Suppliers and packagers for lenalidomide

lenalidomide

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	216213	ANDA	Amneal Pharmaceuticals NY LLC	60219-1714-1	28 CAPSULE in 1 BOTTLE (60219-1714-1)	2025-02-12
Amneal	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	216213	ANDA	Amneal Pharmaceuticals NY LLC	60219-1714-2	100 CAPSULE in 1 BOTTLE (60219-1714-2)	2025-02-12
Amneal	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	216213	ANDA	Amneal Pharmaceuticals NY LLC	60219-1715-1	28 CAPSULE in 1 BOTTLE (60219-1715-1)	2025-02-12
Amneal	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	216213	ANDA	Amneal Pharmaceuticals NY LLC	60219-1715-2	100 CAPSULE in 1 BOTTLE (60219-1715-2)	2025-02-12
Amneal	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	216213	ANDA	Amneal Pharmaceuticals NY LLC	60219-1716-1	28 CAPSULE in 1 BOTTLE (60219-1716-1)	2025-02-12

Suppliers for the Pharmaceutical Drug: LENALIDOMIDE

Last updated: July 27, 2025

Introduction

Lenalidomide is a potent immunomodulatory agent used primarily to treat multiple myeloma, myelodysplastic syndromes, and certain lymphomas. Its complex synthesis, strict regulatory controls, and high demand necessitate a robust supply chain of reputable manufacturers and suppliers. This article examines the primary suppliers of lenalidomide globally, evaluates their roles, and provides insights into the market dynamics shaping supply security.

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Overview of Lenalidomide Manufacturing and Supply Chain

Lenalidomide, chemically known as 3-(4-amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl) pyridine-2-carboxamide, was initially developed by Celgene Corporation (now part of Bristol-Myers Squibb following a significant acquisition in 2019). Its synthesis involves intricate multi-step chemical processes, requiring specialized facilities adhering to Good Manufacturing Practices (GMP).

The supply chain for lenalidomide comprises active pharmaceutical ingredient (API) producers, formulation manufacturers, and distributors. The GxP regulatory landscape, especially within the United States (FDA), European Union (EMA), and other jurisdictions, imposes rigorous standards, constraining the set of qualified suppliers.

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Key Global Suppliers of Lenalidomide API

1. Celgene/Bristol-Myers Squibb

   As the original innovator, Celgene held extensive manufacturing facilities for lenalidomide, including API synthesis and finished drug production. Following the BMS acquisition, the company continues to be a primary supplier through its integrated supply chain. Its global manufacturing network ensures continuity and quality assurance, particularly for North American and European markets.

2. Cipla Limited

   Cipla, a leading Indian pharmaceutical company, has emerged as a significant API supplier for lenalidomide, leveraging their advanced chemical synthesis capacity. Cipla holds approvals from regulatory authorities like the US FDA and EMA, enabling it to export to regulated markets. Their vertical integration accelerates flexible production and adaptation to market demands.

3. Dr. Reddy’s Laboratories

   An Indian multinational, Dr. Reddy’s specializes in complex generics and APIs, including lenalidomide. Their strategic investments in R&D and manufacturing infrastructure facilitate compliance with international standards, positioning them as a reliable supply source.

4. Sun Pharmaceutical Industries Ltd.

   Sun Pharma has developed capacity for USP-grade APIs across various oncology agents, including lenalidomide. The company’s global footprint and commitment to quality make it a key player, particularly for markets in Asia, Latin America, and Africa.

5. Elementis Specialties and Other Contract Manufacturers

   Several contract manufacturing organizations (CMOs) in India and China supply the lenalidomide API under stringent quality controls. These entities often cater to both branded and generic pharmaceutical companies, augmenting the supply landscape.

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Regulatory and Patent Considerations Affecting Suppliers

The motivation for diversifying suppliers stems from patent expirations—most notably, the expiration of Celgene’s patents in various jurisdictions. Once patents expire, generic manufacturers gain access to licensing agreements or develop biosimilar API production, increasing supply competition.

However, due to lenalidomide’s teratogenicity and potential for severe side effects, regulatory authorities enforce strict controls over manufacturing, registration, and distribution. Suppliers must demonstrate rigorous quality and safety standards, often translating into high barriers to entry.

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Market Dynamics and Supplier Strategy

• Patent Landscape: Patent protections, granted by agencies like the USPTO and EPO, historically constrained generic entry. Post-expiry, an influx of generics from Indian and Chinese suppliers has increased available sources.

• Quality Assurance and Regulatory Approvals: Only suppliers with approved manufacturing sites and validated processes can supply key markets. Compliance with the FDA’s Drug Master File (DMF) and the EMA’s Certificate of Suitability (CEP) are critical.

• Geopolitical Shifts and Supply Security: Recent global supply disruptions, including those caused by COVID-19, have underscored the importance of diverse sourcing strategies. Regulatory agencies and large pharmaceutical firms now emphasize supply chain resilience, encouraging partnerships with multiple suppliers across different regions.

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Emerging Suppliers and Future Outlook

• Chinese Manufacturers: Chinese pharmaceutical companies are increasingly investing in GMP-grade API production. Companies like Shanghai Pharmaceuticals and Haitao Pharmaceutical have announced capacity expansion plans.

• Biotech and Contract Manufacturing Developments: With advances in synthetic chemistry, novel manufacturing processes are being explored to lower costs and improve scalability, potentially broadening the supplier pool.

• Regulatory Approvals and Expanding Markets: As lenalidomide’s indications expand into new therapeutic areas, manufacturers are pursuing approvals in emerging markets, further diversifying supply sources.

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Conclusion

The supply of lenalidomide relies on a limited pool of high-quality, regulatory-compliant manufacturers. Leading suppliers include incumbent firms such as Bristol-Myers Squibb, Cipla, Dr. Reddy’s, and Sun Pharma, alongside an expanding cadre of Chinese and Indian contract manufacturers. Market shifts driven by patent expiries and geopolitical factors have increased supplier diversity, yet stringent regulatory standards continue to shape the landscape. Pharmaceutical companies seeking resilient supply chains must prioritize partnerships with approved, GMP-certified manufacturers across multiple regions.

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Key Takeaways

• The global supply chain for lenalidomide is concentrated among a handful of major pharmaceutical and generic manufacturers, with recent diversification owing to patent expirations.

• Regulatory compliance and quality assurance are primary considerations governing supplier eligibility, especially in regulated markets like the US and EU.

• Emerging suppliers from China and India are expanding capacity, offering cost-effective alternatives while maintaining adherence to international standards.

• Global supply disruptions highlight the importance of sourcing from multiple, geographically dispersed manufacturers to ensure uninterrupted access.

• Strategic partnerships and continuous regulatory engagement remain critical for securing reliable lenalidomide supply.

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FAQs

1. Who are the top active pharmaceutical ingredient (API) suppliers for lenalidomide?
The top API suppliers include Bristol-Myers Squibb (formerly Celgene), Cipla, Dr. Reddy’s Laboratories, Sun Pharmaceutical Industries, and various Chinese CDMOs. These entities maintain GMP-compliant manufacturing facilities with regulatory approvals in key markets.

2. Are there generic alternatives to branded lenalidomide?
Yes. Following patent expirations, several established Indian and Chinese generic manufacturers produce lenalidomide APIs, offering cost-effective alternatives across global markets, subject to regulatory approval.

3. How do regulatory agencies influence supplier selection for lenalidomide?
Agencies like the FDA and EMA require suppliers to have approved manufacturing processes, validated quality controls, and compliance with GMP standards. Suppliers lacking regulatory approval cannot legally supply products in these regions.

4. What factors are driving increased diversity among lenalidomide suppliers?
Patent expirations, geopolitical shifts, supply chain resilience strategies, and technological advances are factors fostering greater supplier diversity to mitigate risks and meet rising global demand.

5. What are the risks associated with sourcing lenalidomide from multiple suppliers?
Risks include variability in manufacturing quality, regulatory non-compliance, delays in approval, and intellectual property disputes. Effective due diligence and continuous regulatory engagement are essential to mitigate these risks.

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References

[1] Bristol-Myers Squibb. "Lenalidomide (Revlimid) Clinical Pharmacology," 2021.
[2] U.S. Food and Drug Administration. "Drug Master Files," FDA.gov.
[3] European Medicines Agency. "Certificates of Suitability," EMA.europa.eu.
[4] Market research reports on pharmaceutical APIs and generics industry, 2022.
[5] Recent patent expiry announcements and industry news articles.