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Rufinamide bulk supplier for pharma manufacturers

Rufinamide 200 mg, 400 mg, 40 mg/mL 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 a Neurology product available as Tablets / Oral suspension in strengths 200 mg, 400 mg, 40 mg/mL. It corresponds to the reference brand Banzel (USA). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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📘 Sourcing Guide

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.

Rufinamide — third party manufacturing & bulk supply

Rufinamide 200 mg, 400 mg, 40 mg/mL 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:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

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 Rufinamide 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.

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Frequently Asked Questions


Rufinamide is used as an adjunctive antiepileptic treatment for seizures associated with Lennox–Gastaut syndrome, a severe form of epilepsy. It helps reduce the frequency and severity of seizures in both children and adults by stabilizing abnormal electrical activity in the brain.


Rufinamide is a synthetic antiepileptic drug with a triazole-derived chemical structure. It is not derived from any natural or biological source and is manufactured through controlled pharmaceutical chemical synthesis.


Rufinamide is marketed under different trade names in global markets. The main trade names include Banzel in the United States and Inovelon in the European Union and the United Kingdom.


The original branded versions of Rufinamide were developed and marketed by Eisai. Generic versions are now manufactured by multiple pharmaceutical companies worldwide following patent expiry.


The generic name of the medicine is rufinamide.


The brand names of rufinamide include Banzel in the USA and Inovelon in the EU and UK.


Rufinamide is manufactured in multiple countries depending on the brand or generic supplier. Production facilities are located across regions such as the USA, Europe, and India, in compliance with international regulatory standards like US FDA and EU GMP.

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