Riluzole Tablets 50 mg 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.
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.
Riluzole Tablets — third party manufacturing & bulk supply
Riluzole Tablets 50 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Manufacturers of Riluzole Tablets listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Riluzole Tablets →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Riluzole is used to slow the progression of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease affecting nerve cells in the brain and spinal cord. It helps prolong survival and delay the need for ventilatory support by reducing nerve damage.
Riluzole is a synthetic benzothiazole derivative that modulates glutamate neurotransmission. It inhibits the release of glutamate and inactivates voltage-dependent sodium channels, which reduces excitotoxicity and neuronal damage.
Riluzole is marketed under trade names such as Rilutek and Teglutik.
Riluzole is manufactured by Sanofi (Rilutek) and several generic pharmaceutical companies worldwide.
The complete generic name is riluzole.
The brand names include Rilutek and Teglutik, along with other country-specific generics.
Riluzole is manufactured in multiple countries including the USA, EU nations, and India, depending on the brand and generic manufacturer.
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