Bulk Pharmaceutical API Sources for FYCOMPA

Bulk Pharmaceutical API Sources for FYCOMPA

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-14745
AbaChemScene		CS-1160
Key Organics/BIONET		CH-0056
AKos Consulting & Solutions		AKOS016340421
Molport		MolPort-035-395-270
Hangzhou APIChem Technology		AC-27375

Bulk Active Pharmaceutical Ingredient (API) Sources for FYCOMPA (Perampanel)

Last updated: July 29, 2025

Introduction

FYCOMPA (perampanel) is a once-daily, oral antiepileptic drug approved by the U.S. Food and Drug Administration (FDA) for the adjunct treatment of partial-onset seizures and primary generalized tonic-clonic seizures in patients with epilepsy. As a novel, non-competitive AMPA receptor antagonist, perampanel's manufacturing relies on the availability of high-quality bulk active pharmaceutical ingredients (APIs). Ensuring a reliable, cost-effective, and compliant supply chain for API procurement is critical for pharmaceutical companies, generic manufacturers, and contract manufacturing organizations (CMOs) engaged in perampanel production.

This review provides a comprehensive analysis of the current and potential sources for bulk API procurement of perampanel, emphasizing supplier credibility, manufacturing capacity, regulatory compliance, and geopolitical considerations.

Manufacturing Background of Perampanel API

Perampanel’s synthesis involves complex chemical processes requiring advanced expertise and facilities compliant with Good Manufacturing Practices (GMP). The API's manufacturing process, developed and patented by Eisai, involves multiple chemical steps starting from commercially available precursors. Given the intricate synthesis, API suppliers must maintain stringent quality controls to meet pharmacopoeial standards such as USP, EP, or JP.

Global API Suppliers for Perampanel

1. Original Manufacturer (Eisai Co., Ltd.)

Eisai remains the primary patent holder and original supplier of perampanel API, supporting its proprietary formulations. While Eisai’s direct API supply is predominant during patent exclusivity, access is usually limited to authorized partners or large-scale licensees. The company maintains high-quality standards aligned with regulatory requirements, but initial exclusive supply constrains market competition.

2. Contract Manufacturing Organizations (CMOs)

Post-patent expiry or in cases of licensing agreements, several CMOs have emerged as prominent API suppliers. These firms often operate in regions with robust manufacturing capabilities and regulatory compliance frameworks.

Key CMOs include:

• Piramal Pharma Solutions
  Based in India, Piramal has extensive experience in complex API manufacturing, including CNS-active compounds. Their GMP-compliant facilities have the capacity to produce high-quality perampanel API, supported by rigorous quality assurance processes.

• Clariant Chemicals (India) Ltd.
  Although primarily known for specialty chemicals, Clariant has diversified into pharmaceutical intermediates and APIs. They possess capable infrastructure for APIs like perampanel, subject to further qualification.

• Hovione
  A Portuguese-based firm with a global presence, Hovione specializes in complex APIs and intermediates. They possess the necessary GMP certifications and a history of supplying APIs for CNS indications.

• LTS Lohmann Therapy Systems GmbH
  As a contract manufacturer with a focus on specialty APIs, LTS Lohmann's manufacturing plants meet international standards, including rigorous validation procedures, making them a potential supplier.

3. Regional and Emerging Suppliers

• China-based API Manufacturers:
  China hosts numerous API manufacturers capable of producing perampanel, benefitting from competitive pricing and large-scale manufacturing capacity. Notably, companies such as Zhejiang Hisun Pharmaceutical Co., Ltd. or Shanghai Pharmaceuticals Holding Co., Ltd. have expanded into complex CNS APIs, with GMP certifications aligning with international standards.

• India-based Manufacturers:
  Firms like Sun Pharmaceutical Industries Ltd. and Aurobindo Pharma have established strong API manufacturing units capable of producing perampanel APIs, often at reduced costs with validated quality.

4. Potential for New Entrants and Generics

As patent exclusivity wanes, a wave of generic manufacturers may seek API licensing or develop proprietary synthesis routes. The entry of qualified manufacturers into the API supply chain post-approval or patent settlement significantly enhances supply security and competitive pricing.

Criteria for Selecting API Suppliers

Pharmaceutical companies sourcing perampanel API must consider:

• Regulatory Compliance: GMP certification, regulatory authority approvals (FDA, EMA, PMDA, etc.)
• Manufacturing Capacity & Scalability: Ability to meet current and projected demand
• Quality Assurance & Control: Consistency, purity, and batch-to-batch reproducibility
• Supply Chain Reliability: Geopolitical stability, logistics, and lead times
• Cost & Pricing Structure: Competitive pricing without compromising quality
• Intellectual Property (IP) & Licensing: Patent status and licensing agreements

Regulatory Considerations and Quality Standards

For API suppliers, adherence to cGMP (current Good Manufacturing Practices) is mandatory for FDA and EMA approval. Suppliers should possess valid certifications from recognized authorities, including:

• FDA (U.S. Food and Drug Administration)
• EMA (European Medicines Agency)
• PMDA (Pharmaceuticals and Medical Devices Agency, Japan)

Furthermore, suppliers must routinely provide comprehensive batch documentation, stability data, and analytical verification to ensure consistent API quality.

Supply Chain Risks and Mitigation Strategies

Dependence on a limited set of API sources raises risks, including geopolitical instability, quality lapses, and regulatory changes. Diversification across multiple qualified suppliers and regions is critical. Establishing supply agreements with high-volume, GMP-certified manufacturers mitigates potential disruptions.

Strategic inventory management and early engagement with suppliers during early development phases help secure a steady API pipeline.

Future Outlook

The expiration of perampanel’s primary patents in various jurisdictions is likely to increase the number of API manufacturers, fostering competition and driving down costs. Ongoing validation and qualification of emerging suppliers from India and China are expected, further expanding options for pharmaceutical companies.

Investments in advanced manufacturing capabilities, regulatory compliance, and technological innovation will remain central to maintaining a secure supply of high-quality API.

Key Takeaways

• Major API supply sources for FYCOMPA include original manufacturer Eisai and licensed CMOs, with regional manufacturers in India and China emerging as significant players.
• Ensuring suppliers have valid GMP certifications and regulatory approvals is vital for maintaining compliance standards.
• Diversification of API sources mitigates supply chain risks amidst geopolitical and regulatory uncertainties.
• The global paddle of generic manufacturing following patent expiration expands supply options, often reducing costs.
• Strategic alliances and early qualification of multiple suppliers are critical for uninterrupted API procurement.

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FAQs

1. How does patent expiry impact API sourcing for FYCOMPA?
Patent expiry opens the market to generic manufacturers, increasing the number of API suppliers. This enhances supply security, introduces competitive pricing, and encourages innovation in manufacturing processes.

2. What are the main regulatory considerations when sourcing perampanel API?
Suppliers must hold GMP certifications recognized by agencies like FDA, EMA, or PMDA. Consistent quality, batch documentation, impurity profiles, and stability data are critical for regulatory compliance.

3. Are Chinese and Indian manufacturers reliable sources for perampanel API?
Yes, many Chinese and Indian manufacturers have achieved GMP certification and have established track records, making them reliable sources if thoroughly qualified and validated.

4. How does geopolitical stability influence API supply choices?
Regional stability affects logistics, regulatory acceptance, and long-term supply reliability. Diversifying suppliers across different geographies reduces dependency on any single region.

5. What strategies can companies adopt to ensure uninterrupted API supply?
Developing relationships with multiple qualified suppliers, maintaining safety stocks, early supplier qualification, and monitoring geopolitical developments are key strategies.

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References

[1] FDA Drug Database, FYCOMPA (perampanel) approval details.
[2] Eisai Co., Ltd. – Patent and manufacturing disclosures.
[3] Contract Manufacturing Organizations' Public Certifications and Capabilities.
[4] Global API Manufacturing Sector Reports, 2022.
[5] European Medicines Agency (EMA) GMP Database.