Suppliers and packagers for imuran

imuran

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Legacy Pharma	IMURAN	azathioprine	TABLET;ORAL	016324	NDA	Sebela Pharmaceuticals Inc.	54766-590-10	100 TABLET in 1 BOTTLE (54766-590-10)	2017-12-01

Suppliers for the Pharmaceutical Drug: IMURAN

Last updated: August 2, 2025

Introduction

IMURAN, the brand name for azathioprine, is an immunosuppressive agent primarily prescribed for conditions such as rheumatoid arthritis, Crohn's disease, and organ transplant rejection prophylaxis. As a cornerstone drug in immunotherapy, its supply chain stability significantly influences therapeutic access worldwide. Identifying reliable suppliers involves understanding the manufacturing landscape, regulatory considerations, and global distribution channels.

Manufacturers of IMURAN (Azathioprine)

The original formulation of IMURAN was introduced by GlaxoSmithKline (GSK), which historically held patent rights and manufacturing operations. However, the expiration of patents and the consequent entry of generic manufacturers have markedly diversified the supplier base.

Branded Suppliers

• GlaxoSmithKline (GSK):
  As the original patent holder, GSK's production was pivotal until patent expiry. Although GSK has phased out some formulations post-patent expiration, it remains an authoritative source for branded azathioprine in certain markets.

Generic Manufacturers

The generic landscape boasts numerous pharmaceutical firms capable of manufacturing azathioprine in various formulations and dosages, including tablets and intravenous forms. These companies include:

• Teva Pharmaceuticals:
  A global leader in generics, Teva produces azathioprine and supplies to numerous countries under various regulatory approvals.

• Mylan (now part of Viatris):
  Mylan has historically manufactured affordable generic azathioprine, expanding access, especially in lower-income regions.

• Sandoz (a Novartis division):
  Sandoz produces high-quality generics, including azathioprine, with a focus on strict adherence to regulatory standards, especially in Europe and North America.

• Eipico (Egyptian International Pharmaceutical Industries Company):
  A significant regional producer, Eipico supplies azathioprine formulations within Africa and the Middle East.

• Hospira (a Pfizer Company):
  Known for injectable medicines, Hospira manufactures intravenous formulations for azathioprine, primarily for hospital use.

• Sun Pharmaceutical Industries:
  An Indian pharmaceutical giant with a growing portfolio of immunosuppressants, including azathioprine.

• Mediwin Pharmaceuticals:
  Focused regionally, mediwin provides cost-effective azathioprine in Asia and Africa.

Regulatory Considerations and Approvals

The manufacturing of azathioprine, including IMURAN, is governed by strict regulatory standards such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other national agencies. Suppliers’ compliance with Good Manufacturing Practices (GMP) is critical for market authorization, affecting their credibility and reach.

Manufacturers must submit new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for generics, demonstrating bioequivalence and manufacturing quality. Suppliers with approved licensing can export to major markets, ensuring global product availability.

Supply Chain and Distribution Networks

The distribution of IMURAN and similar drugs often involves partnerships across supply chains. Key components include:

• Global Contract Manufacturers:
  Several companies operate as Contract Manufacturing Organizations (CMOs), producing azathioprine on behalf of brand and generic firms.

• Wholesalers and Distributors:
  Major pharmaceutical distributors, such as McKesson, Cardinal Health, and Al Hosni, play significant roles in delivering IMURAN to hospitals, pharmacies, and clinics.

• Import/Export Regulations:
  Variance in drug approval and licensing requirements influences supply routes. Suppliers with robust regulatory dossiers facilitate seamless international distribution.

Market Dynamics

The azathioprine market reflects a mature pharmaceutical segment dominated by generics. The expiry of patents has led to increased competition, resulting in multiple suppliers across continents. The primary factors influencing supplier choice include:

• Price competitiveness: Cost-effective manufacturing reduces patient and payer burdens.
• Regulatory compliance: Suppliers approved in key markets (U.S., EU, Japan) have superior market access.
• Product quality and consistency: Ensuring active ingredient uniformity and minimal toxicity.
• Supply stability: Ability to meet global demand, especially in times of increased need (e.g., organ transplants, pandemics).

Emerging Suppliers and Future Trends

Growing demand driven by expanding indications, such as autoimmune diseases and transplant medicine, encourages new entrants and biosimilar development. Advances in manufacturing technology, like continuous processes and quality control automation, promise improved supply reliability and cost reductions.

Additionally, regional manufacturing hubs in India, China, and Eastern Europe are emerging as significant suppliers, aided by supportive regulatory reforms and local capacity enhancements.

Conclusion

The supply ecosystem for IMURAN (azathioprine) is extensive and diverse, encompassing original producers like GSK, numerous global generic manufacturers, regional regional players, and CMOs. Suppliers’ ability to meet quality standards, regulatory compliance, and market demands determines their prominence in the global supply chain. As patent protections diminish, the landscape continues to evolve toward increased competition and innovation, aimed at ensuring consistent, affordable access for patients worldwide.

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Key Takeaways

• The global supply of IMURAN hinges on both original manufacturers and a broad array of generic firms, including Teva, Mylan, Sandoz, and regional producers.
• Regulatory approval and compliance with GMP standards are key determinants of supplier credibility and market access.
• Distribution networks and import/export regulations significantly influence the availability of IMURAN in different regions.
• Market growth and technological advancements are likely to introduce new suppliers and biosimilar options, improving supply resilience and affordability.
• Strategic partnerships with CMOs and regional manufacturing hubs are essential to meet global demand and mitigate supply chain disruptions.

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FAQs

1. Who are the leading suppliers of IMURAN globally?
The primary suppliers include original manufacturer GlaxoSmithKline and generic producers like Teva Pharmaceuticals, Mylan (Viatris), Sandoz (Novartis), and regional manufacturers in India, China, and the Middle East.

2. Are generic azathioprine products equivalent to the branded IMURAN in quality?
Yes. Approved generic azathioprine formulations undergo rigorous bioequivalence testing and must meet stringent GMP standards to ensure therapeutic consistency.

3. In which regions is IMURAN most readily available?
IMURAN is widely available in North America, Europe, and parts of Asia. Supply stability depends on local regulatory approvals, market demand, and the presence of approved manufacturers.

4. How does patent expiry influence the supply of azathioprine?
Patent expiry allows multiple generic manufacturers to produce and distribute azathioprine, increasing supply options, reducing prices, and expanding access.

5. What factors should healthcare providers consider when sourcing IMURAN?
Providers should prioritize suppliers with approved regulatory status, consistent product quality, reliable supply chains, and competitive pricing to ensure patient safety and treatment continuity.

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References

1. [1] DrugBank. Azathioprine. Available at: https://go.drugbank.com/drugs/DB00604
2. [2] U.S. Food and Drug Administration. Approved Drug Products. Available at: https://www.fda.gov/drugs/drug-approvals-and-databases
3. [3] European Medicines Agency. Azathioprine Summary of Product Characteristics. Available at: https://www.ema.europa.eu/
4. [4] Teva Pharmaceuticals Official Site. Products. Available at: https://www.tevapharm.com/
5. [5] Mylan Official Website. Product Portfolio. Available at: https://www.viatris.com/

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