARCSA (EC) | 15 | None |
| DIGEMAPS (DO) | 14 | None |
| MINSA (CR) | 2 | None |
| EDA (EG) | 2 | None |
| ZLG (DE) | None | 16 |
| ANVISA (Brazil) | None | 10 |
| EMA | None | 6 |
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