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Suppliers and packagers for generic pharmaceutical drug: URIDINE TRIACETATE
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URIDINE TRIACETATE
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 | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159 | NDA | BTG International Inc | 50633-220-04 | 4 PACKET in 1 CARTON (50633-220-04) / 10 g in 1 PACKET | 2024-07-31 |
| Btg Intl | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159 | NDA | BTG International Inc | 50633-220-20 | 20 PACKET in 1 CARTON (50633-220-20) / 10 g in 1 PACKET | 2024-07-31 |
| 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: Uridine Triacetate
Introduction
Uridine triacetate is a critical pharmaceutical agent utilized as an antidote for certain chemotherapy agents, including fluorouracil and capecitabine, as well as for specific cases of overdose involving pyrimidine analogs. This compound, a prodrug of uridine, effectively replenishes pyrimidine pools, counteracting toxic metabolite accumulation in affected cells. Despite its clinical importance, the supply chain for uridine triacetate involves several specialized pharmaceutical and chemical manufacturers globally. This article provides a comprehensive overview of principal suppliers, their manufacturing capabilities, regulatory considerations, and market dynamics.
Regulatory Landscape and Market Overview
Uridine triacetate is classified as an orphan drug by the U.S. Food and Drug Administration (FDA) and is marketed under the brand name Vistogard by Kedrion Biopharma. Due to its specialized role, production quality and regulatory compliance are paramount, influencing supplier eligibility and market access. The global market remains limited but strategically significant, driven by the rising incidence of chemotherapy-induced toxicities and overdose cases.
The criticality of supply security has prompted healthcare providers to explore multiple sourcing avenues, including original manufacturers and authorized distributors. Supply disruptions can have severe clinical consequences, underscoring the importance of identifying reliable suppliers.
Major Suppliers of Uridine Triacetate
1. Kedrion Biopharma
Overview:
Kedrion Biopharma, based in Italy, is the primary supplier of Vistogard (uridine triacetate) in the United States. Through its manufacturing facilities, the company maintains an authorized, regulatory-compliant production pipeline capable of fulfilling domestic and international demand.
Manufacturing Capabilities:
Kedrion adheres to strict cGMP (current Good Manufacturing Practices), ensuring high-quality standards necessary for pharmaceutical-grade uridine triacetate. Their production process involves complex chemical synthesis and purification steps validated per regulatory standards.
Availability:
As the sole U.S. market source, Kedrion's supply is considered stable under normal conditions, but geopolitical or manufacturing disturbances could impact availability. International supply arrangements exist through licensing agreements with other regional manufacturers.
2. Fosun Pharma and Healthcare
Overview:
Fosun Pharma, a leading Chinese pharmaceutical conglomerate, is actively involved in the development, manufacturing, and distribution of nucleoside analogs and derivatives, including uridine compounds.
Manufacturing Capabilities:
Fosun employs advanced synthetic chemistry platforms and has received regulatory approvals for several nucleoside-based therapeutics. They have expanded their facilities to support the production of uridine triacetate, with intentions to supply Asian markets and potentially global markets via licensing and partnerships.
Availability & Distribution:
Fosun's role as a supplier for uridine triacetate is evolving, with some products available in Asian countries through authorized channels. They have initiated collaborations with international pharmaceutical firms to increase global distribution.
3. Piramal Enterprises
Overview:
Indian pharmaceutical giant Piramal Enterprises produces various nucleoside analogs and pharmaceutical intermediates, with laboratories focused on complex chemical syntheses relevant to antiviral and anticancer agents.
Manufacturing Capabilities:
Piramal leverages its extensive R&D infrastructure to scale-up the synthesis of nucleoside derivatives, including uridine triacetate. Their facilities are compliant with global standards to meet international regulatory requirements.
Supply Dynamics:
While primarily serving the generic drug market, Piramal has scaled up production capacity intending to serve as an alternative or backup supplier, especially for global markets outside North America and Europe.
4. Licenses and Contract Manufacturing Organizations (CMOs)
Overview:
In addition to primary suppliers, numerous CMOs operate under licensing agreements with innovator companies to produce uridine triacetate under strict quality standards. These entities include organizations in Europe, North America, and Asia.
Manufacturing Capabilities:
CMOs provide tailored manufacturing solutions, often focusing on supply continuity and capacity expansion during shortages. Their adherence to international standards ensures product consistent with regulatory expectations.
Examples Include:
- Sterling Pharmaceutical Solutions (UK)
- Patheon (North America)
- WuXi AppTec (China)
Distribution & Reliance:
Healthcare providers and pharmaceutical firms often rely on these CMOs for differentiated product sourcing, particularly in regions with limited local production capacity.
Emerging Suppliers and Market Trends
Given the strategic importance of uridine triacetate, new entrants from emerging markets are exploring production capabilities, driven by patent expiries, technological advances, and increased demand. Developing in-house synthesis methods or licensing agreements is on the rise, aiming to reduce dependency on limited suppliers. Industry collaborations focusing on quality optimization and regulatory approval are central to these efforts.
Regulatory and Quality Considerations
Suppliers must demonstrate compliance with global health authorities, including the FDA, EMA, and PMDA. Validation of purity, stability, and bioavailability is essential for supply chain integrity. Cross-border shipments require adherence to international standards, customs clearances, and documentation. Supply chain security is reinforced by supplier audits, certification, and ongoing regulatory communication.
Supply Chain Risks and Mitigation Strategies
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Manufacturing Disruptions: Quality issues, regulatory non-compliance, or raw material shortages could impair supply. Diversifying suppliers mitigates this risk.
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Geopolitical Factors: Trade restrictions or political instability might influence sourcing. Long-term agreements with multiple suppliers help stabilize supply.
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Demand Fluctuations: Sudden surges in demand due to overdose incidents or increased chemotherapy protocols necessitate flexible manufacturing arrangements.
Healthcare providers and procurement entities must maintain updated supplier lists, verify quality certifications, and establish contingency plans to ensure uninterrupted access to uridine triacetate.
Conclusion
The supply landscape for uridine triacetate involves a limited but strategically vital set of global manufacturers. Kedrion Biopharma remains the predominant supplier in North America, with regional players such as Fosun Pharma and Piramal expanding manufacturing capacity across Asia and other emerging markets. The increasing importance of this drug underscores the need for diversified sourcing, rigorous quality assurance, and proactive risk management.
Key Takeaways
- Primary Supplier: Kedrion Biopharma, the sole U.S. market provider, maintains high-quality, regulatory-compliant production for Vistogard.
- Emerging Market Players: Fosun Pharma and Piramal are expanding their capabilities, offering alternative sourcing options outside North America.
- Regulatory Compliance: Suppliers must adhere to cGMP and international standards, with ongoing validation and certification critical for market access.
- Supply Risks: Market reliance on limited suppliers necessitates diversification, supply chain monitoring, and strategic stockpiling.
- Future Trends: Growing demand and technological advances present opportunities for new entrants, potentially improving availability and reducing costs.
FAQs
1. Who are the main global suppliers of uridine triacetate?
Kedrion Biopharma is the primary supplier in North America, while Fosun Pharma and Piramal serve Asian markets and are expanding globally. Contract manufacturing organizations also play roles in supply chain support.
2. How does regulatory compliance impact uridine triacetate sourcing?
Regulatory standards such as cGMP ensure product safety and efficacy, limiting suppliers to those with validated manufacturing processes approved by agencies like the FDA and EMA.
3. Are there risks associated with reliance on a single supplier?
Yes. Dependence on a sole supplier, like Kedrion, can lead to supply disruptions if manufacturing issues occur. Diversification reduces this risk.
4. What are the prospects for new suppliers entering the uridine triacetate market?
Growing global demand and technological progress facilitate entry by new manufacturers, especially in emerging markets, increasing supply resilience over time.
5. How can healthcare providers ensure stable access to uridine triacetate?
Through supplier diversification, establishing long-term contracts, maintaining safety stock, and monitoring regulatory updates and manufacturing capacities.
References
[1] U.S. Food and Drug Administration. Vistogard (Uridine Triacetate) Prescribing Information.
[2] Kedrion Biopharma Official Website. Product Portfolio.
[3] Fosun Pharma Annual Reports and Corporate Press Releases.
[4] Piramal Enterprises Corporate Strategy and Product Pipeline Documents.
[5] Global Pharma Supply Chain Reports, 2022.
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