Bosentan Tablet Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 62.5 mg and 125 mg
Reference Brands: Tracleer®(US & EU)
Category:
Orphan Drugs
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 tablet is available in Tablets
and strengths such as 62.5 mg and 125 mg.
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, Bosentan tablet is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
Bosentan tablet can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
Product Description:
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.
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