Bulk Pharmaceutical API Sources for KENGREAL

Bulk Pharmaceutical API Sources for KENGREAL

Vendor	Vendor Homepage	Vendor Sku	API Url
BOC Sciences		163706-06-7
Hangzhou APIChem Technology		AC-28809
Pi Chemicals		PI-39419
DC Chemicals		DC7005
Alfa Chemistry		163706-06-7
Cangzhou Enke Pharma Tech Co.,Ltd.		ENKE163706067
MuseChem		R032044

Bulk Active Pharmaceutical Ingredient (API) Sources for: KENGREAL

Last updated: July 27, 2025

Introduction

KENGREAL (cangrelor) is an antiplatelet agent indicated primarily for reducing thrombotic events in adult patients undergoing percutaneous coronary intervention (PCI). Its pharmacological efficacy depends on the availability of high-quality Active Pharmaceutical Ingredient (API). The global supply chain for cangrelor API involves multiple manufacturers and sourcing strategies. This article provides a comprehensive overview of bulk API sources for KENGREAL, focusing on supplier reputation, manufacturing compliance, and market trends to inform procurement and strategic decision-making.

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Overview of Cangrelor API and Manufacturing Context

Cangrelor, a reversible P2Y12 platelet inhibitor, requires precise synthesis and stringent quality controls due to its critical therapeutic role. The API’s complexity often limits the number of qualified suppliers capable of producing batch-to-batch consistency, high purity standards, and compliance with regulatory frameworks such as cGMP (current Good Manufacturing Practice).

The procurement landscape typically involves global pharmaceutical contract manufacturers (CMOs), regional API producers, and the original developer or licensed marketers. The critical factors include regulatory compliance, manufacturing capacity, quality assurance, and geopolitical stability.

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Key Sources of Cangrelor API

1. Original Manufacturer and Licensed Suppliers

As of the latest market data, the original developer of cangrelor was The Medicines Company, later acquired by Merck & Co. (MSD). The licensing agreements typically restrict API manufacturing to authorized producers or approved CMO partners.

• Merck & Co.: The primary source of licensed API post-acquisition. Merck maintains strict control over API production, ensuring high standards conforming to FDA and EMA regulations. Their APIs are typically supplied directly to Merck's manufacturing facilities or licensed partners.

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2. Contract Manufacturing Organizations (CMOs)

Contract manufacturers often serve as pivotal API sources, especially for commercialization and broader market access:

• BASF SE (Germany): Known for robust API manufacturing capacity and cGMP compliance, BASF offers custom synthesis and bulk API supply for complex molecules like cangrelor. Their extensive quality systems and global logistics support reliable procurement.

• Hikal Ltd. (India): A leading API manufacturer with international GMP certifications. Hikal is recognized for flexible scale-up capabilities and cost-effective production, serving multiple pharmaceutical partners globally.

• Erytech Pharma (France): While primarily focused on biologics, Erytech collaborates on small-molecule APIs, including antiplatelet agents, and could potentially supply cangrelor API under strategic partnerships.

• Aisol Pharma (India): An emerging API producer with capacity for complex synthesis, Aisol offers competitive pricing while maintaining regulatory compliance, making them a viable source for bulk API procurement.

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3. Regional API Manufacturers and Emerging Players

Regional manufacturers, particularly in Asia, play an increasingly vital role in API supply chains due to cost advantages and capacity expansion:

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China): Known for active pharmaceutical ingredients, especially cardiovascular drugs. Their API facilities adhere to Chinese GMP standards and aim for WHO cGMP certification, making them suitable for regional markets.

• Jiangsu Hengrui Medicine Co., Ltd. (China): A major innovator with expanding API manufacturing capabilities, Hengrui may supply cangrelor API, contingent upon regulatory approvals.

• Biocon Ltd. (India): Specializes in complex APIs, with a growing portfolio of cardiovascular and antiplatelet agents. Their capacity for large-scale manufacturing supports global distribution.

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Supply Chain Considerations

• Regulatory Compliance: Ensuring API suppliers adhere to cGMP standards aligned with the target markets' regulatory requirements (FDA, EMA, PMDA) is paramount to maintaining product quality and market access.

• Quality Assurance & Certification: Suppliers should possess valid certifications like ISO, WHO-GMP, and pharmacopeial compliance (USP, EP, JP).

• Manufacturing Capacity & Lead Times: Due to the urgent demand fluctuations, sourcing from multiple suppliers reduces risk and ensures continuous supply.

• Cost Dynamics: Indian and Chinese manufacturers typically offer cost advantages but must be vetted for quality consistency.

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Current Market Trends and Challenges

The COVID-19 pandemic and global geopolitical tensions have accentuated supply chain fragility. Many pharmaceutical companies are now diversifying their APIs sources, engaging multiple suppliers across regions. Regulatory barriers, such as US Drug Master Files (DMF) and European Medicines Agency (EMA) dossier approvals, influence the choice of API manufacturers.

Furthermore, the increasing focus on compliance and regulatory transparency has led to stricter audits and supplier qualification requirements, often favoring large, established API manufacturers with proven quality records.

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Strategic Implications for Stakeholders

For pharmaceutical companies and distributors seeking bulk API sources for KENGREAL (cangrelor), critical considerations include:

• Supplier Verification: Conduct thorough audits of manufacturing facilities, quality controls, and regulatory records.

• Supply Chain Resilience: Develop diversified sourcing strategies spanning different regions and manufacturers.

• Regulatory Alignment: Prioritize suppliers with approved DMFs or batch release documentation aligned with target markets' regulatory standards.

• Cost vs. Quality Balance: While cost-effective options are attractive, premium quality and compliance should underpin procurement decisions, especially given KENGREAL's role in critical care.

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Conclusion

The bulk API sourcing landscape for KENGREAL (cangrelor) remains concentrated among established players in North America, Europe, and Asia. Merck’s licensed suppliers underpin the highest assurance of quality and regulatory compliance. However, strategic procurement often involves partnerships with reputable CMOs and regional manufacturers capable of meeting performance standards while offering competitive pricing.

A holistic approach—factoring regulatory adherence, manufacturing capacity, quality assurance, and geopolitical stability—is essential to secure resilient, compliant API supply chains for KENGREAL.

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Key Takeaways

• Primary API sources are controlled by Merck & Co., ensuring high-quality standards for KENGREAL.
• Reliable contracts with established CMOs like BASF and Hikal are critical to securing supply.
• Asian manufacturers, notably in India and China, provide cost-effective alternatives but require rigorous qualification.
• Regulatory compliance, including cGMP certifications and validation of quality systems, remains non-negotiable.
• Diversifying suppliers across regions reduces risks associated with geopolitical and supply chain disruptions.

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FAQs

1. Who supplies the bulk API for KENGREAL?
Merck & Co. is the primary licensor and supplier, with contracted manufacturing partners including established CMOs like BASF and regional manufacturers in Asia.

2. Can regional manufacturers produce high-quality cangrelor API?
Yes, provided they meet regulatory standards such as cGMP, and possess appropriate certifications and validated manufacturing processes.

3. What factors influence API sourcing decisions for KENGREAL?
Regulatory compliance, manufacturing capacity, quality assurance, cost, supply chain resilience, and geopolitical stability.

4. Are there any emerging API manufacturers for cangrelor?
While existing licensed sources dominate, emerging manufacturers in China and India are expanding capabilities, subject to regulatory approvals and quality audits.

5. How does supply chain disruption impact KENGREAL API sourcing?
Disruptions can cause shortages, delays, and increased costs. Diversification and early engagement with multiple qualified suppliers mitigate these risks.

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Sources:

[1] Pharmaceutical supply chain reports, global regulatory databases, and public disclosures from Merck & Co., BASF, Hikal Ltd., and regional manufacturers.