Bulk Pharmaceutical API Sources for ETHOTOIN

Bulk Pharmaceutical API Sources for ETHOTOIN

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		3292
MolPort		MolPort-003-666-682
ABI Chem		AC1L1FLQ
AKos Consulting & Solutions		AKOS008947805
Chembase.cn		634
Angene Chemical		AGN-PC-0JK6I9
eInhibitors		3292

Bulk Active Pharmaceutical Ingredient (API) Sources for Ethotoin

Last updated: July 28, 2025

Introduction

Ethotoin, a barbiturate derivative, was historically utilized as an anticonvulsant in the management of epilepsy. Despite its decline in use, owing to more effective and safer alternatives, the API sourcing landscape remains relevant for legacy pharmaceutical formulations, research, and niche applications. Reliable bulk sourcing of ethotoin API involves understanding supplier profiles, manufacturing quality standards, regulatory compliance, and regional availability. This analysis synthesizes current supply channels, identifies key manufacturers, and discusses sourcing considerations.

Overview of Ethotoin API

Ethotoin (chemical name: 5-phenyl-3-ethyl-1H-pyrrol-2,4(3H)-dione) is characterized by its structural relation to other barbiturates. Synthesized via multi-step chemical processes, it requires high purity levels for pharmaceutical applications. While marketed under brand names in the past, most commercial ethotoin APIs today are sourced for research, custom formulations, or limited clinical use.

Global API Manufacturing Landscape

The globalization of pharmaceutical manufacturing has diversified API sources, with major production hubs in India, China, and Europe. For ethotoin, the supply chain is specialized, often involving retired or niche chemical manufacturers capable of producing complex barbiturates. The supply landscape is characterized by a limited number of suppliers with validated production capacity, strict quality standards, and comprehensive regulatory documentation.

Key API Suppliers and Manufacturers of Ethotoin

1. India-Based API Manufacturers

   India remains a dominant player in bulk API production due to cost advantages, extensive manufacturing infrastructure, and regulatory compliance frameworks guided by the Central Drugs Standard Control Organization (CDSCO). Notable companies include:

   • Capsugel (now part of Lonza): Offers custom synthesis services, with experience in barbiturates and CNS-active compounds. While primarily known for excipients and delivery systems, they partner with manufacturing specialists for APIs like ethotoin.

   • Hetero Labs Ltd.: Has past experience in manufacturing barbiturates; however, the current production of ethotoin is limited and subject to regulatory approval.

   • Aurobindo Pharma: Engages in advanced chemical synthesis, though specific production data for ethotoin is scarce, emphasizing the importance of partnership inquiries for custom synthesis.

2. Chinese API Producers

   China boasts a robust chemical manufacturing sector for APIs, with several companies capable of custom synthesis:

   • North China Pharmaceutical Group Corporation (NCPC): Offers a range of CNS-active API compounds, with documented capabilities in barbiturates.

   • Zhejiang Hisun Pharmaceutical Co., Ltd.: Has manufacturing processes for complex pharmaceuticals and custom APIs with GMP compliance.

   • China Resource Sanjiu Medical & Pharmaceutical Co.: Specializes in finished formulations and APIs, including older CNS compounds.

3. European and North American Suppliers

   These regions primarily focus on stringent quality standards and niche productions, often catering to research institutions or specialized pharmaceutical companies:

   • Novartis and Bayer: Historically involved in barbiturate production; current API availability may be limited to legacy stock or specialized contracts.

   • Research-Driven Suppliers: Companies like Toronto Research Chemicals and Spectrum Chemical supply laboratory-grade ethotoin for research purposes, not GMP-certified pharmaceuticals.

Sources for Ethotoin API

• CRO and Custom Synthesis Organizations

  CROs such as CordenPharma and Bachem offer custom synthesis services for APIs like ethotoin, often tailored to specific regulatory and purity standards. These organizations can procure or produce ethotoin via established chemical processes, albeit typically at higher costs for smaller batches.

• Import/Export Brokers and Distributors

  Several international chemical distributors facilitate the procurement of bulk APIs, including ethotoin, for research and clinical trials. While not always holding GMP certifications, they provide flexible sourcing options.

• Chemical Suppliers and Catalogs

  Catalog suppliers may offer ethotoin at research-grade purity. Companies such as Thermo Fisher Scientific and Sigma-Aldrich provide ethotoin for laboratory use, but bulk GMP-grade API availability is limited and often necessitates direct engagement with manufacturers.

Quality and Regulatory Considerations

• GMP Compliance: For pharmaceutical manufacturing, sourcing API from GMP-certified manufacturers is essential to ensure adherence to regulatory standards (FDA, EMA, etc.).

• Certificate of Analysis (CoA): Crucial for verifying purity (>99%), residual solvents, heavy metals, and other impurities.

• Documentation & Validation: Regulatory submissions and industrial production require comprehensive documentation, process validation, and stability data.

• Custom Synthesis & Scaling: Due to the niche nature of ethotoin, scaling bulk production may involve bespoke synthesis pathways, with lead times spanning several months.

Challenges in Sourcing Ethotoin API

• Limited Production: Ethotoin has been largely phased out in favor of newer anticonvulsants, resulting in limited current production capacity.

• Regulatory Restrictions: Due to its classification as a controlled or restricted substance in some jurisdictions, obtaining ethotoin requires stringent licensing and compliance checks.

• Quality Assurance: Variability among suppliers necessitates rigorous quality assessments before integrating sourced APIs into manufacturing processes.

Future Outlook

While ethotoin API production is limited, emerging research or legacy pharmaceutical formulations may sustain niche demand. Suppliers investing in cGMP manufacturing, coupled with improved sourcing channels via trade associations and industry consortia, could stabilize supply availability over the next decade.

Conclusion

The primary sources for bulk ethotoin API are predominantly located in India and China, with limited availability from European and academic suppliers. Businesses seeking ethotoin must prioritize compliance with regulatory standards, verify supplier certifications, and negotiate for custom synthesis options. Transparency, quality assurance, and regulatory diligence are indispensable in ensuring sourcing efficacy for this niche API.

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Key Takeaways

• Ethotoin API is primarily sourced from Indian and Chinese manufacturers specializing in complex CNS compounds.
• GMP-certified suppliers and verified Certificates of Analysis are critical in ensuring product quality.
• Due to reduced production and narrow regulatory window, sourcing ethotoin requires strategic engagement with specialized API producers.
• Custom synthesis services offer flexibility but involve longer lead times and higher costs.
• Due diligence on supplier regulatory compliance and documentation is essential, especially for pharmaceutical-grade applications.

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FAQs

1. Is ethotoin still commercially available from API manufacturers?
Limited production persists primarily for research purposes; commercial pharmaceutical supply has declined due to obsolescence of ethotoin as an anticonvulsant.

2. What are the regulatory considerations for sourcing ethotoin API?
Manufacturers and buyers must ensure GMP compliance, proper licensing, and thorough documentation, especially if intended for pharmaceutical use.

3. Can I source ethotoin API for research purposes easily?
Yes, laboratory-grade ethotoin is widely available from chemical suppliers such as Sigma-Aldrich and Thermo Fisher Scientific, although GMP quality may not be guaranteed.

4. Which regions are best suited for sourcing bulk ethotoin API?
India and China are the primary regions with active chemical manufacturing sectors capable of producing bulk ethotoin API.

5. What are the main challenges in sourcing ethotoin?
Limited current production, regulatory restrictions, and variability in quality among suppliers pose significant challenges for bulk procurement.

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References

[1] Global pharmaceutical API manufacturing data (Industry reports, 2022).
[2] Regulatory guidance on controlled substances and CNS-active APIs (FDA, EMA standards).
[3] Chemical supplier catalogs and product datasheets for ethotoin, Sigma-Aldrich, Thermo Fisher Scientific.
[4] Industry analyses on niche API markets and legacy drug manufacturing trends.