Regeneron Ireland Designated Activity Company
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
- Raheen Business Park, LIMERICK, , Ireland (IRL)
- Operations here
- analysisapi manufacturemanufacture
- FDA identifiers
- FEI 3011684330 · DUNS 986063166
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-06-13
- VAIDrug Quality Assurance2019-09-27
Drugs this plant is listed as making
5 distinct drugs across 12 products name this site in their FDA label.
- alirocumabSanofi-Aventis U.S. LLC
- atoltivimab, maftivimab, and odesivimab-ebgnRegeneron Pharmaceuticals, Inc.
- cemiplimab-rwlcRegeneron Pharmaceuticals, Inc.
- DupilumabSanofi-Aventis U.S. LLC
- evinacumabRegeneron Pharmaceuticals, 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.