Riluzole Tablets Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 50 mg
Reference Brands: Rilutek(US)
Category:
Orphan Drugs
Riluzole inhibits glutamate release and activity in neurons, reducing excitotoxicity involved in ALS progression. It slows disease progression, prolongs survival, and supports motor function. Benefits include delayed symptom worsening, improved quality of life, and extended survival time for ALS patients, with support for neuroprotection.
Riluzole tablets is available in Tablets
and strengths such as 50 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, Riluzole tablets 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) |
Riluzole tablets 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.
Product Description:
Riluzole tablets, marketed as Rilutec and generics, are approved in the US by the FDA and in the EU via EMA for ALS treatment. Regulatory approval requires a detailed dossier including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial data and quality information for timely approval, while the EMA ensures compliance with regional safety and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Adhering to regional requirements supports swift approval, safe use, and global availability, helping ALS patients worldwide access effective disease management solutions.
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