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
Accord Hlthcare	ALLOPURINOL	allopurinol	TABLET;ORAL	203154	ANDA	Accord Healthcare Inc.	16729-135-16	500 TABLET in 1 BOTTLE (16729-135-16)	2015-04-29
Accord Hlthcare	ALLOPURINOL	allopurinol	TABLET;ORAL	203154	ANDA	A-S Medication Solutions	50090-5168-3	30 TABLET in 1 BOTTLE (50090-5168-3)	2015-04-29
Accord Hlthcare	ALLOPURINOL	allopurinol	TABLET;ORAL	203154	ANDA	A-S Medication Solutions	50090-5168-4	90 TABLET in 1 BOTTLE (50090-5168-4)	2015-04-29

Suppliers for the Pharmaceutical Drug: Allopurinol

Last updated: July 27, 2025

Introduction

Allopurinol is a cornerstone medication in the management of hyperuricemia and gout, as well as certain types of kidney stones and tumor lysis syndrome. Since its discovery in the 1960s, allopurinol has remained a key component in uric acid control therapy. Its global demand necessitates a diversified and reliable supplier base, encompassing large pharmaceutical companies, generics manufacturers, and contract manufacturing organizations (CMOs). This article provides an in-depth overview of the principal suppliers of allopurinol, their market positioning, manufacturing capacities, regulatory compliance, and strategic significance within the pharmaceutical supply chain.

Overview of Allopurinol Manufacturing

Allopurinol (chemical name: 1,5-dihydro-4-hydroxy-2-phenyl-3H-pyrazol-3-one) is primarily produced via chemical synthesis involving complex multi-step processes. The manufacturing demands strict adherence to Good Manufacturing Practices (GMP), with suppliers required to maintain high standards to meet international regulatory requirements from agencies like the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and PMDA (Japan Pharmaceuticals and Medical Devices Agency). The suppliers span geographic regions including Asia, Europe, and North America, with Asia-Pacific increasingly becoming a dominant manufacturing hub owing to cost efficiencies and expanding capacity.

Major Global Suppliers of Allopurinol

1. Sanofi (France)

Sanofi has historically been a significant supplier of allopurinol. Its portfolio includes branded formulations such as Zyloprim, which is marketed extensively across North America and Europe. Sanofi's manufacturing facilities are GMP-compliant, leveraging robust R&D capabilities and extensive distribution networks. Although Sanofi has divested some assets in recent years, it continues to play an essential role in global allopurinol supply, especially through licensing agreements and regional manufacturing partnerships.

2. Lupin Limited (India)

Lupin is a leading Indian pharmaceutical manufacturer with a substantial footprint in generic drugs, including allopurinol. The company’s manufacturing plants in India are accredited by major regulatory authorities, enabling export to the US, Europe, and other markets. Lupin’s strategic focus on cost-effective manufacturing makes it a key supplier for both bulk API and finished dosage forms in emerging markets.

3. Ming Fai Pharmaceutical (China)

Ming Fai Pharmaceutical is a prominent API producer based in China, with specialized capabilities in pyrazol compounds like allopurinol. The company boasts a vertically integrated supply chain, from raw material synthesis to finished product manufacturing, serving both domestic and international markets. Ming Fai’s emphasis on quality and regulatory compliance positions it as a critical supplier for generics manufacturers seeking reliable API sources.

4. Alpharma (India)

Part of the Aurobindo Pharma Group, Alpharma is known for its extensive portfolio of APIs, including allopurinol. The company’s GMP-certified facilities in India produce APIs that are exported globally, particularly to the US and Europe. Alpharma emphasizes rigorous quality controls, making it a preferred partner for both branded and generic formulations.

5. Sun Pharmaceutical Industries Ltd. (India)

Sun Pharma is another key Indian manufacturer with a significant share in the allopurinol API and finished dosage market. The company has expanded its manufacturing capacity through acquisitions and new investments, aiming to meet the rising global demand. Sun Pharma’s compliance with international standards supports its market penetration in regulated territories.

6. Hebei Fuyuan Pharmaceutical (China)

Hebei Fuyuan Pharmaceutical specializes in pyrazol derivatives and manufactures allopurinol API for both domestic and export markets. Its facilities are certified by the Chinese regulatory authority, and it maintains compliance with international standards, making it a viable supplier for global clients seeking quality APIs.

Key Factors Influencing Supplier Selection

Regulatory Compliance: Quality assurance through GMP certification and adherence to international regulations remain the top criterion for global pharmaceutical companies seeking raw APIs.

Manufacturing Capacity: Suppliers with scalable production capabilities can meet increasing demand, especially during global shortages or supply chain disruptions.

Cost Efficiency: Countries with lower production costs, notably India and China, offer more competitive pricing, although concerns about quality standards necessitate rigorous supplier audits.

Supply Chain Reliability: Suppliers with diversified manufacturing sites and long-standing track records enhance supply chain resilience.

R&D and Innovation: Companies investing in process optimization and quality improvements offer a comparative advantage, especially in meeting evolving regulatory standards.

Market Dynamics and Trends

Recent trends indicate a growing reliance on Asian manufacturers for API supply, driven by cost advantages and expanding production capabilities. However, recent geopolitical tensions and supply chain disruptions have prompted many multinational pharma firms to diversify their supplier base and revisit strategic stockpiling. Regulatory scrutiny on quality practices has also increased, favoring suppliers with stringent compliance and certification histories.

Furthermore, the shift towards biosimilar and innovative therapies has catalyzed investments in API manufacturing facilities, which benefits established and emerging allopurinol producers. The trend underscores the importance of quality management systems and transparent supply chain practices.

Regulatory Challenges and Quality Considerations

The global pharmaceutical industry faces heightened regulatory scrutiny on API manufacturers’ quality systems. Non-compliance issues have led to product recalls and regulatory actions, illustrating the importance of rigorous audits and validation processes. Suppliers like Lupin, Sun Pharma, and Ming Fai have maintained high standards, securing certifications such as ISO 9001 and certifications from regulatory agencies.

Additionally, geographic diversification mitigates risks associated with regional regulatory changes, natural disasters, or geopolitical tensions. Ensuring suppliers align with current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) remains essential.

Strategic Recommendations for Pharmaceutical Companies

• Diversify Supplier Base: Engaging multiple validated suppliers from different regions minimizes risks associated with supply chain disruptions.
• Prioritize Quality and Compliance: Rigorous qualification and ongoing audits ensure API quality, reducing the risk of regulatory actions.
• Invest in Supply Chain Transparency: Implementing track-and-trace systems enhances supply chain security and authenticity verification.
• Develop Strategic Stockpiles: Adjust inventory levels for critical APIs like allopurinol to buffer against supply uncertainties.
• Foster Long-term Partnerships: Building collaborative relationships with quality-focused suppliers ensures continuity and mutual growth.

Conclusion

The supply landscape for allopurinol is characterized by a mix of established multinational pharma companies and robust Asian API manufacturers. While regions such as China and India dominate through cost-effective and scalable manufacturing, regulatory adherence remains paramount. Ensuring a diversified, compliant, and resilient supply chain is key for pharma companies aiming to mitigate risk functions, meet demand, and maintain regulatory compliance.

Key Takeaways

• Major suppliers include Sanofi, Lupin, Ming Fai, Aurobindo Pharma, and Sun Pharma.
• Asian manufacturers significantly influence supply due to high capacity and competitive costs.
• Regulatory compliance and quality assurance are critical in supplier evaluation.
• Supply chain diversification reduces risk amid geopolitical and logistical uncertainties.
• Continuous supplier qualification and strategic inventory management are essential for uninterrupted supply.

FAQs

Q1: What are the primary regions manufacturing allopurinol APIs?
A1: The primary regions include India and China, with additional production in Europe and North America.

Q2: How do regulatory standards impact allopurinol suppliers?
A2: Suppliers must comply with GMP, ISO, and local regulatory certifications to ensure product quality, affecting their ability to export to strict markets like the US and Europe.

Q3: Are generic manufacturers the main suppliers of allopurinol?
A3: Yes, most allopurinol supplied globally comes from generic manufacturers, owing to cost advantages and patent expirations.

Q4: How has recent geopolitical tension affected allopurinol supply?
A4: Tensions have prompted companies to diversify suppliers and regions, reducing dependence on a single source, especially from China.

Q5: What trade considerations should pharmaceutical companies consider when sourcing allopurinol?
A5: Companies should assess tariffs, import regulations, regional compliance standards, and logistical infrastructure to streamline procurement.

References

1. [1] World Health Organization. (2021). Guidelines for Good Manufacturing Practices.
2. [2] U.S. FDA. (2022). API Inspection and Manufacturing Standards.
3. [3] IQVIA Institute. (2022). Global API Market Analysis.
4. [4] Pharma Intelligence. (2023). API Supply Trends and Market Dynamics.
5. [5] Chinese State Food and Drug Administration. (2022). API Regulatory Frameworks.