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Amifampridine phosphate bulk supplier for pharma manufacturers

Amifampridine Phosphate 10 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 10 mg

Reference Brands: Firdapse (USA)

Category: Neurology

Amifampridine phosphate is used for the treatment of Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder that affects nerve–muscle communication, leading to muscle weakness. It acts by blocking potassium channels and prolonging nerve terminal depolarization, enhancing acetylcholine release at the neuromuscular junction.

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📘 Sourcing Guide

Amifampridine Phosphate — third party manufacturing & bulk supply

Amifampridine Phosphate 10 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:

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 Amifampridine Phosphate 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

Amifampridine phosphate is used to treat Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder that affects the connection between nerves and muscles, causing muscle weakness. The medication helps improve muscle strength by enhancing the release of acetylcholine at the neuromuscular junction, improving nerve signal transmission to muscles. 

Amifampridine phosphate is made from the active ingredient amifampridine phosphate, a potassium channel blocker that prolongs nerve terminal depolarization and increases acetylcholine release. Its chemical name is 3,4-diaminopyridine phosphate. Inactive ingredients may include mannitol, magnesium stearate, and microcrystalline cellulose depending on the formulation. 

The trade names of amifampridine phosphate are Firdapse and Amifampridine Phosphate Ruzurgi (for specific regions and indications). 

Amifampridine phosphate (Firdapse) is manufactured and marketed by Catalyst Pharmaceuticals in the United States and BioMarin Pharmaceutical in Europe. 

The generic name of the drug is amifampridine phosphate. 

The brand names of amifampridine phosphate are Firdapse and Ruzurgi. 

Amifampridine phosphate is manufactured in the United States by Catalyst Pharmaceuticals and in Europe by BioMarin Pharmaceutical, with distribution across North America, the European Union, and other global markets.

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