Ercros is an API manufacturer based in Spain. It holds 9 active US drug master files and 8 valid CEPs across a filed portfolio of 8 molecules. Its filings concentrate with MINSA (CR) and INVIMA (CO). Its GMP standing is certified by EMA, AEMPS (ES) and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 22 June 2018 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Aranjuez, Spain | Not on file |
| MADRID, Spain | Not on file |
| Madrid, Spain | Not on file |
| Spain, Spain | 3003562118 |
| Molecule | Regulators | Docs |
|---|---|---|
| Fosfomycin | EDQM, SFDA (Saudi Arabia), US FDA | 6 |
| Erythromycin | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Fusidic Acid | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Clarithromycin | EDQM, SFDA (Saudi Arabia) | 2 |
| Sodium Fusidate | EDQM, SFDA (Saudi Arabia) | 2 |
| Azithromycin | EDQM | 1 |
| Erythromycin Ethylsuccinate | EDQM | 1 |
| Famotidine | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 4 | None |
| INVIMA (CO) | 1 | None |
| EMA | None | 1 |
| AEMPS (ES) | None | 1 |
| ANVISA (Brazil) | None | 1 |
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