Active Pharmaceutical Ingredient

Amifampridine API Manufacturer & Supplier in India

Also known as: Firdapse / 3,4-DAP

CAS: 54-96-6 K⁺ Channel Blocker / Neurology EP Standard Rare Disease API
Amifampridine API Manufacturer India | Mediocon Inc
Amifampridine — Pharmaceutical Grade API

Product Overview

CAS No: 54-96-6  |  MF: C₅H₇N₃  |  MW: 109.13 g/mol

Amifampridine (3,4-diaminopyridine) is a potassium channel blocker used in the treatment of Lambert-Eaton myasthenic syndrome (LEMS). It enhances acetylcholine release at the neuromuscular junction. Mediocon Inc supplies pharmaceutical-grade Amifampridine for rare disease and specialty neurological manufacturers.

Key Features

  • Potassium channel blocker for LEMS
  • EP compliant quality
  • Enhances neuromuscular transmission
  • Approved for rare neuromuscular disease

Applications

  • Lambert-Eaton myasthenic syndrome tablets
  • Neuromuscular disease management
  • Rare disease specialty formulations
  • Congenital myasthenic syndrome

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameAmifampridine
Also Known AsFirdapse / 3,4-DAP
CAS Number54-96-6
Molecular FormulaC₅H₇N₃
Molecular Weight109.13 g/mol
CategoryPotassium Channel Blocker / Neurology
AppearanceWhite to Off-white Powder
GradeEP / In-house GMP Standard

Analytical Specifications

ParameterSpecification
Assay98.0% – 101.0%
Loss on DryingNMT 1.0%
Melting Point215°C – 220°C
Heavy MetalsNMT 10 ppm
pHN/A
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing1 kg foil pouches / as per requirement

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Amifampridine (CAS 54-96-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Amifampridine is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Stability data available (ICH Q1A guidelines) for regulatory submissions
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Amifampridine API

What is the minimum order quantity for Amifampridine API?
Mediocon Inc supplies Amifampridine with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Amifampridine does Mediocon supply?
We supply Amifampridine conforming to EP / In-house GMP Standard pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Amifampridine API?
Every shipment of Amifampridine comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Amifampridine bulk orders?
Standard lead time for Amifampridine is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.
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