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
Alembic	FEBUXOSTAT	febuxostat	TABLET;ORAL	205421	ANDA	Alembic Pharmaceuticals Limited	46708-190-31	100 TABLET, COATED in 1 BOTTLE (46708-190-31)	2019-07-01
Alembic	FEBUXOSTAT	febuxostat	TABLET;ORAL	205421	ANDA	Alembic Pharmaceuticals Limited	46708-190-91	1000 TABLET, COATED in 1 BOTTLE (46708-190-91)	2019-07-01
Alembic	FEBUXOSTAT	febuxostat	TABLET;ORAL	205421	ANDA	Alembic Pharmaceuticals Limited	46708-191-06	60 TABLET, COATED in 1 CARTON (46708-191-06)	2019-07-01
Alembic	FEBUXOSTAT	febuxostat	TABLET;ORAL	205421	ANDA	Alembic Pharmaceuticals Limited	46708-191-10	100 TABLET, COATED in 1 CARTON (46708-191-10)	2019-07-01

Febuxostat Drug Substance Suppliers

Last updated: February 19, 2026

This analysis identifies key suppliers for the febuxostat drug substance, detailing their manufacturing capabilities, regulatory standing, and potential impact on supply chain stability.

Who Are the Leading Manufacturers of Febuxostat Drug Substance?

Multiple entities globally are engaged in the production of febuxostat drug substance. Major players include manufacturers based in China and India, regions recognized for their significant Active Pharmaceutical Ingredient (API) production.

• Chinese Manufacturers: Several Chinese chemical and pharmaceutical companies are listed as suppliers or potential manufacturers of febuxostat. These include entities with broad API portfolios and established export channels.
• Indian Manufacturers: Indian pharmaceutical companies, also known for their API manufacturing prowess, are active in the febuxostat market. These companies often serve both domestic and international markets and possess significant regulatory compliance experience.

Specific company names are often found through pharmaceutical ingredient databases and trade publications. For instance, companies that have previously filed Drug Master Files (DMFs) with regulatory agencies like the U.S. Food and Drug Administration (FDA) or hold Certificates of Suitability to the monographs of the European Pharmacopoeia (CEP) are indicative of established production.

What are the Regulatory Filings and Certifications for Febuxostat Suppliers?

Regulatory filings and certifications are critical indicators of a supplier's adherence to quality standards and their ability to supply to regulated markets.

• Drug Master Files (DMFs): Companies manufacturing febuxostat drug substance often file DMFs with regulatory authorities. A DMF contains detailed information about the manufacturing process, facilities, and quality control of the API. In the U.S., a DMF is submitted to the FDA.
  • Example: A supplier holding an active U.S. DMF for febuxostat indicates they have provided comprehensive data to the FDA, facilitating its review when a drug product manufacturer references the DMF in their New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
• Certificates of Suitability (CEPs): In Europe, a CEP issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) certifies that an API complies with the European Pharmacopoeia monograph. This simplifies the regulatory process for marketing authorization holders in European Union member states.
• Good Manufacturing Practice (GMP) Certifications: Facilities producing febuxostat must operate under GMP guidelines. Inspections and certifications from regulatory bodies such as the FDA, European Medicines Agency (EMA), or other national health authorities confirm compliance.
  • Significance: GMP compliance ensures that the drug substance is consistently produced and controlled according to quality standards appropriate for its intended use.

What is the Typical Manufacturing Capacity and Scalability of Febuxostat Suppliers?

Manufacturing capacity and scalability are key considerations for ensuring a stable supply chain, especially for drugs with significant market demand.

• Batch Sizes: API manufacturers operate with varying batch sizes depending on their reactor capacities and process optimization. Typical batch sizes for intermediates and APIs can range from tens of kilograms to several tons.
• Facility Infrastructure: Established API manufacturers possess dedicated or multi-purpose reaction vessels, purification equipment, and drying facilities. The number and size of these assets determine overall production volume.
• Scalability: Suppliers with robust process development and engineering teams can demonstrate the ability to scale up production from pilot to commercial quantities. This often involves validation runs at larger scales.
• Geographic Concentration: A concentration of manufacturing in a single region or by a limited number of suppliers can pose supply chain risks due to geopolitical factors, environmental regulations, or localized disruptions. Diversification across multiple reputable suppliers in different regions is a common risk mitigation strategy.

What are the Key Quality Control Parameters for Febuxostat Drug Substance?

Stringent quality control ensures that the febuxostat drug substance meets predefined specifications for safety and efficacy.

• Assay: The purity of febuxostat is typically determined by High-Performance Liquid Chromatography (HPLC). The acceptable range is generally within 98.0% to 102.0% on an anhydrous and solvent-free basis.
• Related Substances/Impurities: Impurities, including process-related impurities and degradation products, are meticulously controlled. Specific limits are set for known and unknown impurities, often in the range of not more than 0.1% for individual impurities and a total impurity limit (e.g., not more than 0.5%). Analytical methods are developed and validated to detect and quantify these.
  • Example: Impurities such as 3-(2-cyano-4-isobutoxyphenyl)-4-(4-methyl-1,3-thiazol-2-yl)-1H-pyrazole-5-carboxamide may have defined limits.
• Residual Solvents: Limits for residual solvents used during synthesis and purification are established based on ICH (International Council for Harmonisation) guidelines. Solvents are categorized based on their toxicity (Class 1, 2, 3), with strict limits for more toxic solvents.
  • Example: Solvents like Methanol, Ethanol, Acetone, and Toluene may be present and are controlled within specified ppm (parts per million) limits.
• Water Content: Determined by Karl Fischer titration, the water content is controlled to ensure API stability and prevent degradation. Typical limits are below 0.5%.
• Heavy Metals: The absence or presence of heavy metals above specified limits (e.g., <10 ppm or <20 ppm) is assessed.
• Particle Size Distribution (PSD): For solid dosage forms, the PSD of the febuxostat API can influence dissolution rates and bioavailability. Manufacturers may offer specific grades with controlled PSD.

What are the Supply Chain Risks Associated with Febuxostat Production?

The global pharmaceutical supply chain faces inherent risks, and febuxostat production is not immune.

• Raw Material Sourcing: The synthesis of febuxostat involves multiple chemical intermediates. Disruptions in the supply of these key starting materials or intermediates, whether due to geopolitical issues, single-source dependency, or environmental controls affecting upstream manufacturers, can impact febuxostat availability.
• Regulatory Changes: Evolving environmental regulations in major manufacturing hubs like China and India can lead to temporary or permanent plant closures, impacting production capacity. Similarly, stricter impurity profiling requirements can necessitate process revalidation and alter supplier qualification.
• Geopolitical Instability: Trade disputes, tariffs, or political instability in key manufacturing regions can disrupt the flow of goods and increase costs.
• Quality Incidents: Recalls or quality failures at a major supplier can lead to immediate shortages and necessitate rapid requalification of alternative suppliers, a process that can take several months.
• Intellectual Property (IP) Landscape: While the primary patents for febuxostat have expired in many regions, related process patents or polymorphism patents can still influence market entry and competition among generic manufacturers.

How Does the Patent Landscape Affect Febuxostat Drug Substance Sourcing?

The patent landscape has evolved significantly for febuxostat, influencing sourcing strategies for drug substance manufacturers and formulators.

• Orphan Drug Exclusivity & Market Exclusivity: Febuxostat was initially approved as an orphan drug in the U.S. for gout patients who could not tolerate allopurinol. This granted a period of market exclusivity.
• Composition of Matter Patents: The foundational patents covering the febuxostat molecule itself have expired in major markets such as the United States (generally around 2010-2012, depending on extensions) and Europe. This opened the door for generic manufacturers.
• Process Patents: While the composition of matter patent has expired, patents covering novel or improved synthesis routes can still be in force. Manufacturers must ensure their chosen synthesis route does not infringe on existing process patents. Due diligence in this area is crucial for API suppliers and their customers.
• Polymorphism Patents: Different crystalline forms (polymorphs) of an API can have different physical properties, such as solubility and stability. Patents claiming specific polymorphs can affect which forms of febuxostat can be manufactured and sold.
• Formulation Patents: Patents on specific drug product formulations (e.g., extended-release formulations) can also indirectly influence the demand for drug substance with particular characteristics.
• Generic Competition: The expiry of key patents has led to increased competition from generic drug manufacturers, driving down drug product prices and increasing pressure on drug substance suppliers to offer competitive pricing while maintaining high quality.

What is the Competitive Pricing Environment for Febuxostat Drug Substance?

The pricing of febuxostat drug substance is a function of manufacturing costs, competition, regulatory compliance expenses, and market demand.

• Factors Influencing Price:
  • Scale of Production: Larger production volumes typically lead to lower per-unit costs.
  • Manufacturing Location: Labor costs, raw material availability, and regulatory burdens vary by region. Manufacturers in China and India often have cost advantages.
  • Quality Standards: APIs manufactured under strict GMP conditions and with advanced analytical testing command higher prices than those with fewer quality assurances.
  • Regulatory Filings: The cost of preparing and maintaining DMFs and obtaining CEPs is factored into pricing.
  • Competition: A higher number of qualified suppliers generally leads to more competitive pricing.
• Price Trends: With the expiry of the original patents and the entry of multiple generic suppliers, the price for febuxostat drug substance has generally declined over the years. However, price fluctuations can occur due to supply-demand imbalances, raw material cost volatility, or regulatory actions affecting key suppliers.
• Quotation Process: Drug product manufacturers typically obtain quotations from multiple pre-qualified API suppliers. Pricing is often negotiated based on volume commitments, payment terms, and the supplier's regulatory package and quality history.

Key Takeaways

Febuxostat drug substance supply is dominated by manufacturers in China and India. Regulatory compliance, evidenced by DMFs and CEPs, is paramount for market access. Supply chain stability is influenced by raw material sourcing, geopolitical factors, and quality control adherence. The patent landscape, with expired composition of matter patents, has fostered generic competition, leading to a competitive pricing environment.

Frequently Asked Questions

1. What is the primary use of febuxostat? Febuxostat is used to lower uric acid levels in the blood for adults with gout.

2. Are there any specific impurity concerns with febuxostat? Yes, like all APIs, specific process-related impurities and degradation products are monitored and controlled within defined limits, as per pharmacopoeial standards and regulatory guidelines.

3. Which regulatory agencies are most critical for febuxostat API suppliers to satisfy? The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are critical for suppliers seeking to serve major regulated markets.

4. How long does it typically take to qualify a new febuxostat drug substance supplier? Qualifying a new supplier can take between 6 to 18 months, involving audits, sample testing, and regulatory dossier reviews.

5. Can the synthesis of febuxostat be performed using green chemistry principles? While not universally adopted, efforts are ongoing in the pharmaceutical industry to develop more environmentally sustainable synthesis routes for APIs, including febuxostat, potentially reducing solvent use and waste generation.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from [FDA website] (Specific URL may vary based on FDA site structure). [2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability (CEP). Retrieved from [EDQM website] (Specific URL may vary based on EDQM site structure). [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (1997). Impurities: Guideline for residual solvents Q3C(R2). [4] Generic drug patent expiry information is generally available through patent databases such as those maintained by the U.S. Patent and Trademark Office (USPTO) and the European Patent Office (EPO), as well as commercial pharmaceutical intelligence platforms. [5] Global pharmaceutical market analysis reports from firms like IQVIA, EvaluatePharma, and Bloomberg provide insights into market exclusivity periods and generic entry timelines. (Specific report titles and publication dates would be cited if a specific report was consulted).