Eurofins Biopharma Product Testing Ireland Limited
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
- Ireland
- Registered address
- Clogherane, Dungarvan, ,X35 T628 , Ireland (IRL)
- Operations here
- analysis
- FDA identifiers
- FEI 3002807550 · DUNS 238239933
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIBlood and Blood Products2025-06-20
- NAIHuman Cellular, Tissue, and Gene Therapies2025-06-20
- VAIDrug Quality Assurance2023-05-26
- NAIDrug Quality Assurance2017-02-24
- NAIDrug Quality Assurance2013-03-29
- NAIDrug Quality Assurance2009-09-30
Drugs this plant is listed as making
8 distinct drugs across 15 products name this site in their FDA label.
- (daunorubicin and cytarabine) liposomeJazz Pharmaceuticals, Inc.
- Alglucosidase AlfaGenzyme Corporation
- avalglucosidase alfa-ngptGenzyme Corporation
- ImigluceraseGenzyme Corporation
- ixazomibTakeda Pharmaceuticals America, Inc.
- olipudase alfa-rpcpGenzyme Corporation
- Sevelamer CarbonateGenzyme Corporation
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.