Suppliers and packagers for perampanel

perampanel

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Msn	PERAMPANEL	perampanel	SUSPENSION;ORAL	218152	ANDA	Novadoz Pharmaceuticals LLC	72205-071-79	340 mL in 1 BOTTLE (72205-071-79)	2025-07-11
Msn	PERAMPANEL	perampanel	TABLET;ORAL	218178	ANDA	Novadoz Pharmaceuticals LLC	72205-221-30	30 TABLET, FILM COATED in 1 BOTTLE (72205-221-30)	2025-11-25
Msn	PERAMPANEL	perampanel	TABLET;ORAL	218178	ANDA	Novadoz Pharmaceuticals LLC	72205-221-90	90 TABLET, FILM COATED in 1 BOTTLE (72205-221-90)	2025-11-25
Msn	PERAMPANEL	perampanel	TABLET;ORAL	218178	ANDA	Novadoz Pharmaceuticals LLC	72205-222-30	30 TABLET, FILM COATED in 1 BOTTLE (72205-222-30)	2025-11-25
Msn	PERAMPANEL	perampanel	TABLET;ORAL	218178	ANDA	Novadoz Pharmaceuticals LLC	72205-222-90	90 TABLET, FILM COATED in 1 BOTTLE (72205-222-90)	2025-11-25
Msn	PERAMPANEL	perampanel	TABLET;ORAL	218178	ANDA	Novadoz Pharmaceuticals LLC	72205-223-30	30 TABLET, FILM COATED in 1 BOTTLE (72205-223-30)	2025-11-25

PERAMPANEL API AND KEY INTERMEDIATE SUPPLIERS

Last updated: February 19, 2026

This report analyzes the supply chain landscape for perampanel, a selective, non-competitive AMPA receptor antagonist. Key active pharmaceutical ingredient (API) and critical intermediate manufacturers are identified, alongside an overview of their geographic distribution and potential implications for supply chain resilience.

WHO ARE THE PRIMARY API SUPPLIERS FOR PERAMPANEL?

The primary active pharmaceutical ingredient (API) for perampanel is manufactured by a limited number of entities. Eisai Co., Ltd., the originator and marketing authorization holder, maintains significant control over its supply chain. External manufacturing is typically outsourced to contract development and manufacturing organizations (CDMOs) with specialized capabilities.

• Eisai Co., Ltd.: As the innovator, Eisai likely operates internal manufacturing or directs its captive production facilities. Their role as the primary source ensures quality control and intellectual property protection.
• Contract Development and Manufacturing Organizations (CDMOs): While specific public disclosures of CDMOs manufacturing perampanel API are scarce due to proprietary agreements, established pharmaceutical ingredient manufacturers with cGMP (current Good Manufacturing Practice) compliance are the likely partners. These entities often possess advanced synthesis capabilities and regulatory experience.

Geographic concentration for API manufacturing often favors regions with established pharmaceutical infrastructure and skilled labor. Asia, particularly China and India, represents a significant portion of global pharmaceutical API production due to cost advantages and robust manufacturing ecosystems. Europe also hosts specialized API manufacturers, often focusing on complex syntheses or niche therapeutic areas.

WHAT ARE THE KEY INTERMEDIATES IN PERAMPANEL SYNTHESIS?

The synthesis of perampanel involves several complex chemical steps, requiring specialized intermediates. While a comprehensive breakdown of proprietary synthetic routes is not publicly available, published literature and patent filings indicate the involvement of several key chemical building blocks.

CRITICAL INTERMEDIATES IDENTIFIED FROM PATENT LITERATURE

Analysis of patents related to perampanels synthesis suggests the following key intermediates are likely to be critical:

• 2-Phenylpyridine Derivatives: These form a core structural element of the perampanel molecule. Modifications at specific positions on the phenyl or pyridine rings are crucial for achieving the desired pharmacological activity.
• Substituted Benzoyl Chlorides: These reagents are employed to introduce the benzoyl moiety, a significant functional group in perampanel. The precise substitution patterns on the benzene ring of the benzoyl chloride are critical.
• Amine Building Blocks: The introduction of the tertiary amine group is a late-stage step in the synthesis. Specific substituted piperazine derivatives or their precursors are likely utilized.

The synthesis often involves chiral resolution or asymmetric synthesis steps to obtain the desired enantiomer, as perampanel is administered as a single enantiomer. This adds complexity to the intermediate supply chain, requiring manufacturers capable of producing enantiomerically pure compounds or intermediates.

WHERE ARE THESE INTERMEDIATES PRIMARILY MANUFACTURED?

The manufacturing of pharmaceutical intermediates is more geographically dispersed than API production. Companies specializing in custom synthesis and fine chemical production are the primary suppliers.

• China: Dominates the global intermediate market due to its extensive chemical industry infrastructure and competitive pricing. Numerous manufacturers offer a wide range of building blocks and custom synthesis services.
• India: Another major hub for pharmaceutical intermediate production, with a strong emphasis on process chemistry and cost-effective manufacturing.
• Europe: Specialized fine chemical companies in countries like Germany, Switzerland, and the UK offer high-purity intermediates and advanced synthesis capabilities. These may be preferred for early-stage development or when stringent quality requirements are paramount.
• North America: While less dominant than Asia, specialized custom synthesis providers in the United States and Canada contribute to the intermediate supply chain, particularly for niche or complex molecules.

The supply chain for intermediates is characterized by a larger number of potential suppliers compared to API. However, ensuring the consistent quality, purity, and regulatory compliance of these intermediates is crucial for the final API's integrity.

WHAT ARE THE IMPLICATIONS FOR SUPPLY CHAIN RESILIENCE?

The perampanel supply chain, like many in the pharmaceutical industry, faces inherent vulnerabilities. Concentration of manufacturing, geopolitical factors, and regulatory hurdles can impact availability.

FACTORS INFLUENCING SUPPLY CHAIN RESILIENCE

• Geographic Concentration: Over-reliance on specific regions for API or critical intermediate manufacturing can create single points of failure. Disruptions due to natural disasters, political instability, or trade disputes in these regions can have significant consequences.
• Regulatory Landscape: Changes in regulatory requirements in key manufacturing countries (e.g., stricter environmental controls in China) can lead to temporary or permanent shutdowns of manufacturing facilities, impacting supply. Pharmaceutical companies must navigate evolving cGMP standards and import/export regulations.
• Intellectual Property (IP) Protection: The synthesis route and specific intermediates are often protected by patents. This limits the number of authorized manufacturers and can create barriers to entry for alternative suppliers.
• Raw Material Sourcing: The precursor chemicals and raw materials used in intermediate synthesis also have their own supply chains, which can be subject to volatility in pricing and availability.
• Quality Control and Auditing: Rigorous quality control and auditing of all supply chain partners, from raw material suppliers to intermediate manufacturers and API producers, are essential. This ensures the final drug product meets all safety and efficacy standards.
• Dual Sourcing Strategies: For critical intermediates and API, establishing relationships with multiple qualified suppliers in different geographic locations can mitigate risk. This requires significant investment in supplier qualification and ongoing quality oversight.
• Inventory Management: Maintaining adequate safety stocks of critical intermediates and API can buffer against short-term supply disruptions. However, this must be balanced against inventory carrying costs and product shelf life.

The pharmaceutical industry's increasing reliance on globalized supply chains necessitates proactive risk assessment and mitigation strategies. For perampanel, understanding the specific chemical synthesis and the locations of its key manufacturing nodes is foundational to building a robust and resilient supply chain.

WHAT ARE THE KEY REGULATORY CONSIDERATIONS FOR PERAMPANEL MANUFACTURING?

Manufacturing of perampanel API and its intermediates is subject to stringent regulatory oversight from health authorities worldwide. Compliance with cGMP is paramount.

CRITICAL REGULATORY ASPECTS

• cGMP Compliance: All manufacturing sites involved in producing perampanel API and its critical intermediates must adhere to current Good Manufacturing Practices as defined by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA). This includes robust quality management systems, validated processes, and meticulous documentation.
• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. These confidential documents provide detailed information about the manufacturing process, facilities, quality control measures, and stability data of the API. This allows drug product manufacturers to reference the DMF in their marketing authorization applications.
• ICH Guidelines: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines provide harmonized standards for quality, safety, efficacy, and multidisciplinary aspects. Compliance with ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) is essential for API manufacturers.
• Impurity Profiling: Regulatory agencies require thorough identification and control of impurities in both intermediates and the final API. Manufacturers must establish rigorous analytical methods to detect and quantify known and potential impurities, including genotoxic impurities.
• Change Control: Any significant changes to the manufacturing process, raw materials, or specifications for intermediates or the API must be carefully evaluated, documented, and reported to regulatory authorities. This ensures that product quality is not adversely affected.
• Supply Chain Audits: Regulatory agencies conduct inspections of manufacturing facilities. Additionally, pharmaceutical companies routinely audit their API and intermediate suppliers to ensure ongoing compliance and product quality.

Navigating these regulatory requirements is a significant undertaking, impacting the selection of manufacturing partners and the overall cost and timeline of bringing perampanel to market and maintaining its supply.

WHAT ARE THE KEY TECHNICAL CHALLENGES IN PERAMPANEL SYNTHESIS?

The synthesis of perampanels chemical structure presents several technical challenges that influence manufacturing complexity and cost.

NOTABLE SYNTHETIC HURDLES

• Stereochemistry Control: Perampanel is administered as a single enantiomer. Achieving high enantiomeric purity requires sophisticated asymmetric synthesis methodologies or efficient chiral resolution techniques. The selection and scalability of these methods are critical.
• Multi-Step Synthesis: The overall synthesis involves a considerable number of distinct chemical transformations. Each step introduces potential for yield loss, impurity formation, and increased production costs. Optimizing each reaction for efficiency and robustness is paramount.
• Handling of Reagents: Certain reagents used in the synthesis may be hazardous, sensitive to air or moisture, or require specialized handling procedures. This necessitates appropriate engineering controls and stringent safety protocols.
• Purification of Intermediates and API: Achieving the required purity levels for both intermediates and the final API can be challenging. Developing effective and scalable purification methods, such as crystallization or chromatography, is crucial.
• Process Scale-Up: Transitioning a synthetic route from laboratory scale to commercial manufacturing requires significant process development and engineering expertise. Factors like heat transfer, mixing, and reaction kinetics change with scale, requiring careful optimization.

Addressing these technical challenges effectively is key to ensuring a reliable, cost-effective, and high-quality supply of perampanel.

KEY TAKEAWAYS

• Eisai Co., Ltd. is the primary originator and likely holder of significant internal manufacturing capacity for perampanel API.
• Specialized CDMOs are key external partners for API production, with manufacturing concentrated in Asia and Europe.
• Critical intermediates in perampanel synthesis include substituted 2-phenylpyridine derivatives, benzoyl chlorides, and amine building blocks.
• Intermediate manufacturing is more dispersed, with China and India being major global hubs, complemented by specialized producers in Europe and North America.
• Supply chain resilience is challenged by geographic concentration, regulatory evolution, IP protection, and raw material sourcing complexities.
• Dual sourcing, robust inventory management, and stringent quality control are essential risk mitigation strategies.
• Regulatory compliance with cGMP, ICH guidelines, and thorough impurity profiling are non-negotiable requirements for all manufacturing stages.
• Technical challenges in perampanels synthesis include stereochemistry control, multi-step reaction optimization, safe reagent handling, and scalable purification processes.

FAQS

• Who is the primary manufacturer of perampanel API? Eisai Co., Ltd., the originator, is the primary manufacturer, likely utilizing internal facilities and/or directing outsourced production through qualified CDMOs.
• Which countries are dominant in perampanel intermediate manufacturing? China and India are dominant in the global production of pharmaceutical intermediates due to their extensive chemical industries.
• What are the main regulatory requirements for perampanel manufacturing? Adherence to current Good Manufacturing Practices (cGMP), compliance with ICH guidelines (e.g., ICH Q7), and rigorous impurity profiling are the main regulatory requirements.
• How does stereochemistry control impact perampanel supply? Achieving the required enantiomeric purity for perampanel necessitates advanced asymmetric synthesis or chiral resolution techniques, adding complexity and cost to the manufacturing process.
• What steps can be taken to improve perampanel supply chain resilience? Implementing dual sourcing strategies for critical components, maintaining strategic inventory levels, and conducting thorough supplier audits are key measures to enhance supply chain resilience.

CITATIONS

[1] Eisai Co., Ltd. (n.d.). Perampanel. Retrieved from [Relevant Eisai Product Information or Corporate Website - specific URL would be required if available publicly] [2] Various Patent Filings related to Perampanel Synthesis. (e.g., US Patent [Patent Number], EP Patent [Patent Number] - specific patent numbers are not provided as this is a general analysis. A detailed report would cite specific patents.) [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from [Official ICH Website - specific URL would be required if available publicly]