Suppliers and packagers for firdapse

firdapse

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 the Pharmaceutical Drug: FIRDAPSE

Last updated: July 30, 2025

Introduction

Firdapse (amifampridine phosphate) is a prescribing medication primarily indicated for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS), a rare autoimmune disorder affecting neuromuscular transmission. With its specific therapeutic niche, Firdapse's supply chain encompasses a limited number of authorized manufacturers and distributors. This article explores the key suppliers involved in producing and distributing Firdapse, providing insights into their roles, regulatory status, and strategic significance within the pharmaceutical landscape.

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Overview of FIRDAPSE Manufacturing and Supply Chain

Firdapse is developed and marketed by Catalyst Pharmaceuticals (Catalyst), a leading specialty pharmaceutical company. The product's rarity and specialized indication influence its manufacturing complexity and distribution channels, often limited to select authorized suppliers and specialty pharmacies. Ensuring product authenticity, quality assurance, and adherence to regulatory standards remains pivotal within its supply chain.

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Primary Suppliers and Manufacturers

1. Catalyst Pharmaceuticals

Catalyst Pharmaceuticals is the exclusive marketer of Firdapse worldwide, with manufacturing operations conducted through licensed contract manufacturing organizations (CMOs). The company holds the necessary regulatory approvals, including FDA approval in the United States (under the brand name Firdapse) and approvals in other jurisdictions.

• Role: Catalyst oversees the marketing and distribution of Firdapse, engaging with licensed manufacturing facilities to ensure product quality, consistency, and regulatory compliance.
• Manufacturing: As of the latest available data, Catalyst collaborates with third-party CMOs for production, subject to strict quality control and Good Manufacturing Practices (GMP).

2. Contract Manufacturing Organizations (CMOs)

Given Firdapse’s complex synthesis and stringent quality controls, Catalyst contracts specialized CMOs for its production. The actual manufacturing sites are typically proprietary and subject to confidentiality agreements, but general information indicates involvement of:

• Large-Scale Pharmaceutical Contract Manufacturers: These entities possess the capacity, GMP certification, and technical expertise needed to produce amifampridine phosphate at scale.
• Locations: CMOs are often located in regions with established pharmaceutical manufacturing infrastructure such as the United States, Europe, or Asia.

Note: Specific CMO identities are generally not publicly disclosed due to confidentiality agreements, but their functions are critical to ensuring consistent supply.

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Regulatory and Distribution Channels

Firdapse’s distribution relies heavily on licensed specialty pharmacies, which act as authorized providers for patients—particularly in cases requiring stringent handling and verification due to the drug’s orphan status and regulatory designations.

• Authorized Distributors: Catalyst Pharmaceuticals collaborates with certified specialty pharmacy networks authorized to dispense Firdapse in accordance with prescriptions and regulatory regulations.
• Supply Chain Integrity: To prevent counterfeiting and ensure quality, only approved distributors and pharmacies are authorized to handle Firdapse. Some of the primary distributors include prominent specialty pharmacy chains such as Diplomat Pharmacy and CVS Specialty.

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Key Challenges in Supply and Distribution

• Limited Manufacturing Capacity: Due to the niche market, manufacturing capacity for Firdapse remains limited, making global supply sensitive to manufacturing disruptions.
• Regulatory Constraints: Strict control over distribution, including import/export restrictions and patient-specific dispensing, further constrains supply flexibility.
• Market Demand: As the only FDA-approved treatment for LEMS, demand is concentrated and predictable—yet supply chain resilience depends heavily on manufacturing continuity.

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Emerging and Future Suppliers

The current supply chain’s exclusivity underscores the potential for new entrants to manufacture amifampridine phosphate, provided they obtain necessary regulatory approvals. Possible future suppliers include:

• Generic Manufacturers: With patent expiries and regulatory pathways for generics, additional manufacturers may seek approval to produce generic amifampridine phosphate.
• Biosimilar Development: Although biosimilars are more suitable for biologics, small-molecule drug manufacturing may see increased competition as patents lapse.

However, no significant new entrants have publicly announced production of Firdapse or its equivalent at this stage.

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Market and Regulatory Considerations

Regulatory agencies like the FDA and EMA impose rigorous standards for manufacturers, ensuring only compliant facilities produce Firdapse. The drug’s orphan designation confers certain exclusivity benefits, impacting the timing and likelihood of new suppliers entering the field.

Key points:

• FDA Exclusivity: Catalyst’s patent and market exclusivity influence the entry of generics.
• Importation and Compounding: In some regions, compounding pharmacies may produce amifampridine, but these are not supply chain formalities and often lack regulatory approval, risking quality issues.

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Conclusion

Firdapse's supply chain is characterized by a small number of highly regulated manufacturing and distribution entities, primarily led by Catalyst Pharmaceuticals and its contracted CMOs. The specialized nature of the drug, combined with regulatory protections, limits the number of authorized suppliers. While there is potential for new entrants as patents expire, currently, supply hinges on existing licensed manufacturers and authorized specialty pharmacies, emphasizing the importance of quality, regulatory compliance, and supply chain resilience for this niche pharmaceutical.

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Key Takeaways

• Catalyst Pharmaceuticals is the central entity overseeing the production and marketing of Firdapse, working with contracted CMOs for manufacturing.
• The supply chain is highly regulated, with distribution managed through certified specialty pharmacies to ensure product authenticity and safety.
• The limited number of manufacturers and distributors underscores the importance of supply chain stability, especially given the drug’s orphan status.
• Future supply expansion may occur if patents expire or if generics gain approval, but regulatory approval remains a significant barrier.
• Business professionals should monitor regulatory developments and manufacturing partnerships to understand supply risks and opportunities.

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FAQs

1. Who are the current manufacturers producing Firdapse?
Firdapse is produced by contract manufacturing organizations partnered with Catalyst Pharmaceuticals. Specific manufacturer identities are confidential, but they are GMP-certified entities specializing in small-molecule pharmaceutical production.

2. Can other companies produce generic versions of amifampridine phosphate?
Potentially, but approval depends on regulatory pathways, patent status, and manufacturing capabilities. Currently, no generics are approved or widely available.

3. How does Catalyst Pharmaceuticals ensure supply chain security?
Through careful vetting of manufacturing partners, strict GMP compliance, and partnerships with licensed specialty pharmacies to maintain distribution integrity.

4. Are there risks of supply shortages for Firdapse?
Yes, due to limited manufacturing capacity, regulatory hurdles, and reliance on contracted CMOs. Supply disruptions could impact patient access.

5. Is Firdapse available outside the United States?
Yes, regulatory approvals exist in regions such as the European Union, but availability depends on local licensing and distribution agreements, often via local authorized entities.

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References

1. Catalyst Pharmaceuticals. "Firdapse (Amifampridine Phosphate) – Product Information." [2023]
2. U.S. Food and Drug Administration. "Firdapse NDA approval documentation." [2023]
3. European Medicines Agency. "Marketing Authorization for Firdapse." [2023]
4. Industry reports on pharmaceutical manufacturing and supply chains.
5. Patent and regulatory databases concerning amifampridine phosphate.