Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Divi's Laboratories Limited | Visakhapatnam District, India | Makes the active ingredient and tests it | Problems found, fixed voluntarilyJul 19, 2024 · 8 inspections, 1 with FDA action |
| HAS Healthcare Advanced Synthesis SA | Biasca, Switzerland | Makes the active ingredient and tests it | No problems foundFeb 20, 2025 · 4 inspections |
| Haupt Pharma Wuelfing GmbH | Gronau (Leine), Germany | Makes it | Problems found, fixed voluntarilyJun 6, 2023 · 6 inspections |
| Allpack Group AG | Reinach, Switzerland | Packages it and labels it | Problems found, fixed voluntarilyApr 28, 2023 · 6 inspections |
| Jetpharma SA | Balerna, Switzerland | Mills it | No problems foundJun 23, 2023 · 6 inspections |
Product details
- Generic drug
- Bosentan: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 62.5 mg
- Approval
- NDA NDA021290
- On the market since
- Nov 20, 2001
- Package NDCs
66215-101-0366215-101-06- Official label
- DailyMed (National Library of Medicine), updated Nov 17, 2025
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