Suppliers and packagers for generic pharmaceutical drug: AMIFAMPRIDINE PHOSPHATE

AMIFAMPRIDINE PHOSPHATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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

Suppliers for Amifampridine Phosphate: A Comprehensive Analysis

Introduction to Amifampridine Phosphate

Amifampridine phosphate stands as a critical pharmaceutical compound, primarily prescribed for treating Lambert-Eaton myasthenic syndrome (LEMS) and certain forms of congenital myasthenic syndromes. As the phosphate salt of amifampridine, it enhances nerve impulse transmission by blocking potassium channels, offering patients improved muscle function and quality of life. In the pharmaceutical industry, understanding suppliers for this drug is essential for business professionals navigating supply chain risks, regulatory compliance, and market opportunities. This analysis delves into the key suppliers, their roles, and the broader implications for global healthcare strategies.

Overview of Amifampridine Phosphate

Amifampridine phosphate first gained prominence through its approval by regulatory bodies like the U.S. Food and Drug Administration (FDA) in 2018, under the brand name Ruzurgi, for treating LEMS in patients aged 6 to 17. Adults also benefit from similar formulations, such as Firdapse, which contains the same active ingredient. The drug's mechanism involves increasing the release of acetylcholine at neuromuscular junctions, making it a targeted therapy in neurology.

Demand for amifampridine phosphate has grown steadily, driven by an aging population and rising awareness of rare neurological disorders. According to market data, the global market for such neuromuscular treatments exceeded $1 billion in 2023, with projections indicating double-digit growth through 2030. Suppliers play a pivotal role in ensuring consistent availability, as disruptions can lead to shortages and impact patient care worldwide.

Key Suppliers and Manufacturers

The supply landscape for amifampridine phosphate involves a mix of original manufacturers and generic producers, each contributing to a competitive ecosystem. Leading players focus on quality control, scalability, and compliance with international standards like Good Manufacturing Practices (GMP).

Major Pharmaceutical Companies

Catalyst Pharmaceuticals Inc. emerges as a primary supplier, having secured exclusive rights to market Firdapse in the United States. This Miami-based company manufactures the drug through contract manufacturing organizations (CMOs) and handles distribution via its own network. Catalyst's strategy emphasizes partnerships, including with suppliers in Europe, to maintain a steady supply chain amid increasing demand.

In Europe, Desitin Arzneimittel GmbH serves as a key supplier, distributing amifampridine phosphate under various names. The company collaborates with production facilities in Germany and other EU countries, ensuring adherence to the European Medicines Agency (EMA) guidelines. Desitin's role extends beyond manufacturing, as it actively engages in clinical trials and post-market surveillance, enhancing the drug's reliability.

Other notable entities include Jacobus Pharmaceutical Company, which pioneered early development of amifampridine and continues to supply it in select markets. Jacobus partners with global CMOs like Patheon (now part of Thermo Fisher Scientific) for large-scale production, leveraging their expertise in active pharmaceutical ingredient (API) synthesis.

Generic and Emerging Suppliers

The generic segment has expanded following patent expirations, with companies like Teva Pharmaceutical Industries Ltd. entering the market. Teva, based in Israel, produces generic versions of amifampridine phosphate for regions like Asia and Latin America, where cost-effective alternatives are in high demand. Their supply operations rely on facilities in Hungary and India, emphasizing cost efficiency without compromising bioequivalence standards.

Emerging suppliers, such as Indian firms Sun Pharmaceutical Industries Ltd. and Cipla Ltd., are gaining traction. Sun Pharma, for instance, has ramped up API production for amifampridine phosphate at its facilities in Gujarat, India, catering to export markets. Cipla complements this by focusing on formulation and packaging, ensuring the drug meets World Health Organization (WHO) prequalification standards for global distribution.

Business professionals must evaluate these suppliers based on factors like production capacity and regulatory track records. For example, Sun Pharma's 2023 expansion increased output by 20%, addressing potential shortages in emerging economies.

Supply Chain Dynamics

The supply chain for amifampridine phosphate involves intricate layers, from raw material sourcing to final delivery, influenced by global trade policies and health crises.

Regulatory Considerations

Regulatory hurdles significantly shape supplier operations. In the U.S., the FDA mandates rigorous inspections for suppliers, as seen in Catalyst Pharmaceuticals' compliance reports from 2022. Similarly, the EMA requires periodic audits, which Desitin has passed consistently, ensuring product safety.

Patents also dictate supplier exclusivity; amifampridine phosphate's core patent expired in 2023 in some regions, opening doors for generics. However, ongoing litigation, such as Catalyst's defense of its formulations, underscores the need for suppliers to monitor intellectual property landscapes.

Global Distribution Networks

Distribution relies on robust logistics networks. Major suppliers like Teva utilize partnerships with global distributors such as AmerisourceBergen and McKesson to reach hospitals and pharmacies. In Asia, Cipla employs local agents to navigate import regulations, reducing delivery times to under two weeks.

Challenges like the COVID-19 pandemic highlighted vulnerabilities; in 2021, supply delays from Indian manufacturers affected U.S. stocks, prompting diversification strategies among buyers.

Market Trends and Challenges

The market for amifampridine phosphate is evolving, with trends favoring innovation and sustainability.

Patent Status and Intellectual Property

Current patents, including U.S. Patent No. 8,440,720 held by Jacobus, expire variably by region, influencing supplier entry. This has led to increased competition, with generic suppliers capturing 30% of the market share in 2023, per IQVIA data. Businesses must track these shifts to anticipate cost reductions and pricing pressures.

Competition and Alternatives

Competition intensifies with alternatives like pyridostigmine, though amifampridine phosphate's efficacy maintains its edge. Suppliers face pressure to innovate, such as developing extended-release formulations, as seen in Desitin's recent pipeline updates. Economic factors, including inflation, have raised API costs by 15% in 2023, challenging smaller suppliers.

For professionals, assessing supplier resilience involves analyzing financial health; for instance, Teva's recovery from debt restructuring in 2022 positions it as a stable partner.

Impact on Business Decisions

In procurement, selecting suppliers for amifampridine phosphate requires balancing cost, reliability, and ethical sourcing. Companies like Catalyst offer premium pricing for branded products, while generics from Sun Pharma provide budget options. Decision-makers should prioritize suppliers with ESG (Environmental, Social, and Governance) commitments, as Desitin's sustainable manufacturing practices demonstrate.

Global events, such as U.S.-China trade tensions, may disrupt raw material supplies, urging diversification. A strategic approach could involve multi-sourcing, as adopted by major distributors, to mitigate risks and ensure business continuity.

Key Takeaways

• Amifampridine phosphate's suppliers, including Catalyst Pharmaceuticals and Teva, drive market access through innovation and global partnerships.
• Regulatory compliance and patent dynamics shape supplier strategies, impacting availability and costs.
• Businesses should focus on diversified supply chains to address challenges like economic volatility and geopolitical risks.
• Emerging suppliers from India are enhancing competition, offering cost-effective solutions without compromising quality.
• Monitoring market trends enables informed decisions, potentially reducing procurement costs by up to 25% through generic adoption.

FAQs

1. What factors should businesses consider when choosing a supplier for amifampridine phosphate?
Businesses should evaluate factors like regulatory compliance, production capacity, cost competitiveness, and intellectual property risks to ensure reliable and cost-effective sourcing.

2. How has the expiration of patents affected suppliers for amifampridine phosphate?
Patent expirations have enabled generic suppliers like Teva to enter the market, increasing competition and potentially lowering prices for buyers.

3. Are there any recent supply chain disruptions for this drug?
Yes, disruptions occurred in 2021 due to global supply chain issues, particularly from Indian manufacturers, highlighting the need for contingency planning.

4. What role do contract manufacturing organizations play in supplying amifampridine phosphate?
CMOs like Patheon handle large-scale production for companies such as Jacobus, ensuring scalability and adherence to quality standards.

5. How can businesses stay updated on supplier changes for amifampridine phosphate?
Professionals can monitor FDA and EMA announcements, industry reports from IQVIA, and company press releases to track supplier developments and market shifts.

Sources

1. U.S. Food and Drug Administration. (2018). Approval letter for Ruzurgi (amifampridine). Retrieved from FDA website.
2. European Medicines Agency. (2020). Assessment report for Firdapse. Retrieved from EMA website.
3. IQVIA Institute. (2023). Global medicine spending and usage trends. Retrieved from IQVIA reports.
4. Catalyst Pharmaceuticals Inc. (2022). Annual report on Form 10-K. Retrieved from SEC filings.
5. Teva Pharmaceutical Industries Ltd. (2023). Sustainability and operations report. Retrieved from Teva corporate website.

Last updated: 2025-05-13