Bulk Pharmaceutical API Sources for PERAMPANEL

Bulk Pharmaceutical API Sources for PERAMPANEL

Vendor	Vendor Homepage	Vendor Sku	API Url
Alsachim		976
Apexmol		AM806751
Chembase.cn		128869
ChemTik		CTK1B5138

Bulk Active Pharmaceutical Ingredient (API) Sources for Perampanel: Market Overview and Industry Insight

Last updated: July 28, 2025

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Introduction

Perampanel, a selective non-competitive antagonist of the AMPA glutamate receptor, is approved primarily for the treatment of partial-onset seizures with or without secondary generalized seizures, and primary generalized tonic-clonic seizures. Marketed under the brand name Fycompa by Eisai Co., Ltd., perampanel's success hinges on reliable and high-quality sources of active pharmaceutical ingredients (API). As the global demand for antiepileptic drugs (AEDs) increases, understanding the landscape of bulk API suppliers for perampanel becomes vital for pharmaceutical manufacturers, researchers, and investors seeking to maintain supply chain security and competitive advantage.

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Global API Manufacturing Landscape for Perampanel

The API manufacturing sector for perampanel is characterized by a combination of established pharmaceutical giants and specialized API producers. They operate across various regions, including North America, Europe, India, and China, reflecting the globalized nature of pharmaceutical supply chains.

Key Industry Players

1. Eisai Co., Ltd.
   As the innovator and original marketer of perampanel, Eisai maintains an active role in API procurement, often sourcing from qualified, high-quality API manufacturers to ensure product consistency and regulatory compliance. While Eisai develops and controls the synthesis process, it often collaborates with third-party API producers for commercial supply.

2. CordenPharma (a part of IPCA Laboratories)
   A leading contract manufacturing organization (CMO) specializing in APIs for CNS and other therapeutic areas, CordenPharma offers high-quality synthesis capabilities, emphasizing cGMP standards. Their presence in Europe and North America makes them a preferred partner for pharma companies seeking reliable API sourcing.

3. Sun Pharma Advanced Research Company (SPARC)
   Known for its innovation in complex APIs, Sun Pharma has the capacity to produce perampanel APIs at commercial scales, leveraging its robust R&D and manufacturing infrastructure in India. Their focus on cost-effective manufacturing positions them as a significant API source for generic producers.

4. Hetero Labs Ltd.
   An Indian pharmaceutical manufacturer with extensive experience in producing APIs for CNS disorders, Hetero Labs supplies perampanel API to various generic drug producers worldwide, backed by APIC knowledge and cGMP compliance.

5. Zhejiang Hisun Pharmaceutical Co., Ltd.
   A Chinese API producer with rapidly expanding capacities, Zhejiang Hisun offers competitive pricing and scalable production of APIs including those for CNS indications, possibly including perampanel, where quality and regulatory compliance are assured.

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Emerging API Suppliers and Regional Dynamics

The API source landscape is dynamic, with new entrants emerging due to the increasing demand for antiseizure medications. Chinese and Indian API manufacturers continue to expand capacities, driven by cost advantages and regulatory improvements. The trend towards outsourcing manufacturing to API-specialized CMOs or contract development and manufacturing organizations (CDMOs) has increased, providing pharmaceutical companies with flexible supply chain models.

India and China dominate the API manufacturing sector for perampanel, driven by lower production costs and government incentives. However, stringent quality requirements and evolving regulatory standards in the U.S. and Europe compel these manufacturers to adopt higher quality standards, including cGMP compliance and ISO certification.

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Regulatory Considerations

API sources for perampanel must meet rigorous standards mandated by regulatory agencies such as the FDA, EMA, and PMDA. Suppliers must provide comprehensive documentation, stability data, and manufacturing process validation to ensure API quality and consistency.

Certifications like cGMP, ISO, and DMF (Drug Master Files) are critical for API suppliers to maintain credibility and access to global markets. Manufacturers with proven regulatory compliance tend to be preferred as API sources for leading pharmaceutical firms.

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Supply Chain Security and Quality Assurance

The recent global geopolitical challenges, supply chain disruptions, and quality crises (e.g., the China API quality authorities' increased scrutiny) emphasize the importance of diversifying sources for perampanel API. Companies seek suppliers that offer:

• Reliable quality control and batch-to-batch consistency
• Transparent manufacturing processes
• Scalable production capacities
• Competitive pricing

Establishing multiple approved API sources reduces supply risk and ensures continuous production, especially critical for chronic therapies like epilepsy.

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Future Outlook

The API sourcing landscape for perampanel is poised to evolve favorably, driven by ongoing capacity expansions and technological innovations in synthesis processes. Advances in synthetic biology and greener manufacturing methods could also influence supply dynamics, leading to more sustainable and cost-effective API production.

As global demand for novel AEDs increases and patent expirations encourage generics, the API market will likely see heightened competition and innovation in supply chain models. Strategic partnerships and robust quality management will be pivotal for maintaining consistent API supplies.

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Key Takeaways

• The main API sources for perampanel include established players such as CordenPharma, Sun Pharma, Hetero Labs, and Zhejiang Hisun, primarily based in India, China, and Europe.
• The importance of regulatory compliance (cGMP, ISO) is paramount in selecting API suppliers for global markets.
• Diversification of API sourcing minimizes supply chain risks, especially amid geopolitical and global health challenges.
• Emerging manufacturing capacities in China and India continue to boost supply competitiveness, but quality assurance remains critical.
• Future trends point towards sustainable manufacturing practices and technological advances enhancing API quality and supply stability.

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FAQs

Q1: Are there any approved generic versions of perampanel, and where are their APIs sourced from?
A: Yes, several generic formulations of perampanel are available, often sourced from API manufacturers in India and China. These suppliers typically adhere to global cGMP standards, ensuring regulatory compliance for markets like the US and Europe.

Q2: What are the primary considerations when selecting an API supplier for perampanel?
A: Key factors include regulatory compliance (cGMP, DMF), API quality and purity, manufacturing capacity, supply reliability, cost-effectiveness, and transparency of the production process.

Q3: How do geopolitical factors influence the supply chain for perampanel API?
A: Political tensions, trade restrictions, and supply chain disruptions in regions like China and India can impact API availability. Diversification and establishing multiple sources mitigate these risks.

Q4: What role do contract manufacturing organizations play in the perampanel API supply chain?
A: CMOs offer specialized manufacturing services, enabling pharmaceutical companies to access high-quality, scalable, and cost-effective API production without maintaining full in-house facilities, thereby enhancing supply flexibility.

Q5: How do sustainable manufacturing practices impact API sourcing decisions?
A: Growing emphasis on environmental sustainability leads manufacturers and pharma companies to prefer API suppliers employing greener synthesis methods, reducing environmental footprint and aligning with corporate social responsibility goals.

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References

1. [1] Eisai Co., Ltd. Fycompa (perampanel) prescribing information.
2. [2] CordenPharma website, API manufacturing capabilities overview.
3. [3] Sun Pharma Advanced Research Company investor presentations and capacity reports.
4. [4] Hetero Labs Ltd. official website, API manufacturing standards.
5. [5] Zhejiang Hisun Pharmaceutical Co., Ltd., API capacity expansions and quality certifications.