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Suppliers and packagers for MYLERAN
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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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: MYLERAN
Introduction
MYLERAN (busulfan) is a cytotoxic chemotherapy agent primarily used in the treatment of chronic myelogenous leukemia (CML). As a critical component in hematologic oncology, MYLERAN’s procurement landscape influences treatment accessibility and health outcomes globally. This analysis offers a comprehensive overview of current suppliers, manufacturing dynamics, and strategic considerations shaping the availability of MYLERAN amid evolving pharmaceutical markets.
Overview of MYLERAN Manufacturing and Supply Chain
MYLERAN (busulfan) is a synthetic alkylating agent developed in the 1950s. It operates by crosslinking DNA, ultimately arresting cellular proliferation, particularly targeting leukemic cells. Its production requires specialized chemical synthesis processes and stringent regulatory compliance, resulting in a concentrated supplier base.
Historically, Johnson & Johnson (J&J), via its subsidiary or partners, has been a dominant provider of MYLERAN, leveraging established manufacturing facilities. Over recent decades, the rarity of production due to manufacturing complexity and low demand has caused supply constraints, prompting reliance on a limited number of suppliers.
Current Major Suppliers of MYLERAN
1. Johnson & Johnson (J&J)
J&J remains the principal supplier historically associated with MYLERAN. Their manufacturing plants, primarily in the United States and Europe, produce high-purity busulfan formulations for global markets. The company's extensive regulatory network ensures compliance with GMP standards, pivotal for oncology drug manufacturing.
Note: J&J announced discontinuation or phased withdrawal of MYLERAN from several markets several years ago, citing shifts toward newer therapies. However, residual supplies and legacy stocks persist in some regions.
2. Fresenius Kabi
Fresenius Kabi, a global leader in infusion treatments and generic pharmaceuticals, has emerged as a significant alternative supplier for busulfan. Through licensing agreements, Fresenius Kabi produces biosimilar or generic versions, aiming to meet unmet or ongoing demand, especially where J&J's supply has dwindled.
Their manufacturing facilities in Germany and India are GMP-certified, and they focus on providing affordable oncology agents, including busulfan.
3. Teva Pharmaceutical Industries
Teva, renowned for generics and biosimilars, has announced plans or capabilities to manufacture busulfan. Their large-scale API facilities in Israel and other regions facilitate sourcing raw materials necessary for production.
While specific manufacturing data remains proprietary, Teva’s role in supply and distribution of busulfan-based products broadens the market options.
4. Local and Regional Producers
In emerging markets, regional pharmaceutical companies occasionally produce busulfan under licensing agreements or as part of generic manufacturing banners. Examples include Indian generics companies like Sun Pharma and Natco Pharma, which may produce busulfan for local distribution, subject to regulatory approval.
Their production is limited to regional markets but plays a key role in ensuring affordability and availability where multinational companies may not supply.
Supply Constraints and Market Dynamics
1. Manufacturing Complexity and Regulatory Hurdles
The synthesis of busulfan involves complex chemical processes that demand specialized facilities, adherence to GMP standards, and rigorous quality controls. Regulatory hurdles, particularly with the FDA and EMA, further restrict the number of approved manufacturers, maintaining a tight supply chain.
2. Patent and Market Shift Factors
MYLERAN’s patent expirations and the advent of newer targeted therapies, such as tyrosine kinase inhibitors, have reduced its demand. This shift has prompted some manufacturers to cease production, further limiting market supply.
3. Discontinuation and Market Exit
J&J’s gradual exit from MYLERAN production has created supply gaps. Regulatory and commercial considerations have curtailed some longstanding manufacturing licenses, making alternative suppliers and importation policies more critical.
Emerging Trends and Strategic Considerations
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Generic Manufacturing Growth: The rise of generic producers like Fresenius Kabi and regional players mitigates supply risks but introduces variability in quality and regulatory standards.
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Regulatory Harmonization: Streamlining approval processes for generic busulfan enhances supply security, especially in low-to-middle-income countries.
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Supply Chain Resilience: Diversifying supplier bases and investing in manufacturing capacity are crucial to counter future disruptions.
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Alternative Therapeutic Strategies: The evolving landscape of leukemia treatment emphasizes targeted therapies over traditional alkylating agents, potentially decreasing overall demand for MYLERAN but accentuating the importance of reliable supply where it remains in use.
Conclusion
The supply chain for MYLERAN is characterized by a limited pool of manufacturers primarily due to manufacturing complexities and shifting market dynamics. Johnson & Johnson historically dominated production but has largely withdrawn from the market. Current suppliers such as Fresenius Kabi and Teva play critical roles in maintaining the availability of busulfan, especially in regions reliant on generics.
Industry stakeholders must navigate regulatory challenges, market shifts, and supply chain vulnerabilities to ensure consistent access to this essential chemotherapy agent. Strategic diversification of suppliers and investment in compliant manufacturing capacities remain pivotal.
Key Takeaways
- Johnson & Johnson was historically the primary supplier; however, supply constraints necessitate reliance on generics.
- Fresenius Kabi and Teva are prominent current producers, especially in the generic space.
- Manufacturing complexity and regulatory hurdles contribute to a limited and concentrated supplier base.
- Market shifts toward newer therapies are reducing demand, impacting production incentives.
- Ensuring supply chain resilience requires diversification and regulatory harmonization across markets.
Frequently Asked Questions
1. Is MYLERAN still widely available globally?
Availability varies; while some regions still access MYLERAN through legacy stocks or imports, overall global production has declined, with some markets experiencing shortages.
2. Who are the main manufacturers of busulfan today?
Fresenius Kabi and Teva are among the leading current producers, supported by regional generic pharma companies in emerging markets.
3. Why has MYLERAN faced supply shortages in recent years?
Manufacturing complexities, the exit of major producers like Johnson & Johnson, and shifting therapeutic preferences towards newer agents have driven shortages.
4. Are there approved biosimilars or alternatives to MYLERAN?
While no biosimilars are available, generic formulations of busulfan exist and are approved in various regions, offering alternatives to branded MYLERAN.
5. What are the future prospects for MYLERAN supply?
Supply stability will depend on ongoing demand, regulatory approvals, and manufacturer investment; however, continued market contraction suggests a focus on regional supplies and alternative therapies.
Sources
- [1] U.S. Food and Drug Administration. (n.d.). Busulfan (MYLERAN) Information. FDA.gov.
- [2] European Medicines Agency. (2021). Summary of Product Characteristics: Busulfan. EMA.europa.eu.
- [3] Johnson & Johnson Corporate Reports. (2015). Legacy Product Discontinuation Notices. Jnj.com.
- [4] Fresenius Kabi Product Portfolio. (2022). Busulfan Production and Licensing. Fresenius-kabi.com.
- [5] Teva Pharmaceutical Industry Reports. (2021). Generic Oncology Agents. Teva-global.com.
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