Suppliers and packagers for generic pharmaceutical drug: WARFARIN SODIUM

WARFARIN SODIUM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Upsher Smith Labs	JANTOVEN	warfarin sodium	TABLET;ORAL	040416	ANDA	Upsher-Smith Laboratories, LLC	0832-1211-00	100 TABLET in 1 BOTTLE (0832-1211-00)	2010-02-23
Upsher Smith Labs	JANTOVEN	warfarin sodium	TABLET;ORAL	040416	ANDA	Upsher-Smith Laboratories, LLC	0832-1211-01	100 BLISTER PACK in 1 CARTON (0832-1211-01) / 1 TABLET in 1 BLISTER PACK (0832-1211-89)	2010-02-23
Upsher Smith Labs	JANTOVEN	warfarin sodium	TABLET;ORAL	040416	ANDA	Upsher-Smith Laboratories, LLC	0832-1211-10	1000 TABLET in 1 BOTTLE (0832-1211-10)	2010-02-23
Upsher Smith Labs	JANTOVEN	warfarin sodium	TABLET;ORAL	040416	ANDA	Upsher-Smith Laboratories, LLC	0832-1212-00	100 TABLET in 1 BOTTLE (0832-1212-00)	2010-02-23

Suppliers for the Pharmaceutical Drug: Warfarin Sodium

Last updated: July 28, 2025

Introduction

Warfarin sodium, a widely used oral anticoagulant, plays a crucial role in the prevention and treatment of thromboembolic disorders such as deep vein thrombosis, pulmonary embolism, and atrial fibrillation-associated stroke. Its global demand underscores the necessity for a reliable supply chain featuring diverse manufacturers and suppliers. Recognizing the pivotal role of suppliers is essential for healthcare providers, pharmaceutical companies, and regulatory agencies striving to ensure uninterrupted access to this essential medication.

Global Manufacturing Landscape

Warfarin sodium, a derivative of dicoumarol, is produced through a complex chemical synthesis process, necessitating specialized manufacturing facilities adhering to Good Manufacturing Practices (GMP). While originally developed in the 1950s, its production has become widespread, predominantly concentrated in region-specific pharmaceutical hubs.

Leading global suppliers include:

• Pfizer Inc.: Historically, Pfizer has been a dominant player in the warfarin market, producing both branded and generic formulations. Pfizer’s extensive manufacturing infrastructure ensures a steady supply, especially in North America and Europe.

• Mitsubishi Tanabe Pharma Corporation: A key manufacturer in Japan, Mitsubishi Tanabe supplies warfarin sodium to Asian markets and has strategic partnerships for global distribution.

• Teva Pharmaceutical Industries Ltd.: As one of the world's largest generic drug manufacturers, Teva offers warfarin sodium in multiple markets, often at competitive prices, leveraging its extensive global supply chain.

• Accord Healthcare: A prominent generic producer with a strong presence in Europe and emerging markets, Accord manufactures warfarin sodium with compliance to international regulatory standards.

• Sun Pharmaceutical Industries Ltd.: An Indian-based pharmaceutical giant, Sun Pharma supplies warfarin sodium formulations across multiple regions, contributing to regional drug security.

Key Suppliers by Region

• North America: Besides Pfizer and Teva, additional regional suppliers include BorsodChem and Sandoz (a Novartis division), focusing on high-quality generics.

• Europe: EMA-licensed manufacturers such as Sanofi and Stada Arzneimittel supply warfarin, alongside local generic companies.

• Asia-Pacific: Indian manufacturers, including Sun Pharma and Lupin Limited, dominate regional supply with cost-effective options. Japanese companies such as Mitsubishi Tanabe also contribute significantly.

• Emerging Markets: Local manufacturers in Africa, Latin America, and Southeast Asia are increasingly producing warfarin sodium, often sourcing APIs from India or China, to meet local demand.

API Suppliers and Raw Material Sourcing

The active pharmaceutical ingredient (API) for warfarin sodium is sourced mainly from chemical intermediates producers in China and India, which supply bulk API to regional formulators. Prominent API suppliers include:

• Hengyue Group (China): Known for synthesizing high-quality warfarin APIs used by multiple manufacturers.

• Zhe Jiang NHU Pharmaceuticals Co., Ltd. (China): A major API producer offering competitive prices and consistent quality.

• Granules India Ltd. (India): Supplies API and finished dosage forms, increasingly integrated into global supply chains.

• Matsumoto Clinical Laboratory (Japan): Provides specialty chemicals for pharmaceutical synthesis.

Regulatory and Quality Considerations

Quality assurance remains paramount. Suppliers must comply with stringent regulatory standards—FDA (Food and Drug Administration), EMA (European Medicines Agency), WHO prequalification, and other regional regulatory bodies (e.g., PMDA in Japan). The API suppliers’ adherence to ISO standards, GMP, and rigorous testing protocols influences their market access and reputation.

Furthermore, geopolitical factors and international trade policies impact supply chain stability. The ongoing global focus on supply chain resilience amplifies the importance of diversified sourcing strategies, where reliance on a limited number of API producers may present strategic risks.

Market Dynamics and Supplier Trends

Recent trends indicate a shift toward intensified regional manufacturing, prompted by:

• Supply Chain Disruptions: COVID-19 pandemic exposed vulnerabilities in concentrated supply chains, motivating companies to diversify supplier pools.

• Cost Optimization: Indian and Chinese suppliers continue to provide cost-effective APIs, challenging Western manufacturers to maintain competitive pricing.

• Regulatory Stringency: Increasingly rigorous quality regulations have limited the participation of inferior-quality API producers, sharpening the focus on certified suppliers.

• Innovation and Formulation Strategies: Advanced formulations and alternative anticoagulants emerging as substitutes necessitate continuous supplier evaluation for warfarin sodium.

Future Outlook

The market for warfarin sodium suppliers will likely evolve with:

• Enhanced Supply Chain Transparency: Companies will prioritize supply chain mapping and auditing to mitigate risks.

• Increased Regulatory Scrutiny: Suppliers must maintain certification standards for continued market access.

• Emergence of Biosimilar Alternatives: While warfarin is small-molecule-based, the advent of biosimilar anticoagulants could impact suppliers’ market share.

• Strategic Alliances and Vertically Integrated Manufacturing: Vertical integration—combining API production with formulation—may strengthen supply security.

Conclusion

A resilient supply of warfarin sodium hinges on a diversified network of API producers and finished drug manufacturers across key geographical regions. Major players include Pfizer, Teva, Mitsubishi Tanabe, and Indian pharmaceutical companies such as Sun Pharma and Lupin. Ensuring supply continuity requires strict adherence to regulatory standards, supply chain transparency, and adaptation to global market dynamics. Stakeholders must monitor geopolitical trends, quality compliance, and technological advancements to sustain secure access to this essential anticoagulant.

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Key Takeaways

• The global supply of warfarin sodium is characterized by a mix of established pharmaceutical giants and regional generic producers, reflecting diverse sourcing strategies.

• API sourcing predominantly relies on Chinese and Indian manufacturers, emphasizing the importance of quality assurance and regulatory compliance.

• Disruptions in supply chains underscore the need for diversification and strategic partnerships among formulators and suppliers.

• Regulatory standards, including GMP and international certifications, are critical for maintaining market access and ensuring drug safety.

• Monitoring geopolitical and market trends is essential for stakeholders to secure a reliable supply of warfarin sodium.

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FAQs

1. Who are the leading API suppliers for warfarin sodium globally?
Chinese companies like Hengyue Group and Zhe Jiang NHU Pharmaceuticals dominate API production, supported by Indian manufacturers such as Granules India. These suppliers offer high-volume, quality-assured APIs to global markets.

2. How do regional manufacturers contribute to warfarin sodium supply?
Regional manufacturers provide formulations tailored to local markets, often sourcing API from global suppliers. This decentralization enhances supply reliability and reduces dependence on a single source.

3. What regulatory standards must warfarin sodium suppliers meet?
Suppliers must comply with GMP, ISO standards, and obtain certifications from agencies like the FDA, EMA, and WHO prequalification programs to ensure product quality and safety.

4. How has the COVID-19 pandemic affected warfarin sodium supply chains?
Pandemic disruptions highlighted vulnerabilities in concentrated supply routes, prompting a push toward diversification, increased regional manufacturing, and inventory build-up.

5. What future trends are shaping the warfarin sodium supplier market?
Emerging trends include supply chain diversification, enhanced regulatory oversight, and technological innovations—such as improved formulations and potential substitutes—driving ongoing supplier evaluation.

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References

[1] Statista. "Global pharmaceutical API market, 2022."
[2] IMS Health. "The evolving global supply chain for active pharmaceutical ingredients," 2021.
[3] WHO. "Good manufacturing practices for active pharmaceutical ingredients," 2019.
[4] MarketWatch. "Warfarin market analysis," 2022.
[5] EvaluatePharma. "Pharmaceutical production sustainability report," 2022.