Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Bayer AG | Leverkusen, Germany | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyMar 20, 2025 · 10 inspections, 2 with FDA action |
| Bayer AG | Wuppertal, Germany | Makes the active ingredient and tests it | Problems found, fixed voluntarilyJan 18, 2023 · 8 inspections |
| Bayer AG | Bergkamen, Germany | Tests it | Problems found, fixed voluntarilyNov 14, 2024 · 7 inspections, 1 with FDA action |
| Bayer Aktiengesellschaft | Berlin, Germany | Tests it and mills it | Problems found, fixed voluntarilyJun 16, 2023 · 5 inspections |
| Sharp Packaging Services, LLC | Allentown, PA, United States | Packages it and labels it | No problems foundNov 21, 2025 · 7 inspections |
Product details
- Generic drug
- Sevabertinib: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 10 mg
- Approval
- NDA NDA219972
- On the market since
- Nov 19, 2025
- Package NDCs
50419-397-01- Official label
- DailyMed (National Library of Medicine), updated Sep 17, 2026
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