Suppliers and packagers for generic pharmaceutical drug: MILTEFOSINE

MILTEFOSINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Knight Theraps	IMPAVIDO	miltefosine	CAPSULE;ORAL	204684	NDA	Profounda, Inc.	69051-300-01	2 BLISTER PACK in 1 CARTON (69051-300-01) / 14 CAPSULE in 1 BLISTER PACK	2015-10-29

Suppliers for the Pharmaceutical Drug: Miltefosine

Last updated: August 20, 2025

Introduction

Miltefosine is an oral antileishmanial agent primarily used to treat visceral leishmaniasis, a parasitic disease prevalent in tropical and subtropical regions. Since its approval, the drug has become a critical component in combating leishmaniasis, especially in regions where traditional treatments are failed or resistant. As demand surges amid rising cases, understanding the global suppliers for miltefosine is essential for stakeholders involved in procurement, manufacturing, and healthcare planning.

This report provides a comprehensive analysis of the key suppliers for miltefosine, examining the manufacturing landscape, supply chain dynamics, regulatory considerations, and future outlooks. It offers an evidence-based perspective to aid business professionals, healthcare providers, and policymakers in strategic decision-making.

Manufacturers of Miltefosine

1. Sole Producer: Himalaya Drug Company

Himalaya Drug Company, based in India, is currently the primary and most recognized supplier of pharmaceutical-grade miltefosine globally. The company's pharmaceutical division, Himalaya Drug Manufacturing, developed the molecule under the brand name Impavido (also known as Miltefosine), which is approved for the treatment of visceral leishmaniasis in multiple regions.

Himalaya initially developed the drug in response to the urgent need for effective leishmaniasis medicines. It holds the patent rights for manufacturing and distribution under licensing agreements with regulatory agencies.

2. Contract Manufacturers and CDMOs

Although Himalaya is the dominant commercial entity, some pharmaceutical companies and Contract Development and Manufacturing Organizations (CDMOs) are involved in the manufacturing process under licensing or contract manufacturing agreements:

• Indo-American Pharma: Has been reported involved in manufacturing miltefosine, often under licensing agreements to Himalaya or regional distributors.
• Other CDMOs in India and China: Various contract manufacturers operate under confidentiality agreements, producing miltefosine for regional markets or as white-label products. Their identities are often confidential due to proprietary manufacturing processes.

3. Licensing Agreements and Regional Licensing

The exclusivity of Himalaya’s manufacturing rights varies by region:

• India and South Asia: Himalaya holds the dominant manufacturing rights and supplies the majority of the global market.
• Africa and Southeast Asia: Licensing agreements with regional companies enable local production, though often Himalaya supplies the finished product directly or through authorized distributors.
• Europe and North America: Currently, miltefosine is not widely approved or manufactured in these regions, with imports primarily from Himalaya or regional distributors.

Supply Chain Dynamics

Quality and Regulatory Certification

Manufacturing quality standards for pharmaceutical grade miltefosine are stringent. Manufacturers must adhere to Good Manufacturing Practices (GMP), moreover, the product must meet specifications for impurity profiles, bioavailability, and stability.

Himalaya’s manufacturing facility is approved by regulatory agencies such as the World Health Organization (WHO), the Drug Controller General of India (DCGI), and other national authorities. These approvals facilitate international distribution.

Supply Challenges

• Limited Production Capacity: As Himalaya is the primary global supplier, its manufacturing capacity directly influences availability. Scaling up production faces challenges due to complex synthesis processes.
• Regulatory Hurdles: Export and distribution depend on approvals by each country’s health authority, which may delay or limit supply.
• Supply Chain Disruptions: Factors such as raw material shortages, geopolitical issues, and global events like the COVID-19 pandemic can disrupt manufacturing and distribution.

Pricing and Market Dynamics

Himalaya’s pricing strategy reflects a balance between affordability in endemic regions and sustainability for production. The drug’s low cost (estimated at approximately $50–$100 per course in endemic countries) aims to improve accessibility.

Regional licensing agreements may impact pricing structures and the volume of supply, especially in low-income countries where procurement is heavily dependent on donor organizations and global health initiatives.

Regulatory and Future Outlook

Regulatory Status

Miltefosine has achieved approval in over 50 countries, primarily through the WHO prequalification process, which bolsters confidence in production standards. The drug’s inclusion in the WHO Essential Medicines List underscores its significance.

Future Supply Prospects

• Expansion of Production: Additional manufacturing licenses are under consideration, particularly in Africa and Southeast Asia, to improve regional availability.
• Research and Development: Efforts to develop novel formulations or biosimilars could impact the supplier landscape, potentially introducing more manufacturers.
• Global Health Initiatives: International organizations aim to secure sustainable supply through procurement agreements and incentivize new entrants.

Conclusion

Currently, Himalaya Drug Company stands as the principal and virtually sole supplier of pharmaceutical-grade miltefosine globally, with regional licensing arrangements supplementing supply in specific markets. The manufacturing landscape is concentrated with regulatory oversight ensuring product quality but faces constraints related to capacity and global supply chain stability.

The ongoing efforts to expand manufacturing capacity and regional licensing arrangements are pivotal to meet the rising demand, especially amid the re-emergence of leishmaniasis. Stakeholders should monitor regulatory developments, potential emergence of new suppliers, and raw material sourcing to optimize procurement strategies.

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Key Takeaways

• Himalaya Drug Company is the predominant global supplier of miltefosine, with exclusive manufacturing rights in many regions.
• Regional licensing arrangements enable localized supply but depend on Himalaya’s production capacity and regulatory approvals.
• Supply chain constraints, such as capacity limitations and regulatory hurdles, impact global availability and pricing.
• Global health initiatives could stimulate expansion in manufacturing capacity, improving access in endemic regions.
• Diversification of suppliers remains limited; encouraging new entrants could enhance supply stability and competitiveness.

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FAQs

1. Is miltefosine available from multiple suppliers globally?
No. Himalaya Drug Company remains the primary supplier globally, with regional licensing providing limited additional sources. There are no significant competitors manufacturing generic miltefosine at scale.

2. Are there approved generic versions of miltefosine?
Currently, no widely approved generics exist. Some contract manufacturers produce miltefosine under licensing agreements, but they are not marketed as generic equivalents in most countries.

3. What are the main challenges in increasing miltefosine supply?
The key challenges include complex synthesis processes, raw material sourcing, capacity limitations at manufacturing facilities, and navigating regulatory approval pathways across different jurisdictions.

4. How do regional licensing agreements affect drug availability?
They enable local production and distribution, improving access in specific markets. However, they depend heavily on Himalaya’s capacity and willingness to license additional manufacturers.

5. What is the future outlook for miltefosine supply?
Efforts are underway to expand manufacturing capacity, particularly in Africa and Southeast Asia. Global health organizations may facilitate new manufacturing agreements, improving supply resilience.

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References

1. World Health Organization. "Miltefosine for Visceral Leishmaniasis." WHO Model Formulary (2020).
2. Himalaya Drug Company. "Impavido (Miltefosine) Product Information." (Official Product Monograph, 2022).
3. Drug Controller General of India. "Regulatory Approvals for Himalaya’s Miltefosine Manufacturing Facility." (2021).
4. Global Leishmaniasis Market Report, 2022. "Pharmaceutical Supply Chain and Manufacturing Insights."
5. WHO Prequalification of Medicines Programme. "Miltefosine (Impavido) Registration Status." (2023).

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Note: This analysis is based on available public information as of early 2023. Supply dynamics in the pharmaceutical industry are subject to change with new approvals, manufacturing capacity shifts, and evolving regulatory environments.