Bulk Pharmaceutical API Sources for STIRIPENTOL

Bulk Pharmaceutical API Sources for STIRIPENTOL

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001247042
NovoSeek		5311454
MolPort		MolPort-005-942-442
ABI Chem		AC1NSKO6
ChemMol		49425822
Chembase.cn		154586
Wolves R&D chemical		EBD2763

Bulk Active Pharmaceutical Ingredient (API) Sources for: Stiripentol

Last updated: July 28, 2025

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Introduction

Stiripentol is a pharmaceutical compound primarily used as an adjunctive therapy for Dravet syndrome, a severe form of epilepsy. Its therapeutic efficacy hinges on high-quality active pharmaceutical ingredients (APIs), which are critical for ensuring safety, potency, and regulatory compliance. The sourcing of stiripentol API involves a complex global supply chain, with manufacturers spanning Europe, Asia, and North America. This article examines the primary sources for bulk stiripentol API, analyzing key manufacturers, geographic distribution, quality standards, and industry trends.

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Overview of Stiripentol API Manufacturing

Stiripentol's API synthesis is intricate, involving multiple chemical steps to achieve the required purity and bioavailability. Its synthesis pathways typically encompass:

• Raw material procurement: starting from precursor compounds.
• Multi-step chemical reactions: including halogenation, functionalization, and purification.
• Final active ingredient isolation and crystallization.

Manufacturers adhering to Good Manufacturing Practices (GMP) conform to strict quality controls, essential for APIs destined for central nervous system (CNS) indications like epilepsy.

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Major Global API Suppliers for Stiripentol

1. European Manufacturers

Europe boasts several established pharmaceutical APIs manufacturers, driven by stringent regulatory frameworks such as the European Medicines Agency (EMA). The key players include:

• SMC Ltd. (UK): Historically, SMC Ltd. has supplied various rare and specialized APIs, including stiripentol, with a focus on quality and regulatory compliance. Their facilities are GMP-certified, adhering to EMA standards.

• Pharmaron (France): As an innovative CRO and API manufacturer, Pharmaron offers custom synthesis services, including APIs for CNS disorders. They maintain robust GMP-certified facilities suitable for high-purity APIs like stiripentol.

2. Asian API Manufacturers

Asia's pharmaceutical industry is a dominant force in API manufacturing, offering cost-effective production coupled with expanding quality assurance capabilities.

• Jiangsu Hengrui Medicine Co., Ltd. (China): Engaged in complex chemical synthesis of various APIs, Hengrui maintains advanced GMP-certified facilities. Although primarily known for other APIs, they have capabilities for custom synthesis of specialized compounds like stiripentol.

• Jubilant Biosys (India): A subsidiary of Jubilant Life Sciences, Jubilant Biosys specializes in API development and manufacturing, with GMP standards suitable for CNS-active APIs.

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China): Focused on niche APIs, including CNS-related compounds, Hisun's facilities are GMP-compliant with capabilities for custom API synthesis.

3. North American API Suppliers

North American companies offer high-quality APIs aligned with stringent regulatory standards:

• Cambrex Corporation (USA): Specializes in small-molecule manufacturing, including APIs for neurological indications. Cambrex emphasizes quality control, GMP compliance, and supply chain reliability.

• Hikal Ltd. (Canada): Provides custom synthesis and manufacturing services with GMP certification, capable of producing APIs like stiripentol.

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Regulatory and Quality Considerations

Manufacturers supplying stiripentol API must comply with regulatory standards such as:

• FDA (U.S. Food and Drug Administration): For APIs destined for the North American market.
• EMA (European Medicines Agency): Ensuring EU compliance.
• ICH Guidelines: International standards for pharmaceutical quality (Q7 for APIs).

Suppliers typically furnish Certificates of Analysis (CoA), batch documentation, stability data, and adherence to International Organization for Standardization (ISO) certifications.

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Supply Chain Trends and Industry Dynamics

The global API market for rarer compounds like stiripentol is evolving, driven by:

• Regulatory harmonization: Improved batch traceability and quality consistency.
• Capacity expansion: Asian manufacturers expanding GMP-certified facilities.
• Cost considerations: Shift towards outsourcing production to reduce costs, while maintaining quality.
• Supply chain resilience: Diversification of sources to mitigate risks, especially during disruptions like the COVID-19 pandemic.

The current trend favors partnerships with established GMP-certified API manufacturers capable of supply chain transparency and regulatory compliance.

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Key Criteria for Selecting API Suppliers

Business professionals should evaluate potential API sources based on:

• GMP Certification: Ensuring compliance with regional and international standards.
• Quality Control: Availability of batch testing reports, purity levels, and stability data.
• Manufacturing Capacity: Ability to meet forecasted demands.
• Lead Times: Scheduling flexibility to align with clinical or commercial timelines.
• Pricing and Contract Terms: Transparent cost structures and favorable terms.

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Conclusion

The sourcing of bulk stiripentol API involves a global network of manufacturers, primarily located in Europe, Asia, and North America. While European companies offer high regulatory compliance, Asian manufacturers provide competitive pricing and expanding capabilities. North American suppliers focus heavily on quality assurance and supply reliability. Engaging with reputable, GMP-certified API manufacturers ensures the availability of high-quality stiripentol, supporting the safe manufacture of medicinal products for patients with severe epileptic conditions.

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Key Takeaways

• Stamper and quality standards are paramount when sourcing stiripentol API, with GMP certification serving as a benchmark.
• European, Asian, and North American manufacturers collectively fulfill global demand, with specific strengths in quality, cost, and capacity.
• Close supplier evaluation, including regulatory compliance, batch consistency, and lead times, is essential for reliable API procurement.
• Industry trends favor diversification of sources to ensure supply chain resilience amid regulatory complexity and global disruptions.
• Strategic partnerships with established API producers optimize supply security and regulatory compliance for pharmaceutical companies.

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FAQs

1. What are the primary regions manufacturing stiripentol API?
Europe, Asia (notably China and India), and North America are the main regions manufacturing stiripentol API, each offering unique advantages related to quality, cost, and capacity.

2. How does GMP certification influence API sourcing decisions?
GMP certification assures that the API is produced under strict quality standards, which is crucial for regulatory approval and patient safety, especially for CNS-active compounds like stiripentol.

3. Are there enough manufacturing facilities capable of producing high-purity stiripentol API?
Yes, several established facilities in Europe, Asia, and North America possess the capacity and expertise to produce high-purity stiripentol API, but capacity planning is essential to meet demand.

4. What are the challenges faced in sourcing stiripentol API globally?
Challenges include regulatory variability, supply chain disruptions, fluctuating costs, and ensuring consistent quality across different manufacturing sites.

5. How can companies ensure the quality of stiripentol API from suppliers?
By requiring comprehensive documentation such as Certificates of Analysis, manufacturing batch records, stability data, and audits of manufacturing facilities, companies can verify API quality.

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References

[1] European Medicines Agency. (2022). Guidelines on good manufacturing practice.
[2] U.S. Food and Drug Administration. (2022). Current Good Manufacturing Practice (CGMP) regulations.
[3] ICH Guidelines. (2020). Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
[4] Global API Market Reports. (2021). Industry insights on API manufacturing trends worldwide.