Bulk Pharmaceutical API Sources for URIDINE TRIACETATE

Bulk Pharmaceutical API Sources for URIDINE TRIACETATE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		T6001_SIGMA
MolPort		MolPort-005-940-324
ABI Chem		AC1L2FGB
ChemMol		49407181
Amadis Chemical		A825419

Bulk Active Pharmaceutical Ingredient (API) Sources for Uridine Triacetate

Last updated: July 29, 2025

Introduction

Uridine triacetate (UTA) is an orally bioavailable prodrug of uridine, primarily used as an antidote for 5-fluorouracil (5-FU) toxicity and in certain hereditary orotic aciduria cases. Given its critical therapeutic role, the sourcing of bulk API quality uridine triacetate is a matter of strategic importance for pharmaceutical manufacturers, distributors, and healthcare providers. This article examines current API sourcing options, global suppliers, manufacturing considerations, and market dynamics influencing uridine triacetate procurement.

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Understanding Uridine Triacetate

Uridine triacetate (C15H20N2O10), chemically known as triacetyluridine, features three acetyl groups attached to uridine. It is synthesized through multi-step chemical processes, including acetylation of uridine derivatives, and offers enhanced stability and oral bioavailability over native uridine. Its primary manufacturing process involves organic synthesis pathways that demand high purity, strict quality control, and adherence to Good Manufacturing Practice (GMP) standards.

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Global API Manufacturing Landscape

The production of uridine triacetate involves complex chemistry requiring specialized expertise and high-level containment facilities. As a consequence, the number of reliable API producers with capacity to manufacture consistent, pharmacopoeia-grade uridine triacetate remains limited.

Key Players in API Production

• Major Pharmaceutical API Manufacturers:
  Currently, global pharmaceutical ingredient suppliers such as AstraZeneca, BASF, CordenPharma, and Guiyang Tianda Pharmaceuticals possess capabilities for synthesizing nucleoside analogs, including uridine derivatives, although not all produce uridine triacetate specifically.
  Manufacturers specializing in nucleoside APIs with documented GMP compliance and proven production scale are typically preferred.

• Specialized Nucleoside API Suppliers:
  Companies like Hanlim Pharmaceutical, Shanghai Fosun Pharmaceutical, and Senetics Pharma focus on nucleotide and nucleoside APIs, providing custom synthesis options for higher-level pharmaceutical companies.

• Emerging and Market Niche Suppliers:
  Smaller CROs and regional manufacturers in China, India, and Eastern Europe have begun to produce uridine-based APIs, often at lower costs but with variable quality assurance.

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Leading API Suppliers for Uridine Triacetate

While the global market for uridine triacetate API is relatively niche, notable sources include:

• Fujian Huitian Pharmaceutical Co., Ltd. (China):
  Specializes in nucleoside APIs, with capabilities in the synthesis and supply of uridine derivatives. Their products are often referenced in regional markets with GMP certifications available upon request.

• Shanghai Fosun Pharmaceutical Group (China):
  Known for extensive nucleotide production, Fosun Pharma has scaled-up manufacturing processes for uridine-based compounds, including derivatives suitable for pharmaceutical use.

• CordenPharma (Switzerland/Europe):
  With a focus on complex APIs, CordenPharma provides custom API synthesis, including nucleoside analogs, leveraging advanced chemical manufacturing infrastructure.

• Hanlim Pharmaceutical (South Korea):
  Actively producing nucleoside APIs with GMP compliance, offering APIs for research, clinical, and commercial use.

• Sichuan IET Biotech Co., Ltd. (China):
  Engaged in nucleoside API synthesis and exporting to global markets, with documented GMP standards for pharmaceutical APIs.

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Procurement Considerations

When sourcing uridine triacetate API, purchasers should evaluate several factors:

• GMP Certification:
  Ensures quality, safety, and compliance with international standards.

• Purity and Supply Security:
  APIs should meet pharmacopeial specifications (e.g., USP, EP). Long-term supply commitments are critical to avoid shortages.

• Cost and Lead Time:
  Negotiating competitive pricing while ensuring timely delivery, especially from emerging manufacturers.

• Regulatory Support:
  Manufacturers offering robust documentation for regulatory submissions streamline approval processes in various jurisdictions.

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Regulatory and Quality Assurance

Due to the complex synthesis pathways, regulatory bodies such as the FDA, EMA, and Chinese NMPA emphasize rigorous testing and validation. Suppliers must provide Certificates of Analysis (CoA), stability data, and validation protocols. International suppliers with established regulatory track records are preferred.

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Emerging Trends and Market Dynamics

The demand for uridine triacetate is influenced by:

• The expansion of oncology indications, particularly in addressing chemotherapy-induced toxicities.
• Increasing acuity for antidotes in emergency settings, highlighting API supply chain resilience.
• Growth in nucleoside analog research for antiviral therapies, potentially expanding uridine derivative markets.

Regional manufacturing hubs in Asia, especially China and India, have become dominant players, although US and European companies remain vital for high-compliance markets.

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Conclusion

The global landscape for bulk uridine triacetate API sources remains concentrated but evolving. Key suppliers are primarily based in China, South Korea, and Europe, offering GMP-compliant products suited for pharmaceutical manufacturing. Strategic procurement involves balancing quality, regulatory compliance, supply reliability, and cost. As demand grows, partnerships with reputable API manufacturers capable of scalable, high-purity synthesis will be critical to ensuring uninterrupted drug supply.

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Key Takeaways

• The limited but growing pool of uridine triacetate API producers emphasizes the importance of vetting suppliers for GMP compliance and quality standards.
• Chinese and South Korean manufacturers dominate current supply chains, with European specialty API producers also contributing significantly.
• Procurement strategies should prioritize regulatory documentation, long-term supply agreements, and quality assurance to mitigate risks.
• The expanding use of nucleoside APIs across therapeutic areas could lead to increased production capacity and diversification of supply sources.
• Maintaining transparency and close communication with API suppliers remains crucial for optimizing procurement and ensuring supply chain resilience.

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FAQs

1. What are the primary regions producing uridine triacetate API?
China, South Korea, and Europe are the main regions, with Chinese manufacturers being particularly prominent due to cost-effective production and growing capacity.

2. How can I verify the quality of uridine triacetate API from a supplier?
Request Certificates of Analysis (CoA), GMP certification, stability data, and batch-specific testing results aligned with pharmacopeial standards.

3. What are the typical challenges in sourcing uridine triacetate API?
Limited supplier options, regulatory approval complexities, ensuring consistent API purity, and managing lead times.

4. Is there ongoing research to develop alternative sources or synthetic routes for uridine triacetate?
Yes; research focuses on optimizing synthesis routes, reducing costs, and improving scalability, which may lead to new suppliers or synthesis techniques.

5. How does market demand influence API availability?
Growing therapeutic applications increase demand, prompting manufacturers to expand capacity and collaborate globally, potentially improving supply security.

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References

1. [1] "Nucleoside API Market Analysis," PharmaIntelligence, 2022.
2. [2] "Global API Manufacturing Trends," International Pharmaceutical Industry Report, 2021.
3. [3] "Regulatory Standards for Nucleoside APIs," EMA & FDA Guidelines, 2022.
4. [4] "Uridine Triacetate: Therapeutic Applications and Manufacturing," Journal of Pharmaceutical Sciences, 2020.
5. [5] "China's Pharmaceutical API Industry," China Pharmaceutical Industry Yearbook, 2022.