Bulk Pharmaceutical API Sources for PARAMETHADIONE

Bulk Pharmaceutical API Sources for PARAMETHADIONE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		8280
ABI Chem		AC1L1QNH
ChemMol		49400434
AKos Consulting & Solutions		AKOS006239791
ISpharm		I14-43844
Chembase.cn		499
ChemTik		CTK6D0119

Bulk Active Pharmaceutical Ingredient (API) Sources for PARAMETHADIONE

Last updated: July 27, 2025

Introduction

Paramethadione, chemically known as 3,3-dimethyl-2,4-pentanedione, is an anticonvulsant used primarily in the management of epilepsy. As a hydantoin derivative, it modulates neuronal activity by altering sodium and potassium channels. The global supply chain for Paramethadione’s active pharmaceutical ingredient (API) is critical for pharmaceutical manufacturers, particularly in regions with high epilepsy prevalence. This document provides an authoritative review of key bulk API sources, manufacturing trends, and supplier landscape for Paramethadione, informing procurement strategies and regulatory compliance considerations.

Chemical Profile and Industry Context

Paramethadione belongs to the hydantoin class, similar in structure and mechanism to phenytoin and primidone. Despite its niche application, the API’s demand persists, primarily driven by legacy formulations and specific patient populations. The API’s synthesis involves intricate chemical processes, necessitating high purity standards complying with pharmacopeial specifications like USP or EP. As a result, sourcing reliable, high-quality API suppliers becomes a foundational aspect of ensuring drug safety and efficacy.

Global API Manufacturing Landscape

Manufacturers of Paramethadione APIs are concentrated across certain geographies renowned for chemical synthesis expertise, namely India, China, and parts of Europe. The API market is characterized by the presence of several large-scale pharmaceutical ingredient producers as well as regional players offering custom synthesis services.

Major API Suppliers for Paramethadione

1. Indian API Manufacturers

India dominates the API supply chain for many anticonvulsants, including Paramethadione, owing to its well-established pharmaceutical industry, extensive chemical synthesis infrastructure, and competitive pricing.

• Sun Pharmaceutical Industries Ltd.

  • Known for a broad product portfolio, Sun Pharma supplies several hydantoin derivatives, including Paramethadione, to global markets.

• Aurobindo Pharma Ltd.

  • A key player with capabilities in chemical synthesis, Aurobindo offers high-quality API manufacturing compliant with global standards, including cGMP.

• Hetero Labs

  • Specialized in custom synthesis, Hetero produces APIs with stringent quality controls suitable for both generic and niche pharmaceutical applications.

• Jubilant Pharma

  • Capable of large-scale API synthesis, Jubilant’s manufacturing facilities are approved by major regulatory agencies, ensuring compliance and supply reliability.

2. Chinese API Manufacturers

China's role in the global API supply chain is significant, offering cost-efficient manufacturing and extensive production capacities.

• Zhejiang Hisun Pharmaceutical Co., Ltd.

  • An established manufacturer with anesthetic, anticoagulant, and anticonvulsant APIs, including hydantoin derivatives.

• Shenzhen Xinbai Pharmaceutical Co., Ltd.

  • Focused on niche APIs with good quality control, supplying to both domestic and international markets.

• Jiangsu Hengrui Medicine Co., Ltd.

  • Known for a diversified portfolio, including APIs for neurological applications.

3. European and North American Suppliers

While less dominant due to higher manufacturing costs, these regions maintain critical quality standards and certification statuses.

• Rogers Chemical Corporation (USA)

  • Offers high-purity APIs, including hydantoin derivatives, with extensive documentation for regulatory submissions.

• BASF SE (Germany)

  • Provides pharmaceutical intermediates and APIs, adhering to rigorous quality standards aligned with EMA and FDA regulations.

Emerging and Contract Manufacturing Organizations (CMOs)

With the rise of contract manufacturing, several CMOs specializing in API synthesis offer custom paramethadione production.

• Thermo Fisher Scientific

  • Offers API manufacturing services with comprehensive quality assurance programs.

• Fujifilm Diosynth Biotechnologies

  • Although more focused on biologics, they have capabilities in small molecule API Synthesis and cGMP production.

• Bachem AG

  • Known for peptide and small molecule synthesis, capable of producing hydantoin-based APIs.

Supply Chain Challenges and Considerations

• Regulatory Compliance: Suppliers must meet ICH Q7 guidelines, cGMP standards, and pharmacopeial specifications.
• Quality Control: Purity, residual solvents, heavy metals, and stereochemical aspects influence supplier selection.
• Pricing and Lead Times: India and China offer competitive rates, but lead times can vary based on capacity and regulatory status.
• Intellectual Property: Ensure contractual clarity on proprietary synthesis routes and patent rights.

Market Trends and Future Outlook

Despite its declining prominence compared to newer antiepileptic drugs, Paramethadione retains relevance due to established efficacy and historical formulations. The API market faces shifts towards genericization, emphasizing cost-effective production from Indian and Chinese manufacturers. Regulatory hurdles, such as import restrictions and quality audits, influence sourcing strategies. Innovations in chemical synthesis, including greener processes and continuous manufacturing, are poised to enhance supply chain robustness.

Regulatory and Quality Assurance

Strict adherence to regulatory standards is paramount. Suppliers must possess valid approvals from agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or respective national agencies. Certificate of Suitability (CoS) for European Pharmacopeia, Drug Master Files (DMFs), and compliance with USP monographs are critical documentation.

Conclusion

The global API landscape for Paramethadione features a diverse array of suppliers, predominantly from India and China, supported by European quality-focused manufacturers. Pharmaceutical companies should prioritize suppliers with proven regulatory compliance, consistent quality, and reliable supply capacities. Strategic sourcing considering cost, quality, and regulatory environment will be fundamental to maintaining uninterrupted production of Paramethadione formulations.

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Key Takeaways

• Dominant Regions: India and China are the primary sources of bulk Paramethadione API, offering cost-effective and scalable production.
• Quality Assurance: Suppliers must meet stringent regulatory standards, possess necessary certifications, and adhere to cGMP guidelines.
• Regulatory Vigilance: Ensure thorough documentation, such as DMFs and pharmacopeial certifications, to facilitate registration and import procedures.
• Supply Chain Flexibility: Diversify sourcing to mitigate risks posed by geopolitical shifts, regulatory changes, or capacity constraints.
• Emerging Trends: Innovations in synthetic chemistry and manufacturing technologies are expected to bolster supply stability and environmental compliance.

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FAQs

1. What are the main considerations when selecting an API supplier for Paramethadione?
Suppliers should meet quality standards (cGMP compliance, purity requirements), possess regulatory approvals, guarantee capacity and reliability, and offer competitive pricing.

2. Are there regional differences in API quality for Paramethadione?
Yes. European suppliers typically adhere to stricter quality standards and regulatory frameworks, while Indian and Chinese manufacturers often provide cost-effective options with comparable quality, provided they comply with recognized standards.

3. How does regulation impact API sourcing for Paramethadione?
Regulatory demands necessitate detailed documentation, certification of compliance, and high-quality manufacturing standards. Discrepancies can delay approval or lead to import sanctions.

4. Is there a risk of supply shortages with Chinese and Indian API manufacturers?
While these regions dominate the market, supply risks may arise from geopolitical issues, export restrictions, or capacity constraints. Diversification and proactive inventory management mitigate these risks.

5. What are the emerging trends in API manufacturing that could influence Paramethadione sourcing?
Green chemistry, continuous manufacturing, and digital quality systems are transforming API production, enabling safer, more sustainable, and more reliable supply chains.

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Sources

1. United States Pharmacopeia. USP Monograph for Hydantoins (2022).
2. European Pharmacopoeia. European Pharmacopoeia Monograph on Hydantoin Derivatives (2023).
3. Global Pharma Business Reports. API Market Trends and Outlook, 2022-2025.
4. Indian Pharmaceutical Alliance. Annual Report on API Manufacturing Capacities (2022).
5. Chinese Pharmaceutical Industry Association. API Development & Export Data, 2022.