Drug factory · FDA FEI 3002806675
EUROAPI Hungary Ltd.
To utca 1-5., Budapest, Hungary
No problems found at FDA's last inspection, Jun 21, 2019.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2010: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dinoprostone | Makes the active ingredient and tests it | Ferring Pharmaceuticals Inc. | 55566-2800 |
| Fexinidazole | Makes the active ingredient and tests it | Sanofi-Aventis U.S. LLC | 0024-4512 |
| Hydrochlorothiazide and Irbesartan | Makes the active ingredient and tests it | Sanofi-Aventis U.S. LLC | 0024-5855, 0024-5856 |
| Irbesartan | Makes the active ingredient and tests it | Sanofi-Aventis U.S. LLC | 0024-5851, 0024-5852 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 21, 2019 | No problems found | Drug Quality Assurance | — |
| Apr 20, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 30, 2014 | No problems found | Drug Quality Assurance | — |
| Feb 4, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; pack.