EUROAPI Hungary is an API manufacturer based in Hungary. It holds 13 active US drug master files and 7 valid CEPs across a filed portfolio of 15 molecules. Its most recent recorded inspection, by US FDA, closed on 21 June 2019 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Budapest, Hungary | Not on file |
| Hungary, Hungary | 3002806675 |
| Molecule | Regulators | Docs |
|---|---|---|
| Alprostadil | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Bimatoprost | SFDA (Saudi Arabia), US FDA | 2 |
| Irbesartan | EDQM, US FDA | 2 |
| Latanoprost | EDQM, US FDA | 2 |
| Selegiline | EDQM, US FDA | 2 |
| Carboprost | US FDA | 1 |
| Dinoprost | EDQM | 1 |
| Dinoprostone | US FDA | 1 |
| Hydroxychloroquine | US FDA | 1 |
| Iloprost | US FDA | 1 |
| Olmesartan | US FDA | 1 |
| Olmesartan Medoxomil | EDQM | 1 |
| Pentamidine Diisetionate | EDQM | 1 |
| Travoprost | US FDA | 1 |
| Treprostinil | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 6 | None |
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