Drug factory · FDA FEI 3011684330

Regeneron Ireland Designated Activity Company

Raheen Business Park, Limerick, Ireland

Ireland: 1

Problems found, fixed voluntarily at FDA's last inspection, Jun 13, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

2 drug inspections on record since 2019: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AfliberceptMakes it, makes the active ingredient and tests it Regeneron Pharmaceuticals, Inc. 61755-005
AlirocumabMakes it, makes the active ingredient and tests it Regeneron Pharmaceuticals, Inc., Sanofi-Aventis U.S. LLC 61755-020, 61755-021, 0024-5901 +3
Atoltivimab and Maftivimab and OdesivimabMakes the active ingredient and tests it Regeneron Pharmaceuticals, Inc. 61755-018, 61755-019
CemiplimabMakes the active ingredient and tests it Regeneron Pharmaceuticals, Inc. 61755-008
DupilumabMakes the active ingredient and tests it Sanofi-Aventis U.S. LLC 0024-5914, 0024-5915, 0024-5918 +1
EvinacumabTests it Regeneron Pharmaceuticals, Inc. 61755-010, 61755-013

FDA inspection history

EndedResultProgramProblems noted
Jun 13, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 27, 2019Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture; manufacture.