Product/Composition:- | Riluzole tablets |
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Strength:- | 50 mg |
Form:- | Tablets |
Reference Brands:- | Rilutek(US) |
MOQ | As per the manufacturer batch size |
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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, 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.