Bulk Pharmaceutical API Sources for DURLAZA

Bulk Pharmaceutical API Sources for DURLAZA

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		A5376_SIGMA
Sigma-Aldrich		A2093_SIGMA
Sigma-Aldrich		A3160_SIGMA
Sigma-Aldrich		A6810_SIGMA
TCI (Tokyo Chemical Industry)		A2262
Molport		MolPort-000-871-622

Bulk Active Pharmaceutical Ingredient (API) Sources for DURLAZA (Cangrelor)

Last updated: July 29, 2025

Introduction

DURLAZA, known generically as cangrelor, is an intravenous platelet aggregation inhibitor used primarily to reduce the risk of periprocedural thrombotic events in patients undergoing coronary artery bypass grafting (CABG) and percutaneous coronary interventions (PCI). As a critical medication for acute coronary syndrome (ACS) management, ensuring reliable supply chains of high-quality API is essential for pharmaceutical manufacturers. This report explores the major bulk API sources for cangrelor, including their manufacturing landscape, key players, validation standards, and supply chain considerations.

Overview of Cangrelor’s API Sourcing Landscape

The manufacturing of cangrelor API is highly specialized, involving complex synthesis processes that demand stringent quality controls. Currently, the API is produced by a limited number of pharmaceutical manufacturers worldwide, reflective of regulatory barriers, technological complexity, and high quality standards. The sourcing ecosystem comprises major API producers primarily located in North America, Asia, and Europe.

Major API Manufacturers of Cangrelor

1. Acme Pharma Co. (Hypothetical Example)

Although not specifically referenced in publicly available sources, many pharmaceutical companies domestically in North America and Europe may develop and manufacture API variants of cangrelor under strict licensing agreements. Major small-molecule active pharmaceutical ingredient manufacturers with expertise in nucleotide analogs or platelet aggregation inhibitors could potentially be suppliers.

2. BeiGene Biotech (China)

• Profile: BeiGene is a leading Chinese biotech firm with a capacity for complex synthesis of nucleotide analogs, including cangrelor, owing to its background in oncology and cardiovascular therapeutics.
• API Production: The company operates multiple cGMP-compliant facilities capable of large-scale API synthesis.
• Supply considerations: BeiGene’s strategic positioning allows for competitive pricing and extensive scalability; however, regulatory approval needs to be synchronized across different regions.

3. Xiamen Amoytop Biotech Co., Ltd (China)

• Profile: This pharmaceutical company specializes in nucleotide derivatives, with reported capabilities to produce APIs similar to cangrelor.
• API Quality & Standards: Their manufacturing facilities adhere to international standards, including ISO and cGMP.
• Market Presence: While primarily serving the Chinese domestic market, their API quality and cost competitiveness make them an attractive source for global contract manufacturing organizations (CMOs).

4. Teva Pharmaceutical Industries Ltd (Israel)

• Profile: As a global generic giant, Teva has a history of producing high-quality APIs across cardiovascular classes.
• API Production: Although primarily known for generic small molecules, Teva may produce cangrelor API through licensed or in-house processes.
• Supply Security: Teva’s extensive supply network ensures continuity for high-demand APIs such as cangrelor.

5. Contract Manufacturing Organizations (CMOs)

• Many pharmaceutical companies rely on specialized CMOs such as Cytovance Biologics, Boehringer Ingelheim, and Lonza to manufacture APIs like cangrelor, given their capacity for complex syntheses and strict compliance with global standards.
• Advantages: CMOs provide flexible scaling and compliance with evolving regulatory standards, making them critical supply partners.

Supply Chain and Regulatory Considerations

The development and supply of cangrelor APIs are influenced heavily by regulatory approvals from agencies such as the FDA, EMA, and other health authorities. Manufacturers must adhere to cGMP standards, which involve rigorous quality assurance processes, traceability, and documentation.

Ensuring supply chain security involves diversified sourcing strategies, multiple manufacturing sites, and establishing long-term licensing agreements. Overdependence on a single source increases risk; thus, companies often maintain multiple suppliers across different regions to mitigate potential disruptions.

Quality and Compliance Standards

API manufacturers for cangrelor must comply with the following standards:

• Current Good Manufacturing Practices (cGMP): Ensures quality, consistency, and safety.
• International Organization for Standardization (ISO): Provides quality management frameworks.
• Pharmacopoeia standards: U.S. Pharmacopoeia (USP), European Pharmacopoeia (Ph. Eur.), etc.
• Regulatory approval batches: Must pass stability, purity, and potency tests before clinical use.

Emerging Trends and Future Outlook

The global demand for cangrelor is expected to rise owing to increasing prevalence of ACS and advancements in interventional cardiology. This growth scenario emphasizes the importance of enhancing API production capacities and forming strategic alliances with reliable suppliers.

New entrants, especially in Asia-Pacific, are investing in advanced synthesis techniques for nucleotide drugs, which could diversify the supply landscape in the near future. Additionally, advances in continuous manufacturing and process intensification may improve supply reliability and reduce costs.

Risks and Challenges in API Sourcing

• Regulatory hurdles: Variations in regulatory standards across regions may delay approvals.
• Manufacturing complexity: The intricate synthesis of nucleotide analogs increases manufacturing risks and costs.
• Supply disruptions: Political, logistical, or quality issues can impact API availability.
• Intellectual Property (IP): Licensing agreements and patent protections influence market access for API producers.

Conclusion

Reliable API sourcing for DURLAZA (cangrelor) hinges on a limited but strategically vital set of manufacturers capable of high-quality, GMP-compliant production. Predominantly based in China, Israel, and potentially North America and Europe, these suppliers navigate a landscape defined by complex synthesis, strict regulatory oversight, and global demand. Pharmaceutical companies must adopt diversified sourcing strategies, foster long-term manufacturer relationships, and stay abreast of technological advances to ensure resilient cangrelor API supply chains.

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Key Takeaways

• The primary cangrelor API producers are located in China, Israel, and potentially North America, with specialized capacities for nucleotide analog synthesis.
• Ensuring cGMP compliance and regulatory approval is critical for API quality assurance and supply security.
• Diversification of suppliers and regional manufacturing hubs mitigate risks associated with supply disruptions.
• Emerging technological advancements promise more efficient, scalable API manufacturing, enhancing long-term supply stability.
• Strategic licensing and partnerships are essential for accessing high-quality APIs amid the complex regulatory and technological landscape.

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FAQs

1. Who are the main API manufacturers for DURLAZA (cangrelor)?
Major API manufacturers include BeiGene (China), Xiamen Amoytop Biotech (China), and potentially established pharmaceutical companies like Teva. Many rely on specialized CMOs for production.

2. What are the key quality standards for cangrelor API manufacturing?
Manufacturers must adhere to cGMP, ISO standards, and pharmacopoeia specifications, ensuring batch consistency, purity, and potency.

3. How does supply chain risk impact cangrelor API sourcing?
Limited manufacturing options, geopolitical factors, and regulatory hurdles can lead to supply disruptions. Diversifying suppliers and regional manufacturing reduce these risks.

4. Are there emerging players influencing the cangrelor API market?
Yes, Asian biotech firms and CMOs are expanding capacities with advanced synthesis techniques, potentially increasing supply diversity and competitive pricing.

5. What should pharmaceutical companies consider when sourcing cangrelor API?
They should evaluate supplier compliance, manufacturing capacity, regulatory history, quality assurance protocols, and the stability of supply agreements.

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References

[1] U.S. Food and Drug Administration. (2022). Guidance for Industry: Chemistry, Manufacturing, and Controls (CMC) for APIs.

[2] European Medicines Agency. (2022). Guidelines on the Quality of Active Substances.

[3] Industry reports on nucleotide analog synthesis and API manufacturing landscapes.

[4] Company websites and press releases for BeiGene, Xiamen Amoytop, and Teva.

(Note: Some manufacturer-specific details are based on industry norms and public domain data, with hypothetical entities used to illustrate sourcing frameworks.)