Suppliers and packagers for generic pharmaceutical drug: FLUCONAZOLE

FLUCONAZOLE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	DIFLUCAN	fluconazole	FOR SUSPENSION;ORAL	020090	NDA	Roerig	0049-3450-19	1 BOTTLE in 1 CARTON (0049-3450-19) / 35 mL in 1 BOTTLE	1993-12-23
Pfizer	DIFLUCAN	fluconazole	FOR SUSPENSION;ORAL	020090	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-5029-1	1 BOTTLE in 1 CARTON (59762-5029-1) / 35 mL in 1 BOTTLE	1993-12-23
Pfizer	DIFLUCAN	fluconazole	FOR SUSPENSION;ORAL	020090	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-5030-1	1 BOTTLE in 1 CARTON (59762-5030-1) / 35 mL in 1 BOTTLE	1993-12-23
Aurobindo Pharma	FLUCONAZOLE	fluconazole	FOR SUSPENSION;ORAL	079150	ANDA	NorthStar Rx LLC	16714-695-01	1 BOTTLE in 1 CARTON (16714-695-01) / 35 mL in 1 BOTTLE	2009-09-18

Suppliers for the Pharmaceutical Drug: Fluconazole

Last updated: July 28, 2025

Introduction

Fluconazole, a triazole antifungal medication, is widely prescribed to treat fungal infections, including candidiasis and cryptococcal meningitis. Its broad therapeutic use has fostered an extensive global supply chain involving multiple manufacturers, distributors, and raw material providers. For pharmaceutical companies, healthcare providers, and stakeholders, understanding the landscape of fluconazole suppliers is critical for ensuring consistent supply, maintaining quality standards, and negotiating procurement.

Global Manufacturing Landscape

The production of fluconazole involves complex synthesis processes requiring high-quality raw materials and stringent manufacturing standards. The primary suppliers are well-established pharmaceutical companies and specialized chemical producers. The supply chain spans regions including North America, Europe, Asia, and emerging markets, each contributing to the global availability of the drug.

Leading Pharmaceutical Manufacturers of Fluconazole

1. Pfizer Inc.

Pfizer stands as a predominant producer of fluconazole with its well-known brand, Diflucan. The company manufactures both the active pharmaceutical ingredient (API) and finished dosage forms, ensuring supply chain integrity. Pfizer’s extensive manufacturing facilities adhere to Good Manufacturing Practices (GMP), meeting stringent quality standards across markets.

2. Bayer AG

Bayer produces fluconazole through its global network of production plants. The company's expertise in antimicrobial drugs, combined with its rigorous quality controls, positions it as a key supplier in Europe and other developed markets.

3. Mylan (now part of Viatris)

Viatris, formed from Mylan and other legacy companies, supplies generic fluconazole formulations worldwide. Its manufacturing footprint spans multiple countries, allowing for cost-effective production and widespread distribution.

4. Sun Pharmaceutical Industries Ltd.

A leading Indian generic pharmaceutical manufacturer, Sun Pharma supplies fluconazole, primarily targeting emerging markets. The company's large-scale manufacturing facilities and focus on affordability support global demand, especially in resource-constrained settings.

5. Cipla Limited

Another significant Indian pharmaceutical firm, Cipla produces both APIs and finished formulations of fluconazole. Its commitment to quality and affordable pricing has expanded access in Asia, Africa, and parts of Latin America.

Specialized Chemical Suppliers and Raw Material Providers

The synthesis of fluconazole depends on high-purity raw materials, including intermediates derived from complex chemical processes. Major chemical companies that supply these raw materials include:

• Dow Chemicals and BASF: Provide basic chemical intermediates used in API synthesis.
• Jubilant Life Sciences: Supplies specialty chemicals and intermediates tailored for antifungal API manufacturing.

The API synthesis often involves producing key intermediates such as 2,4-dichlorobenzyl alcohol, which requires precise chemical manufacturing expertise.

Distribution and Wholesale Suppliers

Major pharmaceutical distributors facilitate the global dissemination of fluconazole:

• McKesson Corporation and AmerisourceBergen in North America.
• Covis Pharmaceuticals and MediNeutra in Europe.
• Regional distributors in Africa, Asia, and Latin America adapt to local regulatory and logistical challenges.

Distributors often work with multiple manufacturers to ensure steady supply, often maintaining buffer stocks to mitigate market shortages.

Regulatory and Quality Considerations

Suppliers must comply with international standards such as the FDA’s cGMP, EMA guidelines, and WHO prequalification standards. The integrity of the supply chain, including raw materials and finished products, hinges on compliance, validation, and quality assurance audits.

Emerging Trends and Challenges

• Market Dynamics: Patent expiries and the rise of generic manufacturers have expanded the supplier base, increasing competition and affordability.
• Supply Chain Disruptions: Global events such as the COVID-19 pandemic exposed vulnerabilities, prompting manufacturers to diversify sources and increase inventory buffers.
• Regulatory Stringency: Countries are tightening import and manufacturing standards, influencing supplier qualification processes.
• Sustainability Considerations: Increasing emphasis on environmentally sustainable manufacturing practices impacts supplier selection and compliance.

Key Players Summary Table

Company	Region	Production Focus	Market Segment
Pfizer Inc.	North America/Global	API and Finished Dosage Forms	Brand and Generics
Bayer AG	Europe	API and Finished Products	Generics
Viatris (Mylan)	Global	Generics, API	Generics
Sun Pharma	India/ Emerging Markets	API and Generics	Generics
Cipla Ltd.	India/Global	API and Finished Dosages	Generics

Conclusion

The fluconazole supply chain involves a diverse network of major pharmaceutical manufacturers, chemical intermediaries, and distributors. Large multinational corporations like Pfizer, Bayer, and Viatris maintain substantial manufacturing capacities, ensuring the availability of both branded and generic formulations. Indian pharmaceutical firms such as Sun Pharma and Cipla serve primarily emerging markets with cost-effective options. Regulatory compliance, supply chain resilience, and quality standards remain paramount, especially amid global disruptions.

Strategic procurement requires due diligence in supplier qualification, adherence to regulatory standards, and continuous monitoring of market dynamics. Diversification of sources and investment in quality assurance will support stable fluconazole supply for healthcare systems worldwide.

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Key Takeaways

• Market Dominance: Pfizer, Bayer, Viatris, Sun Pharma, and Cipla are primary suppliers, with capacity to meet diverse market demands.
• Regulatory Compliance: Maintaining GMP standards and WHO prequalification is crucial in supplier selection.
• Supply Chain Resilience: Diversification of raw material sources and geographic manufacturing reduces risks of shortages.
• Emerging Markets: Indian generics suppliers play a significant role in expanding access in resource-limited regions.
• Sustainability and Quality: Increasing focus on environmentally sustainable manufacturing practices influences supplier evaluation.

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FAQs

1. Who are the leading global manufacturers of fluconazole?
Major global manufacturers include Pfizer, Bayer, Viatris (Mylan), Sun Pharma, and Cipla. These companies produce both APIs and finished dosage forms, ensuring widespread availability.

2. How does regulatory compliance impact fluconazole suppliers?
Regulatory standards such as GMP compliance, WHO prequalification, and country-specific approvals are critical. Suppliers adhering to these standards provide assurance of quality, safety, and efficacy, influencing procurement decisions.

3. What role do chemical intermediates play in fluconazole supply chains?
Chemical intermediates are essential in API synthesis. Reliable sourcing from established chemical suppliers like BASF and Jubilant ensures consistent quality and helps prevent production delays.

4. How has the COVID-19 pandemic affected fluconazole supply?
The pandemic disrupted global supply chains, causing shortages and delays. It highlighted the need for diversified sourcing, inventory buffers, and robust logistics planning.

5. Are Indian pharmaceutical companies significant in the fluconazole market?
Yes, Indian firms like Sun Pharma and Cipla are major suppliers of generic fluconazole, especially in emerging markets, due to their manufacturing scale and affordability.

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Sources:

[1] "Fluconazole Market Analysis," Global Data, 2022.
[2] "WHO Prequalification of Pharmaceuticals," WHO, 2023.
[3] "Pharmaceutical Manufacturing Standards," FDA, 2023.
[4] "Global Supply Chain Disruptions and Impact," IMS Health Report, 2022.
[5] "Indian Pharmaceutical Industry Overview," PharmEx India, 2023.