Last updated: July 31, 2025
Introduction
Daprodustat, marketed under brand names such as Evrenzo, is an orally administered HIF-prolyl hydroxylase inhibitor developed primarily for treating anemia in chronic kidney disease (CKD) patients. Its innovative mechanism stimulates erythropoietin production, differentiating it from conventional erythropoiesis-stimulating agents (ESAs). Given its growing clinical importance, understanding the current landscape of suppliers involved in the manufacturing, sourcing, and distribution of daprodustat is crucial for pharmaceutical companies, distributors, and healthcare providers.
Manufacturers of Daprodustat
1. GlaxoSmithKline (GSK)
As the originator of daprodustat, GSK developed the molecule through extensive research and clinical trials. The company holds the primary patent rights and is responsible for the drug’s formulation, manufacturing, regulatory approval, and global commercialization strategies. During its development phases, GSK established manufacturing agreements with third-party facilities to facilitate large-scale production [1].
2. Contract Manufacturing Organizations (CMOs)
To meet global demand and navigate regional regulatory requirements, GSK and other pharmaceutical entities often collaborate with specialized CMOs. These organizations provide high-volume manufacturing, quality control, and packaging services.
- WuXi STA: A leading CMO in China known for synthesizing complex intermediates in pharmaceutical production, including small-molecule drugs like daprodustat [2].
- Samsung Biologics and Samsung Bioepis: While primarily focused on biologics, they sometimes partner in manufacturing drug precursors or intermediates.
- Vetter Pharma: Provides fill-finish services, ensuring daprodustat is packaged securely for distribution.
3. Regional Suppliers
In some regions, local manufacturers acquire licensing rights or produce generic versions post-patent expiry. These suppliers operate under strict quality standards, often collaborating with regional regulatory agencies for compliance.
Supply Chain Dynamics and Key Suppliers
1. Active Pharmaceutical Ingredient (API) Suppliers
The core component for daprodustat synthesis is its API. The API synthesis involves complex small-molecule chemical processes requiring specialized intermediates and reagents.
- Sigma-Aldrich (Merck): Offers chemical reagents necessary for API synthesis, including intermediates used in daprodustat manufacturing [3].
- Jubilant Life Sciences: Provides chemical APIs and intermediates with experience in synthesizing similar HIF-prolyl hydroxylase inhibitors [4].
2. Raw Materials and Chemical Precursors
Primary raw materials include starting reagents such as various aromatic compounds and heterocycles, sourced from global chemical suppliers:
- Lonza: Supplies high-quality chemical building blocks necessary for daprodustat synthesis.
- BASF & Clariant: Regional suppliers providing specialty chemicals used as intermediates or catalysts in API manufacturing.
3. Packaging and Distribution Suppliers
Distribution is critical to ensuring drug safety and efficacy:
- Catalent: Provides packaging, stability testing, and distribution solutions tailored to oral solid dosage forms.
- Thermo Fisher Scientific: Supplies analytical testing kits and stability chambers to ensure consistency across batches.
Regulatory and Licensing Agreements
Daprodustat’s supply chain efficacy depends heavily on regulatory approvals. GSK maintains exclusive licensing with regional authorities, assuring authorized suppliers maintain good manufacturing practices (GMP). Post-patent expiration, generic manufacturers may enter the market, sourcing API through licensed channels or establishing theirown supply chains.
Recent Developments and Emerging Suppliers
As daprodustat advances into broader markets—particularly in Europe, Asia, and emerging markets—the landscape shifts to include local manufacturers with approved manufacturing licenses.
- Chinese Generics Manufacturers: Some companies, like Zhejiang Huahai Pharmaceutical and Hengkang Biological Technology, aim to develop and produce daprodustat generics, contingent upon patent status [5].
- Indian Pharmaceutical Companies: Firms like Cadila Healthcare and Dr. Reddy’s Laboratories are exploring daprodustat development for regional markets, sourcing APIs from global suppliers or establishing in-house synthesis capabilities [6].
Market and Supply Risks
The supply chain for daprodustat faces potential disruptions owing to:
- Patent expiries leading to increased generic competition.
- Regulatory hurdles affecting approval and manufacturing standards.
- Geopolitical tensions impacting raw material access, particularly from regions like China and India.
- Environmental and safety regulations impairing production capacity at certain facilities.
An example is the COVID-19 pandemic, which disturbed raw material supply chains globally, emphasizing the need for diversified sourcing strategies.
Concluding Remarks
The major supplier for daprodustat remains GlaxoSmithKline, holding the original patents and leading manufacturing activities through partnerships with CMOs such as WuXi STA. Raw material sourcing is distributed among global chemical suppliers such as Merck (Sigma-Aldrich), Lonza, and BASF. As patent protections diminish, regional generic manufacturers are anticipated to emerge as key players, potentially altering the supply landscape. Strategic partnerships, robust quality controls, and diversified sourcing are vital to ensuring the continuous availability of daprodustat.
Key Takeaways
- GSK is the primary manufacturer and licensor of daprodustat, leveraging global CMOs for large-scale production.
- API suppliers include global chemical companies like Sigma-Aldrich, Lonza, and BASF.
- Regional generic manufacturers are poised to enter the market post-patent expiry, possibly sourcing APIs from licensed suppliers or developing in-house synthesis.
- Supply chain risks include patent challenges, regulatory barriers, geopolitical issues, and pandemic-related disruptions.
- Building supply chain resilience involves diversifying sources, ensuring regulatory compliance, and fostering strategic industry partnerships.
FAQs
Q1: Who are the main producers of daprodustat currently?
A1: GlaxoSmithKline is the primary producer, utilizing contract manufacturing organizations like WuXi STA. Post-patent expiry, regional generic manufacturers may begin production, contingent on licensing and regulatory approvals.
Q2: What are the key raw materials used in daprodustat synthesis?
A2: The core raw materials include aromatic and heterocyclic chemical intermediates sourced from companies such as Merck (Sigma-Aldrich), Lonza, and BASF.
Q3: Are there regional suppliers for daprodustat?
A3: Yes, regional companies in China and India are developing generic versions, sourcing APIs either from licensed global suppliers or through local synthesis.
Q4: How do supply chain disruptions impact daprodustat availability?
A4: Disruptions can delay manufacturing, lead to shortages, and increase manufacturing costs. Diversification and strategic sourcing are essential for resilience.
Q5: What regulations influence daprodustat’s supply chain?
A5: Regulatory standards like GMP, regional approval processes (FDA, EMA, NMPA), and patent laws significantly influence manufacturing and distribution channels.
References
[1] GSK Corporate Overview. (2022). GlaxoSmithKline.
[2] WuXi STA Capabilities. (2023). WuXi STA.
[3] Sigma-Aldrich Product Catalog. (2023). Merck.
[4] Jubilant Life Sciences. (2022). Jubilant.
[5] China Pharmaceutical News. (2022). Emerging generics.
[6] Indian Express. (2023). Generic drug development in India.
This comprehensive review seeks to inform stakeholders about the current suppliers and supply chain intricacies surrounding daprodustat, supporting strategic decision-making in pharma manufacturing, distribution, and market entry initiatives.
