Excella Gmbh is an API manufacturer based in Germany. It holds 26 active US drug master files and 23 valid CEPs. Its filings concentrate with MINSA (CR), ARCSA (EC) and INVIMA (CO). Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and MFDS (Korea), among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 19 October 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Feucht, United Arab Emirates | Not on file |
| Feucht, United Arab Emirates | Not on file |
| FEUCHT, Germany | Not on file |
| Feucht, Germany | Not on file |
| Germany, Germany | 3000242652 |
| Feucht Germany, Nigeria | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Methotrexate | EDQM, SFDA (Saudi Arabia), US FDA | 6 |
| Anastrozole | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Timolol | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Acyclovir | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Deferoxamine | SFDA (Saudi Arabia), US FDA | 3 |
| Ganciclovir | EDQM, US FDA | 3 |
| Levothyroxine | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Baclofen | EDQM, US FDA | 2 |
| Bicalutamide | EDQM, US FDA | 2 |
| Bupivacaine | EDQM, US FDA | 2 |
| Haloperidol | EDQM, US FDA | 2 |
| Masitinib | US FDA | 2 |
| Ropivacaine | SFDA (Saudi Arabia), US FDA | 2 |
| Tamoxifen | EDQM, US FDA | 2 |
| Temozolomide | EDQM, US FDA | 2 |
| Adapalene | US FDA | 1 |
| Alfuzosin | EDQM | 1 |
| Azathioprine | EDQM | 1 |
| Buspirone | US FDA | 1 |
| Busulfan | EDQM | 1 |
| Capecitabine | SFDA (Saudi Arabia) | 1 |
| Cevimeline | US FDA | 1 |
| Deferoxamine Mesilate | EDQM | 1 |
| Dobutamine | EDQM | 1 |
| Doxazosin | US FDA | 1 |
| Doxazosin Mesilate | EDQM | 1 |
| Lanthanum Carbonate | US FDA | 1 |
| Mianserin | EDQM | 1 |
| Mycophenolic Acid | US FDA | 1 |
| Talazoparib | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 20 | None |
| ARCSA (EC) | 15 | None |
| INVIMA (CO) | 10 | None |
| NCELS (KZ) | 2 | 1 |
| NAFDAC (NG) | 2 | 1 |
| BOMRA (BW) | 1 | None |
| ZLG (DE) | None | 16 |
| ANVISA (Brazil) | None | 7 |
| MFDS (Korea) | None | 2 |
| EMA | None | 2 |
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