Healthy Inc > Products > Ambrisentan Tablets

Ambrisentan Film-Coated Tablets (5 mg / 10 mg)

Healthy Inc is a specialized global supplier and exporter of advanced pulmonology, cardiology, and targeted high-containment therapeutics. We provide ultra-high-purity, kinetically optimized Ambrisentan Tablets, manufactured in WHO–GMP certified, high-precision specialized oral solid dosage facilities. This “Selective $ET_A$ Receptor Antagonist” is a premium strategic export to pulmonary hypertension centers, specialized cardiac units, and government health ministries, serving as the globally mandated intervention for Pulmonary Arterial Hypertension (PAH) (WHO Group 1).

Product Overview

This formulation operates as a “Pulmonary Pressure Relief Valve.” Ambrisentan is engineered to block the strongest natural blood-vessel-constricting chemical in the human body, specifically within the lungs.

  • Mechanism 1 (Selective $ET_A$ Receptor Antagonism): Ambrisentan binds with high affinity to the Endothelin Type-A ($ET_A$) receptors on the smooth muscle cells of the pulmonary arteries. Endothelin-1 normally binds here to cause severe narrowing of the vessels; Ambrisentan physically blocks this, leading to Vasodilation.

  • Mechanism 2 (Sparing $ET_B$ Receptors): Unlike non-selective agents, Ambrisentan is highly selective for $ET_A$ over $ET_B$. This is critical because $ET_B$ receptors help clear Endothelin-1 from the blood and trigger the release of natural relaxants (Nitric Oxide). By sparing $ET_B$, the drug works with the body’s natural chemistry.

  • Mechanism 3 (Hemodynamic Improvement): By widening the pulmonary “pipes,” the drug significantly reduces the workload on the right side of the heart, physically improving the patient’s ability to walk, breathe, and perform daily activities without exhaustion.

Product Composition & Strength

We supply this product as a Precision-Blended, High-Potency Tablet, packed in high-barrier Alu-Alu blister strips to ensure API stability.

Active IngredientStrengthPrimary Clinical Function
Ambrisentan USP/Ph.Eur.5 mgThe Initiation Unit: The standard starting dose for adults to establish tolerance and initial pulmonary dilation.
Ambrisentan USP/Ph.Eur.10 mgThe Maximum Maintenance Payload: For patients requiring additional symptomatic improvement after the 5 mg dose.
ExcipientsProprietary MatrixBio-Optimized System: Engineered to ensure a consistent $T_{max}$ (peak concentration) of approx. 2 hours for reliable daily protection.

Technical & Logistics Specifications

  • HS Code: 3004.90.99 (Medicaments containing other active substances – Pulmonology/PAH)

  • CAS Number: 177036-94-1 (Ambrisentan)

  • Dosage Form: Film-Coated Tablet

  • Packaging: Alu-Alu Blisters. Protects the API from light and environmental humidity; our moisture-lock packaging ensures 24-month stability in Zone IVb tropical climates.

Manufacturing Authority & Compliance

  • ERA Selectivity Excellence: Our manufacturing process focuses on absolute chemical purity to ensure the $ET_A$ vs $ET_B$ selectivity ratio remains exact, providing the predictable clinical response required for PAH patients.

  • Safety & Monitoring Compliance: We provide comprehensive documentation to support the REMS (Risk Evaluation and Mitigation Strategy) requirements, including data on liver enzyme safety and fetal toxicity prevention.

Primary Indications

  • Pulmonology: Treatment of Pulmonary Arterial Hypertension (PAH) (WHO Group 1) in patients with WHO Class II or III symptoms.

  • Cardiology: Delaying clinical worsening and improving exercise capacity in patients with pulmonary vascular resistance.

  • Combination Therapy: Often used alongside Tadalafil for a dual-pathway approach to PAH.

Dosage & Administration

  • Standard Adult Dosing: 5 mg once daily, which may be increased to 10 mg once daily if 5 mg is well tolerated.

  • Administration: Can be taken with or without food. Tablets must be swallowed whole; do not crush or chew.

Safety Warning: Fetal Toxicity. Strictly contraindicated in pregnancy. Females of reproductive potential must use effective contraception and have monthly pregnancy tests. Monitor for Peripheral Edema (fluid retention) and decrease in Hemoglobin levels. While safer than older ERAs, periodic liver function tests (LFTs) are recommended.

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-value Orphan Drugs. Whether you are a PAH Specialist Network in Africa or a B2B Pharma Marketplace partner in the CIS, we ensure secure, WHO-GMP compliant delivery.

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