NDC 66215-814
Opsynvi 10 mg / 40 mg tablet, film coated
On the label: Actelion Pharmaceuticals US, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Jetpharma SA | Balerna, Switzerland | Makes the active ingredient and mills it | No problems foundJun 23, 2023 · 6 inspections |
| Lonza AG | Visp, Switzerland | Makes the active ingredient and tests it | Problems found, fixed voluntarilyMar 28, 2023 · 7 inspections |
| Penn Pharmaceutical Services Limited | Tredegar, United Kingdom | Makes it and tests it | Problems found, fixed voluntarilyApr 1, 2022 · 6 inspections |
| SMS Pharmaceuticals Limited | Hyderabad, India | Makes the active ingredient, tests it, packages it and labels it | Problems found, fixed voluntarilyMar 21, 2025 · 4 inspections |
| Almac Pharma Services Limited | Craigavon, United Kingdom | Tests it, packages it and labels it | Problems found, fixed voluntarilyNov 28, 2025 · 8 inspections |
| Janssen Cilag SpA | Borgo San Michele, Italy | Tests it | Problems found, fixed voluntarilySep 27, 2024 · 6 inspections |
| Johnson & Johnson Private Limited | Mumbai, India | Tests it | No problems foundApr 30, 2025 · 4 inspections |
| SMS Pharmaceuticals limited | Hyderabad, India | Tests it | No problems foundJun 25, 2025 · 2 inspections |
| Vimta Labs Limited | Hyderabad, India | Tests it | Problems found, fixed voluntarilyNov 7, 2025 · 5 inspections |
Product details
- Generic drug
- Macitentan and Tadalafil: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 10 mg / 40 mg
- Approval
- NDA NDA218490
- On the market since
- Mar 22, 2024
- Package NDCs
66215-814-0166215-814-1066215-814-30- Official label
- DailyMed (National Library of Medicine), updated Apr 11, 2025
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