Suppliers and packagers for generic pharmaceutical drug: FEBUXOSTAT

FEBUXOSTAT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alembic	FEBUXOSTAT	febuxostat	TABLET;ORAL	205421	ANDA	Alembic Pharmaceuticals Limited	46708-190-08	80 TABLET, COATED in 1 CARTON (46708-190-08)	2019-07-01
Alembic	FEBUXOSTAT	febuxostat	TABLET;ORAL	205421	ANDA	Alembic Pharmaceuticals Limited	46708-190-10	100 TABLET, COATED in 1 CARTON (46708-190-10)	2019-07-01
Alembic	FEBUXOSTAT	febuxostat	TABLET;ORAL	205421	ANDA	Alembic Pharmaceuticals Limited	46708-190-30	30 TABLET, COATED in 1 BOTTLE (46708-190-30)	2019-07-01

Suppliers for the Pharmaceutical Drug: FEBUXOSTAT

Last updated: July 29, 2025

Introduction

Febuxostat is a powerful medication prescribed primarily for the management of hyperuricemia in patients with gout. As a non-purine selective inhibitor of xanthine oxidase, febuxostat reduces serum uric acid levels, thereby preventing gout attacks and tophi formation. Given its clinical significance, numerous pharmaceutical companies and suppliers have entered the market to produce and distribute febuxostat globally. This article provides a comprehensive overview of the key suppliers, their manufacturing capabilities, regional footprints, and strategic implications for stakeholders.

Overview of Febuxostat Manufacturing and Supply Chain Dynamics

The global supply chain for febuxostat involves several stages—research and development, manufacturing, distribution, and regulatory approval. While patent protections have historically limited competition, the expiration of certain patents and the rise of generic manufacturers have broadened the supplier landscape. The high therapeutic demand and regulatory standards necessitate rigorous quality controls, making supplier credibility paramount.

Major Suppliers and Manufacturers of Febuxostat

1. Teijin Limited

Overview: Teijin Limited, a Japanese pharmaceutical giant, originally developed febuxostat under the brand name Uloric. As a pioneer in this space, Teijin remains a prominent supplier in Asia and internationally.

Manufacturing Capabilities: Teijin operates advanced production facilities in Japan, adhering to strict cGMP standards. Their supply chain benefits from robust R&D, ensuring high-quality API production aligned with regulatory compliance.

Market Presence: Teijin's febuxostat is approved across multiple regions, including Japan, Europe, and the United States. Their extensive distribution network supports consistent supply for healthcare providers and governments.

2. Teva Pharmaceuticals

Overview: As a leading global generic manufacturer, Teva acquired rights to produce generic formulations of febuxostat following patent expiry in certain jurisdictions.

Manufacturing Capabilities: Teva’s manufacturing plants, notably in Israel and Eastern Europe, are equipped with high-capacity APIs and finished-dose facilities conforming to international standards.

Market Presence: Teva supplies febuxostat predominantly in the US and European markets, often offering more cost-effective options to healthcare systems.

3. Sun Pharmaceutical Industries

Overview: Sun Pharma, India’s largest pharmaceutical company, produces generic febuxostat after patent restrictions expired in various markets.

Manufacturing Capabilities: Their manufacturing facilities in India and the Middle East are certified for global exports, with significant investments in API synthesis and formulation.

Market Presence: Sun Pharma’s febuxostat supplies reach Asia, Africa, and select European markets, making it a key player in emerging-partner regions.

4. Hikma Pharmaceuticals

Overview: Hikma, a Jordan-based multinational, offers generic febuxostat formulations primarily targeting Middle Eastern and North African markets.

Manufacturing Capabilities: Their facilities in Europe and the Middle East produce quality-assured generics, conforming to international standards such as EMA and FDA requirements.

Market Presence: Hikma’s regional focus provides critical supply stability where local demand for gout management is rising.

5. Other Regional and Local Suppliers

Beyond the major global corporations, various regional manufacturers supply febuxostat to local markets, often as authorized generics or under licensing agreements. These suppliers tend to focus on specific territories such as Southeast Asia, Latin America, and Africa, providing more accessible options amidst fluctuating global supply chains.

Regulatory and Quality Considerations

The quality assurance of febuxostat hinges on compliance with Good Manufacturing Practices (GMP), FDA approvals, EMA certifications, and corresponding regional authorities. Suppliers with robust regulatory filings and quality audits ensure a reduced risk of recalls or substandard production, critical for maintaining supply chain integrity.

Emerging Trends and Strategic Implications

• Patent Expiry and Generics: The expiration of patents in key markets like the US (2019) has significantly expanded the number of suppliers, increasing market competition and decreasing prices.

• API Synthesis and Supply Risks: The complexity of febuxostat's synthesis process emphasizes the importance of reliable API suppliers. Disruptions—such as raw material shortages or geopolitical issues—can impact global supply.

• Regional Manufacturing and Supply Security: Countries are increasingly incentivized to develop local manufacturing capabilities for febuxostat, reducing dependency on imports and improving access.

• Vertical Integration: Some suppliers are investing in downstream manufacturing, including finished-dose formulations, to control quality and ensure smoother supply chains.

Conclusion

The supply landscape for febuxostat is diverse, with major global players like Teijin, Teva, Sun Pharma, and Hikma dominating the market. These companies leverage advanced manufacturing, stringent quality controls, and extensive distribution networks to meet global demand. In light of patent expirations and regional market developments, a broadening of supplier base affords healthcare providers flexibility but underscores the importance of rigorous quality assurance. Strategic sourcing, coupled with proactive regulatory compliance and supply chain resilience, remains vital for stakeholders navigating the febuxostat market.

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Key Takeaways

• Major global manufacturers including Teijin, Teva, Sun Pharma, and Hikma dominate febuxostat supply, with regional suppliers supplementing the market.
• Patent expirations have facilitated increased generic manufacturing, intensifying competition and lowering costs.
• Robust regulatory adherence and quality assurance are critical for supplier credibility and supply chain stability.
• Diversification of sourcing strategies mitigates risks associated with raw material shortages and geopolitical disruptions.
• Building local manufacturing capacities remains a strategic priority for ensuring long-term access and reducing dependency on imports.

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FAQs

1. Who are the leading global manufacturers of febuxostat?
Teijin Limited, Teva Pharmaceuticals, Sun Pharmaceutical Industries, and Hikma Pharmaceuticals are the primary global suppliers producing febuxostat, supported by regional manufacturers.

2. What factors influence the choice of febuxostat suppliers?
Quality assurance, regulatory compliance, manufacturing capacity, supply reliability, and cost-effectiveness are key considerations influencing supplier selection.

3. Are generic febuxostat products equivalent to branded formulations?
Yes. Approved generics undergo rigorous regulatory review to ensure bioequivalence, safety, and efficacy comparable to the branded product.

4. How has patent expiration impacted febuxostat supply?
Patent expiry has opened the market to a proliferation of generics, increasing supply options but also emphasizing the importance of quality control.

5. What are the risks associated with febuxostat supply chains?
Risks include raw material shortages, manufacturing disruptions, regulatory hurdles, geopolitical instability, and quality non-compliance.

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References

1. [1] Teijin Limited. (2022). Corporate Overview and Product Portfolio.
2. [2] U.S. Food and Drug Administration. (2019). Approved Drug Products with Therapeutic Equivalence Evaluations.
3. [3] Sun Pharmaceutical Industries Ltd. Annual Report, 2022.
4. [4] Hikma Pharmaceuticals PLC. Approved Product List.
5. [5] European Medicines Agency. Febuxostat Summary of Product Characteristics.