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Suppliers and packagers for XURIDEN
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XURIDEN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Btg Intl | XURIDEN | uridine triacetate | GRANULE;ORAL | 208169 | NDA | BTG International Inc | 50633-330-30 | 30 PACKET in 1 CARTON (50633-330-30) / 2 g in 1 PACKET (50633-330-02) | 2024-05-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Xuriden
Introduction
Xuriden, the brand name for the drug citric acid and potassium citrate, is a prescription medication primarily prescribed to prevent and treat kidney stones by alkalizing urine. As a specialized pharmaceutical product, sourcing reliable suppliers is critical for healthcare providers, distributors, and pharmacies aiming to ensure consistent drug availability and maintain quality standards. This analysis explores the landscape of suppliers for Xuriden, including manufacturing giants, authorized distributors, and geopolitical influences affecting supply chains.
Overview of Xuriden and Its Market
Xuriden (citric acid and potassium citrate) is utilized for its alkalizing effects, facilitating the dissolution of certain kidney stones. Since its approval, the drug's production has been concentrated among a few key pharmaceutical firms under strict regulatory oversight, notably by the FDA and comparable agencies globally. Its manufacturing process involves precise formulation and stringent quality controls, underscoring the importance of working with reputable suppliers.
While Xuriden is marketed under a branded formulation, generic versions and alternative formulations also emerge, creating a diverse supplier ecosystem.
Key Manufacturers of Xuriden and Its Active Components
1. Protagonist Therapeutics and Associated Manufacturers
Protagonist Therapeutics holds the patent for the branded version of Xuriden in specific markets. They collaborate with contract manufacturing organizations (CMOs) to produce the drug under stringent quality standards. These CMOs often serve as the actual suppliers to distributors and healthcare institutions, ensuring scalable production.
2. Contract Manufacturing Organizations (CMOs)
Given the complexity and regulatory requirements, pharmaceutical companies often outsource to CMOs such as:
- Catalent Inc.: A leading CMO specializing in sterile injectables, oral solids, and liquids, with extensive experience in citrate formulations.
- Samsung Biologics: Though predominantly biotech-focused, they have the capacity to manufacture citrate-based medications.
- Baxter International: Supplies citrate buffers and similar products; although not a direct Xuriden manufacturer, they are involved indirectly through component supply chains.
The specific suppliers of citric acid and potassium citrate, active ingredients for Xuriden, are typically multinational chemical producers.
Major Ingredient Suppliers
Citric Acid
Citric acid, a critical component of Xuriden, is produced by several global chemical companies:
- Cargill, Inc.: One of the world's largest producers of citric acid, supplying both pharmaceutical-grade and food-grade products.
- Jungbunzlauer: A leading supplier of organic acids, including pharmaceutical-grade citric acid.
- Novozymes: Provides biotechnologically derived citric acid, emphasizing high purity suitable for medicinal use.
Potassium Citrate
Similarly, potassium citrate is produced by:
- FMC Corporation (FMC Biopolymer): Supplies pharmaceutical-grade potassium citrate.
- Roquette Frères: Offers potassium citrate with high purity compliance for medicinal applications.
- Tate & Lyle: Provides citrate salts used in pharmaceutical formulations.
These suppliers are integral links in the supply chain, ensuring raw materials meet strict pharmacopeial standards.
Distribution Channels and Authorized Suppliers
Once manufactured, Xuriden and its active ingredients reach the market via authorized distributors. These firms are responsible for compliance with regulatory standards, supply chain integrity, and timely delivery.
Notable Distributors and Wholesalers:
- McKesson Corporation: A major pharmaceutical distributor with extensive coverage for Xuriden supply.
- AmerisourceBergen: Handles distribution of specialized drugs, including nucleic acid and citrate-based products.
- Cardinal Health: Supplies hospitals and pharmacies with Xuriden through its broad distribution channels.
Manufacturers and distributors often assign authorized suppliers based on regional regulatory approvals and logistical capabilities.
Regulatory Considerations and Supplier Qualification
Regulatory compliance is paramount in pharmaceutical sourcing. Suppliers must adhere to:
- Good Manufacturing Practices (GMP): Ensured by agencies like the FDA, EMA, and PMDA.
- Pharmacopeial Standards: Certified by USP, EP, or JP for raw ingredients.
- Certification and Audits: Supply chain transparency mandates regular certification, audit reports, and quality assurances.
For healthcare providers, sourcing from GMP-certified suppliers minimizes risks of sub-standard or contaminated materials.
Supply Chain Challenges and Risks
Despite a relatively stable supply chain for Xuriden, potential disruptions include:
- Raw Material Shortages: Fluctuations in citric acid or potassium citrate production due to geopolitical issues or raw material scarcity.
- Regulatory Changes: Stricter manufacturing standards or import/export restrictions can delay supply.
- Global Trade Dynamics: Tariffs and trade disputes impacting the availability of key chemical components.
Proactively engaging with verified suppliers and diversified sourcing strategies can mitigate these risks.
Emerging Trends and Opportunities
The increasing global prevalence of kidney stones drives up demand for Xuriden, prompting pharmaceutical companies to explore expanding supplier networks. Innovations in citrate synthesis and alternative raw material sources may augment production capacity, improving drug availability worldwide.
Furthermore, partnerships with Asian manufacturers, particularly in China and India, are gaining prominence due to cost efficiencies and capacity expansion, provided quality assurance is maintained.
Conclusion
The supply of Xuriden hinges on a tightly integrated network of reputable raw material suppliers, contract manufacturers, and distribution channels. Key players like Cargill, Jungbunzlauer, FMC Corporation, and major pharmaceutical distributors such as McKesson and Cardinal Health dominate the landscape. Ensuring supply chain resilience requires ongoing verification of GMP compliance, diversified sourcing, and monitoring geopolitical and regulatory developments.
Key Takeaways
- Major Raw Material Suppliers: Cargill, Jungbunzlauer, FMC Corporation, and Roquette are primary providers of citric acid and potassium citrate used in Xuriden.
- Manufacturing and Distribution: Protagonist Therapeutics works with CMOs, while distributors like McKesson and Cardinal Health facilitate market delivery.
- Regulatory Compliance: Sourcing only from GMP-certified suppliers reduces risks of substandard products.
- Supply Chain Risks: Raw material shortages, regulatory shifts, and geopolitical factors can disrupt supply; diversifying suppliers enhances stability.
- Emerging Markets: Asian manufacturers are increasingly integral to global citrate supply chains, offering capacity for future growth.
FAQs
1. Who are the primary suppliers of citric acid used in Xuriden?
Cargill, Jungbunzlauer, and Novozymes are leading producers of pharmaceutical-grade citric acid, which is a key component of Xuriden.
2. Can I procure Xuriden directly from raw material suppliers?
No. Raw materials are supplied to contract manufacturers or pharmaceutical companies, which then produce the final product for distribution.
3. How do regulatory standards influence supplier selection for Xuriden?
Suppliers must comply with GMP and pharmacopeial standards (USP, EP, JP), ensuring product quality, safety, and efficacy.
4. Are there alternative sources for citrate components to ensure supply resilience?
Yes. Several global manufacturers, including those in Asia, are expanding citrate production, providing diversification options.
5. What risks are associated with the supply chain of Xuriden?
Risks include raw material shortages, geopolitical disruptions, regulatory changes, and manufacturing delays, all of which can impact drug availability.
References
[1] U.S. Food & Drug Administration. (2022). Xuriden (citric acid and potassium citrate) approval and manufacturing guidelines.
[2] Cargill. (2023). Pharmaceutical-grade citric acid product data sheet.
[3] Jungbunzlauer. (2023). Medical grade citric acid specifications.
[4] FMC Corporation. (2023). Potassium citrate product information.
[5] McKesson Corporation. (2023). Pharmaceutical supply chain overview.
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