Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Excella GmbH & Co. KG | Feucht, Germany | Makes it and tests it | Problems found, fixed voluntarilyOct 19, 2022 · 7 inspections |
| Lonza AG | Visp, Switzerland | Makes the active ingredient and tests it | Problems found, fixed voluntarilyMar 28, 2023 · 7 inspections |
| Patheon France S.A.S | Bourgoin Jallieu, France | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilySep 29, 2023 · 5 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 |
| Johnson & Johnson Private Limited | Mumbai, India | Tests it | No problems foundApr 30, 2025 · 4 inspections |
| Micro-Macinazione Sa | Monteggio, Switzerland | Tests it and mills it | Problems found, fixed voluntarilyNov 13, 2024 · 6 inspections |
| SGS Institut Fresenius GmbH | Taunusstein, Germany | Tests it | Problems found, fixed voluntarilyFeb 21, 2025 · 4 inspections |
Product details
- Generic drug
- Macitentan: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 10 mg
- Approval
- NDA NDA204410
- On the market since
- Nov 4, 2013
- Package NDCs
66215-501-1566215-501-30- Official label
- DailyMed (National Library of Medicine), updated Apr 11, 2025
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