Suppliers and packagers for PRASUGREL

PRASUGREL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Accord Hlthcare	PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205987	ANDA	Accord Healthcare Inc.	16729-272-10	30 TABLET, FILM COATED in 1 BOTTLE (16729-272-10)	2019-01-16
Accord Hlthcare	PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205987	ANDA	Accord Healthcare Inc.	16729-273-10	30 TABLET, FILM COATED in 1 BOTTLE (16729-273-10)	2019-01-16
Amneal Pharms	PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205913	ANDA	Amneal Pharmaceuticals LLC	65162-001-03	30 TABLET, FILM COATED in 1 BOTTLE (65162-001-03)	2018-06-22

Suppliers for the Pharmaceutical Drug: PRASUGREL

Last updated: July 28, 2025

Introduction

Prasugrel, marketed primarily under the brand name Effient, is an antiplatelet agent used to prevent thrombotic cardiovascular events such as myocardial infarction in patients undergoing percutaneous coronary intervention (PCI). As a pivotal medication in cardiovascular care, its supply chain is critical for healthcare providers globally. This article provides an in-depth analysis of the primary suppliers of prasugrel, elucidates the manufacturing landscape, and examines market dynamics influencing its availability.

Overview of Prasugrel Supply Chain

Manufacture and distribution of prasugrel involve a complex global network comprising active pharmaceutical ingredient (API) producers, finished drug formulators, and distribution entities. The drug's patent status, regional regulatory approvals, and manufacturing capabilities significantly influence supplier selection and market competition.

Key Suppliers of Prasugrel API

1. Chiesi Farmaceutici

Chiesi Farmaceutici, an Italy-based biopharmaceutical company, is recognized as a prominent API manufacturer for prasugrel. The company's expertise in cardiovascular APIs and established manufacturing facilities ensure the consistent supply of high-purity prasugrel API.

2. Jiangsu Hengrui Medicine Co., Ltd.

Jiangsu Hengrui, a leading Chinese pharmaceutical firm, has expanded its portfolio to include prasugrel API. Leveraging regional manufacturing capabilities, Hengrui supplies APIs to generic drug manufacturers across Asia and beyond, potentially impacting regional access and pricing.

3. Chinese Generics Manufacturers

Several Chinese generic API producers, such as Zhejiang Hisun Pharmaceutical and Hebei Changshan Biochemical Pharmaceutical, have developed prasugrel APIs through technology transfer agreements or reverse engineering processes. While market share data is limited, these manufacturers play an integral role in regional supply, especially where patent restrictions are less stringent.

4. European and North American API Suppliers

Although specific API suppliers in Europe and North America for prasugrel are less publicly disclosed, pharmaceutical giants like Teva Pharmaceuticals and Novartis have historically engaged in API manufacturing or sourcing arrangements. Their involvement ensures supply chain security in regions with stringent regulatory standards.

Original Patent and Generic Market Dynamics

The patent for prasugrel was held by Eli Lilly and Servier when it gained regulatory approval, limiting generic production to licensed manufacturers. Following patent expiry or invalidation, the entry of generic manufacturers has increased, diversifying the supply landscape. In regions where patent protections are still active, authorized generics from original patent holders dominate, influencing supplier dominance.

Manufacturing and Quality Standards

API producers for prasugrel are required to meet stringent Good Manufacturing Practices (GMP) set by regulatory authorities such as the FDA and EMA. Quality assurance protocols influence supplier selection, especially in markets with high regulatory scrutiny. Capacity expansions at existing facilities and development of new manufacturing sites are ongoing to meet global demands.

Distribution and Logistics

Pharmaceutical companies and authorized distributors handle the downstream supply of prasugrel, with distribution networks tailored for regional demands. Supply chain resilience, transportation logistics, and regulatory compliance are key to ensuring uninterrupted drug availability, particularly in emergency cardiovascular care.

Market Factors Affecting Supplier Dynamics

• Patent Status and Regulatory Approvals: Patent expirations open markets to generic manufacturers, increasing supplier options.
• Pricing and Cost Competition: Chinese and Indian API suppliers often offer competitive pricing, influencing regional procurement strategies.
• Quality and Regulatory Compliance: Suppliers with validated facilities and proven quality systems dominate in developed markets.
• Supply Chain Disruptions: Geopolitical tensions, trade policies, and pandemics can impact API supply continuity.

Conclusion

The supply of prasugrel hinges on a blend of established pharmaceutical companies and emerging generic manufacturers, with key players spanning Europe, Asia, and North America. The API landscape is characterized by a combination of branded, licensed, and generic sources, each contributing to global drug availability. Enhancing supply chain transparency and diversifying supplier pools remain essential strategies for ensuring consistent access to prasugrel, especially amid evolving patent landscapes and regulatory environments.

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Key Takeaways

• Major API suppliers include Chiesi Farmaceutici, Jiangsu Hengrui Medicine, and various Chinese generics manufacturers.
• Patent status significantly influences supplier diversity, with generic entry increasing post-expiry.
• Regulatory standards demand high-quality manufacturing processes, favoring established, compliant suppliers.
• Regional infrastructure and geopolitical factors impact supply chain resilience.
• Supply chain diversification reduces risks of shortages and enhances global access.

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FAQs

1. Who are the leading API manufacturers for prasugrel globally?
Leading API manufacturers include Chiesi Farmaceutici (Italy), Jiangsu Hengrui Medicine (China), and other regional Chinese producers. These companies possess the technological expertise and facilities necessary to produce high-quality prasugrel API at scale.

2. How does patent expiration affect the supply of prasugrel?
Patent expiration typically permits generic manufacturers to produce prasugrel API and finished formulations, increasing supply options, reducing costs, and improving regional access. However, patent protection can temporarily restrict generic entry, maintaining market dominance for original patent holders.

3. Are there regional differences in prasugrel API suppliers?
Yes. Developed markets usually rely on Western or licensed API producers, emphasizing regulatory compliance and quality standards. Conversely, Asian generic manufacturers contribute significantly to regional supply, often offering cost-effective options.

4. What regulatory standards do prasugrel API producers need to meet?
API manufacturers must adhere to GMP standards set by authorities like the FDA, EMA, and China’s NMPA. These standards ensure the APIs' purity, potency, and safety, critical for cardiovascular medications like prasugrel.

5. How might geopolitical factors influence prasugrel supply?
Trade tensions, import-export restrictions, and pandemics can disrupt production or logistics. Diversifying supplier sources and establishing regional manufacturing hubs can mitigate such risks.

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References

[1] U.S. Food and Drug Administration (FDA). Effient (Prasugrel) Prescribing Information. 2022.
[2] European Medicines Agency (EMA). Effient (Prasugrel) Summary of Product Characteristics. 2023.
[3] Eli Lilly and Company. Patent and Licensing Agreements for Prasugrel. Intellectual Property Reports. 2021.
[4] Jiangsu Hengrui Medicine Co., Ltd. Corporate Website. Product Portfolio. 2023.
[5] Chinese National Medical Products Administration (NMPA). API Manufacturing Standards. 2022.