NDC 50242-125

Columvi 2.5 mg per 2.5 mL solution, concentrate

On the label: Genentech, Inc..

Germany: 2

Where it's made

FactoryWhereRoleLast FDA inspection
Roche Diagnostics GmbHMannheim, GermanyMakes it, tests it, packages it and labels it Problems found, fixed voluntarilyOct 29, 2021 · 5 inspections
Roche Diagnostics GmbHPenzberg, GermanyMakes the active ingredient and tests it Problems found, fixed voluntarilyMay 22, 2025 · 6 inspections
F. Hoffmann-La Roche AGKaiseraugst, SwitzerlandPackages it and labels it Problems found, fixed voluntarilyMar 21, 2025 · 8 inspections
Genentech, Inc.Oceanside, CA, United StatesTests it No problems foundAug 16, 2024 · 5 inspections

Product details

Generic drug
Glofitamab: every company that makes it
Form
solution, concentrate, intravenous
Strength
2.5 mg per 2.5 mL
Approval
BLA BLA761309
On the market since
Jun 15, 2023
Package NDCs
50242-125-01
Official label
DailyMed (National Library of Medicine), updated Jun 25, 2026

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