Endothelin Receptor Antagonist, Phosphodiesterase 5 Inhibitor
Where is Macitentan and Tadalafil made?
1 company sell it under their own name. Their labels name 4 factories in Switzerland, the United Kingdom and India.
Switzerland 2United Kingdom 1India 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Actelion Pharmaceuticals US, Inc. Opsynvi10 mg / 20 mg, 10 mg / 40 mg · NDC 66215-812, 66215-814 | Jetpharma SAMakes the active ingredient and mills it | Balerna, Switzerland | No problems foundJun 2023 |
| Lonza AGMakes the active ingredient and tests it | Visp, Switzerland | Problems found, fixed voluntarilyMar 2023 | |
| Penn Pharmaceutical Services LimitedMakes it and tests it | Tredegar, United Kingdom | Problems found, fixed voluntarilyApr 2022 | |
| SMS Pharmaceuticals LimitedMakes the active ingredient, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyMar 2025 |