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Macitentan bulk supplier for pharma manufacturers

Macitentan 10 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 10 mg

Reference Brands: Opsumit (USA)

Category: Heart Disorder

Macitentan is a Heart Disorder product available as Tablets in strengths 10 mg. It corresponds to the reference brand Opsumit (USA). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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📘 Sourcing Guide

Product Description:

Macitentan is an orally active, non-peptide dual endothelin receptor antagonist developed by Actelion and marketed under the brand name Opsumit. It selectively blocks both endothelin receptor subtypes, ETA and ETB, with a markedly higher affinity for the ETA receptor, which plays a key role in vasoconstriction and vascular remodeling in pulmonary arterial hypertension (PAH). By inhibiting endothelin-mediated pathways, macitentan helps reduce pulmonary vascular resistance and disease progression.

Opsumit is indicated for the long-term treatment of pulmonary arterial hypertension in adults classified as World Health Organization Functional Class II or III. It is used to reduce morbidity in patients with idiopathic or heritable PAH, as well as PAH associated with connective tissue disease or congenital heart disease. Macitentan can be administered as monotherapy or in combination with phosphodiesterase-5 inhibitors. It is available as 10 mg film-coated tablets, taken once daily, and is designed for sustained efficacy and improved tolerability in chronic PAH management.

Macitentan — third party manufacturing & bulk supply

Macitentan 10 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Macitentan listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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Frequently Asked Questions

Macitentan is used for the treatment of pulmonary arterial hypertension (PAH). It helps delay disease progression, improve exercise capacity, and reduce the risk of hospitalization related to PAH.

Macitentan is a synthetic small-molecule drug. It is an endothelin receptor antagonist that blocks the effects of endothelin-1, a substance responsible for narrowing blood vessels and increasing blood pressure in the lungs.

The trade name of Macitentan is Opsumit.

Macitentan (Opsumit) is manufactured and marketed by Actelion Pharmaceuticals Ltd., which is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

The generic name of the drug is macitentan.

The brand name of macitentan is Opsumit.

Macitentan is manufactured in regulated pharmaceutical facilities operated by Actelion/Janssen, primarily in Europe, following strict GMP standards.

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