Suppliers and packagers for PLAVIX

PLAVIX

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839	NDA	Sanofi-Aventis U.S. LLC	0024-1171-90	90 TABLET, FILM COATED in 1 BOTTLE (0024-1171-90)	1997-11-17
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839	NDA	Sanofi-Aventis U.S. LLC	0024-1332-30	3 BLISTER PACK in 1 CARTON (0024-1332-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK	2009-05-09

Suppliers for the Pharmaceutical Drug: PLAVIX (Clopidogrel)

Last updated: July 28, 2025

Introduction

PLAVIX, the brand name for clopidogrel bisulfate, is an antiplatelet medication widely prescribed to prevent blood clots in patients at risk for stroke, myocardial infarction, and other cardiovascular events. As a cornerstone medication in cardiovascular therapy, understanding its supply chain dynamics, including key suppliers and manufacturing insights, is crucial for stakeholders in healthcare, pharmaceutical distribution, and investment sectors.

Overview of PLAVIX Manufacturing and Supply Chain

Clopidogrel was first approved by the FDA in 1997 under the brand PLAVIX, developed and marketed by Sanofi and in some markets by Bristol-Myers Squibb. The drug’s active pharmaceutical ingredient (API) and finished product production involves multiple global suppliers, including API manufacturers, formulation plants, and packaging facilities.

Key API Suppliers for Clopidogrel (PLAVIX)

1. Mccann Explores API Production Globally

The synthesis of clopidogrel's API is complex, involving multiple chemical transformations. Major API manufacturers include:

• Jiangsu Aosaikang Pharmaceutical Co., Ltd. (China) – A notable producer involved in bulk API production for various cardiovascular drugs, including clopidogrel. China remains the dominant supplier due to its large chemical manufacturing capacity and cost advantages [1].

• HIKMA Pharmaceuticals (Jordan) – Known for producing high-quality APIs, HIKMA’s facilities are approved by both the FDA and European regulators, and the company supplies APIs to various pharmaceutical companies globally [2].

• Sun Pharmaceutical Industries Ltd. (India) – A significant player in active ingredient manufacturing, Sun Pharma provides APIs for multiple generic medications including clopidogrel, emphasizing quality and regulatory compliance [3].

• Dr. Reddy’s Laboratories (India) – With a global footprint and WHO-GMP certifications, Dr. Reddy's supplies high-quality APIs, including for cardiovascular medications [4].

2. Chinese API Manufacturers Leading the Market

China's API manufacturing capacity dominates the market due to lower production costs and large-scale chemical production capabilities. Top Chinese API suppliers for clopidogrel include:

• Jiangsu Hengrui Medicine Co., Ltd. – Engaged in API and finished drug manufacturing, with increasing exports to global markets.

• Suzhou Hisound Pharmaceutical Co., Ltd. – Specializes in synthesis of APIs for cardiovascular therapies, including clopidogrel.

3. Regulatory and Quality Considerations

API suppliers for PLAVIX are subject to stringent regulatory oversight:

• FDA and EMA Approvals: Suppliers supplying to Western markets are either approved or must demonstrate compliance with Good Manufacturing Practices (GMP).
• Quality Certifications: CMO (Contract Manufacturing Organization) partnerships require certifications such as ISO 9001, EMA GMP, and FDA approval.

Finished Dosage Form (FDF) Suppliers and Manufacturing

The final PLAVIX tablets are produced by:

• Sanofi (France) – Original manufacturer with integrated manufacturing facilities for both API and FDF.
• Bristol-Myers Squibb – Developed the drug initially, with manufacturing rights licensed to other entities.
• Generic Manufacturers – Post-patent expiry, numerous generic companies globally have entered the market, sourcing APIs from approved suppliers to produce generic clopidogrel tablets.

Leading generic manufacturers include:

• Teva Pharmaceuticals (Israel) – Among the world’s largest generic drug producers, sourcing APIs from certified Chinese and Indian suppliers.
• Mylan (USA) – Has a broad API sourcing network, including Indian and Chinese API manufacturers.
• Lupin Limited (India) – Produces finished dosage forms with APIs supplied by domestically approved and international API suppliers.

Global Procurement and Supply Chain Challenges

The supply chain for PLAVIX faces challenges including:

• API Supply Disruptions: Geopolitical tensions, especially US-China trade relations, may impact API supply continuity.
• Regulatory Stringency: Increasing quality standards necessitate rigorous supplier vetting.
• Pricing Pressures: Generic market competition exerts downward pressure on prices, incentivizing supply chain optimization.

Emerging Trends in PLAVIX Supply

• Diversification of API Sources: To mitigate geopolitical risk and ensure supply security, manufacturers diversify API sources across multiple regions.
• Strategic Stockpiling: Hospitals and healthcare systems increasingly stockpile essential cardiovascular medications due to pandemic-related supply disruptions.
• Supply Chain Digitalization: Implementation of blockchain and supply chain traceability tools to enhance transparency and compliance.

Conclusion

The supply of PLAVIX hinges on a diversified network of API suppliers and manufacturing partners across China, India, Jordan, and Europe. Leading Chinese and Indian API manufacturers maintain dominance due to cost-efficiency and capacity, while regulatory quality compliance remains a critical factor. Collaboration between original developers, generic manufacturers, and global suppliers ensures continued availability of this essential cardiovascular medication amidst evolving supply chain challenges.

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Key Takeaways

• Major API suppliers for clopidogrel include Chinese companies like Jiangsu Aosaikang and Sun Pharma in India, emphasizing the globalized nature of its supply chain.
• Regulatory compliance and quality certifications are critical factors influencing supplier selection, especially for markets with stringent standards like the US and Europe.
• The post-patent landscape has expanded sourcing options, leading to increased competition and potentially lower prices for generic PLAVIX.
• Supply chain resilience strategies, including diversification and digital traceability, are vital to counter disruptions and sustain continuous supply.
• Stakeholders should monitor geopolitical developments and regulatory shifts that could impact API sourcing and manufacturing operations.

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FAQs

1. Who are the primary API suppliers for PLAVIX?
Major API suppliers include Jiangsu Aosaikang Pharmaceutical (China), Sun Pharma (India), HIKMA Pharmaceuticals (Jordan), and Dr. Reddy's Laboratories (India).

2. How does quality regulation influence PLAVIX supply chain stability?
Regulatory standards such as GMP certification and FDA approval ensure API safety and efficacy, influencing supplier credibility and supply continuity, especially in Western markets.

3. Are there alternative sources for clopidogrel APIs?
Yes, manufacturers are increasingly sourcing from multiple regions, including China, India, and Jordan, to reduce dependency and mitigate supply risks.

4. How has patent expiration affected the supply landscape of PLAVIX?
Patent expiry has facilitated entry of numerous generic manufacturers, expanding sourcing options and reducing prices, but also necessitating rigorous supplier qualification processes.

5. What future trends could impact PLAVIX supplies?
Global geopolitical tensions, supply chain digitalization, and evolving regulatory frameworks are likely to influence sourcing strategies and supply stability.

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Sources

[1] U.S. FDA drug approval records.
[2] HIKMA Pharmaceuticals official website.
[3] Sun Pharmaceutical Industries Ltd. Annual Report.
[4] Dr. Reddy’s Laboratories regulatory filings.