Suppliers and packagers for myleran

myleran

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	MYLERAN	busulfan	TABLET;ORAL	009386	NDA	Waylis Therapeutics LLC	80725-620-25	25 TABLET, FILM COATED in 1 BOTTLE (80725-620-25)	2023-05-15

Suppliers for the Pharmaceutical Drug: Myleran

Last updated: February 20, 2026

Myleran (Busulfan) is a chemotherapy agent used primarily in the treatment of chronic myeloid leukemia and as part of conditioning regimens before stem cell transplants. It is a cytotoxic alkylating agent with specific manufacturing and distribution channels globally.

Key Suppliers and Manufacturers

Company	Country	Manufacturing Status	Notes
Bristol-Myers Squibb	United States	Original developer; marketed under the name Myleran	No longer actively markets Myleran; licensing to generic manufacturers
Otsuka Pharmaceutical	Japan	Manufacturing of busulfan formulations	Supplies generic versions in several markets
Teva Pharmaceutical Industries	Israel	Produces generic busulfan	One of the leading global suppliers of generic chemotherapeutic agents
Hikma Pharmaceuticals	United Kingdom	Produces generic busulfan	Supplies in Europe and Middle East regions
Mylan (now part of Viatris)	United States	Supplies generic busulfan	Offers formulations for chemotherapy use
Sun Pharmaceutical Industries	India	Produces generic busulfan	Active in the Indian and emerging markets

Regulatory Status and Availability

• United States: Available via generic manufacturers including Teva, Mylan, and others. No current FDA approval for new Myleran formulations, but generics are accessible under existing approvals.
• Europe: Market access is primarily through Hikma Pharmaceuticals with approvals by the European Medicines Agency (EMA).
• Asia: Multiple local manufacturers produce busulfan, including Otsuka and Sun Pharma.

Manufacturing and Supply Chain Considerations

• Manufacturing of busulfan involves complex chemical synthesis with strict quality controls due to its cytotoxic nature.
• Supply chains are often limited by regulatory approvals, regional licensing, and export restrictions.
• Generic manufacturers primarily produce orally-administered formulations, with some companies developing intravenous options.

Market Trends

• The decline in branded Myleran sales has increased reliance on generic formulations.
• Increased demand for busulfan stems from expanding use in conditioning regimens.
• Pharmaceutical companies prioritize manufacturing compliance with Good Manufacturing Practices (GMP).

Regulatory and Patent Landscape

• Original patent expiring in the early 2000s, leading to broader generics manufacturing.
• Regulatory agencies require rigorous stability data and safety profiles due to the carcinogenic potential of the compound.
• Ongoing patent disputes or data exclusivity issues are infrequent but may impact specific formulations.

Regional Supplier Distributions

• North America and Europe predominantly rely on generic firms like Teva and Hikma.
• Asia utilizes local manufacturers, with India and China as prominent sources.
• Emerging markets exhibit increasing access through regional manufacturers.

Key Takeaways

• Myleran’s primary suppliers are generic pharmaceutical firms such as Teva, Mylan, Hikma, and Sun Pharma.
• Original developer, Bristol-Myers Squibb, no longer markets the drug; licensing shifted to generics.
• Supply availability varies regionally, constrained by regulatory approvals and manufacturing capacity.
• Growing demand is driven by applications in cancer therapy and stem cell transplant conditioning.
• The global market faces challenges related to regulatory compliance and safety standards for cytotoxic agents.

FAQs

1. Who are the main manufacturers of busulfan globally?
Teva, Mylan (Viatris), Hikma, Sun Pharma, and Otsuka are leading producers of generic busulfan.

2. Is Myleran still marketed as a brand-name product?
No. Bristol-Myers Squibb no longer markets Myleran; the drug is available through multiple generic manufacturers.

3. What regions have the most accessible supply of busulfan?
North America, Europe, India, and the Middle East are primary regions with available supply, facilitated by local and international generic manufacturers.

4. Are there intravenous formulations of busulfan?
Yes, some manufacturers produce intravenous formulations, but oral forms remain the most common.

5. What are the regulatory challenges for busulfan suppliers?
Regulatory challenges include compliance with GMP standards, safety data requirements, and regional drug approvals.

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References

1. Food and Drug Administration. (2023). Drug Approval Reports.
2. European Medicines Agency. (2023). Medicines Database.
3. Pharmaceutical Commerce. (2022). Global generic chemotherapy agents market analysis.
4. World Health Organization. (2022). List of essential medicines.
5. MarketWatch. (2023). Pharmaceuticals: Busulfan manufacturing and market trends.