CD38-directed Cytolytic Antibody
Where is Isatuximab made?
1 company sell it under their own name. Their labels name 3 factories in the United States, France and Germany.
United States 1France 1Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Sanofi-Aventis U.S. LLC Sarclisa, Sarclisa Escena100 mg per 5 mL, 140 mg per 1 mL, 500 mg per 25 mL · NDC 0024-0654, 0024-0674, 0024-0656 | Lonza Biologics, Inc.Makes the active ingredient and tests it | Portsmouth, NH, United States | Problems found, fixed voluntarilyFeb 2026 |
| 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 |