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Suppliers and packagers for generic pharmaceutical drug: SORAFENIB TOSYLATE
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SORAFENIB TOSYLATE
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 |
| Dr Reddys | SORAFENIB TOSYLATE | sorafenib tosylate | TABLET;ORAL | 216073 | ANDA | Dr.Reddys Laboratories Inc | 43598-458-04 | 120 TABLET, FILM COATED in 1 BOTTLE (43598-458-04) | 2022-06-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: SORAFENIB TOSYLATE
Introduction
Sorafenib tosylate is an oral multikinase inhibitor primarily used in the treatment of advanced renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), and differentiated thyroid carcinoma. Its efficacy hinges on its strategic procurement, supplied by multiple pharmaceutical manufacturers globally. This article provides a comprehensive analysis of key suppliers, examining their manufacturing capabilities, market presence, regulatory landscape, and implications for stakeholders in the pharmaceutical supply chain.
Overview of Sorafenib Tosylate
Developed and marketed under brand names such as Nexavar, sorafenib tosylate gained regulatory approval starting in 2005 (FDA). Its molecular mechanism involves inhibiting tumor growth and angiogenesis through kinase blockade. The increased demand for sorafenib has spurred a network of suppliers capable of producing high-quality active pharmaceutical ingredients (APIs) and finished dosage forms.
Major Suppliers of Sorafenib Tosylate
1. Bayer AG
As the original developer of Nexavar, Bayer remains a dominant supplier of sorafenib tosylate. The company maintains a robust manufacturing infrastructure, with facilities certified by regulatory authorities such as the FDA, EMA, and PMDA. Bayer's integrated supply chain ensures consistent API quality and availability to global markets. Despite high R&D costs, Bayer’s fully integrated production model supports reliable supply, though reliance on a single origin can pose risks during regional disruptions.
2. Zhejiang Hisun Pharmaceutical Co., Ltd.
A leading Chinese pharmaceutical firm, Hisun has expanded its portfolio to include sorafenib tosylate, leveraging local expertise and cost advantages. The company has achieved GMP certification and exports to multiple countries, including emerging markets. Their manufacturing capabilities include API synthesis, regulatory support, and formulations, making them a significant player in the Asian region.
3. Greenfield Global
Greenfield specializes in the production of active pharmaceutical ingredients and intermediates. They possess capacities for manufacturing sorafenib APIs, compliant with international standards. Their strategic focus on quality and scalability has made them a reliable supplier for generic manufacturers and third-party firms seeking OEM services.
4. H. R. Wachs, Inc. and Other Generic Manufacturers
Several smaller generic pharmaceutical companies worldwide obtain sorafenib tosylate from third-party API producers or produce it under licensing agreements. These companies often focus on regional markets and offer competitive pricing but may face regulatory and quality assurance challenges. The marketplace for such suppliers is dynamic, with frequent mergers and licensing agreements shaping supply options.
5. Contract Manufacturing Organizations (CMOs)
Major CMOs such as Dr. Reddy’s Laboratories and Sun Pharmaceutical Industries have diversified their portfolios to include sorafenib API production. These organizations offer scalable manufacturing solutions, with capabilities to support both clinical trials and commercial-scale production, subject to regulatory approvals. Their flexibility makes them attractive partners for pharmaceutical companies seeking supply chain robustness.
Regulatory and Quality Considerations
Suppliers for sorafenib tosylate must meet strict regulatory standards, including cGMP compliance, to ensure API purity, potency, and safety. Regulatory agencies such as the FDA, EMA, and China FDA routinely audit production facilities. Suppliers with established certifications are preferred, especially when sourcing for high-precision oncology drugs.
Market Dynamics and Supply Chain Risks
The global distribution of suppliers reflects regional manufacturing strengths—Europe, the United States, and China. However, geopolitical tensions, export restrictions, and manufacturing disruptions can threaten supply continuity. Diversification of suppliers and fostering strategic partnerships are essential for buyers to mitigate risks.
Emerging Trends and Future Outlook
The increasing prevalence of biosimilars and generics is expected to influence the sorafenib market. Suppliers investing in advanced manufacturing technologies, such as continuous flow synthesis and quality by design (QbD), aim to improve API yields and reduce costs. Additionally, regulatory harmonization will facilitate cross-border supply chain integration. As patent exclusivity diminishes, an influx of generic suppliers will expand global access, but quality vigilance remains crucial.
Conclusion
The supply of sorafenib tosylate is characterized by a diverse array of players, ranging from original developers like Bayer to regional manufacturers and contract organizations. Ensuring a reliable supply chain involves evaluating manufacturing quality, regulatory compliance, capacity, and geopolitical stability of suppliers. Stakeholders must adopt strategic sourcing to safeguard product availability and maintain high standards for patient safety.
Key Takeaways
- Bayer AG remains the primary, fully integrated supplier of sorafenib tosylate globally, ensuring stability but also presenting reliance risks.
- Regional manufacturers like Zhejiang Hisun expand access in Asia, emphasizing cost advantages and localized supply.
- High-quality APIs are produced to stringent regulatory standards, with suppliers required to hold certifications such as cGMP and EMA.
- Diversification of suppliers and engagement with CMOs are crucial to mitigate geopolitical and manufacturing risks.
- Technological advances in API synthesis and regulatory harmonization will continue to shape the global supply landscape.
Frequently Asked Questions (FAQs)
1. Who are the primary global suppliers of sorafenib tosylate?
Bayer AG is the original and leading supplier, complemented by regional manufacturers like Zhejiang Hisun and various CMOs such as Dr. Reddy’s Laboratories.
2. What are the regulatory standards for sorafenib API manufacturing?
Suppliers must adhere to cGMP standards, with certifications from agencies like the FDA, EMA, and China FDA, ensuring API quality, purity, and safety.
3. How does geopolitical risk affect sorafenib tosylate supply?
Regional manufacturing dependencies and export restrictions can disrupt supply chains. Diversification and strategic partnerships are essential to mitigate geopolitical risks.
4. Are there generic options for sorafenib tosylate?
Yes, numerous generic manufacturers produce sorafenib API, often sourced from third-party API producers or licensed facilities, primarily serving emerging markets.
5. What are future trends in sorafenib tosylate supply?
Emerging trends include technological advances in API synthesis, increased generic competition, and ongoing regulatory harmonization facilitating global supply chain integration.
References
[1] U.S. Food and Drug Administration (FDA). Nexavar (sorafenib) drug approval.
[2] European Medicines Agency (EMA). Sorafenib summary of product characteristics.
[3] Industry reports on pharmaceutical manufacturing and API suppliers.
[4] Bayer AG Corporate Reports.
[5] Zhejiang Hisun Pharmaceutical Co., Ltd. Official documentation.
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