Esteve Química is an API manufacturer based in Spain. It holds 4 active US drug master files across a filed portfolio of 8 molecules. Its GMP standing is certified by AEMPS (ES).
| Site | FDA FEI |
|---|---|
| Gerona, Spain | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Omeprazole | SFDA (Saudi Arabia), US FDA | 3 |
| Azelastine | SFDA (Saudi Arabia), US FDA | 2 |
| Levetiracetam | SFDA (Saudi Arabia), US FDA | 2 |
| Bosutinib | SFDA (Saudi Arabia) | 1 |
| Crisaborole | SFDA (Saudi Arabia) | 1 |
| Cyclopentolate | US FDA | 1 |
| Esomeprazole | SFDA (Saudi Arabia) | 1 |
| Voxilaprevir | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 5 | None |
| AEMPS (ES) | None | 1 |
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