Suppliers and packagers for generic pharmaceutical drug: FONDAPARINUX SODIUM

FONDAPARINUX 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
Mylan Ireland Ltd	ARIXTRA	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	021345	NDA AUTHORIZED GENERIC	Mylan Institutional LLC	67457-582-10	10 SYRINGE, GLASS in 1 CARTON (67457-582-10) / .5 mL in 1 SYRINGE, GLASS (67457-582-00)	2015-01-05
Mylan Ireland Ltd	ARIXTRA	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	021345	NDA AUTHORIZED GENERIC	Mylan Institutional LLC	67457-583-04	10 SYRINGE, GLASS in 1 CARTON (67457-583-04) / .4 mL in 1 SYRINGE, GLASS (67457-583-00)	2015-01-05
Mylan Ireland Ltd	ARIXTRA	fondaparinux sodium	INJECTABLE;SUBCUTANEOUS	021345	NDA AUTHORIZED GENERIC	Mylan Institutional LLC	67457-584-06	10 SYRINGE, GLASS in 1 CARTON (67457-584-06) / .6 mL in 1 SYRINGE, GLASS (67457-584-00)	2015-01-05

Suppliers for the Pharmaceutical Drug: Fondaparinux Sodium

Last updated: July 29, 2025

Introduction
Fondaparinux sodium is a synthetic pentasaccharide anticoagulant widely used to prevent and treat thromboembolic events such as deep vein thrombosis (DVT) and pulmonary embolism (PE). Its unique mechanism targets factor Xa, offering an effective alternative to traditional heparins. As demand for anticoagulants surges, understanding the global supply landscape for fondaparinux sodium becomes critical for pharmaceutical companies, healthcare providers, and procurement entities. This article provides an in-depth analysis of the primary suppliers, manufacturing sources, regulatory environment, and emerging players within this niche but vital segment of the anticoagulant market.

Market Overview of Fondaparinux Sodium
The global fondaparinux sodium market is characterized by a limited number of manufacturing entities, primarily due to the complex synthesis process and stringent regulatory standards. Originally developed by GlaxoSmithKline (GSK), the drug is now produced and supplied by multiple pharmaceutical companies across different regions. The drug’s patent expiration has increased opportunities for generic manufacturers, resulting in a broader supplier base and more competitive pricing.

Key Suppliers and Manufacturing Entities

1. GlaxoSmithKline (GSK)

GSK pioneered the development of fondaparinux sodium through its marketing brand Arixtra. As the originator, GSK held exclusive rights until patent expiry and remains a major supplier in regions where its production continues. The company maintains robust manufacturing standards, ensuring high purity and consistency. However, GSK’s market share has gradually declined with the entry of generics.

2. Sandoz (Novartis)

A significant player in the generic anticoagulant market, Sandoz manufactures and supplies generic versions of fondaparinux sodium. Their production facilities are FDA, EMA, and WHO GMP-certified, ensuring quality compliance. Sandoz benefits from Novartis’ global distribution network, facilitating widespread availability.

3. Fresenius Kabi

Fresenius Kabi, a leader in sterile injectables and biosimilars, has developed expertise in sourcing synthetic anticoagulants like fondaparinux sodium. Their manufacturing facilities in Europe and Asia are certified for high-volume production, focusing on hospitals and institutional uses.

4. Cipla Limited

Cipla, an Indian pharmaceutical giant, produces and supplies generic fondaparinux sodium, primarily serving the Asian, African, and Middle Eastern markets. Their manufacturing facilities are ISO-certified, and the company invests heavily in R&D to streamline synthesis processes and reduce production costs.

5. Macleods Pharmaceuticals

Another key Indian generics manufacturer, Macleods offers affordable fondaparinux sodium options. Their focus on cost-efficient manufacturing and global regulatory compliance enables entry into emerging markets.

6. Other Notable Suppliers

Additional suppliers include Zydus Cadila, Hikma Pharmaceuticals, and Biocon. These companies are expanding their portfolios of anticoagulants and biosimilars, diversifying supply sources, and increasing competitive dynamics.

Manufacturing and Synthesis Challenges**
Fondaparinux’s complex synthesis involves multiple stereospecific steps, which necessitate advanced process controls to ensure product purity and batch consistency. The key ingredients are derived from bacterial or synthetic processes that demand specialized raw materials and stringent quality controls. Consequently, only manufacturers with significant investment in R&D, quality assurance, and regulatory compliance dominate the supply landscape.

Regulatory Landscape and Market Entry Barriers
Regulatory approval for generic fondaparinux sodium requires demonstration of bioequivalence and manufacturing process validation across multiple jurisdictions, including the U.S. FDA, European EMA, and WHO. As a result, only well-established manufacturers with robust quality systems tend to succeed in market penetration. Notably, patent expiration timelines—initially in the U.S. and EU—have facilitated the entry of generics.

Emerging Players and Future Supply Trends
The growing aging population and rising prevalence of thromboembolic conditions have increased demand for fondaparinux sodium. Consequently, new entrants from China, India, and regional emerging markets are investing in synthetic manufacturing capabilities. Companies such as Hetero Drugs and Shilpa Medicare are expanding their portfolios, with some developing biosimilar versions that could alter the supply dynamics over the next five years.

Supply Chain Considerations
The global supply chain for fondaparinux sodium involves sourcing specialized raw materials, multi-stage synthesis, and rigorous sterilization. Supply disruptions have been reported due to raw material shortages, regulatory delays, or manufacturing facility inspections. Diversification of suppliers and regional manufacturing hubs are critical strategies for ensuring supply resilience.

Impact of Patent Expiry and Market Competition
Patent expiry has significantly increased the number of suppliers and driven down prices. While GSK’s Arixtra remains a premium product, generic alternatives now account for a substantial market share, especially in price-sensitive regions. Competition has incentivized quality improvements and supply chain optimization among suppliers.

Conclusion
The landscape for fondaparinux sodium suppliers is evolving, with established pharmaceutical firms like GSK maintaining strong positions in innovation and quality, while generic manufacturers from India and China broaden availability. To succeed, suppliers must navigate complex synthesis, stringent regulatory standards, and supply chain reliability. Continuous investment in manufacturing excellence and regulatory compliance will be crucial for maintaining and expanding market share amid intensifying competition.

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Key Takeaways

• Leading Suppliers: GSK (originator), Sandoz, Fresenius Kabi, Cipla, Macleods, and emerging players from Asia dominate the fondaparinux sodium supply chain.
• Supply Challenges: Complex synthesis processes and regulatory hurdles limit market entries; raw material sourcing and manufacturing capacity pose risks.
• Market Dynamics: Patent expiries and increasing demand drive competition, lower prices, and broaden product availability globally.
• Emerging Trends: New entrants and biosimilar developments are poised to reshape the supply landscape over the next decade.
• Supply Chain Resilience: Diversification, regional manufacturing hubs, and quality assurance are critical to mitigating supply disruptions.

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FAQs

1. Who are the primary global suppliers of fondaparinux sodium?
The primary suppliers include GSK (the original patent holder), Sandoz (generic manufacturer under Novartis), Fresenius Kabi, Cipla, and Macleods Pharmaceuticals, among others. These companies operate manufacturing facilities compliant with international standards to ensure quality and supply continuity [1].

2. How do patent expiries influence the supply landscape for fondaparinux sodium?
Patent expiration allows generics manufacturers to enter the market, increasing the number of suppliers, reducing prices, and improving global access. However, manufacturing complexity and regulatory requirements continue to limit rapid expansion and new entrants.

3. What manufacturing challenges are associated with fondaparinux sodium?
Its synthesis involves multiple stereospecific steps and requires high-purity raw materials, complicating scalable production. Ensuring batch-to-batch consistency and meeting strict regulatory standards further increases manufacturing complexity.

4. Are biosimilar or alternative anticoagulants impacting the fondaparinux sodium market?
Yes. Biosimilars and synthetic alternatives targeting the same indications are emerging, driven by patent expiries and demand for more affordable options. These developments could impact market share and supply dynamics.

5. What future trends are expected in sourcing and supplying fondaparinux sodium?
Expect increased regional manufacturing initiatives, further diversification of suppliers, and advances in synthetic process technology. Additionally, regulatory harmonization efforts may streamline approvals and market entry for new suppliers.

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References

1. GlobalData Healthcare. "Anticoagulant Market Analysis." 2022.
2. European Medicines Agency (EMA). "Product Information for Arixtra." 2023.
3. U.S. Food and Drug Administration (FDA). "Generic Drug Approvals." 2023.
4. MarketResearch.com. "Growth Trends in Anticoagulant Drugs." 2022.
5. Pharma Intelligence. "Supply Chain Resilience in Global Pharmaceuticals." 2022.