Unión Químico Farmacéutica is an API manufacturer based in Spain. It holds 22 active US drug master files across a filed portfolio of 22 molecules. Its GMP standing is certified by EMA and AEMPS (ES). Its most recent recorded inspection, by US FDA, closed on 7 July 2022 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Spain, Spain | 3002808431 |
| Barcelona, Spain | Not on file |
| Sant Celoni, Spain | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Allopurinol | US FDA | 2 |
| Esomeprazole | SFDA (Saudi Arabia), US FDA | 2 |
| Mivacurium | US FDA | 2 |
| Omeprazole | SFDA (Saudi Arabia), US FDA | 2 |
| Quetiapine | SFDA (Saudi Arabia), US FDA | 2 |
| Sitagliptin | US FDA | 2 |
| Acyclovir | US FDA | 1 |
| Bicalutamide | US FDA | 1 |
| Cimetidine | US FDA | 1 |
| Clindamycin | US FDA | 1 |
| Doxylamine | US FDA | 1 |
| Emtricitabine | SFDA (Saudi Arabia) | 1 |
| Famotidine | US FDA | 1 |
| Ketoconazole | US FDA | 1 |
| Lansoprazole | US FDA | 1 |
| Memantine | SFDA (Saudi Arabia) | 1 |
| Nimodipine | US FDA | 1 |
| Pantoprazole | SFDA (Saudi Arabia) | 1 |
| Ranitidine | US FDA | 1 |
| Ranolazine | US FDA | 1 |
| Solifenacin Succinate | US FDA | 1 |
| Tropicamide | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| INFARMED (PT) | 2 | None |
| EMA | None | 1 |
| AEMPS (ES) | None | 1 |
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