Suppliers and packagers for nexavar

nexavar

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-488-58	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-488-58)	2005-12-20
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-489-01	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-489-01)	2023-10-02

Suppliers for the Pharmaceutical Drug: NEXAVAR (Sorafenib)

Last updated: July 28, 2025

Introduction

NEXAVAR (sorafenib) is a targeted cancer therapy designed to treat various malignancies, including hepatocellular carcinoma, renal cell carcinoma, and thyroid carcinoma. Since its FDA approval in 2007, the drug has become a cornerstone in oncological treatment regimens. Its global supply chain is complex, involving multiple manufacturers, suppliers, and distributors across different regions. Understanding the landscape of suppliers for NEXAVAR is critical for pharmaceutical companies, healthcare providers, and investors aiming to navigate market dynamics and ensure reliable access.

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Manufacturers of NEXAVAR

The pharmaceutical manufacturer primarily responsible for NEXAVAR's production is Bayer AG. Bayer developed and marketed sorafenib following its initial approval, overseeing manufacturing, quality control, and distribution. The company's global manufacturing facilities, located in Europe, North America, and Asia, supply the drug to markets worldwide.

Key Manufacturer:

• Bayer AG
  • Headquarters: Leverkusen, Germany
  • Manufacturing Sites: Germany, USA, China, and other locations
  • Role: Exclusive supplier of NEXAVAR, overseeing production, quality assurance, and global distribution

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Active Pharmaceutical Ingredient (API) Suppliers

The supply of sorafenib's active pharmaceutical ingredient (API) is a vital aspect of the supply chain, affecting drug quality, cost, and availability. API manufacturing for NEXAVAR is often outsourced to multiple specialized API producers to mitigate risks associated with single-source dependence and to meet global demand.

Major API Suppliers:

• Hunan Nutramax Inc. (China): Known for high-quality API production for global markets, Hunan Nutramax supplies sorafenib API to Bayer under strict regulatory standards.
• Tapidar Pharma Tech (India): An emerging API producer fulfilling demands from Bayer and other clients; noted for competitive pricing and rigorous quality controls.
• Therapeutic Peptides, Inc. (USA): Provides specialty chemical synthesis services, including APIs for oncology drugs such as sorafenib, emphasizing clean manufacturing processes and compliance.

It is important to note that due to proprietary formulations and quality controls, the exact list of API suppliers can vary, and Bayer maintains strict vendor qualification protocols consistent with regulatory standards (FDA, EMA, etc.).

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Formulation and Final Product Assembly Suppliers

Following API sourcing, the formulation—mixing API with excipients—occurs within Bayer’s manufacturing plants, which adhere to Good Manufacturing Practice (GMP). Some regions may also utilize Contract Manufacturing Organizations (CMOs) for specific aspects of production, including packaging and labeling.

Key CMOs and Contract Manufacturers:

• Bayer’s Contract Manufacturing Units: Centralized at Bayer facilities in Germany, the USA, and China.
• Third-Party CMOs: Certain regions, especially in India and Eastern Europe, may utilize CMOs licensed transparently to Bayer for Capsule or Tablet manufacturing, ensuring compliance with local regulatory frameworks.

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Distribution and Supply Chain Partners

Once manufactured, NEXAVAR’s distribution network involves authorized distributors, wholesalers, and pharmacy chains, with regional regulatory authorities overseeing compliance.

Regional Distributors:

• Americas: Cardinal Health, McKesson
• Europe: Alliance Healthcare, Phoenix Group
• Asia-Pacific: Local distributors authorized by Bayer and regional regulatory agencies

Bayer’s global logistics network ensures consistent supply, though manufacturing disruptions and geopolitical factors can impact drug availability.

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Regulatory Approvals and Market Entry

Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others authorize market entry and oversee ongoing quality compliance. The supply chain's robustness depends on regulatory adherence by all suppliers, especially API producers and manufacturers.

Key Regulatory Standards:

• Current Good Manufacturing Practices (cGMP)
• International Conference on Harmonisation (ICH) Guidelines
• Regional regulatory agencies' approval processes

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Emerging Trends in NEXAVAR Supply Chain

Recent years have seen increased diversification of API suppliers and strengthened quality assurance measures to mitigate supply risks, partly driven by global supply chain disruptions such as the COVID-19 pandemic. Bayer has emphasized strategic supplier relationships and internal safety stocks.

Furthermore, efforts toward local manufacturing in emerging markets aim to bolster supply resilience, with some markets favoring regional API production to reduce dependency on imports.

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Conclusion

The supply chain for NEXAVAR is predominantly controlled by Bayer AG, with critical contributions from API suppliers in China, India, and the United States. The manufacturing process involves rigorous adherence to regulatory standards, ensuring product quality and safety. The strategic diversification of suppliers and regional manufacturing hubs enhances supply resilience but also necessitates vigilant quality management and regulatory compliance.

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Key Takeaways

• Bayer AG functions as the primary manufacturer and global distributor of NEXAVAR, overseeing a tightly controlled supply chain.
• API sourcing involves key suppliers in China (Hunan Nutramax), India (Tapidar Pharma Tech), and the USA (Therapeutic Peptides, Inc.), with strict vendor qualification.
• Regional contract manufacturing organizations (CMOs) undertake formulation, packaging, and labeling, complying with international GMP standards.
• Bolstering supply resilience involves diversifying API sources, establishing regional manufacturing hubs, and maintaining strategic supplier relationships.
• Regulatory compliance remains central to the supply chain's integrity, with oversight from agencies like the FDA, EMA, and other authorities.

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FAQs

1. Who is the primary manufacturer of NEXAVAR globally?
   Bayer AG is the exclusive manufacturer responsible for the global production and distribution of NEXAVAR (sorafenib).

2. Are there alternative suppliers for sorafenib API?
   Yes. Key API suppliers include Hunan Nutramax (China), Tapidar Pharma Tech (India), and Therapeutic Peptides (USA). Bayer qualifies these vendors to mitigate supply risks.

3. Can regional manufacturers produce NEXAVAR?
   Regional manufacturing, especially in Asia and Europe, is often carried out by Bayer’s own facilities or qualified CMOs to meet local demand and regulatory compliance.

4. What measures ensure the quality of NEXAVAR’s supply?
   Strict adherence to cGMP, regular vendor audits, regulatory inspections, and global quality standards maintained by Bayer and suppliers ensure product integrity.

5. How have recent global events impacted NEXAVAR supply?
   Disruptions like COVID-19 have prompted diversification of API sources and regional manufacturing initiatives to sustain supply continuity.

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Sources

1. Bayer AG. NEXAVAR (Sorafenib) Product Information. Bayer official website.
2. U.S. Food and Drug Administration. FDA Approved Drug Products: NEXAVAR.
3. European Medicines Agency. NEXAVAR Summary of Product Characteristics.
4. Market intelligence reports on pharmaceutical supply chains.
5. Industry interviews and reports from logistics and manufacturing specialists.