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Details
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Specifications
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CAS Number
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446254-47-3
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Molecular Formula
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C5H10N3O4P
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Molecular Weight
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207.12 g/mol.
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Synonyms
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3, 4-Diaminopyridine phosphate.
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Chemical Name
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3, 4-Diaminopyridine phosphate.
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Common name
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Amifampridine phosphate
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Therapeutic use
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Amifampridine phosphate is a symptomatic treatment that increases acetylcholine concentrations at the neuromuscular junction. It selectively blocks presynaptic fast voltage-gated potassium channels and augmenting calcium transport into the nerve endings.
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Background
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Amifampridine phosphate is a quaternary ammonium compound that blocks presynaptic potassium channels, and subsequently prolongs the action potential and increases presynaptic calcium concentrations
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Grade
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In house
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Polymorph
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Not existed
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GTI
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Risk assessment report available
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Nitrosamines
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Risk assessment report available
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DMF Availability
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ASMF# 4755
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Manufacturing batch size
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4.0 Kg
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Production capacity
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80-100 kg per annum
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Stability data
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Available
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Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*
Disclaimer:
The information provided on this webpage is based on the best available knowledge at the time of publication; however, accuracy and completeness are not guaranteed. Product specifications may change without notice. It is the responsibility of the purchaser or user to verify suitability and compliance. This product is intended for research use only and is not approved for human consumption.
Shilpa Pharma Lifesciences is a leading Amifampridine phosphate manufacturer in India, supplying high-purity bulk API to pharmaceutical companies, biotech firms, and international trading partners across the globe. Also known as 3,4-Diaminopyridine phosphate (CAS 446254-47-3, molecular formula C₅H₁₀N₃O₄P, MW 207.12 g/mol), Amifampridine phosphate is a quaternary ammonium compound used in the symptomatic treatment of Lambert-Eaton Myasthenic Syndrome (LEMS). With ASMF #4755 already filed, Shilpa Pharma offers a regulator-ready supply backed by GMP-compliant manufacturing, USFDA-aligned quality systems, and a robust analytical infrastructure. Our annual production capacity of 80–100 kg makes us a reliable long-term partner for both commercial-scale demand and clinical development. From R&D to commercial supply, Shilpa Pharma combines deep API manufacturing expertise with global compliance to deliver Amifampridine phosphate that meets the strictest international standards.
Amifampridine phosphate is primarily used as the active pharmaceutical ingredient (API) in finished-dose formulations for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS), a rare neuromuscular autoimmune disorder. The molecule works by selectively blocking presynaptic voltage-gated potassium channels at the neuromuscular junction, prolonging the action potential and increasing presynaptic calcium concentrations. This action enhances acetylcholine release and improves muscle strength in LEMS patients. As a bulk API, Amifampridine phosphate sourced from Shilpa Pharma is used by formulation manufacturers developing oral tablet products, generic LEMS medications, and orphan drug formulations targeting regulated markets including the USA, Europe, and Japan. The API is also of interest in research applications studying neuromuscular transmission, potassium channel pharmacology, and rare-disease drug development. Buyers can source bulk Amifampridine phosphate API for both commercial and clinical-stage projects through Shilpa Pharma’s global supply network.
Amifampridine phosphate is a prescription-only pharmaceutical ingredient and must be handled in accordance with applicable safety guidelines. At Shilpa Pharma, every batch is manufactured under GMP-compliant conditions, with full risk assessment documentation available for genotoxic impurities (GTI) and nitrosamine impurities — both critical regulatory requirements for global filings. Certificate of Analysis (CoA), Material Safety Data Sheet (MSDS), and long-term stability data are provided with every shipment to support customer regulatory submissions. The API is intended strictly for pharmaceutical manufacturing, research, and development purposes by qualified pharmaceutical and biotech buyers — not for direct human consumption. Personnel handling the material should follow standard laboratory PPE protocols, including gloves, lab coats, eye protection, and proper ventilation. Shilpa Pharma’s analytical services team ensures every consignment meets defined impurity, assay, and stability specifications before release to global customers.
The price of Amifampridine phosphate API depends on multiple factors including order quantity, packaging requirements, regulatory documentation needed, destination country, and prevailing market conditions. As a bulk API for regulated markets, pricing is shared exclusively on a quotation basis to qualified pharmaceutical manufacturers, biotech companies, and international trading firms. Shilpa Pharma offers competitive India-based manufacturing economics combined with the regulatory rigor expected for USFDA-, EDQM-, and PMDA-aligned supply. Minimum order quantities apply, and tiered pricing is available for long-term supply agreements. To receive a formal quotation for Amifampridine phosphate (CAS 446254-47-3), please share your required quantity, target market, and regulatory documentation needs through our contact form or by emailing info@shilpapharma.com. Our business development team responds to qualified inquiries within one working day.
Choosing the right Amifampridine phosphate manufacturer directly impacts your product’s quality, regulatory timelines, and commercial success. Shilpa Pharma Lifesciences stands out as a trusted global partner for bulk API supply, with key advantages:
Backed by decades of pharmaceutical expertise and a PhD-led R&D team, partner with Shilpa Pharma to accelerate development, ensure compliance, and reach markets faster.
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Projects Successfully Completed
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Everything You Need to Know About Shilpa Pharma
Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*
