Urquima is an API manufacturer based in Spain. It holds 4 active US drug master files across a filed portfolio of 4 molecules. Its filings concentrate with AIFA (IT), INFARMED (PT) and EMA. Its most recent recorded inspection, by US FDA, closed on 21 October 2021 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Spain, Spain | 3002808432 |
| Molecule | Regulators | Docs |
|---|---|---|
| Azelastine | SFDA (Saudi Arabia), US FDA | 2 |
| Glipizide | US FDA | 1 |
| Ivabradine | US FDA | 1 |
| Rupatadine | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| AIFA (IT) | 11 | None |
| INFARMED (PT) | 6 | None |
| EMA | 3 | None |
| AEMPS (ES) | 2 | None |
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