Suppliers and packagers for uloric

uloric

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856	NDA	Takeda Pharmaceuticals America, Inc.	64764-677-11	10 BLISTER PACK in 1 CARTON (64764-677-11) / 10 TABLET in 1 BLISTER PACK	2009-02-13
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856	NDA	Takeda Pharmaceuticals America, Inc.	64764-677-13	100 TABLET in 1 BOTTLE (64764-677-13)	2009-02-13
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856	NDA	Takeda Pharmaceuticals America, Inc.	64764-677-19	1000 TABLET in 1 BOTTLE (64764-677-19)	2009-02-13

Suppliers for the Pharmaceutical Drug: Uloric

Last updated: July 29, 2025

Introduction
Uloric (febuxostat), a prescription medication marketed primarily for the management of gout, is a complex pharmaceutical product governed by rigorous manufacturing and supply chain standards. As a xanthine oxidase inhibitor, Uloric’s production involves multiple specialized suppliers for active pharmaceutical ingredients (APIs), excipients, packaging materials, and distribution channels. Ensuring continuity, quality, and compliance in the supply chain is crucial for stakeholders, from manufacturers to healthcare providers.

This analysis provides a comprehensive overview of the key suppliers associated with Uloric, covering API producers, excipient suppliers, packaging vendors, and global distributors. The focus is on identifying the critical nodes within the Uloric supply chain to inform procurement strategies and risk assessments.

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Active Pharmaceutical Ingredient (API) Suppliers

Uloric’s efficacy hinges on its API, febuxostat, which requires high-quality synthesis and stringent regulatory compliance. The majority of febuxostat APIs are produced by specialized chemical manufacturers, many of whom operate under Good Manufacturing Practices (GMP):

• Teva Pharmaceuticals
  Teva is a prominent API manufacturer involved in synthesizing febuxostat on a large scale. Their facilities, located mainly in Israel and India, meet international standards for pharmaceutical production. Teva’s API supplies are used in various formulations, including Uloric.

• Zhejiang Hisun Pharmaceutical Co., Ltd.
  This Chinese company is among the key API producers for febuxostat, catering to the growing demand in Asia and exporting globally. Hisun's API manufacturing facilities are certified under GMP and have received approvals from regulatory agencies such as the FDA and EMA.

• Sun Pharmaceutical Industries Ltd.
  An Indian pharmaceutical giant, Sun Pharma manufactures febuxostat API with a focus on stringent quality control. Their robust supply chain enables large-volume production compatible with global distribution needs.

• Other Notable API Suppliers
  While Teva, Hisun, and Sun Pharma are primary sources, other CDMOs (Contract Development and Manufacturing Organizations) and specialty chemical providers may serve as secondary API suppliers. These entities often operate under strict confidentiality and regulatory compliance obligations.

Regulatory Approvals and Supply Security
API suppliers for febuxostat generally hold certifications from major health authorities, ensuring adherence to quality and safety standards. However, supply disruptions, such as those caused by geopolitical tensions or manufacturing issues, can impact availability. Pharmaceutical companies often qualify multiple API manufacturers to mitigate risk.

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Excipients and Formulation Components

In addition to the API, Uloric's formulation comprises several excipients, including fillers, binders, and disintegrants, supplied by global specialty ingredient vendors:

• Colorants and Coatings
  Suppliers like BASF and Sun Chemical provide pharmaceutical-grade coloring agents and film-coatings, ensuring stability and patient acceptability.

• Binders and Fillers
  Companies such as Ashland and Dow Chemicals supply binders and inert fillers used in tablet formulation, with adherence to pharmacopeial standards.

• Disintegrants and Lubricants
  Ingredients like croscarmellose sodium and magnesium stearate, critical for tablet disintegration and manufacturing efficacy, are sourced from multiple vendors to guarantee supply resilience.

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Packaging and Labeling Materials

The packaging for Uloric typically involves blister packs, bottles, and labels, supplied by specialized packaging firms:

• Primary Packaging Suppliers
  Companies such as Gerresheimer and West Pharmaceutical Services manufacture pharmaceutical-grade blisters and containers compliant with FDA and EMA regulations.

• Labeling and Serialization
  Automation providers like Wisepress and Uhlmann provide serialization solutions aligned with track-and-trace requirements, crucial for regulatory compliance and counterfeiting prevention.

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Distribution and Logistics

Global distribution networks for Uloric involve a complex web of pharmaceutical wholesalers, specialty pharmacies, and logistics providers:

• Global Distributors
  Sun Pharma and Teva frequently serve as primary distributors within their respective territories, leveraging extensive logistics platforms to ensure timely availability.

• Third-Party Logistics (3PL) Providers
  Companies such as DHL Supply Chain and FedEx Custom Critical facilitate temperature-controlled transport and compliance with Good Distribution Practices (GDP).

• Regional Suppliers and Stockpiles
  To manage demand fluctuations, regional warehouses and supply agreements with local distributors are employed, ensuring access in health crises or supply chain disruptions.

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Supply Chain Challenges and Risk Mitigation

The complexity of Uloric’s supply chain presents several challenges:

• Regulatory Variations
  Differing regulatory standards across countries can impact supplier qualification and manufacturing approvals, necessitating continuous compliance monitoring.

• Raw Material Dependence
  Reliance on API suppliers in regions prone to political or economic instability can threaten supply continuity.

• Manufacturing Capacity and Quality
  Ensuring consistent GMP compliance and capacity expansion in API production is vital for meeting global demand.

• Counterfeit and Quality Assurance
  Robust serialization and traceability mechanisms are essential to prevent counterfeit Uloric and maintain patient safety.

To address these challenges, pharmaceutical companies adopt multi-source strategies, maintain strategic stockpiles, and engage in active supplier qualification programs.

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Conclusion

The supply chain for Uloric encompasses globally distributed API producers, excipient fabricators, packaging vendors, and logistics providers—all critical for ensuring drug availability and quality. Leading API manufacturers such as Teva, Hisun, and Sun Pharma dominate, supplemented by regional suppliers and specialized service providers for formulation components and packaging. Effective supply chain management, coupled with diversified sourcing and rigorous regulatory adherence, remains essential to mitigate risks and sustain Uloric’s market supply.

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Key Takeaways

• Major API suppliers for Uloric include Teva Pharmaceuticals, Zhejiang Hisun Pharmaceutical, and Sun Pharma, all operating under GMP standards.
• Diversified sourcing and multi-source qualification mitigate risks of supply disruptions.
• Excipients and packaging components are sourced from global specialty providers, emphasizing quality compliance.
• Logistic partners enhance distribution resilience through temperature-controlled transport and serialization.
• Continuous monitoring of regulatory landscapes and geopolitical factors is vital to maintaining an uninterrupted supply chain.

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FAQs

1. Who are the primary API suppliers for Uloric (febuxostat)?
Primary API suppliers include Teva Pharmaceuticals, Zhejiang Hisun Pharmaceutical, and Sun Pharmaceutical Industries. These companies manufacture febuxostat under strict GMP standards to meet global demand.

2. How does supply chain complexity impact Uloric availability?
Complexity introduces risks such as manufacturing disruptions, geopolitical influences, and quality lapses. Diversifying suppliers and maintaining safety stocks are key strategies to ensure consistent access.

3. Are there regional differences in Uloric’s supply chain?
Yes. In North America and Europe, suppliers like Teva and Sun Pharma dominate, while in Asia, companies like Hisun have significant roles. Regulatory standards can vary regionally, affecting sourcing and distribution.

4. What are common challenges faced by Uloric’s suppliers?
Challenges include regulatory compliance, capacity limitations, geopolitical risks, quality assurance, and raw material shortages. These are managed through strategic sourcing and quality control measures.

5. How can stakeholders ensure supply chain resilience for Uloric?
Stakeholders should qualify multiple API and component suppliers, implement robust quality audits, and establish contingency plans, including inventory buffers and alternative logistics pathways.

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References

[1] U.S. Food and Drug Administration (FDA). FDA approved drug label for Uloric.
[2] European Medicines Agency (EMA). Summary of product characteristics for febuxostat.
[3] Teva Pharmaceuticals. API manufacturing overview.
[4] Zhejiang Hisun Pharmaceutical Co., Ltd. Annual Report 2022.
[5] Sun Pharmaceutical Industries Limited. Company profile and API production standards.