PCSK9 Inhibitor
Where is Alirocumab made?
2 companies sell it under their own name. Their labels name 7 factories in Ireland, the United States, France and Germany.
Ireland 2United States 2France 2Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Sanofi-Aventis U.S. LLC Praluent75 mg per 1 mL, 150 mg per 1 mL · NDC 0024-5902, 0024-5904, 0024-5901 +1 | Genzyme Ireland LimitedMakes it, tests it, packages it and labels it | Waterford, Ireland | Problems found, fixed voluntarilyFeb 2022 |
| Regeneron Ireland Designated Activity CompanyMakes the active ingredient and tests it | Limerick, Ireland | Problems found, fixed voluntarilyJun 2025 | |
| Regeneron Pharmaceuticals, Inc.Makes the active ingredient and tests it | Rensselaer, NY, United States | Problems found, fixed voluntarilyMar 2024 | |
| Sanofi Vaccines US Inc.Makes it | Swiftwater, PA, United States | Problems found, fixed voluntarilyApr 2023 | |
| Sanofi Winthrop IndustrieMakes it, tests it, packages it and labels it | Le Trait, France | Problems found, fixed voluntarilyApr 2023 | |
| Sanofi Winthrop IndustrieMakes the active ingredient and tests it | Vitry sur-Seine, France | Problems found, fixed voluntarilyOct 2024 | |
| Sanofi-Aventis Deutschland GmbHMakes it, tests it, packages it and labels it | Frankfurt am Main, Germany | Problems found, fixed voluntarilyMar 2022 | |
| Regeneron Pharmaceuticals, Inc. Praluent75 mg per 1 mL, 150 mg per 1 mL · NDC 61755-021, 61755-020 | Genzyme Ireland LimitedMakes it, tests it, packages it and labels it | Waterford, Ireland | Problems found, fixed voluntarilyFeb 2022 |
| Regeneron Ireland Designated Activity CompanyMakes it, makes the active ingredient and tests it | Limerick, Ireland | Problems found, fixed voluntarilyJun 2025 | |
| Regeneron Pharmaceuticals, Inc.Makes the active ingredient and tests it | Rensselaer, NY, United States | Problems found, fixed voluntarilyMar 2024 | |
| Sanofi Vaccines US Inc.Makes it | Swiftwater, PA, United States | Problems found, fixed voluntarilyApr 2023 | |
| Sanofi Winthrop IndustrieMakes it, tests it, packages it and labels it | Le Trait, France | Problems found, fixed voluntarilyApr 2023 | |
| Sanofi-Aventis Deutschland GmbHMakes it, tests it, packages it and labels it | Frankfurt am Main, Germany | Problems found, fixed voluntarilyMar 2022 |