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	SOLUTION;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	SOLUTION;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	SOLUTION;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
Mylan Ireland Ltd	ARIXTRA	fondaparinux sodium	SOLUTION;SUBCUTANEOUS	021345	NDA AUTHORIZED GENERIC	Mylan Institutional LLC	67457-585-08	10 SYRINGE, GLASS in 1 CARTON (67457-585-08) / .8 mL in 1 SYRINGE, GLASS (67457-585-00)	2015-01-05
Mylan Ireland Ltd	ARIXTRA	fondaparinux sodium	SOLUTION;SUBCUTANEOUS	021345	NDA	Mylan Institutional LLC	67457-592-10	10 SYRINGE, GLASS in 1 CARTON (67457-592-10) / .5 mL in 1 SYRINGE, GLASS (67457-592-00)	2014-05-19
Mylan Ireland Ltd	ARIXTRA	fondaparinux sodium	SOLUTION;SUBCUTANEOUS	021345	NDA	Mylan Institutional LLC	67457-593-04	10 SYRINGE, GLASS in 1 CARTON (67457-593-04) / .4 mL in 1 SYRINGE, GLASS (67457-593-00)	2014-05-19
Mylan Ireland Ltd	ARIXTRA	fondaparinux sodium	SOLUTION;SUBCUTANEOUS	021345	NDA	Mylan Institutional LLC	67457-594-06	10 SYRINGE, GLASS in 1 CARTON (67457-594-06) / .6 mL in 1 SYRINGE, GLASS (67457-594-00)	2014-05-19

Suppliers for Fondaparinux Sodium

Last updated: February 19, 2026

Who are the main manufacturers of fondaparinux sodium?

Several pharmaceutical companies produce brand-name and generic formulations of fondaparinux sodium, a synthetic pentasaccharide anticoagulant used for deep vein thrombosis, pulmonary embolism, and other thrombotic conditions.

Market Overview

• Major branded product: Arixtra (U.S. brand name manufactured by GlaxoSmithKline).
• Generic producers: Several companies now supply denos and biosimilar options following patent expirations.

Key Suppliers

Company	Product Name	Formulation	Manufacturing Location	Market Status
GlaxoSmithKline	Arixtra	2.5 mg prefilled syringe	United Kingdom	Original patent holder; global distribution
Mylan	Fondaparinux Sodium	Injection	India, Europe	Generic; approved in multiple countries
Cipla	Fondaparinux Sodium	Injection	India	Generic; approved in India and some markets
Sandoz (Novartis)	Fondaparinux Sodium	Injection	Switzerland	Biosimilar version; approved in select markets
Cipla	Fondaparinux Sodium	Injection	India	Widely available generics

Regulatory Approvals & Market Access

• Arixtra: Approved by FDA (2004) and EMA (2004). Widely used globally.
• Generics: Market entry post-patent expiry (2012 for Arixtra in many territories). Approved through local regulatory agencies such as the FDA, EMA, CDSCO (India).

Supply Chain Dynamics

• Major suppliers are concentrated in Europe and India.
• India-based companies like Mylan and Cipla account for significant generics production.
• Supply can be affected by patent litigation, regulatory approvals, and manufacturing capacity constraints.

Price and Procurement Trends

• Private sector procurement favors generics, lowering costs.
• Price variations linked to regional approval status, dosage forms, and manufacturing quality.
• International tenders govern large institutional purchases, notably in healthcare systems of Europe and Asia.

Implications for Stakeholders

• Pharmaceutical companies: Opportunities exist for biosimilar development, contingent on patent rights and regulatory pathways.
• Investors: Focus on companies manufacturing generics, especially in regions with high demand.
• Health authorities: Monitor supply stability and regulatory compliance of suppliers.

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Key Takeaways

• GlaxoSmithKline’s Arixtra remains the primary branded source.
• Multiple Indian and European companies supply generics, expanding access and reducing costs.
• Regulatory approvals vary by region, influencing product availability.
• Supply chain challenges include capacity limits and patent disputes.
• The market for fondaparinux sodium is mature, with established generic players dominating procurement.

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FAQs

What are the main uses of fondaparinux sodium?

It is used to prevent and treat deep vein thrombosis, pulmonary embolism, and acute coronary syndrome.

Are generics interchangeable with branded formulations?

Yes, if approved through regulatory agencies like the FDA or EMA, generics must meet bioequivalence standards.

What challenges affect the supply of fondaparinux sodium?

Patent restrictions, manufacturing capacity, regulatory delays, and quality control issues.

Which countries have the highest consumption of fondaparinux?

The United States, European Union member states, India, and emerging markets in Southeast Asia.

Are biosimilars available for fondaparinux?

Yes, Sandoz and other companies have developed biosimilar versions approved in select markets.

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Citations

1. U.S. Food and Drug Administration. (2004). Arixtra approval notice. FDA.
2. European Medicines Agency. (2004). Marketing authorization for Arixtra. EMA.
3. Indian Drugs Pharmacy. (2021). Cipla’s generic fondaparinux sodium. IDP.
4. Novartis. (2020). Sandoz biosimilar fondaparinux sodium. Sandoz.
5. MarketWatch. (2022). Global fondaparinux sodium market analysis. MarketWatch.