Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Catalent Indiana, LLC | Bloomington, IN, United States | Makes it and tests it | Serious problems, FDA actionApr 24, 2026 · 10 inspections, 2 with FDA action |
| Grand River Aseptic Manufacturing, Inc. | Grand Rapids, MI, United States | Makes it and tests it | Problems found, fixed voluntarilyNov 4, 2025 · 6 inspections |
| Regeneron Ireland Designated Activity Company | Limerick, Ireland | Makes the active ingredient and tests it | Problems found, fixed voluntarilyJun 13, 2025 · 2 inspections |
| Regeneron Pharmaceuticals, Inc. | Rensselaer, NY, United States | Makes it, makes the active ingredient and tests it | Problems found, fixed voluntarilyMar 22, 2024 · 10 inspections |
| Sanofi-Aventis Deutschland GmbH | Frankfurt am Main, Germany | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyMar 25, 2022 · 10 inspections, 1 with FDA action |
| Bioreliance Ltd. | Glasgow Lanarkshire, United Kingdom | Tests it | Problems found, fixed voluntarilyMay 13, 2026 · 7 inspections |
| Nitto Avecia Pharma Services, Inc. | Irvine, CA, United States | Tests it | No problems foundJul 25, 2025 · 8 inspections |
| Sharp Packaging Services, LLC | Allentown, PA, United States | Packages it and labels it | No problems foundNov 21, 2025 · 7 inspections |
Recalls
- Jul 28, 2026 · Class II · Regeneron Pharmaceuticals Inc
Lack of Assurance of Sterility
Lots: Lot: 8494000002, Exp 7/31/28
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Cemiplimab: every company that makes it
- Form
- injection, intravenous
- Strength
- 50 mg per 1 mL
- Approval
- BLA BLA761097
- On the market since
- Sep 28, 2018
- Package NDCs
61755-008-01- Official label
- DailyMed (National Library of Medicine), updated Aug 31, 2026
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?