Prescription drug
Where is Cemiplimab made?
1 company sell it under their own name. Their labels name 5 factories in the United States, Ireland and Germany.
United States 3Ireland 1Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. Libtayo50 mg per 1 mL · NDC 61755-008 | Catalent Indiana, LLCMakes it and tests it | Bloomington, IN, United States | Serious problems, FDA actionApr 2026 |
| Grand River Aseptic Manufacturing, Inc.Makes it and tests it | Grand Rapids, MI, United States | Problems found, fixed voluntarilyNov 2025 | |
| Regeneron Ireland Designated Activity CompanyMakes the active ingredient and tests it | Limerick, Ireland | Problems found, fixed voluntarilyJun 2025 | |
| Regeneron Pharmaceuticals, Inc.Makes it, makes the active ingredient and tests it | Rensselaer, NY, United States | Problems found, fixed voluntarilyMar 2024 | |
| Sanofi-Aventis Deutschland GmbHMakes it, tests it, packages it and labels it | Frankfurt am Main, Germany | Problems found, fixed voluntarilyMar 2022 |
Recalls
- Jul 28, 2026 · Class II · Regeneron Pharmaceuticals Inc
Lack of Assurance of Sterility
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.