Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Roche Diagnostics GmbH | Mannheim, Germany | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyOct 29, 2021 · 5 inspections |
| Roche Diagnostics GmbH | Penzberg, Germany | Makes the active ingredient and tests it | Problems found, fixed voluntarilyMay 22, 2025 · 6 inspections |
| F. Hoffmann-La Roche AG | Kaiseraugst, Switzerland | Packages it and labels it | Problems found, fixed voluntarilyMar 21, 2025 · 8 inspections |
| Genentech, Inc. | Oceanside, CA, United States | Tests it | No problems foundAug 16, 2024 · 5 inspections |
Product details
- Generic drug
- Glofitamab: every company that makes it
- Form
- concentrate, intravenous
- Strength
- 10 mg per 10 mL
- Approval
- BLA BLA761309
- On the market since
- Jun 15, 2023
- Package NDCs
50242-127-01- Official label
- DailyMed (National Library of Medicine), updated Jun 25, 2026
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