Bulk Pharmaceutical API Sources for DAPRODUSTAT

Bulk Pharmaceutical API Sources for DAPRODUSTAT

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-17608
AbaChemScene		CS-5453
TargetMol		T3197

Bulk Active Pharmaceutical Ingredient (API) Sources for Daprodustat

Last updated: July 30, 2025

Introduction

Daprodustat ( marketed under the investigational name GSK1278863) is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) being developed for the treatment of anemia associated with chronic kidney disease (CKD). With its potential for oral administration, daprodustat represents a significant advancement in anemia management, reducing reliance on erythropoiesis-stimulating agents (ESAs). As daprodustat progresses toward commercialization, sourcing high-quality bulk APIs becomes critical for manufacturing, quality assurance, regulatory compliance, and market supply stability. This analysis explores the current landscape for bulk API suppliers of daprodustat, emphasizing procurement strategies, key manufacturers, and market dynamics.

Overview of API Manufacturing Requirements for Daprodustat

Daprodustat's synthesis involves complex organic chemistry, demanding stringent control over purity, particle size, and process reproducibility. The API must meet global pharmacopeial standards, including stringent specifications for impurities and residual solvents. Suppliers must be capable of producing large-scale API batches under Good Manufacturing Practice (GMP) conditions, ensuring regulatory compliance for global markets such as the US, EU, and Japan.

Major API Suppliers for Daprodustat

While daprodustat is still in clinical or early commercialization phases, select pharmaceutical manufacturers and CDMOs (Contract Development and Manufacturing Organizations) have emerged as potential API suppliers, based on their capabilities in synthesizing HIF-PHIs or similar compounds.

1. GlaxoSmithKline (GSK) – Internal API Production

As the developer of daprodustat, GSK maintains in-house API manufacturing facilities capable of producing research quantities and late-stage clinical supplies. GSK’s integrated supply chain ensures control over quality, process development, and scaling, positioning it as the primary source for clinical and early commercialization batches of daprodustat.

2. Contract Manufacturing Organizations (CMOs) and Third-Party Suppliers

The complexity of daprodustat synthesis has led to reliance on specialized CMOs with expertise in complex organic synthesis and GMP compliance. These organizations possess advanced chemical synthesis capabilities and established APIs for other HIF-PHIs, making them suitable suppliers.

• Samsung Biologics & Samsung Biotech: While primarily focused on biologics, Samsung’s chemistry division has the capacity for small molecule API synthesis and could potentially scale up daprodustat manufacture.

• Fujifilm Diosynth Biotechnologies: Known for process development and GMP manufacturing of complex molecules, Fujifilm could serve as a strategic partner for daprodustat API production.

• Lonza Group: With robust experience in active ingredient synthesis, Lonza provides custom API manufacturing and could be contracted for daprodustat synthesis, contingent upon process development and scale-up agreements.

3. Specialized API Manufacturers and Suppliers

Certain companies specialize in the synthesis of HIF-PHI class compounds or similar complex molecules, potentially offering daprodustat APIs:

• Hikal Ltd.: An Indian contract manufacturer with capabilities in complex organic synthesis and intermediates; has experience producing APIs for experimental and commercial purposes.

• Swordsman Pharmaceutical: Focused on small molecule APIs, with capabilities aligned to advanced synthesis.

• Amneal Pharmaceuticals: Known for active ingredient manufacturing and might develop capacity for daprodustat, especially if demand grows.

4. Emerging Suppliers and Market Trends

The growing pipeline of HIF-PHIs and the expansion of biosimilar APIs have stimulated new entrants into the market. As daprodustat commercialization advances, more API suppliers are expected to emerge, particularly from regions like India, China, and Southeast Asia—areas increasingly prominent in pharmaceutical manufacturing.

5. Supply Chain Considerations

Ensuring a consistent, high-quality supply chain for daprodustat API is vital due to the molecule’s complex synthesis and narrow therapeutic window. Suppliers must demonstrate robust process control, impurity profiling capabilities, and scalability. Strategic partnerships with well-established CMOs or in-house production are essential to mitigate supply risks.

Regulatory and Quality Standards

API suppliers must adhere to strict regulatory frameworks, including:

• GMP compliance for manufacturing
• ICH guidelines for impurity testing and process validation
• Pharmacopoeial standards (USP, Ph. Eur., JP) or meet vendor specifications in cases of global distribution

Engagement with regulatory agencies during supplier qualification and validation phases is crucial to ensure seamless market approval.

Market Dynamics and Future Outlook

The competitive landscape for daprodustat API sourcing is evolving. As clinical trials mature and commercialization approaches, higher-volume manufacturing will necessitate partnerships with large-scale API producers. The Indian and Chinese pharmaceutical sectors offer cost-effective manufacturing options with expanding GMP-certified capacities, though regulatory risk assessment remains vital.

Major pharmaceutical companies are likely to develop proprietary API manufacturing capacities or exclusive purchasing agreements to ensure supply security. Given the molecule’s innovative status, early engagement with potential suppliers is recommended. Additionally, diversifying sources reduces supply chain vulnerabilities.

Conclusion

The sourcing of bulk daprodustat API is characterized by tight quality controls, complex synthesis, and strategic partnership considerations. GSK’s own manufacturing capabilities serve as the initial source for clinical supplies, while future commercialization will depend on collaborations with CDMOs and contract manufacturers experienced in complex small molecules. The expanding presence of API suppliers in Asia, particularly India and China, is likely to meet growing global demand, provided quality and regulatory standards are maintained.

Key Takeaways

• Strategic Partnerships Drive Supply Security: Engaging with established GMP-compliant API manufacturers ensures consistent quality and scale-up capacity.
• Complex Synthesis Demands Advanced Capabilities: Synthesis of daprodustat requires expertise in organic chemistry and impurity profiling.
• Regional Trends Influence Market Dynamics: Indian and Chinese manufacturers offer cost-effective options; however, verifying GMP compliance is critical.
• Supply Chain Diversification Is Essential: Multiple sourcing strategies mitigate risks associated with supply disruptions.
• Regulatory Alignment Is Critical: Early qualification and validation of suppliers streamline approval processes across markets.

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FAQs

1. Who are the leading manufacturers capable of producing daprodustat API?
Currently, GSK produces daprodustat API internally for clinical stages. Contract manufacturing organizations with expertise in complex organic synthesis, such as Lonza, Fujifilm Diosynth, and specialized API suppliers in India and China, are potential partners for commercial-scale production.

2. What challenges exist in sourcing daprodustat API?
Challenges include the molecule’s complex synthesis requiring high purity standards, impurity management, ensuring GMP compliance, and scaling up from research to commercial quantities without quality compromise.

3. How does regional manufacturing impact daprodustat API supply?
Asian manufacturers, notably from India and China, offer cost advantages and scalable GMP facilities. However, regulatory oversight and quality assurance remain key considerations for global supply chains.

4. Are any patents influencing daprodustat API sourcing?
Patent protections on daprodustat synthesis processes and formulations influence licensing and procurement. Engaging with patent holders and conducting freedom-to-operate analyses are vital before establishing supplier relationships.

5. What are the future prospects for daprodustat API supply chain development?
As daprodustat advances towards commercial approval, the API supply chain will expand, driven by increasing demand. Strategic collaborations, capacity investments, and quality assurance will shape future sourcing strategies.

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References

[1] GSK Clinical Trial Portfolio – Daprodustat. GSK.
[2] Synthesis Challenges of HIF-PHI Molecules. Organic Process Research & Development.
[3] Global API Manufacturing Trends in Oncology & Specialty Drugs. IQVIA.
[4] Indian Pharmaceutical Industry Overview. Department of Pharmaceuticals, Government of India.
[5] Regulatory Guidelines for GMP in API Manufacturing. WHO Pharmacopoeia.

(Note: The references listed are indicative; actual sources should be cited based on current literature and publicly available data.)