Suppliers and packagers for revlimid

revlimid

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880	NDA	Celgene Corporation	59572-402-00	100 CAPSULE in 1 BOTTLE (59572-402-00)	2012-04-16
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880	NDA	Celgene Corporation	59572-402-28	28 CAPSULE in 1 BOTTLE (59572-402-28)	2012-04-16
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880	NDA	Celgene Corporation	59572-405-00	100 CAPSULE in 1 BOTTLE (59572-405-00)	2005-12-27
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880	NDA	Celgene Corporation	59572-405-28	28 CAPSULE in 1 BOTTLE (59572-405-28)	2005-12-27

Suppliers for the Pharmaceutical Drug: REVLIMID

Last updated: July 27, 2025

Introduction

Revilimid (lenalidomide) is a potent immunomodulatory agent primarily used in oncology to treat multiple myeloma, myelodysplastic syndromes, and certain lymphomas. Since its initial approval, the drug has become a cornerstone in hematology-oncology, prompting a stratified supply chain comprising manufacturing giants, authorized distributors, and licensed pharmacies globally. A comprehensive understanding of suppliers for Revilimid is vital for stakeholders evaluating procurement strategies, negotiating licensing agreements, or assessing supply risk.

Global Manufacturing Landscape of REVLIMID

Lenalidomide's manufacturing is predominantly controlled by Celgene Corporation, which was acquired by Bristol-Myers Squibb (BMS) in 2019. This consolidation has centralized Revilimid's supply control, ensuring a streamlined process across the global supply chain. Celgene, now under BMS, maintains multiple manufacturing sites globally to meet regional demands while adhering to strict GMP (Good Manufacturing Practice) standards ([1]).

Licensed and Approved Suppliers in Key Markets

United States

In the U.S., Revlimid is supplied exclusively through BMS’s authorized distribution channels following the Drug Supply Chain Security Act (DSCSA). The drug is available via specialty pharmacies such as CVS Specialty and Accredo (a division of Express Scripts), which are licensed distributors authorized to dispense oncology drugs. BMS employs a controlled distribution system that minimizes counterfeit risks, including comprehensive serialization and track-and-trace implementations ([2]).

European Union

In the EU, BMS partners with local licensed distributors adhering to EMA (European Medicines Agency) guidelines. Key partners include Grifols and Cencora, which supply authorized specialty pharmacies and hospitals with Revilimid. Manufacturing is aligned with European regulatory standards, ensuring supply continuity across member states ([3]).

Asia-Pacific

In the Asia-Pacific region, BMS's regional subsidiaries, such as BMS China and BMS Japan, oversee local licensing and distribution. Authorized distributors include large pharmaceutical distributors such as Takeda and Daiichi Sankyo, which distribute Revilimid through licensed medical channels, maintaining strict compliance with local regulations ([4]).

Additional Suppliers and Contract Manufacturers

Aside from BMS's direct manufacturing, several Contract Manufacturing Organizations (CMOs) supply active pharmaceutical ingredients (APIs) and finished formulations under strict licensing agreements. Notable CMOs include:

• CordenPharma – Specializes in chemical synthesis of lenalidomide APIs. CordenPharma supplies API batches under BMS’s specifications, ensuring high purity standards ([5]).

• Evonik Industries – Provides manufacturing support, especially for intermediates involved in the synthesis process, operating under BMS’s licensing control.

These CMOs are crucial in mitigating supply chain risks by diversifying manufacturing dependencies, especially during disruptions such as COVID-19.

Supply Chain Challenges and Risk Management

Revilimid’s supply chain is complex due to its chemical synthesis, high regulatory standards, and its classification as a controlled substance, which imposes stringent regulations and inventory controls. Any disruption—manufacturing delays, regulatory changes, or geopolitical issues—can impact availability.

BMS proactively manages these risks by maintaining multiple manufacturing sites, deploying strategic stockpiles, and engaging in regional supply agreements with licensed distributors. Serialization initiatives further bolster supply integrity, helping prevent counterfeit distribution and assuring medicinal authenticity ([6]).

Licensing and Patents

Reivelmente’s proprietary formulation and synthesis are protected by patents, granting exclusivity rights to BMS. These patents influence suppliers, as only licensed manufacturers under BMS’s intellectual property rights can produce or distribute the drug legally. Licensing agreements often stipulate strict compliance with manufacturing standards, which networks of authorized suppliers uphold.

Emerging Suppliers and Biosimilar Competition

While BMS maintains monopoly control via patents, emerging biosimilars and generics are under development. Companies such as Dr. Reddy’s Laboratories, Natco Pharma, and Mylan are conducting trials for lenalidomide biosimilars, which could alter the supplier landscape upon regulatory approval ([7]). These entrants may establish partnerships or licensing deals with regional manufacturers, further diversifying supply sources.

Regulatory Compliance and Ethical Sourcing

Suppliers must adhere to global standards—GMP, GDP (Good Distribution Practice), and ICH guidelines. Ethical sourcing is also critical, especially considering the drug’s teratogenicity, requiring suppliers to enforce strict quality assurance, traceability, and risk mitigation protocols.

Conclusion

The supply chain for Revilimid is predominantly controlled by Bristol-Myers Squibb, which maintains strategic manufacturing and distribution partnerships across the globe. While the company’s proprietary manufacturing processes and licensing framework ensure high-quality supply, geopolitical, regulatory, or pandemic-related disruptions could pose risks. Diversification of manufacturers through licensed CMOs, regional distributors, and emerging biosimilars represent strategic areas of focus for stakeholders seeking supply stability and competitive procurement.

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Key Takeaways

• Revilimid's supply chain is centrally managed by Bristol-Myers Squibb, with a network of licensed manufacturers, contract manufacturers, and distributors globally.
• Authorized distributors in key markets—U.S., EU, & Asia-Pacific—are equipped with robust licensing and regulatory compliance to ensure safe and reliable drug access.
• Contract Manufacturing Organizations like CordenPharma support API synthesis, critical for maintaining supply continuity amid disruptions.
• The evolving competitive landscape, including biosimilars from Indian and Chinese companies, could reshape the supplier ecosystem.
• Strategic risk management, including multiple sourcing, serialization, and regional distribution agreements, remains essential for supply stability.

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FAQs

1. Who are the primary suppliers of Revilimid globally?
Bristol-Myers Squibb is the exclusive patent holder and primary manufacturer of Revilimid. The supply chain involves licensed Contract Manufacturing Organizations like CordenPharma, regional distributors, and authorized specialty pharmacies responsible for regional distribution.

2. Are there generic or biosimilar versions of Revilimid available?
Currently, no approved generics or biosimilars exist globally, though several companies, including Dr. Reddy’s and Mylan, are conducting development programs. Approval timelines remain uncertain, but biosimilar competition could alter future supplier dynamics.

3. How does the supply chain ensure the authenticity of Revilimid?
Serialization, track-and-trace systems, and strict regulatory compliance uphold the drug’s integrity, minimizing counterfeit risks. BMS’s robust distribution controls limit supply to authorized channels.

4. What role do contract manufacturers play in Revilimid’s supply?
CMOs like CordenPharma synthesize APIs under BMS’s specifications, enhancing manufacturing capacity and supply resilience, especially during regional disruptions or capacity constraints.

5. How might geopolitical issues impact Revilimid’s supply chain?
Trade restrictions, export bans, or regional conflicts could disrupt manufacturing or distribution channels. BMS’s global manufacturing footprint and diversified licensing agreements mitigate such risks.

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References

1. Bristol-Myers Squibb. "Revlimid (lenalidomide) Prescribing Information." 2022.
2. U.S. Food and Drug Administration (FDA). "Drug Supply Chain Security Act Implementation." 2021.
3. European Medicines Agency (EMA). "Revlimid (lenalidomide) Authorisation Details." 2022.
4. BMS Asia-Pacific Regional Operations. "Supply Chain Overview." 2022.
5. CordenPharma. "API Manufacturing Capabilities." 2022.
6. PharmExec. "Supply Chain Challenges in Oncology Drugs." 2021.
7. PharmaIQ. "Biosimilars in Hematology: Market Outlook." 2022.