NDC 61755-021
Praluent 150 mg per 1 mL injection, solution
On the label: Regeneron Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Genzyme Ireland Limited | Waterford, Ireland | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyFeb 25, 2022 · 7 inspections |
| Regeneron Ireland Designated Activity Company | Limerick, Ireland | Makes it, makes the active ingredient and tests it | Problems found, fixed voluntarilyJun 13, 2025 · 2 inspections |
| Regeneron Pharmaceuticals, Inc. | Rensselaer, NY, United States | Makes the active ingredient and tests it | Problems found, fixed voluntarilyMar 22, 2024 · 10 inspections |
| Sanofi Vaccines US Inc. | Swiftwater, PA, United States | Makes it | Problems found, fixed voluntarilyApr 22, 2023 · 2 inspections |
| Sanofi Winthrop Industrie | Le Trait, France | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyApr 25, 2023 · 6 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 |
| Advanced Therapies, LLC | Philadelphia, PA, United States | Tests it | No problems foundFeb 7, 2025 · 5 inspections |
| Bioreliance Corporation | Rockville, MD, United States | Tests it | Problems found, fixed voluntarilyJan 29, 2026 · 7 inspections |
| Bioreliance Ltd. | Glasgow Lanarkshire, United Kingdom | Tests it | Problems found, fixed voluntarilyMay 13, 2026 · 7 inspections |
| Eurofins Biopharma Product Testing Ireland Limited | Ireland | Tests it | Problems found, fixed voluntarilyMay 26, 2023 · 5 inspections |
| Eurofins Biopharma Product Testing Munich GmbH | Planegg, Germany | Tests it | Problems found, fixed voluntarilyJun 23, 2023 · 3 inspections |
| Eurofins Lancaster Laboratories, LLC | Lancaster, PA, United States | Tests it | Problems found, fixed voluntarilyAug 26, 2025 · 8 inspections |
| Nelson Laboratories, LLC | Salt Lake City, UT, United States | Tests it | Problems found, fixed voluntarilyJun 2, 2023 · 6 inspections |
| Nitto Avecia Pharma Services, Inc. | Irvine, CA, United States | Tests it | No problems foundJul 25, 2025 · 8 inspections |
| PPD Development Ireland Ltd. | Athlone, Ireland | Tests it | Problems found, fixed voluntarilyMar 9, 2023 · 4 inspections |
| Sanofi Winthrop Industrie | Vitry sur-Seine, France | Tests it | Problems found, fixed voluntarilyOct 4, 2024 · 6 inspections |
Product details
- Generic drug
- Alirocumab: every company that makes it
- Form
- injection, solution, subcutaneous
- Strength
- 150 mg per 1 mL
- Approval
- BLA BLA125559
- On the market since
- Dec 1, 2020
- Package NDCs
61755-021-0161755-021-0261755-021-04- Official label
- DailyMed (National Library of Medicine), updated Jul 16, 2026
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