Bosentan / Bosentán 125 mg T
| Product Overview | |
| Generic Name | Bosentan / Bosentán 125 mg T |
| Brand Name(s) | Tracleer®, Lunastra |
| Product Type | Originator Brand |
| Form | 60, film coated tablets |
| Strength | 125 mg |
| Therapeutic Class | Dual endothelin receptor antagonist. |
| ATC Code | C02KX01 |
| Manufacturing & Regulatory | |
| Manufacturer | Janssen/J&J |
| Country | Switzerland, India, USA,EU |
| GMP Compliance | WHO-GMP |
| DMF/CEP | DMFs 41537 and 41597 |
| COFEPRIS | 010.000.5601.00 |
| Free Sale Certificate | Yes, available as COPP/CPP |
| Logistics & Export | |
| MOQ | 10 Units |
| Shelf Life | 36 months |
| Storage | Store at 20–25 °C |
| Incoterms | EXW, HSN 30049099 |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| SDS | Upon Request, not publicly posted |
| CTD Summary | CTD proprietary; available under commercial agreement/license |
Description
Bosentan is an oral dual endothelin receptor antagonist used for pulmonary arterial hypertension to improve exercise capacity and delay clinical worsening. It requires specialist supervision because of hepatotoxicity risk, embryo-fetal toxicity, drug interactions, liver-function monitoring and pregnancy-prevention controls.
