Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Bidachem S.p.a. | Fornovo S. Giovanni (BG), Italy | Makes the active ingredient | Problems found, fixed voluntarilyMay 17, 2024 · 7 inspections |
| Boehringer Ingelheim Pharma GmbH and Co. KG | Ingelheim am Rhein, Germany | Makes it | Problems found, fixed voluntarilyMay 15, 2025 · 8 inspections, 1 with FDA action |
| Catalent Germany Schorndorf GmbH | Schorndorf, Germany | Packages it and labels it | Problems found, fixed voluntarilyMar 17, 2022 · 7 inspections |
| Sixarp, LLC | Grand Rapids, MI, United States | Packages it and labels it | No problems foundMar 6, 2025 · 4 inspections |
Product details
- Generic drug
- Dabigatran: every company that makes it
- Form
- pellet, oral
- Strength
- 50 mg
- Approval
- NDA NDA214358
- On the market since
- Mar 16, 2022
- Package NDCs
0597-0440-53- Official label
- DailyMed (National Library of Medicine), updated Jun 27, 2025
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