NDC 0024-0656
Sarclisa 500 mg per 25 mL injection, solution, concentrate
On the label: Sanofi-Aventis U.S. LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lonza Biologics, Inc. | Portsmouth, NH, United States | Makes the active ingredient and tests it | Problems found, fixed voluntarilyFeb 6, 2026 · 8 inspections |
| Sanofi Winthrop Industrie | Vitry sur-Seine, France | Makes the active ingredient and tests it | Problems found, fixed voluntarilyOct 4, 2024 · 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 |
| Genzyme Corporation | Northborough, MA, United States | Packages it and labels it | No problems foundAug 14, 2025 · 6 inspections |
| Quality Assistance, SA | Donstiennes, Belgium | Tests it | Problems found, fixed voluntarilySep 4, 2025 · 5 inspections |
Product details
- Generic drug
- Isatuximab: every company that makes it
- Form
- injection, solution, concentrate, intravenous
- Strength
- 500 mg per 25 mL
- Approval
- BLA BLA761113
- On the market since
- Mar 2, 2020
- Package NDCs
0024-0656-01- Official label
- DailyMed (National Library of Medicine), updated Jul 7, 2026
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