Bulk Pharmaceutical API Sources for PHENINDIONE

Bulk Pharmaceutical API Sources for PHENINDIONE

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		jhy@`@@FrJJJIJIYDgIV|EhJ@D@`@@@
Sigma-Aldrich		P26406_ALDRICH
MP Biomedicals		216665
NovoSeek		4760

Bulk Active Pharmaceutical Ingredient (API) Sources for Phenindione

Last updated: July 27, 2025

Introduction

Phenindione, a second-generation oral anticoagulant, is primarily employed in the management of thromboembolic disorders. As a vitamin K antagonist, its efficacy hinges on the access to high-quality Active Pharmaceutical Ingredients (APIs). The sourcing landscape for Phenindione APIs involves a complex interplay of regulatory, manufacturing, and market factors. This article details global API suppliers, manufacturing trends, regulatory considerations, and market dynamics pertinent to Phenindione.

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Overview of Phenindione API Market

Phenindione’s synthesis and supply chain are relatively niche compared to first-line anticoagulants like warfarin. Its production depends on specialized chemical manufacturing capabilities, often concentrated in regions with established pharmaceutical chemistry sectors. Despite its long-standing use, the API sourcing landscape remains limited, emphasizing quality assurance and regulatory compliance.

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Major API Manufacturing Regions and Key Suppliers

1. China

China dominates the global API manufacturing industry, accounting for approximately 50% of the world's API production capacity [1]. Chinese manufacturers leverage cost-effective large-scale synthesis capabilities, including the production of Phenindione APIs.

• Leading Chinese API Manufacturers for Phenindione:
  • Hengxin Pharmaceutical Co., Ltd.: Known for a broad portfolio including anticoagulant APIs, with adherence to cGMP standards.
  • Shandong Luoxin Pharmaceutical Group Co., Ltd.: Offers API production with a focus on anticoagulants, including Phenindione.
  • Zhejiang NHU Co., Ltd.: Engaged in specialty chemicals and APIs, with capacity for Phenindione synthesis.

Regulatory considerations: Chinese suppliers often pursue CN-GMP certification for export markets; however, importers must verify product documentation for equivalency with global standards like the US FDA or EMA.

2. India

India remains a significant API supply source, known for high-quality manufacturing focused on stricter regulatory compliance and quality standards such as WHO-GMP, US FDA, and EMA approvals.

• Leading Indian API Manufacturers:
  • Divi's Laboratories: Recognized for high-quality API manufacturing, including anticoagulants, with extensive regulatory approvals.
  • Sinochem Química (India branch): Offers API synthesis with global compliance.
  • Alembic Pharmaceuticals: Engaged in manufacturing APIs under rigorous quality standards suitable for export.

Strategic attributes: Indian suppliers often serve Western markets due to their compliance with international standards.

3. Europe

While Europe is less prominent in raw API production due to high manufacturing costs, certain specialized companies produce Phenindione APIs under strict GMP regulations.

• European API Manufacturers:
  • Evonik Industries: Offers high-purity APIs for niche pharmaceutical applications.
  • Polpharma: Supplies APIs to the European market, adhering to EMA standards.

European suppliers often focus on APIs for clinical and regulated markets, providing high assurance quality and traceability.

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Emerging and Specialized Sources

4. United States

US-based API manufacturing is limited by high costs but centers around Contract Manufacturing Organizations (CMOs) capable of producing Phenindione APIs under FDA compliance.

• Key US-Based CMOs:
  • Amarex: Specializes in manufacturing APIs under cGMP standards for late-stage development and commercial supply.
  • Patheon (Thermo Fisher Scientific): Offers custom synthesis and bulk manufacturing for niche APIs.

5. Contract Manufacturing and Custom Synthesis

Numerous global CMOs offer Phenindione API synthesis as part of contract manufacturing services, providing flexibility and rapid deployment to meet market demands. The choice of partner often hinges on regulatory credibility, capacity, and quality assurance systems.

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Regulatory and Quality Considerations

Ensuring API compliance with global standards—such as the US FDA, EMA, and ICH guidelines—is critical for downstream pharmaceutical manufacturing.

• GMP Certification: Essential for APIs destined for regulated markets.
• Batch Certification and Traceability: Suppliers must furnish batch-specific documentation.
• Stability and Purity: High purity standards (>99%) tailored for pharmaceutical use.
• Environmental and Ethical Compliance: Suppliers adhering to environmental regulations mitigate future regulatory risks.

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Market Dynamics and Sourcing Strategies

The Phenindione API market is characterized by limited suppliers with high concentration in China, India, and select European companies. Procurement professionals should prioritize:

• Supplier Verification: Auditing manufacturing practices and certifications.
• Cost vs. Quality Balance: Lower-cost Chinese sources are prevalent but require rigorous quality assessment.
• Supply Chain Security: Ensuring supply continuity amid geopolitical and logistical challenges.
• Regulatory Readiness: Selecting suppliers compliant with target markets' regulatory standards.

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Conclusion

The sourcing of Phenindione API predominantly involves Chinese and Indian manufacturers, with European and US-based companies catering to specialized markets. Given the narrow market, procurement strategies must emphasize quality, regulatory compliance, and supply security. Manufacturers and drug developers should maintain close communication with reputable suppliers and conduct thorough due diligence to mitigate risks associated with API sourcing.

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Key Takeaways

• Global sourcing is concentrated mainly in China and India, requiring rigorous quality audits.
• Regulatory compliance remains pivotal, with GMP certification being non-negotiable for APIs destined for commercial markets.
• Diversification of suppliers can reduce supply chain risks, especially in geopolitical uncertainties.
• Contract manufacturing organizations offer customized solutions tailored to pharmaceutical needs, providing flexibility and compliance.
• Regulatory landscape evolution demands ongoing monitoring to ensure API suppliers meet current standards under evolving regulations.

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FAQs

1. Are Chinese Phenindione API manufacturers compliant with international quality standards?
Many Chinese manufacturers export Phenindione APIs under CN-GMP certifications, but buyers should verify compliance with specific regulatory requirements such as US FDA or EMA standards through audits or third-party assessments.

2. What are the key factors influencing the choice of API suppliers for Phenindione?
Quality certification (GMP compliance), regulatory track record, supply stability, cost, and ability to meet delivery schedules are paramount.

3. Is Phenindione API production scalable for large pharmaceutical companies?
Yes; established Chinese and Indian manufacturers possess scalable synthesis capacities, but strategic partnership and quality assurance are critical for large-volume production.

4. How do regulatory differences impact Phenindione API sourcing?
Regulatory regions impose varying requirements. US and EU markets demand stricter documentation, validation, and GMP adherence, necessitating compliant suppliers and rigorous qualification processes.

5. Are there alternative APIs to Phenindione with similar therapeutic profiles?
Warfarin remains the most widely used vitamin K antagonist, with numerous suppliers globally. Phenindione is less common, often replaced by warfarin, but specific formulations or patients may require Phenindione, influencing sourcing choices.

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References

[1] Global API Market Overview, IQVIA Reports, 2022.