Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Torrent Pharmaceuticals Limited | Bharuch, India | Makes it, tests it and packages it | No problems foundJan 23, 2026 · 5 inspections, 1 with FDA action |
Product details
- Generic drug
- Macitentan: every company that makes it
- Form
- tablet, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA211107
- On the market since
- Jun 1, 2026
- Package NDCs
13668-542-0513668-542-3013668-542-90- Official label
- DailyMed (National Library of Medicine), updated May 18, 2026
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