Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Flamma S.p.A. | Chignolo d'Isola, Italy | Makes the active ingredient | Problems found, fixed voluntarilyMar 25, 2022 · 5 inspections |
| Flamma SpA | Isso, Italy | Makes the active ingredient | Problems found, fixed voluntarilyApr 15, 2022 · 1 inspection |
| Patheon Inc. | Mississauga, Canada | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyFeb 24, 2023 · 7 inspections |
| Sanofi S.r.l. | Scoppito, Italy | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyDec 13, 2024 · 2 inspections |
| Genzyme Corporation | Northborough, MA, United States | Tests it, packages it and labels it | No problems foundAug 14, 2025 · 6 inspections |
Product details
- Generic drug
- Rilzabrutinib: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 400 mg
- Approval
- NDA NDA219685
- On the market since
- Aug 29, 2025
- Package NDCs
58468-0251-058468-0251-558468-0251-6- Official label
- DailyMed (National Library of Medicine), updated Aug 26, 2025
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