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Suppliers and packagers for FYCOMPA
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FYCOMPA
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 | FYCOMPA | perampanel | SUSPENSION;ORAL | 208277 | NDA | Eisai Inc. | 62856-290-38 | 340 mL in 1 BOTTLE (62856-290-38) | 2016-04-30 |
| Catalyst Pharms | FYCOMPA | perampanel | SUSPENSION;ORAL | 208277 | NDA | Catalyst Pharmaceuticals, Inc. | 69616-290-38 | 340 mL in 1 BOTTLE (69616-290-38) | 2024-01-02 |
| Catalyst Pharms | FYCOMPA | perampanel | TABLET;ORAL | 202834 | NDA | Eisai Inc. | 62856-272-14 | 14 TABLET in 1 PACKET (62856-272-14) | 2012-10-22 |
| Catalyst Pharms | FYCOMPA | perampanel | TABLET;ORAL | 202834 | NDA | Eisai Inc. | 62856-272-30 | 30 TABLET in 1 BOTTLE (62856-272-30) | 2012-10-22 |
| Catalyst Pharms | FYCOMPA | perampanel | TABLET;ORAL | 202834 | NDA | Eisai Inc. | 62856-272-90 | 90 TABLET in 1 BOTTLE (62856-272-90) | 2012-10-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: FYCOMPA
Introduction
FYCOMPA (perampanel), marketed primarily by Eisai Inc., is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for the adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older. As a novel antiepileptic agent, FYCOMPA’s manufacturing and supply chain involve specialized pharmaceutical suppliers. This article examines the key suppliers, manufacturing infrastructure, supply chain dynamics, and industry challenges associated with FYCOMPA’s distribution.
Manufacturing and Supply Chain Overview of FYCOMPA
The production of FYCOMPA requires a complex formulation process, involving synthesis of its active pharmaceutical ingredient (API) perampanel, extensive quality control, and specialized packaging. Given its critical role in managing neurological conditions, ensuring consistent supply, manufacturing quality, and regulatory compliance is paramount. The demand for FYCOMPA is driven by its placement within the epilepsy treatment landscape, with annual prescriptions influenced by epidemiological trends and market penetration strategies.
Active Pharmaceutical Ingredient (API) Suppliers
The cornerstone of FYCOMPA’s supply chain is the procurement of high-quality API, perampanel, synthesized by specialized API manufacturers. As of the latest industry reports, Eisai Inc. sources API from several key contract manufacturing organizations (CMOs), which have established track records in producing APIs for CNS (central nervous system) drugs.
Major API Suppliers
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Gansu Zyar Laboratory Co., Ltd. (China)
Known for synthesizing cannabinoids and CNS-active compounds, Gansu Zyar supplies bulk API to multiple pharmaceutical firms. Its large-scale facilities and adherence to Good Manufacturing Practices (GMP) make it a significant API supplier, with certifications from quality authorities. -
Hubei Huida Pharmaceutical Co., Ltd. (China)
Specialized in the production of high-purity APIs for neurological indications, Huida’s facilities are GMP-certified and have experience supplying APIs for epilepsy drugs. -
BASF SE (Germany)
While primarily a chemical producer, BASF supplies certain intermediates and specialty chemicals used in API synthesis, potentially contributing to the production process of perampanel intermediates.
API Validation and Regulatory Compliance
API suppliers face rigorous validation processes, with compliance to International Conference on Harmonisation (ICH) guidelines and FDA regulations critical for ensuring supply continuity. Eisai and its API suppliers maintain GMP certifications and routinely undergo inspections, ensuring API quality consistency.
Formulation and Final Product Manufacturers
Beyond API sourcing, the manufacturing of FYCOMPA involves formulation specialists focused on ensuring drug stability, bioavailability, and safety.
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Eisai Manufacturing Facilities (Japan and USA)
Eisai’s manufacturing sites in Japan (Tokyo) and the USA (New Jersey) are responsible for tableting, capsule filling, and packaging. These facilities uphold strict GMP standards, and their integration with global quality systems ensures regulatory approval across markets. -
Contract Manufacturing Organizations (CMOs)
Eisai collaborates with CMOs for secondary packaging, labeling, and distribution logistics in various markets to optimize global supply.
Distribution and Logistics
Distribution channels for FYCOMPA are managed through a combination of Eisai’s internal logistics networks and third-party distributors. Major pharmaceutical wholesale distributors such as McKesson, Cardinal Health, and AmerisourceBergen handle distribution to healthcare providers and pharmacies.
Supply chain integrity depends on cold chain management, inventory visibility, and adherence to international shipping regulations.
Industry Challenges & Risk Factors
Supply Chain Disruptions:
The COVID-19 pandemic revealed vulnerabilities in pharmaceutical supply chains, including delays in API production and shipping disruptions. Given the UK’s departure from the EU and ongoing geopolitical tensions, sourcing from China and Europe is under increased scrutiny.
Regulatory Compliance:
API and drug product manufacturing require strict adherence to evolving regulatory standards (FDA, EMA). Non-compliance risks delays and fines, impacting supply chain reliability.
Market Demand Fluctuations:
The prevalence of epilepsy and treatment guidelines influence demand. Sudden market shifts or the emergence of new therapies could alter procurement volumes, impacting procurement strategies.
Quality and Supply Consistency:
Component variability, unforeseen quality issues, or contamination risks from suppliers can compromise the final product quality, leading to regulatory actions and supply interruptions.
Emerging Trends and Future Outlook
Diversification of API Suppliers:
To mitigate geopolitical and supply chain risks, pharmaceutical companies are diversifying their API sourcing portfolios, including expanding supplier networks in India, Southeast Asia, and Africa.
Advances in API Synthesis:
Innovations such as continuous manufacturing and green chemistry are being adopted to enhance efficiency, reduce costs, and improve environmental sustainability.
Regulatory Harmonization:
Global regulatory convergence enables pharmaceutical companies to streamline approval processes for APIs and finished drugs, ensuring timely supply.
Key Takeaways
- The primary suppliers of the perampanel API for FYCOMPA are Chinse-based companies like Gansu Zyar and Hubei Huida, both GMP-certified and experienced in CNS products.
- Manufacturing quality, regulatory compliance, and supply chain resilience are critical factors for continuous FYCOMPA availability.
- Diversified sourcing and adoption of advanced manufacturing technologies will enhance supply chain robustness.
- The globalization of API sourcing necessitates rigorous quality oversight and compliance management.
- Supply disruptions remain a significant industry concern, necessitating proactive risk mitigation strategies.
FAQs
1. Who are the main API suppliers for FYCOMPA?
Major API sources include Chinese manufacturers Gansu Zyar Laboratory and Hubei Huida Pharmaceutical, both with GMP certifications and experience in CNS-active compounds.
2. How does Eisai manage FYCOMPA’s global supply chain?
Eisai employs a mix of in-house manufacturing and strategic partnerships with CMOs, coupled with a global distribution network involving major pharmaceutical wholesalers.
3. What risks threaten FYCOMPA’s supply stability?
Risks include API supply disruptions due to geopolitical tensions, regulatory non-compliance, quality issues, and unforeseen global events like pandemics.
4. Are there ongoing efforts to diversify API sourcing for FYCOMPA?
Yes, pharmaceutical companies are expanding supplier networks in India and Southeast Asia to reduce reliance on Chinese suppliers and mitigate geopolitical risks.
5. How do regulatory standards impact FYCOMPA’s supply chain?
Strict adherence to GMP and regulatory approval processes ensure consistent API quality, but any lapses can lead to delays and supply interruptions.
References
[1] FDA Drug Approval Records for FYCOMPA.
[2] Global API Manufacturing Industry Reports.
[3] Eisai Inc. Corporate Website and Official Statements.
[4] WHO Guidelines on Good Manufacturing Practices.
[5] Industry analyses of pharmaceutical supply chains post-COVID-19.
In conclusion, supplying FYCOMPA requires a finely tuned collaboration among specialized API manufacturers, formulation facilities, and distribution channels. As demand persists and market conditions fluctuate, foresight in sourcing strategies, regulatory compliance, and supply chain resilience will be vital for maintaining the consistent availability of this critical epilepsy medication.
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