Sanochemia Pharmazeutika is an API and finished-dose manufacturer based in Austria. It holds one active US drug master file and 2 valid CEPs across a filed portfolio of 5 molecules. Its filings concentrate with UZPHARM (UZ), EMA and AIFA (IT). Its GMP standing is certified by UZPHARM (UZ), EMA and MFDS (Korea).
| Site | FDA FEI |
|---|---|
| 2491 Neufeld an der Leitha, United Arab Emirates | Not on file |
| Neufeld an der Leitha, Austria | Not on file |
| Vienna, Austria | Not on file |
| Burgenland, Austria | Not on file |
| Tashkent, Uzbekistan | Not on file |
| Tashkent Region, Uzbekistan | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Gadopentetate Dimeglumine | SFDA (Saudi Arabia) | 1 |
| Gadoteric Acid | SFDA (Saudi Arabia) | 1 |
| Galantamine | US FDA | 1 |
| Galantamine Hydrobromide | EDQM | 1 |
| Torasemide | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| UZPHARM (UZ) | 126 | 3 |
| EMA | 11 | 2 |
| AIFA (IT) | 10 | None |
| EDE (AE) | 7 | None |
| MPA (SE) | 6 | None |
| FAMHP (BE) | 5 | None |
| MFDS (Korea) | None | 2 |
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