Suppliers and packagers for ALLOPURINOL SODIUM

ALLOPURINOL SODIUM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Gland	ALLOPURINOL SODIUM	allopurinol sodium	INJECTABLE;INJECTION	212363	ANDA	Fresenius Kabi USA, LLC	65219-380-30	1 VIAL, GLASS in 1 CARTON (65219-380-30) / 25 mL in 1 VIAL, GLASS	2022-03-14
Gland	ALLOPURINOL SODIUM	allopurinol sodium	INJECTABLE;INJECTION	212363	ANDA	Gland Pharma Limited	68083-380-01	1 VIAL, GLASS in 1 CARTON (68083-380-01) / 25 mL in 1 VIAL, GLASS	2022-01-26
Hikma	ALLOPURINOL SODIUM	allopurinol sodium	INJECTABLE;INJECTION	076870	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9533-01	1 VIAL in 1 BOX, UNIT-DOSE (0143-9533-01) / 25 mL in 1 VIAL	2004-09-01

Suppliers for the Pharmaceutical Drug: ALLOPURINOL SODIUM

Last updated: July 29, 2025

Introduction

Allopurinol sodium is a widely used xanthine oxidase inhibitor primarily prescribed to manage gout, hyperuricemia associated with cancer chemotherapy, and certain kidney conditions. As a critical pharmacological agent, its market landscape spans multiple suppliers, including originators, generic manufacturers, and active pharmaceutical ingredient (API) producers. This overview details key suppliers, market dynamics, and considerations for stakeholders involved in sourcing allopurinol sodium.

Overview of Allopurinol Sodium

Allopurinol sodium is the sodium salt form of allopurinol, enhancing its stability and solubility attributes. Its synthesis involves specific chemical pathways targeting purity and bioavailability. The drug's manufacturing is subject to strict regulatory standards, including Good Manufacturing Practices (GMP), to ensure quality, safety, and efficacy.

Key Supplier Categories

1. Originator (Branded) Suppliers

The pioneer in allopurinol production is Sanofi (formerly Rhône-Poulenc), which originally developed allopurinol in the 1960s. Sanofi remains a significant supplier through its branded product Zyloprim. Despite market competition, the brand retains considerable market share, particularly in regions where brand loyalty and regulatory approvals favor established products.

2. Generic Manufacturers

The global market for allopurinol sodium is predominantly driven by generic manufacturers. These producers supply both bulk API and finished dosage forms, often at reduced costs compared to branded counterparts. Leading global or regional generic companies include:

• Hetero Drugs Ltd. (India): A prominent supplier producing high-quality allopurinol API and finished tablets, catering to Domestic and international markets.

• Sun Pharmaceutical Industries Ltd. (India): Offers various formulations, including allopurinol, aligning with stringent quality standards.

• Kure Bay Medical Co., Ltd. (Japan): Specializes in chemical APIs and formulations, including allopurinol.

• Molab Pharamceuticals Ltd. (India): Focuses on export-oriented API production with certifications from global regulatory authorities.

• Beijing Main Luck Pharmaceutical Co., Ltd. (China): Supplies both API and finished dosage forms, expanding influence in Asian markets.

• Julphar Gulf Pharmaceutical Industries (UAE): Supplies generic formulations across the Middle East and Africa.

3. Active Pharmaceutical Ingredient (API) Producers

API production capacity influences drug availability and pricing. These suppliers often operate in India, China, and other emerging markets with established chemical manufacturing hubs:

• Hetero Labs, Sun Pharmaceutical, Xinhua Pharmaceutical, Wuhan Phytoplankton Bio-Chem Co., Ltd.—these entities supply raw materials for various formulations.

4. Contract Manufacturing Organizations (CMOs)

Some pharmaceutical companies outsource production to CMOs specializing in active ingredients or finished dosage forms, thus broadening the supply options for allopurinol sodium.

Supply Chain and Regional Dynamics

• India and China dominate the API manufacturing landscape due to cost advantages, robust chemical infrastructure, and expertise.
• Europe and North America generally have stricter regulatory oversight and tend to rely on established suppliers for higher compliance standards.
• The Middle East and Africa are increasingly attracting API manufacturers through incentives and growing demand for affordable medications.

Regulatory and Quality Considerations

Suppliers must adhere to GMP standards set by agencies such as the FDA (USA), EMA (Europe), PMDA (Japan), and ISPE guidelines. Certification impacts supplier credibility, especially for exporting to regulated markets.

Market Trends and Challenges

• Pricing pressures due to the influx of generic suppliers have led to reduced costs.

• Regulatory hurdles—compliance with evolving standards, such as ICH guidelines, affects supplier qualification.

• Supply chain disruptions from geopolitical or pandemic-related factors strain availability, prompting diversification of suppliers.

• Intellectual property (IP) rights are largely waived for generics, minimizing legal barriers but emphasizing quality assurance.

Emerging Suppliers and Innovations

Research institutions and smaller biotech firms are actively developing novel synthetic routes or biosimilar approaches to enhance stability, reduce costs, or improve bioavailability, though these are not yet widespread.

Strategic Sourcing Considerations

• Quality Assurance: Always verify supplier GMP compliance, certifications, and prior audit histories.

• Cost Efficiency: Balance between cost and regulatory assurance; low-cost suppliers may pose quality risks.

• Supply Stability: Diversify sources to mitigate risks of shortages.

• Regulatory Track Record: Preference for suppliers with robust documentation and regulatory approvals.

Conclusion

The supply ecosystem for allopurinol sodium is complex, characterized by a mixture of legacy originators and a broad spectrum of generic manufacturers, predominantly in India and China. Ensuring a reliable, high-quality supply chain necessitates continuous monitoring of supplier credentials, regulatory compliance, and market developments. As demand persists and markets evolve, supplier diversification and stringent quality management will be critical for stakeholders seeking continuity and compliance.

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Key Takeaways

• Market Dominance: Sanofi remains a key branded supplier, but generics dominate production, especially from India and China.
• Supplier Selection: Prioritize GMP-compliant, certified suppliers with proven regulatory track records.
• Supply Security: Diversify sources to avoid disruptions and ensure competitive pricing.
• Regulatory Compliance: Monitor evolving standards (e.g., ICH guidelines) impacting supplier qualification.
• Innovation & Competition: Emerging synthetic methods and biosimilar research may influence future supply dynamics.

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FAQs

1. Who are the leading global suppliers of allopurinol sodium API?
India and China host the primary API manufacturers such as Hetero Labs, Sun Pharmaceutical, and Wuhan Phytoplankton Bio-Chem Co., Ltd., known for large-scale, compliant API production.

2. How can I verify the quality of an allopurinol sodium supplier?
Verify GMP certification, regulatory approval status (FDA, EMA), audit reports, and prior compliance history to assess supplier reliability.

3. Are there regional differences in supplier quality standards?
Yes; developed markets like North America and Europe enforce stricter standards. Suppliers in these regions typically have more rigorous quality controls than some emerging markets.

4. What factors influence the choice between originator and generic suppliers?
Cost, regulatory approval, product stability, supply reliability, and the preference for branded versus off-patent drugs determine supplier choice.

5. What risks are associated with sourcing allopurinol sodium from emerging markets?
Potential risks include variable quality standards, regulatory non-compliance, supply chain interruptions, and intellectual property issues. Proper due diligence mitigates these risks.

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References

[1] U.S. Food and Drug Administration (FDA). “Approved Drug Products with Therapeutic Equivalence Evaluations.” 2022.
[2] European Medicines Agency (EMA). “Community Procedures for the Marketing Authorization of Medicines.” 2022.
[3] Market data on API manufacturers. IQVIA Institute Reports. 2022.
[4] Industry analysis reports. Pharma Intelligence. 2022.