Endothelin Receptor Antagonist
Where is Bosentan made?
6 companies sell it under their own name. Their labels name 6 factories in India, Switzerland, Germany and Canada.
India 3Switzerland 1Germany 1Canada 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Actelion Pharmaceuticals US, Inc. Tracleer32 mg, 62.5 mg, 125 mg · NDC 66215-102, 66215-232, 66215-101 | Divi's Laboratories LimitedMakes the active ingredient and tests it | Visakhapatnam District, India | Problems found, fixed voluntarilyJul 2024 |
| HAS Healthcare Advanced Synthesis SAMakes the active ingredient and tests it | Biasca, Switzerland | No problems foundFeb 2025 | |
| Haupt Pharma Wuelfing GmbHMakes it | Gronau (Leine), Germany | Problems found, fixed voluntarilyJun 2023 | |
| Patheon Inc.Makes it | Mississauga, Canada | Problems found, fixed voluntarilyFeb 2023 | |
| Cadila Healthcare Limited32 mg, 62.5 mg, 125 mg · NDC 70771-1018, 70771-1908, 70771-1017 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Caraco Pharmaceutical Laboratories, Ltd.62.5 mg, 125 mg · NDC 47335-039, 47335-038 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Dadra, India | Problems found, fixed voluntarilyMar 2019 |
| Zydus Pharmaceuticals (USA) Inc.32 mg, 62.5 mg, 125 mg · NDC 68382-447, 70710-1508, 68382-446 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Actavis Pharma, Inc.62.5 mg, 125 mg · NDC 0591-2512, 0591-2511 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lupin Pharmaceuticals, Inc.32 mg · NDC 68180-340 | The label doesn't name the factory. Plants this company names for other drugs | ||