Rufinamide Suppliers & Bulk Manufacturers
Available Forms: Tablets / Oral suspension
Available Strengths: 200 mg, 400 mg, 40 mg/mL
Reference Brands: Banzel (USA)
Category:
Neurology
Rufinamide is available in Tablets / Oral suspension
and strengths such as 200 mg, 400 mg, 40 mg/mL.
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, Rufinamide 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) |
Rufinamide 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:
Rufinamide is an anticonvulsant and antiepileptic medication primarily used as adjunctive therapy for the management of seizures associated with Lennox–Gastaut syndrome, a severe and rare form of epilepsy. It is approved for use in children aged four years and older as well as in adult patients. Rufinamide belongs to the triazole derivative class of antiepileptic drugs and exerts its therapeutic effect by modulating sodium channel activity in the brain, thereby helping to stabilize neuronal firing and reduce seizure frequency and severity.
The drug was developed in 2004 by Novartis Pharma AG and is commercially manufactured and marketed by Eisai. Rufinamide is officially approved by regulatory authorities such as the US FDA for Lennox–Gastaut syndrome; however, emerging clinical studies have indicated potential benefits in the treatment of partial seizures, although this indication is not included in its current FDA-approved labeling. Rufinamide is available in oral tablet and oral suspension dosage forms, allowing flexibility in dosing for pediatric and adult patients. It is marketed under the brand name Banzel in the United States and Inovelon in the European Union and the United Kingdom, with multiple generic versions available worldwide.
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