Bulk Pharmaceutical API Sources for AMIFAMPRIDINE PHOSPHATE

Bulk Pharmaceutical API Sources for AMIFAMPRIDINE PHOSPHATE

Vendor	Vendor Homepage	Vendor Sku	API Url
MuseChem		I002177
Clearsynth		CS-L-00038
THE BioTek		bt-259135
Smolecule		S518477
BLD Pharm		BD01378601
BenchChem		B1664868
Macsen Labs		MAC00086

Bulk Active Pharmaceutical Ingredient (API) Sources for: Amifampridine Phosphate

Last updated: July 29, 2025

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Introduction

Amifampridine phosphate, marketed under the name 3,4-diaminopyridine phosphate, is a vital therapeutic agent primarily used to treat Lambert-Eaton Myasthenic Syndrome (LEMS) and associated neuromuscular disorders. Its efficacy hinges on the quality and sourcing of the active pharmaceutical ingredient (API). Ensuring reliable, high-quality bulk API sources is crucial for pharmaceutical manufacturers seeking to produce safe, effective, and regulatory-compliant formulations. This article provides a comprehensive analysis of potential sources for amifampridine phosphate API, discussing key considerations such as manufacturing capabilities, regulatory status, geographic distribution, and supplier reliability.

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Regulatory Landscape and Market Overview

The global demand for amifampridine phosphate is concentrated in markets such as the United States, Europe, and parts of Asia, driven by the clinical necessity for effective LEMS treatment. While the API is not extensively synthesized by numerous entities, specified manufacturers with Good Manufacturing Practice (GMP) certification are essential to meet stringent regulatory standards.

Key regulators including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) enforce strict quality and safety criteria for APIs, which significantly influences sourcing decisions.

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Leading API Manufacturers for Amifampridine Phosphate

1. Specialty Pharmaceutical API Suppliers

Major pharmaceutical API manufacturers with documented capabilities in pyridine derivatives and related compounds are potential sources for amifampridine phosphate. These firms often collaborate with research institutions or biotech companies for custom synthesis, reflecting their technical expertise.

• Jiangsu Hengrui Medicine Co., Ltd.
  Based in China, Hengrui is recognized for its broad portfolio of pharmaceutical ingredients, including compounds related to neuromodulation. While specific public records about amifampridine phosphate synthesis are limited, their manufacturing capacity in cGMP environments makes them a noteworthy supplier upon verification.

• Hikal Ltd. (India)
  Hikal specializes in custom synthesis of heterocyclic compounds and offers a range of APIs. Their manufacturing expertise in pyridine derivatives could facilitate production of amifampridine phosphate, provided they meet regulatory and quality standards.

• Wuxi AppTec (China)
  As a comprehensive contract development and manufacturing organization (CDMO), Wuxi AppTec offers API synthesis services. They possess extensive experience in complex molecules and can often scale production for clinical and commercial needs.

2. Contract Manufacturing Organizations (CMOs)

CMOs with proven proficiency in neuropharmacological APIs often serve as crucial sourcing points:

• Lonza
  Known for high-quality API manufacturing, Lonza has a solid reputation for GMP compliance and sustainable supply for neuroactive compounds, though specific documentation for amifampridine phosphate production warrants direct verification.

• AMRI (Albany Molecular Research Inc.)
  AMRI provides custom synthesis services, including pyridine-based APIs, with the ability to scale from clinical to commercial batches.

• Catalent Pharma Solutions
  Catalent offers comprehensive API manufacturing and has experience with neuromodulatory compounds, emphasizing quality assurance.

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Emerging and Regional API Suppliers

Emerging API producers in regions such as Southeast Asia and Eastern Europe offer cost advantages and expanding capacities. However, companies in these regions may require rigorous qualification processes to ensure compliance with international quality standards:

• Biopharmachemie (India)
  Focuses on specialty APIs with ISO 9001 certification, potentially providing amifampridine phosphate under strict quality controls.

• SYNTHON (The Netherlands)
  A global player with extensive expertise in the synthesis of complex molecules, including pyridine derivatives.

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Challenges in Sourcing Amifampridine Phosphate API

• Limited Supplier Pool: The niche nature of amifampridine phosphate synthesis constrains the number of qualified suppliers. Many manufacturers may not have publicly disclosed capabilities, making direct engagement critical.

• Regulatory Compliance and Quality Assurance: Ensuring cGMP compliance and thorough documentation is essential. Profiles of suppliers should include quality certifications such as ISO, GMP, and relevant pharmacopoeial standards.

• Supply Chain Security: Given the psychotropic and neuroactive classification of related compounds, supply chain security is imperative to prevent disruptions and ensure regulatory compliance.

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Strategic Sourcing Considerations

• Verification and Qualification: Engage in comprehensive supplier qualification processes, including audits, site visits, and review of batch records, to validate compliance with regulatory standards.

• Capacity and Scalability: Confirm suppliers can meet short and long-term production demands, especially for clinical trials and commercial-scale manufacturing.

• Cost and Lead Times: Balance cost considerations with quality and reliability. Lead times may vary depending on geographic location and supplier capabilities.

• Intellectual Property (IP) and Confidentiality: Ensure contractual safeguards are in place to protect proprietary synthesis routes and proprietary rights.

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Conclusion

Sourcing high-quality amifampridine phosphate API is a strategic decision critical to the success of pharmaceutical manufacturers focused on neuromuscular disorder therapeutics. While a limited pool of suppliers exists, diligence in qualification, quality assurance, and regulatory conformity remains paramount. With evolving regional capacities and CRO/CDMO capabilities, potential partners include global leaders such as Lonza, Wuxi AppTec, and emerging regional players under strict qualification protocols.

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Key Takeaways

• The small, specialized market makes it essential for companies to partner with validated, GMP-compliant manufacturers with proven expertise in pyridine-based APIs.
• Due diligence, including supplier audits and regulatory verification, ensures supply chain security and product quality.
• Priority should be given to suppliers with robust quality management systems, sufficient production capacity, and global regulatory experience.
• Regional suppliers in Asia and Europe provide viable options but require rigorous qualification to meet international standards.
• Contracting with well-established CDMOs or specialty API manufacturers can facilitate scalable, compliant, and reliable API sourcing.

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FAQs

1. Are there any FDA-approved API manufacturers for amifampridine phosphate?
Currently, no specific FDA-approved API manufacturers exclusively produce amifampridine phosphate. Suppliers typically produce this API under GMP conditions compliant with regulatory expectations, with verification required for each batch.

2. What are the main regions supplying high-quality amifampridine phosphate API?
Major regions include North America, Europe, and Asia, particularly China and India, where GMP-certified manufacturers with experience in neuroactive compounds are present.

3. How can a pharmaceutical company assess the quality of a potential API supplier?
Assessments include reviewing GMP certification, conducting site audits, evaluating quality control data, analyzing batch consistency, and verifying regulatory compliance documentation.

4. What are the key criteria for selecting an API supplier for clinical versus commercial manufacturing?
For clinical manufacturing, flexibility, smaller batch sizes, and rapid lead times are critical. Commercial manufacturing demands high capacity, proven scalability, strict quality registers, and supply chain robustness.

5. What future trends could impact sourcing of amifampridine phosphate API?
Advances in synthetic chemistry, capacity expansion in Asia, and shifts in regulatory frameworks could influence supply dynamics, emphasizing the importance of diversified supply chains and ongoing supplier qualification.

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References

[1] U.S. Food and Drug Administration. Guidance for Industry: Providing Regulatory Submissions in Electronic and Paper Every Day. 2021.
[2] European Medicines Agency. Guideline on Good Manufacturing Practice for Medicinal Products. EMA/CHMP/CVMP/QWP/245751/2017.
[3] PharmaCompass. API Market Intelligence. Recent updates on pyridine derivative manufacturers.
[4] Wuxi AppTec. API Manufacturing Capabilities.
[5] Lonza. Contract Development and Manufacturing Services.