EUROAPI Hungary Ltd.
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- Hungary
- Registered address
- To utca 1-5., Budapest, 1045, Hungary (HUN)
- Operations here
- analysisapi manufacturelabelpack
- FDA identifiers
- FEI 3002806675 · DUNS 402388457
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2019-06-21
- VAIDrug Quality Assurance2018-04-20
- NAIDrug Quality Assurance2014-05-30
- NAIDrug Quality Assurance2010-02-04
Drugs this plant is listed as making
4 distinct drugs across 6 products name this site in their FDA label.
- DinoprostoneFerring Pharmaceuticals Inc.
- FexinidazoleSanofi-Aventis U.S. LLC
- irbesartanSanofi-Aventis U.S. LLC
- irbesartan and hydrochlorothiazideSanofi-Aventis U.S. LLC
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.