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Omaveloxolone bulk supplier for pharma manufacturers

Omaveloxolone Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 150 mg

Reference Brands: Skyclarys (USA)

Category: Antibiotics

Omaveloxolone is available in Tablets and strengths such as 150 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, Omaveloxolone 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)

Omaveloxolone 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.

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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.

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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.

Yes, Omaveloxolone is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Omaveloxolone is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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