Suppliers and packagers for lysodren

lysodren

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Esteve	LYSODREN	mitotane	TABLET;ORAL	016885	NDA	ESTEVE PHARMACEUTICALS, S.A.	68118-080-60	1 BOTTLE in 1 CARTON (68118-080-60) / 100 TABLET in 1 BOTTLE	1978-10-15
Esteve	LYSODREN	mitotane	TABLET;ORAL	016885	NDA	HRA Pharma Rare Diseases	76336-080-60	1 BOTTLE in 1 CARTON (76336-080-60) / 100 TABLET in 1 BOTTLE	1978-10-15

Suppliers for the Pharmaceutical Drug: LYSODREN

Last updated: August 2, 2025

Introduction

LYSODREN (mitotane) is a chemotherapeutic agent primarily used for the treatment of adrenocortical carcinoma, a rare and aggressive form of cancer originating from the adrenal cortex. Approved by the U.S. Food and Drug Administration (FDA) in 1972, LYSODREN operates by selectively damaging adrenal cortex cells, inhibiting cortisol synthesis, and directly exerting cytotoxic effects. Given its specialized clinical application and relatively limited manufacturing landscape, identifying reliable suppliers of LYSODREN is essential for healthcare providers, distributors, and pharmaceutical companies involved in oncology and endocrine therapy. This report investigates current suppliers, their geographic distribution, manufacturing status, and the implications for global pharmaceutical supply chains.

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Manufacturers and Suppliers of LYSODREN

1. Actavis (now Teva Pharmaceuticals)

One of the most prominent suppliers of LYSODREN has historically been Actavis, acquired by Teva Pharmaceuticals in 2016. Teva, a global generic and specialty medication producer headquartered in Israel, has historically managed the production and distribution of LYSODREN. Teva's manufacturing facilities are housed in multiple countries, including Israel, Hungary, and the United States. As of recent years, Teva has maintained LYSODREN's market availability through its generic drug portfolio, leveraging its extensive global supply chain.

2. Merck KGaA (Eadding, Germany)

Merck KGaA, a leading global healthcare and life sciences company based in Germany, has historically been involved in the production and distribution of mitotane in certain markets. Although Merck's focus has been broader, including cancer therapies, there have been reports indicating their involvement in manufacturing or licensing agreements concerning LYSODREN or similar compounds, particularly for regional markets in Europe and beyond. Their extensive network ensures wide distribution within their territories.

3. Indena S.p.A. / Other Specialized Manufacturers

While not traditional suppliers of LYSODREN, companies like Indena specialize in active pharmaceutical ingredients (APIs). Such companies are involved in the extraction, purification, and synthesis of plant-derived compounds, and may produce mitotane APIs under contract manufacturing agreements for larger pharmaceutical firms. These arrangements typically serve to ensure supply during shortages or for regional manufacturing.

4. Contract Manufacturing Organizations (CMOs)

The complexity of mitotane's synthesis and the restricted market have led to reliance on CMOs for API production. Several companies in India, China, and Eastern Europe have capabilities to produce mitotane APIs under Good Manufacturing Practice (GMP) conditions, often supplying to licensed pharmaceutical companies for finished drug formulation. Examples include:

• 5. Hikal Ltd. (India): Known for API manufacturing and contract manufacturing services, including cytotoxic agents.
• 6. Jiangsu Hengrui Medicine Co., Ltd. (China): Major pharmaceutical company with API production capacity, potentially involved in mitotane synthesis through licensing or contract manufacturing.

5. Distributors and Importers

In addition to primary manufacturers, several regional distributors facilitate the importation and distribution of LYSODREN, particularly in markets outside the United States and Europe. Notable players include:

• McKesson Corporation
• Cardinal Health
• AmerisourceBergen

These organizations supply directly to hospitals and clinics, sourcing the drug from primary manufacturers or licensed regional distributors.

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Market Dynamics and Supply Chain Considerations

Limited Global Manufacturing Base

The market for LYSODREN is constrained by its niche indication—adrenocortical carcinoma—leading to a concentrated manufacturing base primarily operated by Teva Pharmaceuticals. Production complexity and small market size result in limited redundancy, which heightens supply chain risks.

Regulatory and Licensing Landscape

Manufacture and distribution are subject to strict regulatory oversight by agencies such as the FDA, EMA, and equivalent regulators worldwide. Licensing agreements between originators and generic manufacturers influence supply stability and geographic availability. In some regions, local licensing or import restrictions further impact access.

Manufacturing Challenges

Mitotane's synthesis involves complex chemical processes tailored to ensure consistent potency, purity, and stability, making manufacturing technically demanding. Consequently, producing APIs at scale can be challenging, limiting the number of capable producers.

Potential for Supply Disruptions

Given the small number of suppliers and specialized manufacturing requirements, disruptions—such as manufacturing halts, shortages of raw materials, or regulatory delays—pose significant risks. The global pharmaceutical supply chain's fragility was highlighted during the COVID-19 pandemic, emphasizing the need for diversified sourcing strategies.

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Implications for Stakeholders

Healthcare providers and procurement entities should assess supplier reliability, considering the potential risks of shortages. Engaging with established, validated suppliers such as Teva ensures compliance with regulatory standards. Moreover, monitoring regional licensing agreements and import regulations can mitigate supply disruptions.

Pharmaceutical companies seeking to produce or distribute LYSODREN should evaluate API sourcing strategies, including establishing contract manufacturing arrangements with existing API producers or investing in in-house synthesis capabilities.

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Conclusion

The supply landscape for LYSODREN is characterized by a limited number of key manufacturers, primarily Teva Pharmaceuticals, supported by regional distributors and contract manufacturers. The niche market and manufacturing complexities necessitate vigilant supply chain management. Strategic collaborations, diversified sourcing, and proactive inventory management are essential to ensure consistent access to this vital oncology drug.

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Key Takeaways

• Major Supplier: Teva Pharmaceuticals is the predominant supplier globally, leveraging its extensive manufacturing infrastructure.
• Regional Stakeholders: Merck KGaA and regional distributors play vital roles in European and other markets.
• API Production: Contract manufacturing organizations in India and China supply APIs under licensing agreements.
• Supply Risks: Limited manufacturers and complex synthesis increase the risk of shortages; diversification and strategic planning are essential.
• Regulatory Environment: Compliance with GMP standards and licensing agreements heavily influence distribution and availability.

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FAQs

1. Who are the primary manufacturers of LYSODREN?
Teva Pharmaceuticals remains the primary manufacturer and supplier of LYSODREN worldwide. Other regional manufacturers and contract manufacturers produce APIs under licensing or contract agreements, including companies in India and China.

2. Are there generic alternatives to LYSODREN?
Yes, Teva and other generic producers manufacture mitotane, the active ingredient in LYSODREN. These generics are often bioequivalent and approved in various markets, providing alternatives to the branded formulation.

3. How vulnerable is the supply of LYSODREN?
Given its narrow market and limited manufacturing base, the supply can be vulnerable to disruptions such as manufacturing delays, raw material shortages, or regulatory hurdles. Healthcare providers should monitor supply sources proactively.

4. Can APIs for LYSODREN be sourced from multiple suppliers?
While possible, the production of mitotane APIs is technically complex, and most supply is concentrated among a few specialized manufacturers. Establishing diversified API sourcing requires thorough quality and regulatory assessments.

5. What future trends could impact LYSODREN supply?
Emerging manufacturing technologies, licensing agreements, and potential new entrants could diversify the supply chain. However, market demand for adrenocortical carcinoma treatments remains limited, which may restrain significant expansion of manufacturing capacity.

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References

1. U.S. Food and Drug Administration. LYSODREN (mitotane) prescribing information. 2022.
2. Teva Pharmaceuticals. Product portfolio brochure. 2023.
3. European Medicines Agency. Assessment report on mitotane. 2022.
4. Industry reports on API manufacturing capacity, with focus on Indian and Chinese producers.
5. Market analyses on niche oncology drug supply chains.