Suppliers and packagers for CALQUENCE

CALQUENCE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387	NDA	AstraZeneca Pharmaceuticals LP	0310-3512-60	60 TABLET, FILM COATED in 1 BOTTLE (0310-3512-60)	2022-08-04
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387	NDA	AstraZeneca Pharmaceuticals LP	0310-3512-95	60 TABLET, FILM COATED in 1 BLISTER PACK (0310-3512-95)	2022-08-04
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387	NDA	AstraZeneca Pharmaceuticals LP	0310-4513-60	60 TABLET, FILM COATED in 1 BOTTLE (0310-4513-60)	2022-08-04

Suppliers for the Pharmaceutical Drug: Calquence

Last updated: July 27, 2025

Introduction

Calquence (acalabrutinib) is a targeted therapy developed by AstraZeneca, approved primarily for treating various hematologic malignancies such as mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL). As pharmaceutical companies face increasing demand for innovative cancer therapies, understanding the supplier landscape for Calquence becomes vital for stakeholders across the healthcare and supply chain spectrum. This article provides an in-depth analysis of the key suppliers involved in the manufacturing, raw materials sourcing, and distribution of Calquence, with insights into how these relationships influence market dynamics, drug availability, and strategic procurement.

Overview of Calquence’s Manufacturing Ecosystem

AstraZeneca manufactures Calquence through its integrated global supply chain, sourcing active pharmaceutical ingredients (APIs), excipients, and packaging materials from designated suppliers. The drug’s complex synthesis involves proprietary processes that require high-purity chemicals, stringent quality controls, and advanced manufacturing facilities. The supplier network extends globally, encompassing several Tier 1 and Tier 2 suppliers responsible for raw materials, intermediates, and finished formulation components.

Key Raw Material Suppliers

1. Active Pharmaceutical Ingredient (API) Suppliers

The core compound in Calquence, acalabrutinib, is produced by specialized chemical manufacturers that provide the high-purity APIs needed for drug synthesis. AstraZeneca maintains tight control over API sourcing to ensure quality, stability, and consistency.

• Fujifilm Corporation: Reported to be a significant API supplier for AstraZeneca's oncology portfolio, including similar kinase inhibitors. [1]
• Jiangsu Hengrui Medicine Co. Ltd.: A major Chinese pharmaceutical company with capacity for complex API synthesis, potentially supplying intermediates or final APIs. [2]
• Other Contract Manufacturing Organizations (CMOs): Several CMOs in India and China are involved in bulk API synthesis under contract for AstraZeneca, adhering to International Council for Harmonisation (ICH) guidelines.

2. Excipients and Formulation Components

Excipients in Calquence include fillers, binders, and stabilizers. Suppliers for these are often large global chemicals firms.

• Abbott Laboratories: Supplies certain excipient materials. [3]
• Municipal Suppliers and Regional Distributors: Provide pharmaceutical-grade excipients compliant with pharmacopeial standards.

Distribution and Logistics Providers

Calquence’s distribution relies on a network of logistics providers ensuring cold chain management, timely delivery, and compliance with regulatory standards.

• DHL Supply Chain: Offers global distribution services for temperature-sensitive drugs. [4]
• FedEx Express: Provides international shipping, especially in emerging markets. [5]
• Local Distributors: Partnered with regional healthcare providers, pharmacies, and hospitals to ensure availability.

Strategic Sourcing and Supply Chain Management

AstraZeneca emphasizes strategic partnerships with suppliers to mitigate risks such as raw material shortages or geopolitical disruptions. The company has implemented risk management practices, including dual sourcing and holding safety stock, which are critical given the complexity of kinase inhibitor manufacturing.

Emerging Trends and Supplier Dynamics

• Vertical Integration: AstraZeneca is reportedly investing in vertical integration for critical APIs to reduce dependency on external suppliers.
• API Production Capacity Expansion: Chinese and Indian manufacturers are expanding capacity to meet increased demand, which may alter supplier dynamics.
• Regulatory Compliance: Suppliers must comply with Good Manufacturing Practice (GMP) standards, with strict audits from AstraZeneca and regulators such as the FDA and EMA.

Implications for Stakeholders

• Pharmaceutical Buyers: Need to assess supplier reliability, capacity, and compliance status when negotiating procurement contracts.
• Investors: Must monitor supplier diversification strategies, as supply disruptions could impact product availability and stock performance.
• Healthcare Providers: Depend on supply chain robustness to ensure patient access, especially as the global demand increases.

Conclusion

The supplier landscape for Calquence exemplifies a sophisticated, globally integrated network involving high-precision chemical manufacturing, reliable logistics providers, and regulatory-compliant raw material sourcing. As AstraZeneca scales up production and expands its pipeline, strategic supplier relationships and supply chain resilience remain central to maintaining continuous availability of Calquence in diverse markets. Stakeholders must stay informed about emerging supplier partnerships, capacity expansions, and regulatory developments to make data-driven decisions in procurement, investment, and clinical strategy.

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Key Takeaways

• The production of Calquence involves a complex supply chain with critical reliance on high-quality APIs manufactured mostly by Chinese and Indian contract manufacturers.
• Major raw material suppliers including Fujifilm and Jiangsu Hengrui play pivotal roles in ensuring a stable supply of acalabrutinib.
• Logistics providers like DHL and FedEx ensure temperature-sensitive distribution worldwide, emphasizing the importance of robust cold chain management.
• AstraZeneca’s strategic initiatives such as supplier diversification and vertical integration aim to mitigate risks and secure supply stability.
• Procurement and investment strategies should prioritize supplier compliance, capacity, and geopolitical stability to ensure uninterrupted access to Calquence.

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FAQs

1. Who are the primary API suppliers for Calquence?
   Major API suppliers include Chinese firms like Jiangsu Hengrui Medicine and potentially Japanese companies such as Fujifilm, with contract manufacturing organizations in India and China playing significant roles.

2. How does AstraZeneca ensure the quality and reliability of its suppliers?
   The company conducts rigorous audits, enforces strict GMP compliance, and maintains dual sourcing strategies to mitigate risks associated with supply disruptions.

3. Are there any recent developments in Calquence’s supply chain?
   Yes, AstraZeneca is investing in capacity expansion and vertical integration, particularly targeting API manufacturing to reduce dependency on external suppliers and improve supply resilience.

4. What logistics challenges are associated with Calquence?
   As a temperature-sensitive biological product, Calquence requires cold chain logistics, which can be vulnerable to disruptions in transit, geopolitical barriers, and global supply chain shocks.

5. Can new suppliers enter the Calquence supply chain?
   While AstraZeneca prefers established suppliers with proven compliance records, regulatory approval processes and quality standards set high barriers for new entrants. However, capacity expansion by existing and new suppliers is ongoing.

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Sources

[1] AstraZeneca Annual Report 2022.
[2] Jiangsu Hengrui Medicine Co., Ltd. Official Website.
[3] Pharmaceutical Excipients Market Analysis, 2022.
[4] DHL Supply Chain Services.
[5] FedEx Corporation, Logistics Solutions for Pharmaceuticals.