Suppliers and packagers for generic pharmaceutical drug: ITRACONAZOLE

ITRACONAZOLE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alembic	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	206741	ANDA	Alembic Pharmaceuticals Limited	46708-204-04	28 CAPSULE in 1 CARTON (46708-204-04)	2016-12-16
Alembic	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	206741	ANDA	Alembic Pharmaceuticals Limited	46708-204-10	100 CAPSULE in 1 CARTON (46708-204-10)	2016-12-16
Alembic	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	206741	ANDA	Alembic Pharmaceuticals Limited	46708-204-30	30 CAPSULE in 1 BOTTLE (46708-204-30)	2016-12-16
Alembic	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	206741	ANDA	Alembic Pharmaceuticals Limited	46708-204-71	500 CAPSULE in 1 BOTTLE (46708-204-71)	2016-12-16
Alembic	ITRACONAZOLE	itraconazole	CAPSULE;ORAL	206741	ANDA	Alembic Pharmaceuticals Limited	46708-204-90	90 CAPSULE in 1 BOTTLE (46708-204-90)	2016-12-16

Suppliers for the Pharmaceutical Drug: Itraconazole

Last updated: July 30, 2025

Introduction

Itraconazole is a broad-spectrum triazole antifungal agent primarily used to treat fungal infections such as onychomycosis, blastomycosis, histoplasmosis, and aspergillosis. Its importance in clinical practice necessitates a reliable supply chain comprising various suppliers and manufacturers across the globe. This report delineates the key suppliers for itraconazole, examining their market presence, manufacturing capacities, regulatory compliance, and strategic positioning in the global pharmaceutical supply chain.

Global Overview of Itraconazole Suppliers

The supply of itraconazole is concentrated among a handful of pharmaceutical giants and contract manufacturing organizations (CMOs), operating across North America, Europe, Asia, and emerging markets. These entities demonstrate significant capacity for bulk synthesis, quality control, and distribution, ensuring compliance with international regulatory standards such as those outlined by the FDA, EMA, and WHO.

Major Pharmaceutical Manufacturers of Itraconazole

1. Janssen Pharmaceuticals / Johnson & Johnson

Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, is one of the pivotal manufacturers and distributors of itraconazole. Their product, commercially branded as Sporanox, is available globally through various pharmaceutical channels. Janssen maintains integrated manufacturing facilities in the United States and Europe, emphasizing quality control and regulatory compliance. Their extensive distribution network ensures consistent supply to North America, Europe, and select developing countries.

2. Glenmark Pharmaceuticals

Glenmark, an Indian generic pharmaceutical company, produces generic formulations of itraconazole, targeting both domestic and international markets. Their facilities in India are WHO-GMP compliant, enabling the export of high-quality generics to regions with stringent regulatory requirements. Glenmark's strategic alliances with international distributors bolster their reach, especially in Asia, Latin America, and Africa.

3. Torrent Pharmaceuticals

Another key Indian producer, Torrent Pharmaceuticals, manufactures itraconazole for both domestic use and export. Their manufacturing plants are compliant with global standards, and the company has expanded its capacity to meet rising demand, especially amidst the COVID-19 pandemic, which has heightened antifungal needs.

4. Mylan (now part of Viatris)

Mylan operated as a prominent generic drug producer offering itraconazole formulations across multiple markets. Post-merger with Pfizer's Upjohn division, Viatris continues to develop and distribute generic antifungals, including itraconazole, with manufacturing sites in India, Europe, and the US.

5. Lek Pharmaceuticals / Sandoz (Novartis)

Sandoz, the generics division of Novartis, produces itraconazole formulations marketed in various regions. Their manufacturing facilities adhere to high standards, focusing on quality assurance for both branded and generic markets.

Contract Manufacturing Organizations (CMOs) and Supply Chain Dynamics

In addition to branded pharmaceutical companies, many supply chains rely on CMOs for active pharmaceutical ingredient (API) production. Notably:

• Famar (Greece): Specializes in API synthesis, including itraconazole.
• Hetero Labs (India): Offers both API synthesis and formulation services.
• Novasep (France): Provides advanced chemical synthesis services for complex APIs.

These CMOs often serve multiple pharmaceutical companies, facilitating the global supply of itraconazole while maintaining adherence to Good Manufacturing Practices (GMP).

Key Regions and Market Trends

• India: India is a significant hub for generic antifungal APIs and formulations, driven by high manufacturing capacities, cost advantages, and a large domestic market. Indian companies such as Glenmark, Torrent, Hetero, and Cipla dominate this segment.

• China: Growing API manufacturing capacity, with companies like Zhejiang Huahai Pharmaceutical, supplies raw materials and intermediates for itraconazole synthesis. Chinese APIs often meet international standards, supporting global supply chains.

• EU and North America: Suppliers like Sandoz and Janssen maintain manufacturing sites compliant with stringent quality standards, focusing on branded formulations and high-margin products.

• Emerging Markets: Increasing local production aims to improve access to antifungal treatments in Africa, Southeast Asia, and Latin America, often through partnerships between regional manufacturers and global suppliers.

Regulatory and Quality Considerations

The quality and regulatory status of suppliers significantly influence supply stability. Suppliers must hold valid Good Manufacturing Practice (GMP) certifications from recognized authorities such as the FDA, EMA, or WHO prequalification. Verification of these certifications is critical for risk mitigation, especially amid supply shortages or quality recalls.

Furthermore, validated supply chains with dual sourcing strategies help prevent disruptions, especially given the global impact of events like pandemics, geopolitical tensions, and raw material shortages.

Supply Chain Challenges and Opportunities

• Challenges:

  • Raw Material Shortages: Procurement of high-purity intermediates for itraconazole synthesis can face disruptions, impacting production volumes.
  • Regulatory Barriers: Variations in regulatory approvals across countries can delay market access.
  • Quality Assurance: The proliferation of low-cost producers raises concerns about quality consistency of APIs and finished products.

• Opportunities:

  • Strategic Diversification: Manufacturers diversifying sourcing across regions reduce dependency on single points of failure.
  • Advanced Synthesis Technologies: Innovation in synthesis processes can improve yields, reduce costs, and minimize environmental impact.
  • Collaborations: Partnerships between leading pharmaceutical firms and CMOs can enhance production capacity and accelerate market access.

Conclusion

The supply chain for itraconazole is underpinned by a combination of multinational pharmaceutical companies, generic manufacturers, and specialized CMOs. Notably, Indian companies like Glenmark and Torrent, European firms such as Sandoz/NOVARTIS, and US-based Janssen distribute the drug globally. Ensuring regulatory compliance, quality assurance, and supply diversification remain fundamental to maintaining a robust supply chain.

As demand for antifungal medications persists and expands, especially in emerging markets, these suppliers' strategic positioning and capacity will be critical to meeting global health needs.

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Key Takeaways

• Dominant Suppliers: Janssen/J&J, Glenmark, Torrent, Mylan/Viatris, Sandoz are leading providers of itraconazole globally.
• Manufacturing Hubs: India, China, and Europe serve as key manufacturing centers for API synthesis and formulation.
• Regulatory Compliance: Suppliers must maintain GMP certifications to ensure quality and facilitate international market entry.
• Supply Chain Management: Multiple sourcing strategies and partnerships with CMOs are essential for mitigating disruptions.
• Market Dynamics: Growing antifungal demand in emerging markets presents opportunities for new entrants and existing suppliers to expand capacity.

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FAQs

1. Who are the main global manufacturers of itraconazole?
Major global manufacturers include Janssen Pharmaceuticals (Johnson & Johnson), Glenmark Pharmaceuticals, Torrent Pharmaceuticals, Mylan (Viatris), and Sandoz (Novartis). These companies produce both branded and generic formulations and APIs.

2. What regions are the primary sources of itraconazole supply?
India and China are key regions for API and generic formulation manufacturing, while Europe and North America host several high-quality, regulatory-compliant suppliers, particularly for branded products.

3. How do regulatory standards influence supplier selection?
Regulatory standards, especially GMP compliance by agencies such as the FDA or EMA, ensure product quality and safety, influencing procurement decisions and supply chain reliability.

4. Are there risks associated with reliance on specific suppliers?
Yes. Dependence on single or limited suppliers can pose risks of shortages, quality issues, or delays, highlighting the importance of diversification and dual sourcing strategies.

5. What future trends could impact itraconazole supply?
Emerging technologies in synthesis, increased demand due to rising fungal infections, and geopolitical or trade shifts could influence supply dynamics. Continuous monitoring of regulatory changes and capacity expansions is vital for stakeholders.

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References

[1] World Health Organization. (2020). Prequalification of Medicines Programme.
[2] Pharmaceutical Technology. (2022). Top Manufacturers of Antifungal APIs and Formulations.
[3] IQVIA. (2021). Global Pharmaceutical Market Reports.
[4] European Medicines Agency. (2022). GMP Inspection Reports.
[5] Global Data. (2022). API Market Insights.