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Omaveloxolone bulk supplier for pharma manufacturers

Omaveloxolone 150 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 150 mg

Reference Brands: Skyclarys (USA)

Category: Antibiotics

Omaveloxolone is a Antibiotics product available as Tablets in strengths 150 mg. It corresponds to the reference brand Skyclarys (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:

Omaveloxolone, marketed under the brand name Skyclarys, is an oral medication approved for the treatment of Friedreich’s ataxia, a rare and progressive neurodegenerative disorder. Friedreich’s ataxia causes damage to the spinal cord, peripheral nerves, and brain, leading to uncoordinated muscle movements, poor balance, difficulty walking, and changes in speech and swallowing. The disease often develops in childhood or adolescence and can progressively worsen over time, sometimes also affecting cardiac function and reducing life expectancy.

Omaveloxolone works by activating the Nrf2 pathway, a key regulator of cellular antioxidant defense. This mechanism helps reduce oxidative stress and improves mitochondrial function, which can slow disease progression and support neurological function. Taken orally, Omaveloxolone provides a convenient option for long-term management, aiming to improve patients’ mobility, balance, and overall quality of life. As an orphan drug, it offers a targeted therapeutic option for patients with this rare condition, addressing a significant unmet medical need.

Omaveloxolone — third party manufacturing & bulk supply

Omaveloxolone 150 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 Omaveloxolone 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

Omaveloxolone is used for the treatment of rare neurodegenerative disorders, such as Friedreich’s ataxia, to improve mitochondrial function and reduce oxidative stress.

Omaveloxolone is a chemically synthesized small molecule designed to activate the Nrf2 pathway and enhance cellular antioxidant defense.

The trade name of Omaveloxolone is Vyndamax.

Omaveloxolone (Vyndamax) is developed and marketed by Reata Pharmaceuticals, Inc.

The generic name of Vyndamax is Omaveloxolone.

The brand name is Vyndamax., Skyclarys.

Omaveloxolone is manufactured at Reata Pharmaceuticals-approved facilities in compliance with international GMP and regulatory standards.

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