Suppliers and packagers for RIVAROXABAN

RIVAROXABAN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alkem Labs Ltd	RIVAROXABAN	rivaroxaban	FOR SUSPENSION;ORAL	218502	ANDA	Ascend Laboratories, LLC	67877-882-71	1 BOTTLE in 1 CARTON (67877-882-71) / 1 GRANULE, FOR SUSPENSION in 1 BOTTLE	2025-07-07
Lupin Ltd	RIVAROXABAN	rivaroxaban	FOR SUSPENSION;ORAL	218195	ANDA	Lupin Pharmaceuticals, Inc.	70748-355-01	1 BOTTLE in 1 CARTON (70748-355-01) / 1 FOR SUSPENSION in 1 BOTTLE	2025-09-29
Alembic	RIVAROXABAN	rivaroxaban	TABLET;ORAL	210301	ANDA	Alembic Pharmaceuticals Limited	46708-240-51	1 KIT in 1 CARTON (46708-240-51) * 42 TABLET, FILM COATED in 1 BLISTER PACK * 9 TABLET, FILM COATED in 1 BLISTER PACK	2025-05-14
Alembic	RIVAROXABAN	rivaroxaban	TABLET;ORAL	210301	ANDA	Alembic Pharmaceuticals Limited	46708-346-10	100 BLISTER PACK in 1 CARTON (46708-346-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK	2025-05-14
Alembic	RIVAROXABAN	rivaroxaban	TABLET;ORAL	210301	ANDA	Alembic Pharmaceuticals Limited	46708-346-30	30 TABLET, FILM COATED in 1 BOTTLE (46708-346-30)	2025-05-14

Suppliers for the Pharmaceutical Drug: RIVAROXABAN

Last updated: July 28, 2025

Introduction

Rivaroxaban, marketed primarily under the brand name Xarelto, is a direct oral anticoagulant (DOAC) used in preventing and treating thromboembolic events, including deep vein thrombosis (DVT), pulmonary embolism (PE), and reducing stroke risk in atrial fibrillation patients. Since its approval by regulatory agencies such as the U.S. Food and Drug Administration (FDA) in 2011, rivaroxaban has become a globally utilized anticoagulant, prompting a complex supply chain involving multiple manufacturers and suppliers. This report provides a comprehensive overview of the primary suppliers involved in the manufacturing, raw material sourcing, and distribution of rivaroxaban, analyzing their roles, manufacturing capacities, and strategic importance within the pharmaceutical supply landscape.

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Manufacturers of Rivaroxaban

1. Bayer AG

Overview: Bayer AG, headquartered in Germany, is the original developer and patent holder of rivaroxaban. The company holds the core intellectual property rights and is responsible for manufacturing and marketing the drug worldwide, except in markets where generic versions are available.

Manufacturing Facilities: Bayer operates several manufacturing units globally, notably in Germany, Switzerland, and the United States. Their facilities integrate advanced synthetic chemistry methods, ensuring quality and regulatory compliance. Bayer's investment in capacity expansion reflects ongoing demand and strategic positioning.

Supply Chain Role: Bayer oversees the global distribution, ensuring compliance with strict regulatory standards. Their manufacturing capacity enables consistent supply, although patent protections have limited generic competition in key markets.

2. B Yuzhno-Uralsky Plant (Russia)

Overview: A significant regional manufacturer, this plant produces rivaroxaban under licensing agreements, primarily for the Russian and neighboring markets.

Capacity & Role: The plant has scaled capacity to meet regional demand, with quality standards aligned to international GMP (Good Manufacturing Practice) norms, facilitating local supply under Bayer’s oversight.

3. Other Originators and Contract Manufacturers

While Bayer remains the principal global supplier, contract manufacturing organizations (CMOs) play a crucial role in meeting regional or urgent demands:

• Shanghai Penso Pharma (China) and Forward Pharmaceutical (South Korea) have been reported to be involved in the production of rivaroxaban under license or contract manufacturing agreements.

• Several other CMOs in India and Eastern Europe have ramped up production following patent expiry or biosimilar approval, enhancing supply flexibility.

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Generic Manufacturers and Market Competition

Following patent expiration in major markets such as the United States (2018), a wave of generic rivaroxaban manufacturers entered the market, significantly impacting supply dynamics.

1. Teva Pharmaceuticals

• Overview: A leading global generic manufacturer, Teva acquired rights to produce rivaroxaban in various markets post-patent expiry.

• Manufacturing: Operates multiple plants in Israel, India, and Europe, with GMP-certified facilities capable of large-scale production.

• Supply Role: Teva's global distribution network ensures widespread availability and price competitiveness.

2. Mylan (now part of Viatris)

• Overview: As a prominent generics manufacturer, Mylan received approvals for rivaroxaban biosimilars and generics in various jurisdictions.

• Manufacturing: Facilities in India, Europe, and the US handle synthesis, formulation, and packaging.

• Market Impact: Mylan's entry contributed to increased market competition, driving down prices.

3. Sun Pharmaceutical Industries

• Overview: One of India's largest pharmaceutical firms, Sun Pharma produces rivaroxaban biosimilars and generics for global markets.

• Manufacturing Facilities: Extensive facilities in India adhere to global GMP standards, with some set up for export to North America and Europe.

4. Other Notable Generic Suppliers

• Cadila Healthcare (India)

• Glenmark Pharmaceuticals (India)

• Dr. Reddy's Laboratories (India)

• Aurobindo Pharma (India)

Supply Chain Challenges & Opportunities: The proliferation of generics enhances global supply security but also introduces variability in manufacturing capacities, quality assurance standards, and supply timelines. Geopolitical factors, such as trade restrictions and patent litigations, further influence supply stability.

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Raw Material and Active Pharmaceutical Ingredient (API) Suppliers

1. API Manufacturers of Rivaroxaban

Rivaroxaban’s complex chemical synthesis involves specific APIs sourced from specialized chemical companies:

• BASF SE: A leading chemical producer providing key intermediates for rivaroxaban synthesis.

• Sun Chemical (China): Supplies specialty chemicals and intermediates used in API production.

• Mitsubishi Chemical: Provides certain raw materials and intermediates for synthesis processes.

Manufacturers often rely on a global network of chemical suppliers, with supply security contingent on geopolitical stability, raw material availability, and adherence to quality standards.

2. Synthesis Process & Raw Material Specifications

The synthesis of rivaroxaban involves multi-step chemical processes, including halogenation, acylation, and chiral calibration. The purity of raw materials directly impacts the API quality and, consequently, the safety and efficacy of the final drug.

Manufacturers require rigorous quality assessments by certified ISO and GMP standards, with raw material suppliers subjected to comprehensive audits.

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Distribution and Logistics Partners

1. Contract Logistics Providers

• DHL Healthcare: Manages cold chain and temperature-sensitive shipments globally.

• FedEx and UPS Healthcare: Provide distribution networks with specialized handling for pharmaceuticals, ensuring compliance with regulatory requirements.

2. Regional Distributors

Regional players, including national pharmaceutical distributors, integrate with global logistics networks to ensure local access. Their roles are critical in regions with emerging markets and less-developed supply infrastructure.

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Regulatory and Patent Landscape

Patent protections in key markets, including the U.S. and Europe, have historically limited generic production until patent expiration, after which multiple suppliers entered the market. Legal disputes and patent litigations remain active in some jurisdictions, affecting supply timelines.

Low-cost generic suppliers have increased manufacturing in India and China, often utilizing licensing agreements with originators or through patent challenge strategies.

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Strategic Supply Chain Considerations

• Supply Security: The presence of multiple global manufacturing sites mitigates disruption risks; however, regional reliance on specific suppliers presents vulnerabilities.

• Quality Assurance: Suppliers must adhere to stringent GMP standards, with audits and certifications critical for market access.

• Price Competitiveness: The entrance of generic manufacturers post-patent expiry has driven down prices, expanding access.

• Regulatory Approvals: Suppliers must navigate complex registration processes across jurisdictions, affecting time-to-market and supply continuity.

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Key Takeaways

• Bayer remains the primary global supplier of branded rivaroxaban, leveraging advanced manufacturing facilities with a focus on quality and capacity.

• The expiration of patents has catalyzed a robust generic supplier ecosystem, including major players such as Teva, Mylan/Viatris, Sun Pharma, and several Indian manufacturers.

• API sourcing involves specialized chemical companies that supply raw materials crucial for manufacturing, with supply security dependent on global chemical markets.

• Logistics providers like DHL and FedEx ensure temperature-sensitive distribution, especially critical for maintaining API and drug stability.

• Navigating patent rights, supply chain disruptions, and quality standards remains vital for supply stability and market competitiveness.

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FAQs

1. Who are the primary patent-holding manufacturers of rivaroxaban?
Bayer AG is the original patent holder and primary manufacturer, responsible for global supply during patent protection periods.

2. How has patent expiry affected rivaroxaban supply?
Patent expiry opened markets for generic manufacturers, increasing supply options, reducing prices, and diversifying sourcing strategies.

3. What are the main regions producing rivaroxaban APIs?
Major API production occurs in Europe (e.g., BASF), China, and India, with regional manufacturing tailored to market demand.

4. Are there regional differences in rivaroxaban quality standards?
Global GMP standards guide manufacturing, but quality and regulatory compliance vary by region. Leading manufacturers adhere to strict standards aligned with international norms.

5. How do suppliers manage supply chain risks for rivaroxaban?
Through diversification of manufacturing sites, supplier audits, inventory management, and logistical partnerships to ensure timely and quality supply.

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References

[1] U.S. Food and Drug Administration. (2011). Xarelto (rivaroxaban) approval.
[2] Bayer AG. Corporate Overview and Manufacturing Capabilities.
[3] European Medicines Agency. Rivaroxaban marketing authorizations.
[4] GlobalData. Pharmaceutical Market Reports.
[5] Chemical Suppliers Industry Reports.