Edaravone Injection 30 mg/100 mL Suppliers & Bulk Manufacturers

Available Forms: Injectable Solution

Available Strengths: 30 mg/100 mL

Reference Brands: Radicava(US)

Category: Orphan Drugs

Edaravone injection for intravenous use in amyotrophic lateral sclerosis, 30 mg per infusion. For importers, distributors, neurology centres and hospital pharmacies sourcing this orphan medicine.

Product Description:

Edaravone is a free-radical scavenger, thought to protect motor neurones from oxidative damage in amyotrophic lateral sclerosis (ALS), although the exact mechanism of benefit is not fully established. This page covers edaravone solution for intravenous infusion. The US reference product is a ready-to-infuse bag of 30 mg in 100 mL; some markets register ampoules of concentrate for dilution instead, so confirm which format is offered. The intravenous form serves neurology units and infusion centres, while an oral suspension exists for home use.

Edaravone is used to slow functional decline in ALS. In the US regimen, 60 mg is infused over 60 minutes daily for 14 days, then 14 days off; later cycles give doses on 10 of 14 days, then 14 days off. Hypersensitivity reactions, including anaphylaxis, are reported, and the infusion contains sodium bisulfite, which can cause sulfite reactions, particularly in people with asthma. It is not authorised in the EU.

Sourcing notes. Edaravone is prescription-only and holds orphan status in several markets, so registration routes vary. The solution oxidises in air and light: the reference bag sits in an overwrap with an oxygen absorber, so ask how a generic prevents oxidation and what its in-use time is. Storage is at room temperature, not cold chain, with zone IVb data needed for hot humid regions. Request a CoA per batch with degradation products, sterility and endotoxin results, a sterile-manufacture GMP certificate, a CoPP and a CTD or ACTD dossier. State volume, container and format.