Amifampridine phosphate bulk supplier for pharma manufacturers

Amifampridine Phosphate 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. Amifampridine phosphate is available in Tablets and strengths such as 10 mg. 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, Amifampridine phosphate 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)

Amifampridine phosphate 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.

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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.

Yes, Amifampridine phosphate is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Amifampridine phosphate is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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