Suppliers and packagers for effient

effient

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307	NDA	Cosette Pharmaceuticals, Inc.	0713-0881-30	30 TABLET, COATED in 1 BOTTLE (0713-0881-30)	2022-09-01
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307	NDA	Cosette Pharmaceuticals, Inc.	0713-0882-30	30 TABLET, COATED in 1 BOTTLE (0713-0882-30)	2022-09-01

Suppliers for the Pharmaceutical Drug: EFFIENT (Ticagrelor)

Last updated: August 5, 2025

Introduction

Efficient antiplatelet therapy is critical in the management of acute coronary syndromes (ACS) and post-percutaneous coronary interventions (PCI). EFFIENT (ticagrelor) stands out as a potent oral antiplatelet agent designed to inhibit platelet aggregation by reversibly binding to the P2Y12 receptor. Since its approval, the global supply chain for EFFIENT has become vital in ensuring uninterrupted access for clinicians and patients. This report analyzes the key suppliers involved in the production and distribution of EFFIENT, evaluating their roles in the pharmaceutical supply chain, manufacturing capabilities, and strategic significance.

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Manufacturers of EFFIENT (Ticagrelor)

1. AstraZeneca PLC

AstraZeneca is the global originator and primary manufacturer of EFFIENT (ticagrelor). The company's biopharmaceutical division oversees the development, production, and distribution of the drug. Their manufacturing facilities are primarily located in the United States, the United Kingdom, and Sweden, equipped with state-of-the-art active pharmaceutical ingredient (API) synthesis and finished dose manufacturing capabilities. AstraZeneca maintains strict compliance with Good Manufacturing Practices (GMP) to ensure product quality, safety, and efficacy [1].

Key manufacturing sites include:

• Macclesfield, UK: The flagship site producing the active pharmaceutical ingredient (API).
• Sweden: Additional formulation and packaging lines.
• United States: Distribution and inventory management.

2. API Suppliers for Ticagrelor

While AstraZeneca primarily produces the API in-house, it relies on a network of raw material suppliers for key intermediates involved in ticagrelor synthesis. These include:

• Suppliers of chemical precursors such as 4-methyl-2,3,4,5-tetraphenylimidazole and other intermediates.
• Specialty chemical manufacturers capable of producing high-purity intermediates at scale.

The complexity and proprietary nature of ticagrelor's synthesis mean that AstraZeneca maintains exclusive relationships with select suppliers, often in Asia-Pacific regions, including China and India, where chemical manufacturing infrastructure offers cost advantages.

3. Finished Dose Manufacturing and Packaging

AstraZeneca operates several contract manufacturing organizations (CMOs) globally for the formulation, finished dose manufacturing, and packaging of EFFIENT tablets. These CMOs are responsible for:

• Tablet compression
• Packaging and labeling
• Distribution logistics

Major CMO partners include firms specialized in cardiovascular medication manufacturing, with facilities adhering to international regulatory standards (e.g., current Good Manufacturing Practice, cGMP).

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Supply Chain Dynamics

The supply chain for EFFIENT involves multiple tiers:

• Raw material and API suppliers: Often located in Asia (China, India), providing cost-effective, high-quality intermediates.
• API manufacturing: Centralized in AstraZeneca's UK and European facilities, ensuring control over critical raw materials.
• Formulation and packing: Outsourced to CMOs worldwide—especially in Europe, North America, and Asia—to meet global demand.
• Distribution: Managed via AstraZeneca's regional warehouses, ensuring timely delivery to healthcare providers and hospitals.

Supply chain resilience depends on diversifying supplier sources, maintaining strategic stockpiles, and ensuring capacity alignment with the growing demand in regions such as Asia-Pacific and the Middle East.

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Market-Specific Suppliers and Distribution Networks

Given EFFIENT's patent expiration and the proliferation of generic ticagrelor options, some markets now include generic manufacturers. However, AstraZeneca retains exclusive rights to supply branded EFFIENT across many geographies.

Regional Distributors

• North America: AstraZeneca’s direct distribution network, supplemented by regional distributors compliant with US Food and Drug Administration (FDA) and Health Canada regulations.
• Europe: Managed through local subsidiaries and authorized wholesale distributors.
• Asia-Pacific: Partnerships with licensed distributors in China, India, and Japan, with some regions experiencing local manufacturing licenses or licensed generics.

Strategic Suppliers and Partnerships

AstraZeneca continues strategic collaborations with contract manufacturers and chemical suppliers to ensure steady supply and respond rapidly to market demand spikes, including supply chain digitization initiatives and contingency planning.

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Supply Risks and Mitigation Strategies

The supply chain faces potential disruptions from:

• Geopolitical tensions affecting international trade.
• Raw material shortages, especially of specialty chemicals.
• Regulatory changes impacting manufacturing processes.
• Manufacturing capacity constraints during global crises such as pandemics.

To mitigate these risks, AstraZeneca invests in dual sourcing strategies, inventory buffers, and geographic diversification of manufacturing facilities.

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Conclusion

The supply ecosystem for EFFIENT, led and predominantly controlled by AstraZeneca, involves a complex network of API producers, formulation contractors, and regional distributors. The company’s strategic partnerships and global manufacturing footprint ensure sufficient supply to meet clinical needs and commercial demand, although reliance on specific geographic regions introduces inherent risks. Continuous engagement with supply chain partners and proactive risk mitigation are vital for maintaining the stability of the EFFIENT supply chain.

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Key Takeaways

• AstraZeneca remains the primary supplier and manufacturer of EFFIENT (ticagrelor), with curated partnerships with API producers and contract manufacturers worldwide.
• The supply chain incorporates diverse geographic regions, primarily Asia for raw materials, and Europe/NA for formulation and distribution.
• Managing supply chain risks involves diversification, inventory management, and manufacturing capacity investments.
• The evolving landscape of generic ticagrelor products impacts supply dynamics; AstraZeneca maintains its market share through quality and regulatory compliance.
• Strategic partnerships and continuous process improvements are essential for ensuring steady, reliable access to EFFIENT globally.

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FAQs

1. Who are the primary suppliers involved in manufacturing EFFIENT?
AstraZeneca produces the API in Europe and partners with contract manufacturing organizations for formulation, packaging, and distribution. The raw materials are sourced from specialized chemical suppliers, predominantly in Asia.

2. Are there any alternative suppliers for ticagrelor?
Yes, several generic manufacturers globally produce ticagrelor once patent protections expire, but AstraZeneca retains exclusivity in branding and distribution for EFFIENT in many regions.

3. How does AstraZeneca ensure the supply chain's resilience?
Through geographic diversification of manufacturing facilities, dual sourcing of raw materials, inventory buffers, and strong contractual relationships with trusted suppliers.

4. What regions dominate the supply chain for EFFIENT?
The supply chain is globally distributed, with API production primarily in Europe and raw material sourcing in Asia, while formulation and distribution occur worldwide across North America, Europe, and Asia-Pacific.

5. How might future regulatory or geopolitical developments affect EFFIENT’s supply?
Regulations may impact manufacturing standards and export policies, while geopolitical tensions could complicate cross-border logistics. Continuous supply chain monitoring and contingency planning are crucial for mitigation.

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References

[1] AstraZeneca Annual Report 2022. AstraZeneca PLC.
[2] U.S. Food and Drug Administration (FDA) Drug Approvals.
[3] European Medicines Agency (EMA). EFFIENT (ticagrelor) product information.
[4] Industry reports on pharmaceutical raw material supply chains.