Daiichi Sankyo Europe is a finished-dose manufacturer based in Germany. It appears in 767 regulatory filings across 22 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), MHRA (UK) and FAMHP (BE). Its GMP standing is certified by ANSM (FR), ZLG (DE) and NCELS (KZ), among 8 authorities. Its most recent recorded inspection, by US FDA, closed on 18 July 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Pfaffenhofen, United Arab Emirates | Not on file |
| Zürich, Switzerland | Not on file |
| PFAFFENHOFEN, Germany | Not on file |
| Germany, Germany | 3003282622 |
| Munich, Germany | Not on file |
| Pfaffenhofen A.D.Ilm, Germany | Not on file |
5 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Loxoprofen | SFDA (Saudi Arabia) | 1 |
| Tranexamic Acid | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 246 | None |
| MHRA (UK) | 123 | None |
| FAMHP (BE) | 81 | None |
| INHRR (VE) | 50 | None |
| SWISSMEDIC (CH) | 45 | None |
| AEMPS (ES) | 40 | None |
| ANSM (FR) | None | 32 |
| ZLG (DE) | None | 8 |
| NCELS (KZ) | None | 2 |
| ANVISA (Brazil) | None | 2 |
| HSA (SG) | None | 2 |
| MFDS (Korea) | None | 2 |
| EMA | None | 1 |
| US FDA | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2023 | $18.2M | Not reported | Not reported |
| 2012 | $20.6M | Not reported | Not reported |
| 2008 | $17.2M | Not reported | Not reported |
Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.
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