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
Accord Hlthcare	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	218872	ANDA	Accord Healthcare Inc.	16729-692-09	28 CAPSULE in 1 BOTTLE (16729-692-09)	2026-04-08
Accord Hlthcare	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	218872	ANDA	Accord Healthcare Inc.	16729-693-09	28 CAPSULE in 1 BOTTLE (16729-693-09)	2026-02-26
Accord Hlthcare	LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	218872	ANDA	Accord Healthcare Inc.	16729-694-09	28 CAPSULE in 1 BOTTLE (16729-694-09)	2026-02-17

LENALIDOMIDE Suppliers: Who Manufactures, Ships, and Supplies the Active Ingredient and Key Dosage Forms

Last updated: May 23, 2026

Lenalidomide supply in commercial markets is dominated by a small set of originator and generic active pharmaceutical ingredient (API) producers plus a larger roster of contract manufacturers (CMOs) and distributors that fill, package, label, and ship capsules under DEA-regulated controls and REMS-linked distribution constraints. The key question for procurement, licensing, or entry planning is whether you need API supply, finished capsules, or both, and whether your target is US-only (FDA/Orange Book + REMS distribution), EU/UK, or broader ex-US routes.

Which companies supply lenalidomide API and finished capsules in the US?

A reliable lenalidomide supply chain splits into three layers:

1. API producers (chemical manufacturing of lenalidomide)
2. Finished-dose manufacturers (capsules, strength-specific)
3. Authorized distributors and channel partners (shipping under controlled distribution rules)

The originator’s commercial capsule supply is tied to Celgene/Bristol Myers Squibb’s legacy ownership and contract manufacturing structure. Generic entrants in the US typically contract for finished dose manufacturing and draw API from approved suppliers, while some vertical integration exists in the broader chemical supply ecosystem.

What to look for in supplier lists (practical procurement filters)

• Whether the supplier is listed as a manufacturer/holder for the approved product label (US FDA prescribing information)
• Whether the supplier makes API under cGMP and supplies to an ANDA or 505(b)(2) filer
• Whether the supplier supports dosage strengths demanded by the market (5 mg, 10 mg, 15 mg, 20 mg, 25 mg in common US regimens)
• Whether the supplier can support controlled substance-like handling expectations and REMS logistics (lenalidomide operates under REMS-style distribution constraints)

Who are the dominant finished-dose manufacturers of lenalidomide capsules?

Finished-dose manufacturing is usually performed by companies named on the US label (manufacturer, sometimes including multiple sites). Generic products then have their own labeled manufacturers per ANDA approvals. The supplier set changes as product portfolios rotate and as ANDA gaps close.

Who are the dominant lenalidomide API producers?

API producers typically include specialized small-molecule intermediates and final API manufacturers with validated processes for chiral, heterocycle-containing synthesis and crystallization. API supply contracts frequently include qualification packages for regulatory filings.

What role do distributors play in lenalidomide sourcing?

Even when API and CMOs are qualified, distribution is constrained by the drug’s US REMS logistics. Authorized distributor networks and pharmacy fulfillment partners are the final control point for shipments.

What suppliers provide lenalidomide capsules for commercial distribution?

For procurement and competitive intelligence, the practical approach is to map:

• ANDA/label holders (who is selling and under whose approved product)
• Manufacturing sites listed on labels
• Wholesale distribution (authorized channel partners that carry REMS-compliant fulfillment)

Which dosage strengths and presentations drive supplier demand?

US practice generally uses lenalidomide capsules across multiple strengths depending on regimen (multiple myeloma, MDS, and combination therapies). Supplier qualification and batch capacity therefore target:

• Capsule manufacturing lines compatible with high-potency handling
• Strength-specific blending, milling, encapsulation, and QC release

How does REMS logistics affect supplier selection?

REMS requirements tighten the permissible distribution channels. That changes vendor evaluation from “any qualified manufacturer can sell” to “only sellers with compliant distribution routes can deliver to endpoints.” For hospitals and specialty pharmacies, this can narrow the set of practical suppliers even when additional CMOs exist.

Which regulatory listings identify lenalidomide suppliers?

In the US, FDA labels and the Orange Book are the fastest way to tie a supplier to an approved product.

How do Orange Book listings map to suppliers?

Orange Book entries typically provide:

• Applicant/holder information
• Strength/formulation
• Patent linkage (which often maps back to product continuity)

But the US label “Manufactured for” and “Manufactured by” sections are what identify the actual capsule manufacturer and sometimes multiple sites.

What about EMA and UK listings?

In Europe and the UK, the marketing authorization holder and manufacturing authorization details provide a comparable mapping, but product-by-product review is needed because manufacturing sites can differ by marketing authorization.

How many qualified lenalidomide suppliers exist for API and finished product?

The supply base is not large in terms of true API manufacturing capability. Finished-dose manufacturing and distribution are broader. For a full count you need a product-level enumeration across:

• US ANDA/505(b)(2) labels
• EU/UK marketing authorizations
• Label manufacturing sites
• API manufacturer disclosures within regulatory dossiers (not always public)

Because the supplier universe changes with ANDA approvals, label changes, and plant transfers, “how many” is best treated as:

• API: limited number of capable producers
• Finished-dose: more sites due to ANDA ecosystems
• Distribution: constrained by REMS-compliant channels

What contract manufacturers (CMOs) make lenalidomide capsules?

CMO involvement is common because capsule manufacturing at scale requires specialized containment, segregation, and validated high-potency processes. CMO roles include:

• Encapsulation and blister/bottle packaging
• Scale-up with validated analytical methods
• Stability programs and supply continuity planning

The definitive list is the set of “manufactured by” entities on marketed labels across originator and generic SKUs.

Which suppliers are relevant to biosimilar-style risk?

Lenalidomide is a small molecule and is not subject to biosimilar pathways. The relevant comparison is generic substitution risk and ANDA manufacturing control risk, which is driven by:

• Process validation quality
• Impurity profiles and specification tightness
• Crystallization and polymorph control (where relevant)
• Ongoing process consistency across sites

That means supplier risk is measured by supply continuity and batch failure history rather than immunogenicity or biologics comparability.

How does lenalidomide supplier choice affect generic entry risk?

Generic entry (ANDA) risk is driven by:

• Whether the ANDA holder can secure reliable finished-dose manufacturing capacity
• Whether the API supply chain can support consistent impurity and particle-size distributions
• Whether packaging and labeling workflows align with REMS and distribution constraints

If an API supplier or CMO has capacity constraints or quality excursions, generic rollout timelines slip even after ANDA approval.

What supplier consolidation risks exist for lenalidomide?

Lenalidomide supply is vulnerable to:

• Single-site dependence for a given strength
• Limited qualified API sources for high-spec material
• Regulatory actions against manufacturing sites (warning letters, import holds)
• REMS logistic bottlenecks that delay availability even when supply exists

These risks are managed through dual-sourcing, tech transfer to backup CMOs, and safety stock at specialty wholesalers.

Key Takeaways

• Lenalidomide supply is structured across API producers, capsule manufacturers, and REMS-compliant distribution channels.
• The practical supplier set for procurement is determined by label-identified manufacturing sites plus authorized distribution.
• Generic availability depends on finished-dose manufacturing capacity and API consistency, not only on patent status.
• Supplier consolidation risk is real because API manufacturing capability is concentrated and REMS/logistics can narrow deliverable channels.

FAQs

1) What is the fastest way to identify the manufacturer of a specific lenalidomide capsule label?
Check the “Manufactured by/Manufactured for” sections in the US prescribing information for the exact strength and NDC.

2) Can the same lenalidomide API supplier support multiple ANDA capsule brands?
Yes, if the API is qualified for the ANDA and the finished-dose manufacturer’s validated process and impurity specifications align.

3) How do REMS constraints change who can sell lenalidomide to patients?
They restrict distribution to REMS-compliant channels and endpoints, regardless of whether the underlying API/CMO is qualified.

4) What supplier signals matter most for continuity of lenalidomide supply?
Dual-sourced API/packaging materials, multiple finished-dose manufacturing sites, and stable batch release performance.

5) Are there biosimilar manufacturers for lenalidomide?
No. Lenalidomide is a small molecule; competitive supply is through generics/authorized alternatives, not biosimilars.

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References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drug Approval Package and Labeling for lenalidomide-containing products (product-specific prescribing information). https://www.accessdata.fda.gov/scripts/cder/daf/
3. FDA. Risk Evaluation and Mitigation Strategy (REMS) information for lenalidomide-containing products (REMS overview and related documentation). https://www.accessdata.fda.gov/scripts/cder/rems/