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Edaravone injection bulk supplier for pharma manufacturers

Edaravone Injection Suppliers & Bulk Manufacturers

Available Forms: Injectable Solution

Available Strengths: 30 mg/10 ml

Reference Brands: Radicava(US)

Category: Orphan Drugs

Edaravone is a free radical scavenger that reduces oxidative stress in neurons, protecting against nerve cell damage. It slows ALS progression, improves muscle strength, and prolongs survival. Benefits include neuroprotection, symptom stabilization, and improved quality of life for ALS patients by supporting neuronal health. Edaravone injection is available in Injectable Solution and strengths such as 30 mg/10 ml. 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, Edaravone injection 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)

Edaravone injection 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:

Edaravone injection, marketed as Radicava, is approved in the US by the FDA and in the EU via EMA for amyotrophic lateral sclerosis (ALS). Regulatory approval requires comprehensive dossiers including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality data for timely approval, while the EMA ensures regional safety and manufacturing compliance. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Supporting regional adherence supports quick approval, safe administration, and global availability, helping ALS patients worldwide by slowing disease progression and improving quality of life through neuroprotective mechanisms.

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Frequently Asked Questions

Edaravone is used to slow the progression of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease affecting motor neurons.

Edaravone is a free radical scavenger that reduces oxidative stress. Its chemical name is 3-methyl-1-phenyl-2-pyrazolin-5-one.

Edaravone is marketed under the brand names Radicava and Radicava ORS in the USA. No authorized brands are currently marketed in the EU or UK.

Edaravone is manufactured by Mitsubishi Tanabe Pharma Corporation in the USA under the brand name Radicava.

The generic name is Edaravone.

Brand names include Radicava and Radicava ORS (USA).

Edaravone is manufactured in the USA by Mitsubishi Tanabe Pharma Corporation.

Yes, Edaravone injection 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, Edaravone injection 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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