Suppliers and packagers for generic pharmaceutical drug: prasugrel hydrochloride

prasugrel hydrochloride

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
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

Suppliers for the Pharmaceutical Drug: Prasugrel Hydrochloride

Last updated: July 27, 2025

Introduction

Prasugrel hydrochloride is a potent antiplatelet agent primarily prescribed to reduce thrombotic cardiovascular events in patients with acute coronary syndromes undergoing percutaneous coronary intervention (PCI). As a critical component within the thrombotic management landscape, the supply chain for prasugrel hydrochloride is vital to ensure unbroken patient access. This article examines the key suppliers, manufacturing landscape, market dynamics, and factors influencing the procurement of prasugrel hydrochloride.

Overview of Prasugrel Hydrochloride Supply Chain

Prasugrel hydrochloride is a third-generation thienopyridine, and its supply involves a complex global network of APIs (Active Pharmaceutical Ingredients), intermediates, formulation manufacturers, and distribution channels. Due to its molecular complexity and regulatory requirements, synthesis processes are proprietary and confined to select manufacturers.

Major Suppliers of Prasugrel Hydrochloride API

The supply of prasugrel hydrochloride API is relatively concentrated. The primary suppliers are multinational pharmaceutical companies and specialized chemical manufacturers, primarily located in Asia and Europe. These suppliers often operate under strict licensing and compliance standards to meet global regulatory frameworks such as those established by the FDA, EMA, and other health authorities.

1. Laurus Labs (India)
   A major player in the global API market, Laurus Labs has been manufacturing prasugrel hydrochloride APIs since its approval in various markets. Their capabilities extend across synthesis, quality control, and packaging, enabling them to meet large-volume demands. Laurus Labs’ competitive advantage lies in their cost-effective manufacturing and adherence to international quality standards.

2. Mundipharma’s Contract Manufacturing Partners
   Mundipharma markets prasugrel under the brand name Effient. While Mundipharma itself does not produce the raw API, it contracts with specialty API manufacturers, notably those based in Asia, to support global supply demands. This outsourcing model enhances supply flexibility and capacity.

3. Sun Pharmaceutical Industries Limited (India)
   Another significant supplier, Sun Pharma, produces prasugrel hydrochloride APIs for regional markets and potentially for export. Its extensive manufacturing infrastructure and quality assurance processes reinforce its role in the supply ecosystem.

4. Dr. Reddy’s Laboratories (India)
   Dr. Reddy’s has a diverse portfolio of APIs; its role in prasugrel supply is emerging due to strategic investments in antiplatelet APIs. Their manufacturing shines in adhering to strict cGMP (current Good Manufacturing Practice) standards.

5. Seacoast Pharmaceutical (China)
   Chinese API manufacturers like Seacoast Pharmaceutical have increased their market share by offering cost-competitive prasugrel hydrochloride APIs aligned with international quality standards, secured through rigorous regulatory compliance.

Manufacturing and Quality Standards

Manufacturers supplying prasugrel hydrochloride APIs maintain high standards of quality management, often aligned with ICH Q7 guidelines, to meet global market requirements. Quality assurance is rigorous, including process validation, stability testing, and impurity profiling, given prasugrel’s critical health applications.

Market Dynamics and Supply Risks

The market for prasugrel hydrochloride faces several supply risks:

• Consolidation and Patent Expirations: While prasugrel remains under patent protection, manufacturing is concentrated, creating dependency on a few suppliers. Patent expiry could influence the market, encouraging additional manufacturers and supply sources.

• Regulatory Barriers: Strict regulatory oversight can cause delays or supply disruptions if manufacturing facilities do not comply with evolving standards.

• Geopolitical Factors: Political instability, trade restrictions, or tariffs affecting key producer countries, especially India and China, can influence supply continuity.

• Pandemic Impact: The COVID-19 pandemic has disrupted supply chains globally, emphasizing the need for diversified sourcing.

• Raw Material Availability: The synthesis process relies on specific chemical precursors, which can be affected by macroeconomic factors or supply shortages.

Distribution and Market Access

After API production, pharmaceutical firms formulate prasugrel hydrochloride into finished dosage forms (tablets) and distribute globally. This process involves third-party CMOs (Contract Manufacturing Organizations) and distribution networks that must maintain strict cold chain and quality standards to ensure drug stability and efficacy.

Procurement and Partnering Strategies

Healthcare providers and pharmaceutical companies often adopt multiple sourcing strategies, including:

• Engaging with multiple API suppliers to mitigate supply risks.
• Investing in supply chain transparency to monitor quality and compliance.
• Building strategic partnerships with established manufacturers for consistent supply.

Emerging Trends

• Manufacturing Localization: Countries are increasingly incentivizing local API manufacturing to reduce dependency on imports, potentially diversifying supply sources.
• Regulatory Harmonization: International harmonization efforts aim to streamline approvals, reducing barriers for new suppliers.
• Technological Advancements: Innovations such as continuous manufacturing could improve supply robustness and quality.

Conclusion

Prasugrel hydrochloride’s supply chain is defined by a handful of major Asian and European API manufacturers with high-quality standards. While current suppliers are capable of meeting global demand, reliance on concentrated sources poses risks. Diversification, regulatory compliance, and technological innovation remain essential to securing sustained, reliable supply.

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Key Takeaways

• Major prasugrel hydrochloride API suppliers include Laurus Labs, Sun Pharma, Dr. Reddy’s, and Seacoast Pharmaceutical, primarily located in India and China.
• Supply chain integrity hinges on high regulatory compliance, quality assurance, and strategic supplier diversification.
• Geopolitical, regulatory, and pandemic-related disruptions could impact supply stability.
• The industry is trending towards localized manufacturing and technological advancements to enhance supply resilience.
• Establishing strategic partnerships and monitoring global regulatory developments are critical for procurement professionals.

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FAQs

1. Who are the leading global suppliers of prasugrel hydrochloride API?
Laurus Labs, Sun Pharma, Dr. Reddy’s Laboratories, and Seacoast Pharmaceutical are key API suppliers, primarily based in India and China.

2. What are major risks associated with prasugrel hydrochloride supply?
Risks include supply concentration, regulatory delays, geopolitical tensions, raw material shortages, and disruptions caused by health crises like COVID-19.

3. How does regulatory compliance influence API sourcing for prasugrel?
Strict adherence to international standards (e.g., ICH guidelines) is essential. Non-compliant facilities face delayed approvals or bans, impacting supply continuity.

4. Are there emerging new suppliers for prasugrel hydrochloride?
Yes, increased interest from new manufacturers in China and Southeast Asia aims to diversify supply sources and reduce dependency on existing suppliers.

5. What are best practices for pharmaceutical companies to ensure supply security?
Diversify supplier base, monitor geopolitical and regulatory developments, engage in long-term partnerships, and adopt technological innovations in manufacturing.

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Sources

1. Bloomberg Industry Reports (2022). Global API Market Insights.
2. U.S. Food and Drug Administration (FDA). Food and Drug Administration API Manufacturing Standards.
3. Pharmaceutical Technology. (2021). API Supply Chain Resilience.
4. Company disclosures and public filings of Laurus Labs, Sun Pharma, Dr. Reddy’s.
5. International Conference on Harmonisation (ICH) Guidelines.