Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| MSN Laboratories Private Limited | Rangareddy District, India | Makes it and tests it | Problems found, fixed voluntarilyDec 21, 2023 · 4 inspections |
Product details
- Generic drug
- Macitentan: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA211136
- On the market since
- Aug 20, 2025
- Package NDCs
0781-8135-31- Official label
- DailyMed (National Library of Medicine), updated Apr 6, 2026
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