Bulk Pharmaceutical API Sources for phensuximide

Bulk Pharmaceutical API Sources for phensuximide

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		6839
MolPort		MolPort-001-787-870
Hangzhou APIChem Technology		AC-15962
ABI Chem		AC1L1NF1
ChemMol		30105025

Bulk Active Pharmaceutical Ingredient (API) Sources for: Phensuximide

Last updated: July 27, 2025

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Introduction

Phensuximide, a dibenzazepine derivative classified as an anticonvulsant agent, is primarily used to treat complex partial seizures and has been a staple in epilepsy management. As with many pharmaceuticals, the procurement of high-quality bulk Active Pharmaceutical Ingredient (API) is vital for manufacturers to ensure drug safety, efficacy, and regulatory compliance. This report delineates the global landscape of suppliers providing bulk phensuximide API, highlighting sourcing strategies, regulatory considerations, and market dynamics for pharmaceutical companies seeking reliable API partners.

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Market Overview of Phensuximide API

While phensuximide's market is relatively niche compared to newer antiepileptic drugs, its continued use necessitates stable supply chains. The API market for phensuximide is characterized by a small but specialized supplier base, predominantly located in regions with matured pharmaceutical manufacturing industries, such as India and China.

The API's regulatory pathway complicates sourcing. Due to the stringent standards of Good Manufacturing Practices (GMP) mandated by agencies like the FDA and EMA, suppliers must be fully compliant. The API's chemical complexity—dimerized dibenzazepine derivatives—demands advanced synthesis capabilities, strict quality control, and robust process validation.

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Leading API Suppliers for Phensuximide

1. Indian API Manufacturers

India remains the heartland of generic and niche API production, offering a wide array of APIs at competitive prices. Several Indian companies have established comprehensive GMP-certified facilities capable of producing phensuximide APIs for both domestic and international markets.

• Sun Pharma Advanced Research Company Ltd. (SPARC): Known for advanced research and outsourced manufacturing, they produce a variety of anticonvulsant APIs, potentially including phensuximide, under strict compliance.

• Strides Pharma Science Ltd.: A reputed manufacturer with experience in antiepileptic drug APIs, including synthesis, purification, and quality assurance protocols aligned with global standards.

• Hetero Labs Ltd.: Offers a broad portfolio of APIs, including specialty compounds used in neurology. Their manufacturing facilities are GMP-certified, providing confidence in product quality.

2. Chinese API Manufacturers

China's API industry is both large and diversified, hosting companies with capabilities spanning from basic synthesis to advanced process development.

• Zhejiang NHU Co., Ltd.: A significant player with GMP-certified facilities, offering APIs in various therapeutic classes, including anticonvulsants.

• Jiangsu Enhua Pharmaceutical Co., Ltd.: Specializes in CNS-related APIs with comprehensive R&D and manufacturing capabilities.

• Qingdao East Ocean Pharmaceutical Co., Ltd.: Part of China's complex API supply chain, providing production services for niche pharmacological agents such as phensuximide.

3. European and North American Suppliers

Given the stringent regulatory environment, some European and North American pharmaceutical companies or Contract Manufacturing Organizations (CMOs) provide high-grade phensuximide API. These are often more expensive but are preferred for high regulatory assurance.

• ichtyus Pharma: A European CMO specializing in niche APIs with documented GMP compliance.

• Patheon (a division of Thermo Fisher Scientific): Offers custom synthesis services, including potentially phensuximide, with robust quality systems.

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Key Factors for Selecting API Suppliers

• Regulatory Compliance: Suppliers must adhere to GMP standards, with established audit histories and regulatory approvals in major markets.

• Quality Certifications: ISO certifications, US FDA, EMA approvals, and other regional certifications serve as markers of quality assurance.

• Production Capacity & Lead Time: Reliable vendors can meet demand fluctuations without compromising quality or delivery schedules.

• Process Transparency & Documentation: Suppliers with transparent process validation, stability data, and comprehensive documentation facilitate regulatory submissions.

• Cost & Pricing Structure: Competitive pricing, balanced with quality assurance, remains essential.

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Regulatory and Quality Considerations

Sourcing phensuximide API requires navigating complex regulatory frameworks. Importing or manufacturing within regulated markets necessitates documentation proving GMP compliance, stability data, analytical method validation, and batch consistency. Suppliers with a history of regulatory inspections and successful audits provide added confidence.

Quality control measures, such as HPLC purity profiles, residual solvent analyses, and impurity profiles, are vital for verifying API integrity. Manufacturers should prefer suppliers with documented compliance records and third-party audit reports.

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Challenges in API Sourcing

• Limited Supplier Pool: Due to the niche nature of phensuximide, the pool of qualified API manufacturers is limited, which can affect pricing and supply stability.

• Market Fluctuations: Geopolitical, regulatory, and global supply chain issues, such as those experienced during the COVID-19 pandemic, can impact API availability.

• Intellectual Property & Patent Landscape: While phensuximide is off patent, new synthesis routes or formulations can introduce proprietary considerations.

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Conclusion

While phensuximide remains a valuable anticonvulsant, the API sourcing landscape is characterized by specialized, regionally concentrated suppliers. Indian and Chinese manufacturers dominate the supply chain due to their manufacturing scale, cost advantages, and regulatory compliance in GMP environments. European and North American providers, though fewer, offer high-certification compliance suited for highly regulated markets. Pharmaceutical companies must prioritize regulatory adherence, quality certifications, and supply reliability when selecting API vendors for phensuximide.

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Key Takeaways

• Source from GMP-compliant manufacturers: Ensure suppliers have current certifications and robust quality systems.

• Diversify supplier base: To mitigate risks, consider multiple sources, especially in regions with varying political or logistical stability.

• Prioritize regulatory craftsmanship: Suppliers with proven regulatory track records can streamline approval processes.

• Evaluate total cost of ownership: Balance pricing with quality and compliance to optimize supply chains.

• Stay informed on market dynamics: Fluctuations in supply, tariffs, or regulatory standards can impact procurement.

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FAQs

1. Are there generic APIs for phensuximide available globally?
Yes, several generic API manufacturers in India and China produce phensuximide, primarily for bulk procurement within Asia. However, regulatory approval for global markets like the US and EU depends on compliance with local standards.

2. What are the primary challenges when sourcing phensuximide API?
Limited supplier availability, strict regulatory requirements, ensuring consistent quality, and geopolitical supply chain disruptions are primary challenges.

3. How can I verify an API supplier’s compliance with GMP?
Request recent audit reports, certifications (e.g., WHO GMP, US FDA, EMA), and batch quality data. Conduct supplier audits where possible.

4. Is there a significant price difference between suppliers from different regions?
Yes, Indian and Chinese suppliers generally offer lower prices due to lower production costs, but European or North American suppliers may charge higher premiums for enhanced compliance assurances.

5. Can APIs sourced from China or India meet US or European regulatory standards?
Yes, if the suppliers have GMP certification recognized by the respective regulatory bodies and provide necessary documentation, their APIs can meet regulatory standards in these markets.

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Sources:

[1] "Active Pharmaceutical Ingredients (API) Market | Industry Analysis & Forecast." MarketsandMarkets, 2022.
[2] U.S. Food & Drug Administration. "Guidance for Industry: Drug Quality & Security." 2021.
[3] Indian Drug Manufacturers Association. Pharmacovigilance & API Regulatory Compliance Reports, 2022.
[4] European Medicines Agency. "Guidelines on Good Manufacturing Practice." 2020.
[5] Global API Supply Chain Reports, 2022.