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
Aurobindo Pharma	FLUCONAZOLE	fluconazole	FOR SUSPENSION;ORAL	079150	ANDA	NorthStar Rx LLC	16714-696-01	1 BOTTLE in 1 CARTON (16714-696-01) / 35 mL in 1 BOTTLE	2009-09-18

Suppliers for the Pharmaceutical Drug: Fluconazole

Last updated: February 19, 2026

Who Are the Main Suppliers of Fluconazole?

Fluconazole, a triazole antifungal commonly used to treat fungal infections, is produced by several pharmaceutical companies. The supply landscape includes global generic manufacturers, branded drug producers, and contract manufacturing organizations (CMOs).

Major Industry Players

Company	Headquarters	Market Role	Notable Products	Manufacturing Capabilities
Pfizer	United States	Branded and generic	Diflucan (brand)	Large-scale production; global distribution
Sandoz (Novartis)	Switzerland	Generics	Fluconazole tablets	Extensive manufacturing facilities in Europe and Asia
Mylan (acquired by Pfizer)	United States	Generics	Fluconazole	Capable of large-volume production
Teva Pharmaceutical Industries	Israel	Generics	Numerous formulations	Extensive worldwide manufacturing network
Sun Pharmaceutical Industries	India	Generics	Fluconazole	Large manufacturing footprint in India and globally
Cipla	India	Generics	Fluconazole	Manufacturing facilities across Asia
Glenmark Pharmaceuticals	India	Generics	Fluconazole	Multiple manufacturing sites worldwide
Dr. Reddy's Laboratories	India	Generics	Fluconazole	Global manufacturing capabilities
Lupin Limited	India	Generics	Fluconazole	Manufacturing plants in India and abroad

Market Overview

• Supply Concentration: The top five manufacturers account for approximately 85% of global fluconazole production capacity.
• Pricing Trends: Generic competition drives prices down, with average retail costs ranging from $0.10 to $1.00 per dose depending on formulation and region.
• Regulatory Approvals: Most manufacturing firms supply to markets registered with agencies including the FDA, EMA, and NMPA.

Manufacturing Trends and Policies

• Generic Expansion: Indian companies like Cipla, Sun Pharma, and Lupin have expanded capacity to meet global demand.
• Quality Standards: Suppliers adhere to International Conference on Harmonisation (ICH) guidelines, with Good Manufacturing Practice (GMP) certifications.
• Supply Chain Risks: Disruptions in raw material sourcing, especially from China and India, impact manufacturing continuity.

Sources of Raw Materials

• Active Pharmaceutical Ingredient (API): Predominantly sourced from China and India.
• Excipients: International suppliers, with a significant share from India and Europe.
• Manufacturing Inputs: Key components for synthesis, including solvents and catalysts, are sourced globally, often from specialized chemical suppliers.

Supply Chain and Procurement Dynamics

Key Considerations for Buyers

• Pricing: Competitive pricing is heavily influenced by generics market competition.
• Quality assurance: Suppliers with GMP certification mitigate regulatory and quality risks.
• Capacity: Large manufacturers with scalable production can meet high-volume demands.
• Geographical Diversification: Using suppliers across different regions reduces supply disruption risks.

Typical Procurement Channels

• Direct Contracts: With major manufacturers for bulk procurement.
• Tendering Processes: Mostly in public healthcare and PBMs operating in high-volume sectors.
• Distribution Networks: Global pharmaceutical distributors including McKesson, Cardinal Health, and regional firms.

Regulatory and Market Access

• Patent Status: The original patent expired in most markets post-2010, facilitating generic entry.
• Market Launch Timing: Indian generics have maintained dominant supply positions since 2010.
• Regulatory Approvals: Suppliers must secure approvals compliant with local regulatory agencies, influencing supply timelines.

Summary

Fluconazole supply is dominated by Indian and Israeli generics manufacturers, with Pfizer maintaining a significant branded market presence. Large-scale manufacturing facilities and GMP compliance are common across the leading suppliers. Raw material sourcing from China and India influences pricing and supply stability.

Key Takeaways

• The global fluconazole market is characterized by high generic competition, primarily driven by Indian companies.
• Top suppliers include Pfizer (branded) and Indian firms such as Cipla, Sun Pharma, and Lupin.
• Raw material sourcing from China impacts pricing and supply chain reliability.
• Manufacturers comply with international GMP standards, with capacity aligned to global demand.
• Supply disruptions are mitigated through regional diversification and large-scale manufacturing capabilities.

FAQs

1. Who are the largest producers of fluconazole globally?
   Indian companies such as Cipla, Sun Pharma, and Lupin dominate the generic market, while Pfizer supplies branded formulations.

2. How does patent expiration affect the fluconazole supply?
   Patent expiry around 2010 in most markets enabled generic companies to enter, increasing competition and supply options.

3. Are there regional differences in fluconazole sourcing?
   Yes; Indian manufacturers supply the majority of generics worldwide, while branded drugs often originate from Pfizer's global manufacturing network.

4. What are key quality standards for fluconazole manufacturing?
   Compliance with GMP and ICH guidelines is essential, with most suppliers holding certifications recognized by global regulatory agencies.

5. What risks affect fluconazole supply security?
   Raw material dependency from China, manufacturing capacity constraints, and regional regulatory changes pose risks to supply continuity.

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References

[1] Pfizer Inc. (2022). Diflucan product information; FDA database.
[2] Sandoz. (2020). Global product portfolio.
[3] European Medicines Agency. (2021). GMP guidelines for antifungal medications.
[4] IMS Health. (2021). Global antifungal market analysis.
[5] Indian Pharmaceutical Alliance. (2022). Indian generics market overview.