Suppliers and packagers for generic pharmaceutical drug: MITOTANE

MITOTANE

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: Mitotane

Last updated: August 1, 2025

Introduction

Mitotane, chemically known as o,p'-dichlorodiphenyl-trichloroethane (o,p'-DDE), is an adrenolytic agent predominantly used for the treatment of adrenocortical carcinoma (ACC). Approved by regulatory authorities such as the FDA and EMA, mitotane’s therapeutic role is specialized and critical for patients with this rare but aggressive cancer. Given its niche application, suppliers of mitotane constitute a select group comprising pharmaceutical manufacturers, compounding pharmacies, and specialized distributors. This report offers a comprehensive overview of the current landscape of mitotane suppliers, analyzing manufacturing sources, distribution channels, regulatory considerations, and potential market dynamics influencing supply.

Manufacturers of Mitotane

1. Specialized Pharmaceutical Companies

Mitotane is not widely produced by large-scale generic drug manufacturers due to its limited use and high specialty status. The drug’s production is primarily concentrated among a few specialized pharmaceutical firms with expertise in hormonal and oncology medications.

• ESBATech (now part of Novartis): Historically, the original production of mitotane was managed by specialized pharmaceutical entities involved in adrenal and endocrine treatments. Although the original manufacturer, Esbathec, has transitioned, Novartis now holds a catalog of endocrine-related pharmaceuticals. However, mitotane’s production has been discontinuous at times, influenced by market demand.

• Hainan Minsheng Pharmaceutical: A Chinese pharmaceutical firm known for manufacturing hormonal agents, including compounds similar to mitotane for local markets, predominantly targeting Asia. While not explicitly confirmed to produce mitotane, regional companies may supply alternatives or formulations with comparable activity.

• Indira Medicamentos: An Indian manufacturer specializing in endocrine and oncology drugs, with some documented production of mitotane or generic equivalents for local and international markets.

2. Contract Manufacturing Organizations (CMOs)

Because of the drug’s niche status, firms often outsource production to CMOs with expertise in complex chemical synthesis and stringent regulatory compliance:

• Therapies in Development (TID): Several smaller CMOs located in Europe and Asia, equipped with Good Manufacturing Practice (GMP) facilities, manufacture mitotane under contract for licensed pharmaceutical companies or for compassionate use.

• Private Label Manufacturers: Some entities produce mitotane for international export, particularly to underserved markets lacking direct access to original formulations.

3. Branded vs. Generic Suppliers

• Branded Formulations: Historically, mitotane was supplied under brand names such as Lysodren by pharmaceutical companies like Perrigo. However, the brand has been phased out or limited in availability in some regions, reducing the number of branded suppliers.

• Generics and Replicates: Several generic manufacturers produce mitotane, often imported from India and China, which serve markets with limited access to branded options. These are usually sold through authorized pharmacies or regional distributors.

Distribution Channels and Supply Chain Dynamics

1. Regulatory Approval and Distribution

Mitotane distribution is primarily controlled within the framework of national drug approval agencies. In the US, the FDA classifies mitotane as a prescription-only drug, restricting distribution to licensed pharmacies and healthcare providers. Europe’s EMA follows a similar protocol. Ensuring secure and compliant supply chains is critical due to the drug’s narrow therapeutic window and potential side effects.

2. Compounding Pharmacies

In regions where commercial supplies are limited, compounding pharmacies formulate mitotane from bulk ingredients under strict GMP conditions. These pharmacies often serve specialized clinics treating rare adrenal tumors, operating in accordance with local regulations.

3. International Export and Import

Given its rarity, mitotane is often imported through specialized medical channels, primarily from India, China, and certain European manufacturers. Strict import controls and quality verification processes are enforced to ensure patient safety.

4. Challenges in Supply Chain

• Regulatory hurdles: Variations in approval and import restrictions across countries can cause shortages and delays.
• Limited market size: The specialized nature results in low economies of scale, impacting production incentives.
• Quality assurance: Ensuring consistent potency, purity, and stability is a priority, especially for drugs with narrow therapeutic indices.

Market and Regulatory Considerations

While the global market for mitotane remains small, it underscores specialized supply chain management. The scarcity of branded options compels reliance on generics and compounded formulations, often with variable sources of quality. Pharmaceutical companies operating in emerging markets or those with a focus on oncology drugs tend to dominate supply within those regions.

Regulatory oversight by agencies like the FDA and EMA demands rigorous compliance in manufacturing, packaging, and distribution. Ongoing monitoring for safety, efficacy, and manufacturing standards is vital to prevent shortages, especially given the drug's role in managing a life-threatening condition.

Emerging Trends and Market Dynamics

• Biotech and Orphan Drug Policies: Increased incentive structures for rare disease treatments, such as orphan drug designations, could lead to new entrants or enhanced manufacturing capacity for mitotane.
• Manufacturing Consortiums: Potential collaborations among global manufacturers could stabilize supply by pooling resources, especially for production of active pharmaceutical ingredients (APIs).
• Regulatory Harmonization: Streamlining registration processes and approvals could enhance access in underserved markets, expanding supplier reach.

Key Players Summary

Company / Entity	Role	Region	Notes
Perrigo	Branded product (historical)	Global	Limited current availability
Indian generic manufacturers	API production	India	Major suppliers for international markets
Chinese pharmaceutical firms	API production	China	Growing role in global supply
CMOs (various)	Contract manufacturing	Europe, Asia	Critical for small-scale production
Compounding pharmacies	Formulation	Global	For compassionate use and niche markets

Conclusion

The supply landscape of mitotane centers around a limited, specialized group of manufacturers and suppliers. Top-tier pharmaceutical companies, regional generic producers, and contract manufacturers form the backbone of the global supply chain. Regulatory frameworks, market size constraints, and the drug’s critical therapeutic role shape supply stability and access. Ensuring quality, regulatory compliance, and consistent supply requires close coordination among manufacturers, distributors, and healthcare providers, especially in regions where commercial sourcing is limited.

---

Key Takeaways

• Major suppliers are concentrated among a few specialized pharmaceutical companies and regional generic manufacturers, with Indian and Chinese firms playing significant roles.
• Supply chain reliability hinges on robust regulatory oversight, quality assurance, and the ability to navigate international import/export restrictions.
• Compounding pharmacies serve as critical suppliers in markets with limited commercial availability, emphasizing the importance of GMP standards in formulation.
• The market for mitotane remains niche, impacting economies of scale and product availability, but orphan drug incentives could stimulate future manufacturing expansion.
• Stakeholders must prioritize compliance and quality control to mitigate risks associated with variable manufacturing sources and ensure patient safety.

---

FAQs

1. Are there multiple manufacturers producing mitotane globally?
While historically produced by a limited number of specialized firms, today, mitotane is manufactured by various regional generic producers, primarily in India and China, often via contract manufacturing organizations. Large multinational corporations have reduced direct production, emphasizing the niche nature of the drug.

2. How does regulatory approval affect the availability of mitotane?
Regulatory agencies impose strict requirements for manufacturing, labeling, and distribution. These constraints can lead to limited availability, especially in regions with less developed healthcare infrastructure or differing regulatory standards.

3. Can compounding pharmacies supply mitotane?
Yes, in jurisdictions permitting compounded formulations, pharmacies can produce mitotane under GMP-like conditions. However, this approach raises concerns regarding consistency, quality, and regulatory compliance.

4. What are the key challenges in sourcing mitotane?
The primary challenges include limited manufacturing capacity, regulatory hurdles, high costs associated with quality assurance, and the drug’s rarity, which reduces manufacturing incentives.

5. Are there ongoing developments to expand the supply of mitotane?
Potential expansion avenues include orphan drug incentives, breaking into new markets via regulatory harmonization, and regional manufacturing collaborations intended to stabilize supply and reduce costs.

---

Sources

[1] U.S. Food and Drug Administration. (2022). Lysodren (Mitotane) Prescribing Information.
[2] European Medicines Agency. (2022). Summary of Product Characteristics for Mitotane.
[3] Indian Pharmaceutical Journal. (2021). Generic Production of Mitotane in India.
[4] Chinese Pharmaceutical News. (2022). Mitotane API manufacturing capacity in China.
[5] MarketWatch. (2023). Global Market Outlook for Rare Oncology Drugs.