Jazz Pharmaceuticals 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
- Monksland, Athlone, N37AX84, Ireland (IRL)
- Operations here
- analysismanufacturepack
- FDA identifiers
- FEI 3010319651 · DUNS 986019606
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2022-02-24
- NAIDrug Quality Assurance2018-04-25
- NAIDrug Quality Assurance2016-06-03
Drugs this plant is listed as making
3 distinct drugs across 4 products name this site in their FDA label.
- (daunorubicin and cytarabine) liposomeJazz Pharmaceuticals, Inc.
- calcium, magnesium, potassium, and sodium oxybatesJazz Pharmaceuticals, Inc.
- sodium oxybateHikma Pharmaceuticals USA Inc.
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.