Product/Composition:- | Bosentan tablet |
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Strength:- | 62.5 mg and 125 mg |
Form:- | Tablets |
Reference Brands:- | Tracleer®(US & EU) |
MOQ | As per the manufacturer batch size |
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Bosentan is an endothelin receptor antagonist that blocks the effects of endothelin-1, a substance causing blood vessel constriction. It relaxes pulmonary arteries, reducing blood pressure in PAH. Benefits include improved exercise capacity, decreased symptoms, and slowed disease progression in pulmonary arterial hypertension patients.
Bosentan tablets, marketed as Tracleer®, are approved in the US and EU for pulmonary arterial hypertension. Regulatory dossiers include extensive clinical trials, manufacturing compliance, and safety data, facilitating approval by FDA and EMA. These dossiers highlight bosentan’s efficacy in improving exercise capacity and reducing symptoms of PAH. The medication is available in 62.5 mg and 125 mg tablets, with dosing titrated based on patient response. For detailed insights on regulatory submissions, dossier requirements, and market approvals, visit PharmaTradz, your trusted source for pharmaceutical regulatory insights and industry updates.