Bosentan Tablets

Description

Bosentan Film-Coated Tablets (62.5 mg / 125 mg)

Healthy Inc is a specialized global supplier and exporter of advanced cardiology, respiratory, and targeted orphan-drug therapeutics. We provide ultra-high-purity, kinetically optimized Bosentan Tablets, manufactured in WHO–GMP certified, high-precision specialized pharmaceutical facilities. This “Dual Endothelin Receptor Antagonist” is a premium strategic export to pulmonary hypertension centers, cardiology hospitals, and government health ministries, serving as the globally mandated intervention for Pulmonary Arterial Hypertension (PAH) and systemic sclerosis with digital ulcers.

Product Overview

This formulation operates as a biochemical “Vessel Dilator.” Bosentan is engineered to neutralize Endothelin-1, the most potent natural vasoconstrictor in the human body, which is overproduced in the lungs of patients with PAH.

• Mechanism 1 (Dual Receptor Blockade): Bosentan is a non-peptide antagonist of both $ET_A$ and $ET_B$ receptors. By physically blocking these sites on the smooth muscle cells of the pulmonary arteries, it prevents Endothelin-1 from triggering the “tightening” response.

   

• Mechanism 2 (Pulmonary Vasodilation): The resulting relaxation of the pulmonary blood vessels leads to a significant drop in pulmonary vascular resistance. This allows the heart to pump blood through the lungs with much less effort.

   

• Mechanism 3 (Anti-Proliferative Defense): Beyond simple dilation, blocking endothelin receptors helps prevent the abnormal thickening (remodeling) of the vessel walls, slowing the long-term progression of the disease.

   

Product Composition & Strength

We supply this product as a Precision-Blended, High-Bioavailability Tablet, packed in moisture-resistant Alu-Alu blister strips to ensure the stability of the active API.

Technical & Logistics Specifications

• HS Code: 3004.90.99 (Medicaments containing other active substances – Cardiovascular)

   

• CAS Number: 147536-97-8 (Bosentan) / 157212-55-0 (Bosentan Monohydrate)

   

• Dosage Form: Film-Coated Tablet

• Packaging: Alu-Alu Blisters. Bosentan is sensitive to environmental humidity; our moisture-lock packaging ensures 24-month stability in Zone IVb tropical climates.

Manufacturing Authority & Compliance

• Hepatotoxicity Risk Management: Our manufacturing process focuses on the absolute elimination of organic impurities that could exacerbate liver stress, a critical concern for clinicians prescribing Bosentan.

• REMS-Ready Documentation: We provide comprehensive stability data and safety dossiers to support Risk Evaluation and Mitigation Strategies (REMS) required by many international regulatory bodies.

Primary Indications

• Cardiology/Pulmonology: Treatment of Pulmonary Arterial Hypertension (WHO Group 1) to improve exercise ability and decrease clinical worsening.

   

• Rheumatology: Reduction of the number of new digital ulcers in patients with systemic sclerosis.

   

Dosage & Administration

• Standard Dosing: Started at 62.5 mg twice daily for 4 weeks, then increased to the maintenance dose of 125 mg twice daily.

   

• The “Liver Mandate” (CRITICAL): Patients must have liver enzyme tests (ALT/AST) and pregnancy tests performed monthly.

   

• Administration: Can be taken with or without food.

Safety Warning: Teratogenic Risk. Strictly contraindicated in pregnancy. Hepatotoxicity Risk. Potential for serious liver injury; monitoring is mandatory. Avoid co-administration with Cyclosporine A or Glyburide.

Global Export & Contract Manufacturing

Healthy Inc is a premier Specialty Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for high-end Cardiovascular Therapeutics. Whether you are a Specialized Hospital Network in Africa or a B2B Pharma Marketplace partner in Southeast Asia, we ensure secure, WHO-GMP compliant delivery.