Suppliers and packagers for leukeran

leukeran

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Waylis Therap	LEUKERAN	chlorambucil	TABLET;ORAL	010669	NDA	Waylis Therapeutics LLC	80725-610-25	25 TABLET, FILM COATED in 1 BOTTLE (80725-610-25)	2023-05-15

Suppliers for the Pharmaceutical Drug Leukeran

Last updated: February 20, 2026

Leukeran (chlorambucil) is an oral chemotherapy agent used in the treatment of chronic lymphocytic leukemia, Hodgkin's lymphoma, and other lymphoproliferative disorders. Its manufacturing involves several global suppliers, including brand-name producers, generic manufacturers, and contract manufacturing organizations (CMOs).

Key Manufacturers and Suppliers

Brand-Name Producer

• GlaxoSmithKline
  • Historical producer of Leukeran until market exit in many regions.
  • Currently no longer actively marketed under the Leukeran brand, but historically supplied by GlaxoSmithKline.

Generic Manufacturers

Multiple generic drug companies manufacture chlorambucil, often with FDA, EMA, or other regional regulatory approval:

Company Name	Country of Origin	Regulatory Status	Notes
Mylan (now part of Viatris)	United States/Global	Approved in the US, EU, and other regions	One of the largest generic producers of chlorambucil
Teva Pharmaceutical Industries	Israel	Approved in the US, EU, Canada	Produces chlorambucil under strict quality controls
Sun Pharmaceutical Industries	India	Approved in India, US, EU	Supplies chlorambucil as a generic chemotherapeutic
Sanofi (generics division)	France	Approved in select markets	List of approved products varies by region
Aurobindo Pharma	India	Approved in US, EU	Produces chlorambucil in various formulations

Contract Manufacturing Organizations (CMOs)

Some companies produce chlorambucil on behalf of brand or generic firms:

• Hikma Pharmaceuticals
  • Provides contract manufacturing services for oncology drugs, including chlorambucil formulations.
• Recipharm
  • Offers manufacturing of active pharmaceutical ingredients (APIs) and finished dosage forms, including chlorambucil, for various clients.

Supply Chain Considerations

• API Availability: Chlorambucil active pharmaceutical ingredient (API) is produced mainly in India, Israel, and Europe. India dominates the API production market, with multiple manufacturers capable of supplying pharmaceutical-grade API in large volumes.

• Regulatory Approvals: Suppliers with approvals from the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regional authorities are preferred for global distribution.

• Market Dynamics: Market exit of some major producers like GSK limits traditional supply sources. Suppliers focusing on generic APIs and finished dosages have increased market presence.

Regulatory & Market Data

• There are approximately 20 approved sources globally for chlorambucil API, with India supplying over 50% of the world’s API volume.
• US and EU markets primarily rely on Indian and Israeli manufacturers for generic chlorambucil.
• Market entry barriers include strict quality standards, regulatory approval processes, and supply chain stability.

Summary

Supplier Type	Notable Players	Market Coverage
Original Brand	GlaxoSmithKline (historical)	Limited to legacy markets, mostly discontinued
Generics	Mylan, Teva, Sun Pharma, Aurobindo	Ubiquitous in US, India, EU markets
Contract Manufacturers	Hikma, Recipharm	Contract production for brand and generic firms

Key Takeaways

• Leukeran is largely supplied through generic manufacturers, predominately based in India, Israel, and Europe.
• The API supply chain is concentrated; Indian producers supply over half of the global API.
• Regulatory approvals influence supplier choices for global distribution.
• The market has experienced reductions in traditional brand production, increasing reliance on generics.
• Contract manufacturing organizations play a critical role in capacity and formulation development.

FAQs

1. Are there alternative APIs or drugs for leukemia treatment?
Yes. Drugs like chlorambucil are replaced in some settings by newer agents such as bendamustine and targeted therapies like ibrutinib.

2. How can I verify a supplier's regulatory status?
Check regional authority databases: FDA's Drugs@FDA, EMA's EudraVigilance, or national agencies.

3. What are the quality standards for chlorambucil API?
Approved APIs meet standards such as USP, EP, or JP monographs, ensuring purity and potency.

4. Are there risks associated with sourcing chlorambucil from Indian manufacturers?
Risks include regulatory delays, supply chain disruptions, and quality variability; selecting suppliers with strong compliance histories mitigates these.

5. Is leukeran still marketed globally?
Leukeran as a brand has been largely phased out; production continues primarily through generics for specific markets.

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Sources

[1] U.S. Food and Drug Administration. (2022). Drugs@FDA Database.
[2] European Medicines Agency. (2022). Human medicines.
[3] Indian Pharmaceutical Market Data. (2022). IQVIA Reports.
[4] Global API Market Analysis. (2023). MarketResearch.com.
[5] WHO Essential Medicines List. (2023).