NDC 0024-0674

Sarclisa Escena 140 mg per 1 mL injection, solution

On the label: Sanofi-Aventis U.S. LLC.

France: 1Germany: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Sanofi Winthrop IndustrieVitry sur-Seine, FranceMakes the active ingredient and tests it Problems found, fixed voluntarilyOct 4, 2024 · 6 inspections
Sanofi-Aventis Deutschland GmbHFrankfurt am Main, GermanyMakes it, tests it, packages it and labels it Problems found, fixed voluntarilyMar 25, 2022 · 10 inspections, 1 with FDA action
Eurofins Biopharma Product Testing Ireland LimitedIrelandTests it Problems found, fixed voluntarilyMay 26, 2023 · 5 inspections
Genzyme CorporationNorthborough, MA, United StatesTests it, packages it and labels it No problems foundAug 14, 2025 · 6 inspections

Product details

Generic drug
Isatuximab: every company that makes it
Form
injection, solution, subcutaneous
Strength
140 mg per 1 mL
Approval
BLA BLA761445
On the market since
Jul 9, 2026
Package NDCs
0024-0674-01
Official label
DailyMed (National Library of Medicine), updated Jul 10, 2026

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