Edaravone, the free-radical scavenger marketed as Radicava for amyotrophic lateral sclerosis, is available from M Care as originator-linked and FDA-approved generic Indian injection lines.
M Care Exports is a merchant exporter of edaravone, a free-radical-scavenging neuroprotectant that Mitsubishi Tanabe Pharma markets as Radicava (injection) and Radicava ORS (oral suspension) for amyotrophic lateral sclerosis (ALS) in the United States. We source originator-linked and FDA-approved generic Indian edaravone injection through licensed Indian distribution and manufacturing channels and dispatch against buyer specification, not from our own manufacturing.
Edaravone exporter and bulk supplier from India.
For hospital neurology units, ALS clinics, tender desks and specialist-pharmacy orders, M Care quotes edaravone injection against buyer specification: pack format (30 mg/100 mL single-dose vial or bag, or the 60 mg/100 mL single-dose vial available from at least one FDA-approved generic line), brand-or-generic preference, and destination-market regulatory documentation, drawn from WHO-GMP Indian manufacturer lines on the M Care roster. Because neither the UK nor the EU has a centrally authorised edaravone product, we confirm whether the buyer's order is a standard registered-medicine purchase or a named-patient/unlicensed-import shipment before dispatch, then align CTD/eCTD or country-specific dossier paperwork accordingly.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Free-radical scavenger; neuroprotectant, sourced and documented for export.
Edaravone is a small-molecule free-radical scavenger that limits oxidative-stress-mediated neuronal injury; its exact mechanism in ALS is not fully characterised, but it is thought to neutralise the free radicals linked to nerve-cell damage in the disease. It is dosed by intravenous infusion, not orally, in the injection lines M Care sources, supplied ready to infuse as a 30 mg/100 mL single-dose vial or bag, with a 60 mg/100 mL single-dose vial also available from at least one FDA-approved generic manufacturer. The US FDA-approved indication is amyotrophic lateral sclerosis (ALS), dosed in fixed cycles rather than by weight; neither the UK's MHRA nor the EU's EMA has granted a centrally authorised edaravone product, so buyers in those markets should check their own import route before a quote is finalised.
Active ingredient
Edaravone. Free-radical scavenger; neuroprotectant.
Forms and strengths
30 mg/100 mL single-dose vial or bag, solution for infusion; 60 mg/100 mL single-dose vial, solution for infusion (FDA-approved generic).
Indications
Edaravone, a free-radical-scavenging neuroprotectant marketed as Radicava (and the oral suspension Radicava ORS) by Mitsubishi Tanabe Pharma for amyotrophic lateral sclerosis in the United States. M Care sources FDA-approved generic edaravone injection, including a line manufactured in India, and originator-linked lines, to regulated and semi-regulated markets outside India.
Administration
Intravenous. Solution for infusion, single-dose vial or bag (ready to infuse).
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Hospital neurology-unit and ALS-clinic pharmacists, and MoH tender desks running neurology or rare-disease formulary lists, are the primary volume buyers for edaravone in markets where it can be registered as a standard medicine. UK and EU specialist neurology pharmacies and NGO or MND-charity procurement programmes seek edaravone for ALS on a named-patient or unlicensed-import basis, since neither market has a centrally authorised product. Licensed pharmaceutical wholesalers and importers handling either route are also regular buyers.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on edaravone.
Edaravone dosing is fixed-dose, not weight- or BSA-based: the regimen is 60 mg infused over 60 minutes, given as two consecutive 30 mg infusion bags, in an initial 14-day daily cycle followed by a 14-day drug-free interval, then cycles of 10 days on and 14 days off. The injection contains sodium bisulfite as a stabiliser, so patients should be screened for sulfite sensitivity before the first infusion, since anaphylactic and asthmatic reactions have been reported. The solution is light-sensitive: once the overwrap package is opened, it should be used within 24 hours, and other medicines should not be injected into or mixed with the infusion bag. No extravasation-specific management is documented for edaravone in the FDA label; the clinically significant risk to flag is bisulfite hypersensitivity, not a vesicant site reaction.
The documentation pack a regulator actually asks for.
Edaravone injection ships on standard temperature-controlled logistics rather than the deep cold-chain lanes M Care validates for biologics: it is stored at up to 25 degrees C, protected from light, with the opened overwrap used within 24 hours, so light protection is the operationally important handling point rather than refrigeration. What buyers need is batch-level certificate of analysis, CDSCO export documentation and, where the destination market requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product. Edaravone does not appear on the current WHO Model List of Essential Medicines. On brand-versus-generic: Radicava and Radicava ORS remain Mitsubishi Tanabe Pharma's originator products for ALS, but FDA-approved generic edaravone injection, including a line manufactured in India, has been available since 2024 ANDA approvals, so buyers with an ALS-indication registration genuinely have a brand-or-generic choice. Neither the UK's MHRA nor the EU's EMA has granted a centrally authorised edaravone product; Mitsubishi Tanabe Pharma GmbH withdrew its EU marketing authorisation application in 2019 after the CHMP found the pivotal study's evidence on survival, breathing and muscle strength insufficient, so UK and EU buyers proceed on a named-patient or unlicensed-import basis rather than a standard licensed-medicine registration, which M Care's documentation pack is built to support.
How a licensed importer actually brings a consignment like this in is covered once, in the licensed import route guide, rather than repeated on every molecule page.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside edaravone.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for edaravone.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Edaravone supply, the specific questions.
Can M Care supply edaravone as Radicava or as a generic?
We source both routes. For hospital or tender buyers with an ALS-indication registration, we can quote FDA-approved generic edaravone injection manufactured in India, matching the Radicava pack strength, through licensed Indian distribution channels, alongside originator-linked lines. Tell us your destination market and registration status and we confirm which route applies.
What strength and pack format does edaravone injection come in?
A 30 mg/100 mL single-dose vial or bag, ready to infuse, matching the Radicava pack format; at least one FDA-approved generic manufacturer also supplies a 60 mg/100 mL single-dose vial. The standard ALS dose of 60 mg is given as two consecutive 30 mg infusions with the Radicava pack, or can be drawn from the higher-strength vial. Tell us your protocol and we quote the matching format.
Is edaravone registered in the UK and the EU?
No centrally authorised edaravone product exists in either market. Mitsubishi Tanabe Pharma GmbH withdrew its EU marketing authorisation application in 2019 after the EMA's CHMP found the evidence on survival and other key measures insufficient, and no MHRA application has followed in the UK. UK and EU specialist pharmacies currently access edaravone through named-patient or unlicensed-import routes, and M Care's documentation pack is built to support that pathway rather than a standard licensed-medicine registration.
What is the dosing regimen for edaravone in ALS?
The FDA label sets a fixed 60 mg dose infused intravenously over 60 minutes, not adjusted by weight. The first treatment cycle is daily dosing for 14 days followed by a 14-day drug-free period; subsequent cycles run 10 days of daily dosing followed by 14 days off. This cyclical schedule is a key planning factor for tender desks forecasting order volumes.
Does edaravone need cold-chain handling?
No refrigerated cold chain is required. The injection is stored at up to 25 degrees C and protected from light, and once the overwrap package is opened it should be used within 24 hours, so light protection and pack-opening discipline are the operationally important handling points rather than temperature.
What documentation does M Care provide with an edaravone shipment?
Batch-level certificate of analysis, CDSCO export documentation from the Indian side, and CTD/eCTD-aligned dossier support where the destination regulator requires local registration. For named-patient or unlicensed-import shipments into the UK or EU, we also prepare the supporting paperwork that pathway requires, distinct from a standard marketing-authorisation dossier.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-14.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.