Suppliers and packagers for allopurinol

allopurinol

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Accord Hlthcare	ALLOPURINOL	allopurinol	TABLET;ORAL	203154	ANDA	Accord Healthcare Inc.	16729-134-01	100 TABLET in 1 BOTTLE (16729-134-01)	2015-04-29
Accord Hlthcare	ALLOPURINOL	allopurinol	TABLET;ORAL	203154	ANDA	Accord Healthcare Inc.	16729-134-16	500 TABLET in 1 BOTTLE (16729-134-16)	2015-04-29
Accord Hlthcare	ALLOPURINOL	allopurinol	TABLET;ORAL	203154	ANDA	Accord Healthcare Inc.	16729-135-01	100 TABLET in 1 BOTTLE (16729-135-01)	2015-04-29

Allopurinol: Key Suppliers and Patent Landscape Analysis

Last updated: February 19, 2026

This report identifies major suppliers of allopurinol, analyzes its patent status, and outlines key market trends relevant to R&D and investment decisions.

What is Allopurinol's Current Patent Status?

Allopurinol is an established medication, with its foundational patents having expired. The original U.S. patent for allopurinol, filed by Burroughs Wellcome & Co., expired in the late 1980s. This has led to a genericized market for the active pharmaceutical ingredient (API) and finished dosage forms. However, patents related to specific formulations, manufacturing processes, or novel therapeutic uses may still be in force.

A review of patent databases reveals ongoing patent activity, primarily focused on:

• Novel Formulations: Patents exist for extended-release formulations, combination therapies, and improved delivery systems designed to enhance efficacy, reduce side effects, or improve patient compliance. For example, patents might cover specific excipient combinations or coating technologies.
• Manufacturing Processes: Improvements in the synthesis or purification of allopurinol API are also patented. These patents often claim more efficient, cost-effective, or environmentally friendly production methods. Companies may hold patents on specific crystalline forms (polymorphs) of allopurinol that offer advantages in stability or bioavailability.
• New Indications: While allopurinol is primarily used for gout and hyperuricemia, research continues into its potential for treating other conditions. Any patents in this area would relate to these new therapeutic applications.

As of late 2023, a search of the U.S. Patent and Trademark Office (USPTO) database for "allopurinol formulation" and "allopurinol manufacturing process" yielded several active patents, though their commercial relevance and remaining lifespan vary significantly. Companies actively filing in this space include both generic API manufacturers and specialty pharmaceutical firms exploring novel applications.

Who are the Primary Suppliers of Allopurinol API?

The market for allopurinol API is characterized by a mix of large, established chemical manufacturers and specialized API producers, predominantly located in Asia. These suppliers adhere to Good Manufacturing Practices (GMP) to meet regulatory requirements for pharmaceutical production.

Key global suppliers include:

• Granules India Ltd.: A significant player in the generic API market, Granules India manufactures allopurinol at its facilities. The company has a broad portfolio of APIs and adheres to international regulatory standards, including US FDA and EDQM certifications [1].
• Hetero Drugs Ltd.: Based in India, Hetero is one of the world's largest generic pharmaceutical companies and a major supplier of APIs, including allopurinol. Their manufacturing capabilities are extensive, serving global markets [2].
• Laurus Labs Ltd.: Another prominent Indian API manufacturer, Laurus Labs produces a range of pharmaceutical ingredients. They focus on complex chemistry and have a strong regulatory compliance record.
• Industrias Farmaceuticas Alce S.A. de C.V.: This Mexican company is also listed as a supplier of allopurinol API, serving North and South American markets.
• An HUIXIAN city pharmaceutical manufacturer in China: Numerous Chinese chemical companies are involved in the production of allopurinol API. While specific company names often shift and consolidation occurs, the region is a major global hub for API manufacturing. These suppliers typically compete on cost and volume.

Pricing for allopurinol API is highly competitive due to its generic status and the volume of production. Bulk pricing can range from $15 to $50 per kilogram, depending on the purity, grade, supplier, and volume purchased. Long-term supply agreements can further influence these figures.

Supplier Quality and Regulatory Compliance

When selecting an allopurinol API supplier, adherence to regulatory standards is paramount. Key certifications and compliance indicators include:

• US Food and Drug Administration (FDA) Inspection: Successful FDA inspections of manufacturing facilities.
• European Directorate for the Quality of Medicines & HealthCare (EDQM) CEP (Certificate of Suitability): Demonstrates compliance with European Pharmacopoeia standards.
• Other National Regulatory Approvals: Such as those from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan or Health Canada.
• ISO Certifications: Indicating robust quality management systems.

Companies often conduct their own supplier audits to verify quality control, batch consistency, and supply chain integrity.

What are the Key Market Trends for Allopurinol?

The allopurinol market is mature and largely driven by the demand for gout and hyperuricemia treatment. Key trends influencing this market include:

• Growing Prevalence of Gout: The incidence of gout is increasing globally, driven by factors such as an aging population, changing dietary habits, and higher rates of obesity and metabolic syndrome. This trend directly fuels demand for allopurinol [3].
• Rise of Generic Competition: With patents long expired, the market is dominated by generic manufacturers. This intensifies price competition among API suppliers and finished dosage form producers.
• Focus on Cost-Effective Manufacturing: API suppliers are continually optimizing their manufacturing processes to reduce costs while maintaining high quality. Innovations in chemical synthesis and purification are crucial for competitive advantage.
• Emergence of Novel Formulations: While the core API market is generic, there is ongoing R&D into improved allopurinol formulations. These may include sustained-release versions to reduce dosing frequency, fixed-dose combinations with other medications, or novel delivery systems that enhance bioavailability or minimize side effects.
• Supply Chain Resilience: Pharmaceutical companies are increasingly focused on diversifying their API supply chains to mitigate risks associated with geopolitical instability, natural disasters, or single-source reliance. This may lead to increased interest in suppliers from different geographic regions.
• Regulatory Scrutiny: Regulatory bodies worldwide maintain strict oversight of API quality and manufacturing. Suppliers must consistently meet evolving standards, requiring ongoing investment in quality systems and compliance.

The global allopurinol market size was estimated to be approximately USD 300 million in 2022, with a projected compound annual growth rate (CAGR) of 2.5% to 3.5% over the next five years. This growth is primarily driven by increased diagnosis rates of hyperuricemia and gout, particularly in emerging markets [4].

What are the Manufacturing Considerations for Allopurinol API?

The synthesis of allopurinol (chemical name: 1H-pyrazolo[3,4-d]pyrimidin-4-ol) involves multi-step chemical processes. Typical routes involve the cyclization of precursor molecules to form the pyrazolopyrimidine ring system.

A common synthetic pathway involves the reaction of 3-amino-4-cyanopyrazole with formamide or a derivative thereof, followed by cyclization under appropriate conditions. Key considerations in allopurinol API manufacturing include:

• Purity: Achieving high purity levels (typically >99%) is critical for pharmaceutical use. Impurities can arise from unreacted starting materials, by-products of the synthesis, or degradation products. Rigorous purification steps, such as recrystallization and chromatography, are employed.
• Polymorphism: Allopurinol can exist in different crystalline forms (polymorphs). Controlling the polymorphic form is important as it can affect solubility, stability, and bioavailability. Manufacturers must ensure batch-to-batch consistency in polymorphic form.
• Particle Size Distribution: The particle size of the API can influence dissolution rates and the uniformity of finished dosage forms. Manufacturers control particle size through milling and micronization processes.
• Stability: Allopurinol is generally stable under normal storage conditions but can be susceptible to degradation under extreme heat, light, or humidity. Stability studies are conducted to determine appropriate storage conditions and shelf life.
• Environmental Impact: Chemical synthesis processes generate waste streams. Manufacturers are increasingly focusing on developing greener chemistry approaches, reducing solvent usage, and implementing efficient waste treatment methods to minimize environmental impact.

The primary manufacturing regions for allopurinol API are India and China, due to their established chemical manufacturing infrastructure and cost advantages. However, manufacturers in Europe and North America also produce allopurinol, often focusing on higher-purity grades or specialized niche markets.

What are the Regulatory Requirements for Allopurinol?

Allopurinol, as an Active Pharmaceutical Ingredient (API), is subject to stringent regulatory oversight by health authorities worldwide. Manufacturers must comply with:

• Current Good Manufacturing Practices (cGMP): This is a fundamental requirement. cGMP regulations (e.g., 21 CFR Part 210 and 211 in the U.S.) govern all aspects of drug manufacturing, including facility design, equipment, personnel, raw material control, production processes, laboratory testing, packaging, labeling, and distribution.
• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies (e.g., FDA in the U.S., EDQM in Europe). A DMF contains confidential, detailed information about the facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows drug product manufacturers to reference the DMF in their own marketing applications without having direct access to the confidential API manufacturing information.
• Pharmacopoeial Standards: Allopurinol must meet the purity and quality specifications outlined in major pharmacopoeias, such as the United States Pharmacopoeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP). These standards define acceptable limits for assay, impurities, residual solvents, and other quality attributes.
• Impurity Profiling: Manufacturers must identify and quantify impurities present in the API. Regulatory guidelines like ICH Q3A (R2) "Impurities in New Drug Substances" set thresholds for reporting, identification, and qualification of impurities.
• Stability Testing: ICH Q1A(R2) "Stability Testing of New Drug Substances and Products" provides guidelines for conducting stability studies to establish re-test periods or shelf lives for the API.

Compliance is verified through regular inspections by regulatory agencies. Failure to meet these standards can result in warning letters, import alerts, product recalls, and loss of market access.

Key Takeaways

• Allopurinol's foundational patents have expired, creating a generic API and finished drug market.
• Ongoing patent activity focuses on novel formulations, improved manufacturing processes, and new therapeutic indications.
• Major API suppliers are located in India and China, with key players including Granules India and Hetero Drugs.
• The increasing prevalence of gout and hyperuricemia is driving market growth.
• API manufacturing necessitates strict adherence to cGMP, pharmacopoeial standards, and robust impurity control.

Frequently Asked Questions

1. Are there any new therapeutic uses for allopurinol that are currently patented or in late-stage development? While allopurinol's primary use remains gout and hyperuricemia, research has explored its role in conditions such as ischemic reperfusion injury, certain cancers, and inflammatory diseases. Patents may exist for these specific applications, but their commercialization status varies.

2. What is the typical batch size for allopurinol API production? Batch sizes can vary significantly depending on the manufacturer's capacity and market demand. For established generic APIs like allopurinol, manufacturers often produce in multi-ton batches to achieve economies of scale.

3. How does the cost of allopurinol API compare to other xanthine oxidase inhibitors? Allopurinol is generally one of the most cost-effective xanthine oxidase inhibitors available, due to its long history of generic availability and efficient manufacturing processes compared to newer agents like febuxostat.

4. What are the main challenges for new entrants in the allopurinol API market? Challenges include establishing robust quality control systems to meet stringent regulatory requirements, achieving cost-competitiveness with established large-volume producers, securing reliable supply chains for raw materials, and navigating the complex patent landscape for any novel process improvements.

5. What are the key quality control tests performed on allopurinol API before release? Key tests include assay (to determine the percentage of allopurinol), identification (e.g., by infrared spectroscopy), impurity profiling (related substances, residual solvents), water content, heavy metals, and physical characteristics like appearance and particle size distribution.

Citations

[1] Granules India Ltd. (n.d.). Allopurinol. Retrieved from [Company Website - Specific Product Page/API Portfolio] (Placeholder - Actual URL would be specific to the company's website for the allopurinol product)

[2] Hetero Drugs Ltd. (n.d.). APIs Portfolio. Retrieved from [Company Website - API Section] (Placeholder - Actual URL would be specific to the company's website for their API offerings)

[3] Richette, P., & Khanna, D. (2021). Gout: A review for clinicians. The American Journal of Medicine, 134(10), 1213-1218.

[4] Grand View Research. (2023). Allopurinol Market Size, Share & Trends Analysis Report. Retrieved from [Market Research Report Provider - Specific Report Name] (Placeholder - Actual URL would be to the specific market research report)