Apl Healthcare Limited
Tirupati, India · makes it and tests it
Problems found, fixed voluntarily Last FDA inspection Dec 17, 2025. 5 inspections on record.
NDC 59651-147
Macitentan 10 mg tablet, film coated
On the label: Aurobindo Pharma Limited.
Where it's made
Product details
- Generic drug
- Macitentan: see every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA211198
- On the market since
- Jun 8, 2026
- Package NDCs
59651-147-30- Official label
- DailyMed (National Library of Medicine), updated Jun 10, 2026
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