Bulk Pharmaceutical API Sources for POTIGA

Bulk Pharmaceutical API Sources for POTIGA

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-850-148
Hangzhou APIChem Technology		AC-6908
Amadis Chemical		A809076
AbMole Bioscience		1797
BioChemPartner		BCP0726000089
AKos Consulting & Solutions		AKOS015895311
MedChemexpress MCE		HY-15471

Bulk Active Pharmaceutical Ingredient (API) Sources for POTIGA (Ezogabine)

Last updated: July 28, 2025

Introduction

Potiga (ezogabine) is an anticonvulsant medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of partial-onset seizures in adults. Its active pharmaceutical ingredient (API), ezogabine, acts primarily as a potassium channel opener, stabilizing neuronal activity. The availability of high-quality bulk ezogabine API is critical for pharmaceutical manufacturers aiming to produce generic versions or to supply authorized copies of the drug. This article examines the primary sources for bulk ezogabine API, considering key criteria including quality standards, regulatory compliance, manufacturing capacity, and supply reliability.

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Overview of API sourcing landscape for ezogabine

Unlike blockbuster compounds widely produced at scale, niche medications like ezogabine often rely on specialized manufacturers due to the complexity of synthesis, strict purity requirements, and regulatory hurdles. Major API suppliers are located across various regions, including the United States, Europe, and Asia. The selection of a source hinges on several factors: quality assurance, regulatory compliance (e.g., FDA, EMA, PMDA), contract manufacturing capabilities, and cost-effectiveness.

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Key Manufacturers and Suppliers of Ezogabine API

1. Merck KGaA (Eisai Co. Ltd)

While Merck historically played roles in the development of anticonvulsant APIs, it is not recognized as a current supplier of ezogabine API. Nevertheless, some origin-related compounds may have been sourced from Merck during the drug development phases.

2. Teva Pharmaceutical Industries Ltd.

Teva, a leading generics manufacturer based in Israel, has historically secured rights for various anticonvulsants. While specific data indicates Teva’s involvement in producing bulk ezogabine, publicly available information is limited; most data points to Teva’s comprehensive portfolio of generic antiepileptics rather than a dedicated ezogabine API manufacturing line. Nonetheless, Teva's extensive API manufacturing capabilities suggest potential for sourcing or producing ezogabine, especially for regional markets.

3. Jiangsu Hengrui Medicine Co., Ltd (China)

Jiangsu Hengrui is a prominent Chinese pharmaceutical manufacturer known for its wide antiseizure medication portfolio. Though primarily focused on finished dosage forms, the company’s API production line for anticonvulsants could include ezogabine, given the global demand surge for affordable generics. However, specific certifications or approvals for ezogabine API are not explicitly confirmed.

4. Strides Pharma Science Ltd (India)

Strides Pharma, based in India, supplies various APIs for anticonvulsants. Their manufacturing facilities adhere to current Good Manufacturing Practices (cGMP) and meet international regulatory standards. Although no publicly available confirmation exists that Strides produces ezogabine API specifically, their capacity for complex API synthesis suggests they may serve as a source under confidential supplies or contract manufacturing agreements.

5. Sun Pharmaceutical Industries Ltd

Sun Pharma, one of India’s largest pharmaceutical firms, operates multiple API manufacturing sites with high-quality certifications. The company's extensive portfolio includes APIs used in epilepsy treatments. While explicit documentation of ezogabine API production is scarce, their capability could support custom synthesis or lay the groundwork for future supply.

6. Contract Manufacturing Organizations (CMOs)

Given the specialized synthesis process of ezogabine, many pharmaceutical companies partner with CMOs who possess advanced organic synthesis expertise and cGMP-certified facilities. Notable CMOs with the capacity for low-volume, high-purity API production include:

• Hikal Ltd (India): Known for complex API synthesis; potential source for niche APIs like ezogabine.
• BASF (Germany): World’s largest chemical company with extensive API manufacturing facilities capable of custom synthesis.
• Wuxi AppTec (China): Offers API development and manufacturing services with proven quality standards conducive to pharmaceutical-grade APIs.

7. US and European Suppliers

Due to strict regulatory environments, some US and European firms produce ezogabine API under stringent quality assurance protocols. Notable examples include:

• Fogenix (France): Specializes in synthetic specialty chemicals and APIs, with capabilities tailored to complex molecules.
• Cambrex (USA): Provides custom API synthesis, ensuring compliance with U.S. cGMP, likely to offer ezogabine API for registered clients.

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Regulatory and Supply Chain Considerations

The procurement of ezogabine API demands adherence to regulatory standards such as cGMP, ISO certifications, and validated testing protocols. Suppliers must provide comprehensive technical dossiers, stability data, and purity specifications aligning with pharmacopoeia standards (USP, EP, JP). International trade sanctions, intellectual property rights, and proprietary synthesis methods influence sourcing choices. Additionally, recent supply chain disruptions—such as those caused by the COVID-19 pandemic—have emphasized the importance of diversifying sources to ensure uninterrupted supply.

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Market Dynamics and Future Outlook

Ezogabine was withdrawn from the U.S. market in 2017 due to safety concerns related to retinal abnormalities and skin discoloration. However, the API remains relevant for research, epidemiological studies, and potential re-approvals or improved formulations. The niche status of ezogabine emphasizes the importance of selective sourcing from reliable, high-quality manufacturers. The resurgence of interest in potassium channel modulators may stimulate API production, prompting new entrants or expanded manufacturing capabilities.

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Key Factors for Selecting API Sources

• Quality & Certification: Suppliers must demonstrate compliance with cGMP, ISO, and pharmacopeia standards.
• Regulatory Track Record: Proven regulatory approvals and dossiers facilitate registration in target markets.
• Manufacturing Capacity & Flexibility: Ability to meet production volume, with contingency plans.
• Intellectual Property & Confidentiality: Respect for proprietary synthesis processes.
• Cost & Logistics: Competitive pricing coupled with reliable logistics to ensure a steady supply chain.

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Conclusion

The sourcing of bulk ezogabine API involves a select group of global manufacturers capable of delivering high-quality, regulatory-compliant products. While several companies in India, China, Europe, and the US possess the capacity to produce or contract-manufacture ezogabine, the industry trend favors partnerships with established CMOs with proven expertise in complex API synthesis. The niche market dynamics demand emphasis on quality assurance, regulatory alignment, and supply chain resilience for successful procurement.

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Key Takeaways

• Major API suppliers for ezogabine are located in India, China, and Europe, often through CMOs with specialized expertise.
• Regulatory compliance, cGMP certification, and high purity standards are essential for sourcing.
• Despite market withdrawal, ezogabine API remains relevant for research and potential reintroduction.
• Diversification of suppliers mitigates supply chain risks amidst global disruptions.
• Due diligence and rigorous qualification processes are vital for selecting reliable API sources.

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FAQs

1. Is ezogabine API widely produced today?
No. The production of ezogabine API has significantly declined following the drug’s market withdrawal in the US and safety concerns. However, specialty manufacturers and CMOs with expertise in complex APIs may still produce it on a limited basis.

2. What regions are the primary sources for ezogabine API?
Asia (India and China), Europe, and select North American firms are the main regions with capacity to produce or supply ezogabine API, mainly through contract manufacturing.

3. How can I verify the quality of ezogabine API from a supplier?
Request detailed quality documentation, including GMP certificates, International Organization for Standardization (ISO) certifications, analytical test reports, and stability data. Regulatory approval documents and supplier audits are also crucial.

4. Are there alternative APIs or compounds similar to ezogabine?
Yes. Other potassium channel openers or anticonvulsants may serve similar therapeutic roles. These alternatives often have different manufacturing profiles and regulatory pathways.

5. What are the considerations for sourcing ezogabine API for research purposes?
Research-grade ezogabine API can be sourced from specialized chemical suppliers emphasizing high purity and validation. Suppliers should provide comprehensive analytical data and comply with safety standards.

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Sources

[1] FDA Drug Approval Archives, 2016.
[2] European Medicines Agency (EMA) Drug Database.
[3] Global API Market Reports, 2022.
[4] Pharmaceutical Manufacturers’ Catalogs and Public Disclosures.
[5] Industry Expert Analyses on Complex API Production.