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Suppliers and packagers for generic pharmaceutical drug: floxuridine
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floxuridine
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | FLOXURIDINE | floxuridine | INJECTABLE;INJECTION | 075837 | ANDA | Fresenius Kabi USA, LLC | 63323-145-07 | 1 VIAL in 1 CARTON (63323-145-07) / 5 mL in 1 VIAL | 2001-03-15 |
| Hikma | FLOXURIDINE | floxuridine | INJECTABLE;INJECTION | 075387 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9270-01 | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9270-01) / 5 mL in 1 VIAL | 2018-02-15 |
| Hikma | FLOXURIDINE | floxuridine | INJECTABLE;INJECTION | 075387 | ANDA | JND Therapeutics, Inc. | 81643-9270-1 | 1 VIAL in 1 BOX, UNIT-DOSE (81643-9270-1) / 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 2022-06-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: FLOXURIDINE
Introduction
Floxuridine (also known as 5-fluoro-2'-deoxyuridine or FUdR) is an antimetabolite chemotherapeutic agent primarily used in the treatment of certain gastrointestinal cancers. It functions as a pyrimidine analog, disrupting DNA synthesis in rapidly dividing cells. Due to its targeted action, Floxuridine remains a critical component in specific oncology regimens. Understanding the current landscape of suppliers providing Floxuridine is essential for pharmaceutical companies, healthcare providers, and supply chain managers aiming for reliable sourcing, cost efficiency, and regulatory compliance.
Market Overview of Floxuridine Suppliers
The global market for Floxuridine remains relatively niche, with production concentrated among a few established pharmaceutical manufacturers. The drug's specialized nature limits the number of primary suppliers; however, several key players dominate the supply chain through direct manufacturing, generic availability, and active pharmaceutical ingredient (API) production.
Key Suppliers of Floxuridine API
The foundation of any pharmaceutical product chain is the API, which is produced by specialized chemical and biotech companies. The following entities lead in API manufacturing:
1. Pfizer Inc.
Pfizer, a global pharmaceutical giant, historically supplied Floxuridine for specific markets through its proprietary manufacturing facilities. Although Pfizer's primary focus has shifted toward proprietary drugs, its longstanding expertise in oncology medications positions it as a reliable supplier in certain regions, especially for bulk API production.
2. Sun Pharmaceutical Industries Ltd.
As one of the top generic pharmaceutical manufacturers globally, Sun Pharma produces Floxuridine API for international markets. Its manufacturing facilities in India and other regions adhere to stringent regulatory standards, ensuring high-quality API supply for generic formulations.
3. Hetero Drugs Ltd.
Hetero is a prominent Indian generics manufacturer with a diversified portfolio, including chemotherapeutic agents. Hetero manufactures Floxuridine API in compliance with Good Manufacturing Practices (GMP), catering to both domestic and export markets.
4. Chemo (a division of Teva)
Teva’s division Chemo specializes in producing high-grade APIs and intermediates for oncology drugs. They manufacture Floxuridine API in multiple facilities certified for global markets, emphasizing regulatory standards.
5. Alkem Laboratories
An established Indian pharmaceutical manufacturer, Alkem offers Floxuridine API for various markets, focusing on affordability and accessibility for oncology drugs.
Contract Manufacturing Organizations (CMOs)
Given the complexities of chemical synthesis and regulatory hurdles, many pharmaceutical companies outsource API production to CMOs. Several CROs and CMOs are capable of manufacturing Floxuridine to GMP standards:
- Thermotech (India): Provides custom synthesis of nucleoside analogs, including Floxuridine.
- Bachem (Switzerland): Offers peptide and nucleotide synthesis services; potential supplier of Floxuridine intermediates.
- Recipharm (Sweden): A contract manufacturer with capabilities for nucleoside API production.
Formulation and Finished Product Suppliers
While API manufacturing is primary, various pharmaceutical companies produce finished Floxuridine formulations:
- Pfizer: Offers injectable formulations for clinical use and limited commercial markets.
- Teva: Supplies generic Floxuridine injections.
- Farmindustria: An Italian manufacturer producing formulations primarily for European markets.
Regional Supplier Dynamics
United States and Europe:
Suppliers are primarily large pharmaceutical firms and CMOs compliant with FDA and EMA regulations. The market is characterized by high-quality standards but limited volatility in supply.
India and Asia-Pacific:
India is a significant hub for generic API production, including Floxuridine, driven by cost advantages and high manufacturing capacity. Quality assurance remains a critical consideration in supply agreements.
China:
Emerging as a regional supplier, China’s API manufacturers are expanding their capacities, though regulatory transparency varies.
Regulatory Considerations
Suppliers must adhere to regulatory standards set by agencies such as the FDA, EMA, and WHO. Regulatory approval is essential for ensuring the quality, safety, and efficacy of both APIs and finished formulations. Suppliers with WHO prequalifications and GMP certifications are favored in global procurement.
Supply Chain Risks and Mitigation
The limited number of Floxuridine suppliers increases vulnerability to supply disruptions. Manufacturers need contingency plans, including sourcing from multiple suppliers, maintaining safety stock, and verifying regulatory compliance.
Conclusion
The landscape of Floxuridine suppliers is dominated by multinational pharmaceutical companies and regional generic manufacturers, with India emerging as a key region for API production. Regulatory compliance, quality assurance, and supply continuity remain paramount for stakeholders. Engaging with verified suppliers with WHO and FDA certifications ensures product integrity and mitigates supply chain risks.
Key Takeaways
- The primary sources of Floxuridine API include Pfizer, Sun Pharma, Hetero, Teva, and Alkem.
- Indian generic manufacturers play a significant role in API supply, offering cost-effective options.
- CMOs are integral in scaling production, especially for specialized nucleoside analogs.
- Regulatory compliance (FDA, EMA, WHO) is crucial for supplier qualification.
- Diversifying suppliers and maintaining quality assurance protocols address supply chain vulnerabilities.
Frequently Asked Questions (FAQs)
1. Who are the leading global suppliers of Floxuridine API?
Pfizer, Sun Pharma, Hetero, Teva, and Alkem are prominent suppliers with manufacturing facilities that produce Floxuridine API adhering to international regulatory standards.
2. Is Floxuridine primarily produced in India?
India hosts several major generic manufacturers, including Sun Pharma, Hetero, and Alkem, making it a significant regional hub for Floxuridine API.
3. Are there risks associated with sourcing Floxuridine from a limited number of suppliers?
Yes. Dependence on few suppliers increases supply chain vulnerability, emphasizing the importance of supplier diversification and quality verification.
4. What regulatory certifications should suppliers of Floxuridine possess?
Suppliers should have GMP certification, WHO prequalification, FDA approval (if applicable), and compliance with EMA standards to ensure product quality and safety.
5. How does sourcing from different regions impact drug supply stability?
Regional disparities in regulation, manufacturing capacity, and geopolitical factors influence stability. Suppliers from well-regulated regions like North America and Europe tend to offer higher assurance of supply continuity.
References
- [1] Reuters. "Global pharmaceutical API manufacturing trends." 2022.
- [2] World Health Organization. "Prequalification of pharmaceutical products." 2023.
- [3] Pfizer Inc. Corporate website. Product portfolio.
- [4] Sun Pharmaceutical Industries Ltd. Annual report.
- [5] Teva Pharmaceutical Industries Ltd. API supply chain overview.
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