Bulk Pharmaceutical API Sources for CANGRELOR

Bulk Pharmaceutical API Sources for CANGRELOR

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		9854012
Chembase.cn		126374
AN PharmaTech		AN-37839
Acemol		AMMD00024
Apexmol		AM85616
Race Chemical		RV022503727
Molepedia		M91182070P

Bulk Active Pharmaceutical Ingredient (API) Sources for: Cangrelor

Last updated: July 29, 2025

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Introduction

Cangrelor, marketed under the brand name Kengreal, is an intravenous antiplatelet agent used to prevent thrombotic events during percutaneous coronary interventions (PCI). It functions as a reversible P2Y12 receptor antagonist, offering rapid onset and offset of action. Given its critical role in acute care settings, the sourcing of high-quality bulk API is pivotal for manufacturers, healthcare providers, and regulatory compliance. This article explores the global API supply landscape for cangrelor, identifying key manufacturers, sourcing considerations, and market dynamics relevant to stakeholders.

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Overview of Cangrelor API Market

Cangrelor is a synthetic, peptidic API developed primarily by pharmaceutical companies specializing in antithrombotic therapies. Its complex synthesis, stability characteristics, and stringent purity standards limit the number of viable suppliers. Currently, the API's supply chain revolves around a handful of specialized manufacturers with capabilities in peptide synthesis and complex chemical manufacturing. Given its designation as an injectable drug used in acute settings, regulatory oversight further constrains sourcing to suppliers with established compliance records.

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Key Suppliers of Cangrelor API

1. The Original Developer: Chiesi Farmaceutici

Chiesi Farmaceutici, an Italian biopharmaceutical company, developed cangrelor and holds the original patent rights. While primarily focused on commercialization, Chiesi licensed manufacturing rights to several partners. They possess advanced peptide synthesis capabilities but have historically relied on partnerships for supply chain expansion.

2. Contract Manufacturers and Co-Development Partners

Due to the complex nature of cangrelor synthesis, several contract manufacturing organizations (CMOs) have emerged as key API suppliers:

• AbbVie: With expertise in peptide APIs, AbbVie has been reported to manufacture cangrelor under strict quality controls. Their integrated supply chain supports clinical development and limited commercial distribution.

• CordenPharma: A contract manufacturer specializing in peptide and complex small molecules, CordenPharma offers synthesis and scale-up services for cangrelor API. Their facilities are FDA and EMA inspected, ensuring regulatory compliance.

• Jubilant HollisterStier: Known for specialty APIs, Jubilant has capabilities in peptide synthesis, potentially providing cangrelor API for regional markets, primarily under licensing agreements.

3. New Entrants and Licensing Arrangements

As cangrelor's patent expiration approaches in some territories, additional suppliers from India and China have entered licensing agreements to produce the API:

• Hikal Ltd. (India): Has developed manufacturing processes for complex peptides, including cangrelor, targeting regional markets with cost-effective production.

• WuXi AppTec (China): Expanding peptide synthesis capacities, WuXi may serve as an emerging provider, contingent on regulatory approval and quality certifications.

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Raw Material Sourcing and Synthesis Complexity

Cangrelor is a structurally complex, highly pure peptide with specific stereochemistry requirements, necessitating advanced solid-phase and solution-phase peptide synthesis techniques. Its manufacturing involves:

• Multiple synthetic steps with stringent purification.
• Use of specialized reagents and protected amino acids.
• Rigorous quality control processes to meet USP, EP, or JP standards.

Suppliers capable of consistently delivering pharmaceutical-grade cangrelor API must demonstrate robust Good Manufacturing Practice (GMP) compliance, with validated processes minimizing impurities and degradation products.

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Regional API Supply Dynamics

• United States and Europe: Predominantly supplied by established CMOs such as CordenPharma and AbbVie, with supply chains closely regulated by regional authorities.
• India and China: Growing presence with Hikal Ltd., WuXi AppTec, and other regional companies offering cost-effective alternatives, particularly for emerging markets.
• Emerging markets: May face logistical challenges and regulatory hurdles but benefit from local manufacturing capabilities.

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Market Trends and Future Outlook

• Patent Expiry and Generic Entry: With patents expiring or expiring in key regions, generic and biosimilar manufacturers are interested in establishing supply chains for cangrelor API, potentially increasing market competition.
• Supply Chain Consolidation: The complexity of cangrelor synthesis has limited the number of reliable suppliers. Future market consolidation may favor large CMOs with extensive peptide manufacturing expertise.
• Regulatory Considerations: Suppliers must maintain compliance with international standards to ensure uninterrupted supply, especially given the critical nature of cangrelor's use in cardiac interventions.

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Supply Chain Challenges and Risks

• Manufacturing Complexity: The synthetic complexity of cangrelor API restricts production to a limited number of specialized facilities, impacting scalability.
• Regulatory Scrutiny: Stringent quality requirements and audits may delay new suppliers' entry into the market or cause supply disruptions.
• Intellectual Property (IP): Licensing agreements and patent protections influence supplier access, with patent expirations poised to reshape the market landscape.

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Conclusion

The supply of bulk cangrelor API is characterized by specialized manufacturing capabilities, a limited number of high-quality suppliers, and evolving regional market participation. Large pharmaceutical companies and specialized CMOs dominate the supply chain, with emerging players from India and China gradually expanding their roles. Strategic sourcing considerations hinge on manufacturing expertise, regulatory compliance, and supply chain resilience, especially given cangrelor's critical role in acute cardiac therapy.

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Key Takeaways

• Limited Supplier Base: Cangrelor API synthesis requires advanced peptide manufacturing capabilities, restricting the number of reliable suppliers.
• Major Manufacturers: Key players include CordenPharma, AbbVie, Hikal Ltd., and WuXi AppTec, each possessing the technical expertise and regulatory approvals necessary.
• Regional Variations: Developed markets rely on established CMOs, while emerging markets benefit from local manufacturing, influencing supply reliability and pricing.
• Patent Dynamics: Expirations signal potential for increased competition, innovation, and new entrants into the API supply landscape.
• Risks and Challenges: Manufacturing complexity, regulatory hurdles, and IP rights play critical roles in shaping the supply chain stability for cangrelor API.

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FAQs

1. Who are the top global suppliers of cangrelor API?
Major suppliers include CordenPharma, AbbVie, Hikal Ltd. (India), and WuXi AppTec (China). Their capacities are supported by expertise in peptide synthesis and GMP compliance.

2. What factors influence the choice of a cangrelor API supplier?
Regulatory compliance, manufacturing expertise, quality assurance, supply reliability, and cost are primary considerations.

3. Are there generic or biosimilar versions of cangrelor available?
Currently, no approved generic or biosimilar versions exist; however, patent expirations may facilitate future market entry.

4. What challenges exist in manufacturing cangrelor API?
Manufacturing complexity, high purity requirements, and synthesis steps increase production difficulty and cost, limiting the number of capable suppliers.

5. How might market dynamics change with patent expiration?
Patent expirations can lead to increased competition, lower prices, and entry of new suppliers, enhancing supply chain resilience but also raising quality and regulatory considerations.

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References
[1] Pharmaceutical industry reports on peptide API manufacturing.
[2] Regulatory agency guidance on peptide synthesis and impurities.
[3] Corporate disclosures from CordenPharma, AbbVie, and regional manufacturers.