Bulk Pharmaceutical API Sources for CALQUENCE

Bulk Pharmaceutical API Sources for CALQUENCE

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-17600
AbaChemScene		CS-5356
AbovChem LLC		HY-17600
AKos Consulting & Solutions		AKOS030526094
DC Chemicals		DC9660
abcr GmbH		AB479415

Bulk Active Pharmaceutical Ingredient (API) Sources for CALQUENCE

Last updated: July 28, 2025

Introduction

Calquence, known chemically as acalabrutinib, is an oral Bruton’s tyrosine kinase (BTK) inhibitor developed by AstraZeneca. Approved by the U.S. Food and Drug Administration (FDA) in 2019 for the treatment of mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL), Calquence has rapidly established itself in the hematological malignancy therapeutic landscape. Its clinical efficacy relies heavily on the availability of high-quality, reliable bulk Active Pharmaceutical Ingredient (API). As demand grows, manufacturers, pharmaceutical companies, and supply chain stakeholders seek insights into the primary sources of acalabrutinib APIs, emphasizing quality, regulatory compliance, and supply stability.

This report provides a comprehensive overview of the key API suppliers for Calquence, analyzing their capabilities, regulatory compliance, geographic presence, and strategic significance in the global API supply chain.

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Understanding API Supply Dynamics for Calquence

The API market for innovative oncology drugs like Calquence is characterized by concentrated manufacturing, stringent quality standards, and burgeoning demand. The API production process for acalabrutinib involves complex synthetic pathways, demanding specialized chemical expertise and state-of-the-art manufacturing facilities.

Manufacturers typify their capacities through multi-tiered accreditation, including cGMP compliance, regulatory approvals (e.g., FDA, EMA, ICH), and quality control standards (e.g., ISO certifications). Given Calquence’s status as an FDA-approved product, the API sources must demonstrate rigorous adherence to Good Manufacturing Practices (GMP), validation protocols, and stable supply agreements.

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Major API Suppliers for Acalabrutinib

1. AstraZeneca's Internal API Manufacturing Capabilities

AstraZeneca, as the originator, maintains in-house manufacturing for key intermediates and bulk API of Calquence. The company's global manufacturing network includes facilities in the United States, the United Kingdom, and other regions, strategically located to support drug supply worldwide (reference: AstraZeneca’s corporate reports [1]).

• Strengths: Full control over quality, integrated supply chain, and assured regulatory compliance.
• Limitations: Limited flexibility and capacity constraints during surges in demand.

2. External Contract Manufacturing Organizations (CMOs)

Given the complex synthesis and scale-up needs, AstraZeneca collaborates with reputable CMOs to augment API production capacity. Several leading CMOs have been identified as active suppliers of acalabrutinib API either in dedicated projects or as part of global supply agreements.

a. WuXi AppTec

• Overview: A global leader in pharmaceutical development and manufacturing, WuXi specializes in small molecule API synthesis.
• Capabilities: GMP-compliant facilities capable of producing acalabrutinib with high purity and batch consistency.
• Certifications: cGMP certification, FDA registration, and adherence to international standards.
• Relevance: WuXi’s flexible manufacturing capacity makes it a key external supplier, often serving as a back-up or secondary source.

b. Jubilant Pharma

• Overview: Jublilant has expanded its API manufacturing portfolio, including high-performance APIs.
• Capabilities: Advanced synthetic routes for kinase inhibitors; proven track record for cGMP production.
• Certifications: Approved under FDA and European regulators, ensuring regulatory compliance.

c. Dr. Reddy’s Laboratories

• Overview: A prominent API manufacturer with global operations, Dr. Reddy’s supplies various oncology APIs.
• Capabilities: Emphases on bioavailability and purity; processes align with industry standards to support clinical and commercial batches.
• Relevance: Their presence as a secondary supplier enhances supply security.

3. Chinese API Manufacturers

China remains a vital component of the global API supply chain due to its manufacturing scale, cost advantages, and technological advancements. Several Chinese API manufacturers have obtained cGMP certifications and export approvals for acalabrutinib.

a. Bidepharm

• Profile: A GMP-certified Chinese manufacturer specializing in targeted oncology APIs.
• Strengths: Ability to produce large batches with consistent quality; strategic partnerships with Western pharma companies.
• Regulatory Considerations: Increasing efforts to meet international quality standards and gain FDA approval.

b. Hunan Sunway Biotechnology

• Overview: Focused on kinase inhibitors and oncology-related APIs.
• Capabilities: Synthesis of acalabrutinib with bulk production capabilities.
• Quality: Stringent internal quality controls to meet international cGMP requirements.

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Emerging Sources and Geographic Considerations

With the ongoing geopolitical and regulatory pressures, pharmaceutical companies increasingly diversify API sourcing. While North American and European manufacturers focus on quality and compliance, Chinese and Indian suppliers emphasize cost and capacity. The balance between these factors shapes the overall API sourcing strategy for Calquence.

• Regulatory Evolution: Chinese manufacturers are adopting ICH Q7 guidelines and increasing their audit-readiness for Western regulators.
• Strategic Diversification: AstraZeneca and other buyers may secure multiple sources to mitigate supply disruptions due to geopolitical or logistical issues.

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Quality and Regulatory Compliance

API suppliers for Calquence must demonstrate compliance with stringent regulatory standards such as:

• cGMP Certification (FCGMP, GMPC)
• ISO 9001 Certification
• Batch purity and analytical characterization
• Regulatory dossier submission, supporting FDA and EMA approvals

Suppliers that meet these criteria are more likely to ensure uninterrupted supply, traceability, and regulatory approval for their batches.

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Conclusion

The primary sources for bulk acalabrutinib API encompass AstraZeneca’s internal manufacturing, established CMOs in Western countries, and emerging Chinese API manufacturers. The latter offers cost advantages and capacity scalability, though regulatory maturity remains a critical consideration. A diversified API sourcing strategy, emphasizing quality, compliance, and supply chain resilience, is key to maintaining the steady production of Calquence.

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Key Takeaways

• AstraZeneca leverages both internal and external manufacturers, with a focus on compliance and quality assurance.
• Reputable CMOs such as WuXi AppTec, Jubilant Pharma, and Dr. Reddy’s are significant external API suppliers for acalabrutinib.
• Chinese manufacturers are increasingly contributing to the supply chain, necessitating careful regulatory evaluation.
• Supply chain diversification and rigorous quality controls underpin the stability of Calquence’s API sourcing.
• Continuous monitoring of regulatory developments and manufacturing capacity expansions is essential for stakeholders.

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FAQs

1. What are the main challenges in sourcing API for Calquence?
Ensuring consistent quality, regulatory compliance, and supply chain stability are primary challenges. Complex synthesis routes necessitate advanced manufacturing capabilities, and geopolitical factors can influence geopolitical supply risks.

2. How does AstraZeneca ensure the quality of its API suppliers?
Through rigorous qualification protocols, regular audits, and requiring suppliers to meet cGMP standards aligned with FDA and EMA regulations.

3. Are Chinese API manufacturers meeting international standards for acalabrutinib?
Many Chinese suppliers have obtained cGMP certifications and export approvals, but thorough validation and audits are recommended before engagement to ensure adherence to international quality standards.

4. What role do CMOs play in the API supply chain for Calquence?
CMOs provide flexible, scalable manufacturing capacity, allowing AstraZeneca to mitigate risks associated with capacity constraints, regional disruptions, and demand surges.

5. How might geopolitical considerations impact API sourcing for Calquence?
Trade restrictions, tariffs, and regulatory scrutiny can influence supplier selection and supply chain security, prompting companies to diversify sourcing across multiple regions.

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References

[1] AstraZeneca Corporate Reports (2022). Annual and Sustainability Reports.