AMIFAMPRIDINE PHOSPHATE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078	NDA	Catalyst Pharmaceuticals, Inc.	69616-211-03	240 TABLET in 1 BOTTLE, PLASTIC (69616-211-03)	2019-01-07
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078	NDA	Catalyst Pharmaceuticals, Inc.	69616-211-06	12 BLISTER PACK in 1 CARTON (69616-211-06) / 10 TABLET in 1 BLISTER PACK (69616-211-04)	2019-01-07
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078	NDA	Catalyst Pharmaceuticals, Inc.	69616-211-08	60 TABLET in 1 BOTTLE, PLASTIC (69616-211-08)	2019-01-07
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

Amifampridine phosphate, also known as 3,4-diaminopyridine phosphate, is a potent voltage-gated potassium channel blocker primarily used in the treatment of Lambert-Eaton myasthenic syndrome (LEMS) and certain hereditary motor neuron diseases. As a niche pharmaceutical compound, its supply chain comprises a limited group of specialized raw material and drug manufacturers, predominantly located in North America, Europe, and Asia. This article provides a comprehensive overview of the key suppliers involved in the production, sourcing, and distribution of Amifampridine phosphate, offering insights critical for stakeholders seeking reliable procurement channels.

Manufacturers of Amifampridine Phosphate

1. Akros Organics / Aurobindo Pharma

Overview: Akros Organics, an established supplier of fine chemicals and active pharmaceutical ingredients (APIs), is recognized for manufacturing Amifampridine phosphate. Aurobindo Pharma, a prominent Indian pharma player, has also reportedly engaged in production and distribution of the compound through its specialty API division.
Supply Capabilities: Akros maintains stringent quality controls conforming to cGMP standards, facilitating supply to global markets, including North America and Europe. Aurobindo's API manufacturing facilities are FDA-licensed, ensuring compliance with international pharmaceutical standards.
Market Presence: Both companies serve as primary sources for pharmaceutical firms developing therapeutics for neuromuscular disorders.

2. Catalytic Pharma

Overview: Catalytic Pharma, based in the United States, specializes in niche and specialty APIs, including Amifampridine phosphate. They focus on high-purity formulations suitable for clinical and commercial applications.
Supply Capabilities: Emphasizes customized production scales, with capabilities spanning from research-grade to full-scale commercial API manufacturing.
Market Presence: Catalytic Pharma is a trusted supplier for biotech companies and clinical research organizations exploring therapies involving Amifampridine phosphate.

3. Merck KGaA / EMD Serono

Overview: EMD Serono, the healthcare division of Merck KGaA in Germany, holds licenses for the production of Amifampridine phosphate for therapeutic use within specific markets.
Supply Capabilities: Their manufacturing facilities adhere to stringent quality standards, ensuring consistent API supply to Europe and other regulated markets.
Market Presence: They often serve as the primary supplier for prescribed therapies for LEMS, with distribution channels supporting multiple regions.

4. Specialty API Manufacturers in China and India

Overview: Several Chinese and Indian API producers, such as Hubei Hongyu Pharmaceutical and Natco Pharma, have begun developing capacity for Amifampridine-related compounds, including phosphate salts.
Supply Capabilities: These manufacturers typically offer lower-cost options, although quality and regulatory compliance vary and require rigorous validation.
Market Presence: Often supplying generic or off-patent formulations, these producers are crucial for markets with limited access to branded APIs.

Key Considerations for Procurement

Regulatory Compliance

Supply chain integrity hinges on manufacturers’ adherence to international cGMP standards. Firms seeking reliable suppliers should prioritize those with validated manufacturing facilities compliant with FDA, EMA, or other leading regulatory authorities.

Quality and Purity

Amifampridine phosphate’s therapeutic efficacy depends on high-purity APIs. Suppliers providing comprehensive Certificates of Analysis (CoA) and batch validation data are preferable.

Supply Stability

Given the niche nature of Amifampridine phosphate, ensuring supply continuity requires partnerships with suppliers capable of scaling production and maintaining inventory levels to meet demand fluctuations.

Pricing and Lead Times

Cost considerations involve evaluating offers from multiple suppliers, factoring in lead times, import tariffs, and logistical arrangements, especially when sourcing from geographically distant regions.

Emerging Suppliers and Market Trends

Innovation in API synthesis and increased regulatory scrutiny are prompting new entrants, particularly in Asia. Additionally, partnerships between pharmaceutical companies and API manufacturers are evolving, often involving licensing arrangements, joint ventures, and technology transfer agreements to secure supply chains.

The global emphasis on biosimilars and specialty drugs further accentuates the need for dependable Amifampridine phosphate suppliers, especially as patent protections for original formulations lapse or as new therapeutic indications expand.

Conclusion

Amifampridine phosphate remains a specialized API with a limited but robust supplier network primarily consisting of established manufacturers in North America, Europe, and Asia. Companies procuring this API must prioritize regulatory compliance, quality assurance, and reliable supply arrangements. Strategic partnerships with reputable suppliers such as Akros Organics, Catalytic Pharma, and EMD Serono are vital to ensuring a consistent and compliant supply chain, particularly given the critical therapeutic applications of Amifampridine phosphate.

Key Takeaways

Select reputable manufacturers with validated cGMP facilities for quality assurance.
Prioritize regulatory compliance to meet international standards and facilitate global distribution.
Assess supply chain stability to mitigate risks associated with niche pharmaceutical ingredients.
Explore emerging suppliers in Asia for cost-effective options, with due diligence on quality and regulatory status.
Establish strategic partnerships with reliable suppliers to ensure consistent, high-purity Amifampridine phosphate supply.

FAQs

1. Is Amifampridine phosphate available from major pharmaceutical ingredient suppliers?
Yes. Key suppliers like Akros Organics and Catalytic Pharma manufacture and supply Amifampridine phosphate for clinical and commercial use, adhering to strict regulatory standards.

2. What should I consider when choosing a supplier for Amifampridine phosphate?
Prioritize suppliers with validated cGMP manufacturing processes, high product purity, reliable supply chains, and compliance with regulatory standards such as FDA or EMA.

3. Are generic versions of Amifampridine phosphate available?
Generic versions are generally produced by Chinese and Indian API manufacturers, though their regulatory status and quality assurance processes vary.

4. How do regulatory requirements impact the supply of Amifampridine phosphate?
Regulatory requirements such as cGMP compliance ensure API quality, which directly impacts procurement, especially for drugs used in sensitive therapeutic areas like neuromuscular disorders.

5. What are future trends affecting supply chain dynamics for Amifampridine phosphate?
Increased demand driven by expanded indications, technological advancements in synthesis, and evolving regulatory landscapes will shape the supply chain, encouraging diversification and strategic alliances among manufacturers.

Sources

[1] U.S. Food & Drug Administration (FDA). Active Pharmaceutical Ingredients (APIs) database.
[2] European Medicines Agency (EMA). List of authorized APIs and manufacturers.
[3] Industry reports on pharmaceutical APIs, 2022.
[4] Company websites and press releases.
[5] Market analysis reports on specialty pharmaceutical ingredients.

Suppliers and packagers for generic pharmaceutical drug: AMIFAMPRIDINE PHOSPHATE