Suppliers and packagers for DIFLUCAN

DIFLUCAN

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

Suppliers for the Pharmaceutical Drug: Diflucan

Last updated: July 27, 2025

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Introduction

Diflucan, known generically as fluconazole, is an antifungal medication primarily used to treat a breadth of fungal infections, including candidiasis, cryptococcal meningitis, and other systemic mycoses. Since its initial approval by the U.S. Food and Drug Administration (FDA) in 1990, Diflucan has become a staple in worldwide antifungal therapy. Its widespread use has cultivated a complex global supply chain, involving a variety of manufacturers, generic producers, and authorized distributors. Understanding the landscape of Diflucan suppliers is vital for stakeholders across healthcare, pharmaceuticals, and logistics sectors aiming to ensure consistent drug availability, regulatory compliance, and cost management.

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Manufacturers of Branded Diflucan

Pfizer Inc. remains the original patent holder and sole manufacturer of branded Diflucan. Pfizer’s extensive global manufacturing and distribution network secured its dominance in the early years post-approval. The company's commitment to quality control and regulatory compliance positions it as a key supplier in regulated markets such as North America and Europe. Pfizer's manufacturing facilities adhere to current Good Manufacturing Practices (cGMP), ensuring product safety and efficacy.

However, patent expiration and market exclusivity lapses have paved the way for generic manufacturers, resulting in an increasingly diverse supplier environment.

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Generic Manufacturers of Fluconazole

Following patent expiry, numerous pharmaceutical companies have entered the market as generic producers of fluconazole, vastly increasing supply options and reducing costs. These manufacturers operate across different regions, including Asia, Europe, and North America, with a significant segment based in India and China.

Indian Pharmaceutical Companies:

• Sun Pharmaceutical Industries: One of India's largest pharmaceutical firms, Sun Pharma manufactures both branded and generic fluconazole, with facilities compliant with global regulatory standards.
• Cipla Ltd.: Cipla supplies generic fluconazole globally, emphasizing quality and affordability.
• Dr. Reddy’s Laboratories: Known for their extensive generic portfolio, Dr. Reddy’s produces fluconazole formulations supplied worldwide.
• Lupin Limited: Lupin manufactures various antifungal agents, including fluconazole, catering chiefly to markets in North America, Latin America, and Africa.

Chinese Pharmaceutical Manufacturers:

• Hepalink Pharmaceutical: Specializes in sterile preparations, including fluconazole injections, serving institutional and hospital markets.
• Shanghai Acebright Pharmaceuticals: Produces oral and injectable fluconazole products for domestic and international markets.

European and Other Regional Manufacturers:

• Teva Pharmaceutical Industries: A leading global generic supplier, Teva offers fluconazole formulations, primarily to North American and European markets.
• Mylan (now part of Viatris): Provides fluconazole generics with global distribution capabilities.

Regulatory and Quality Considerations:

Generic manufacturers must meet stringent quality standards mandated by regulatory agencies such as the FDA, European Medicines Agency (EMA), and other national authorities. However, quality variations can occur, making it vital for procurement processes to prioritize sourcing from approved and certified manufacturers.

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Authorized Distributors and Supply Chain Dynamics

In addition to manufacturers, authorized distributors and wholesalers play critical roles in distributing Diflucan globally. Major pharmaceutical wholesalers such as McKesson, Cardinal Health, and AmerisourceBergen in the United States distribute both Pfizer’s branded Diflucan and generic versions. These entities ensure supply chain integrity and facilitate timely delivery to hospitals and pharmacies.

Internationally, regional distributors serve as intermediaries between manufacturers and healthcare providers. Many operate under strict regulatory frameworks to maintain product integrity amid complex logistics, storage requirements, and varying regulatory standards.

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Emerging Trends in Diflucan Supply

1. Market Diversification and Supply Security:
To mitigate risks associated with supply disruptions, many healthcare systems diversify procurement sources, engaging multiple generic manufacturers across geographic regions. This strategy enhances resilience, especially during global crises such as the COVID-19 pandemic, which strained the pharmaceutical supply chain.

2. Regulatory Harmonization:
Global efforts aim to harmonize quality standards and streamline approval processes for generic fluconazole, easing market entry for reliable manufacturers and expanding access.

3. Contract Manufacturing Arrangements:
Pharmaceutical companies increasingly engage in contract manufacturing organizations (CMOs) to produce fluconazole batches. CMOs enable capacity scaling and component sourcing flexibility.

4. Price Competition and Tendering:
Generics have intensified price pressures, with procurement agencies adopting tender-based purchasing. This dynamic fosters competitive supplier environments and drives down costs.

5. Focus on Quality Assurance:
Regulatory agencies enforce rigorous quality checks for imported generics, influencing supplier selection criteria favoring certified manufacturers with Good Manufacturing Practice (GMP) compliance.

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Supply Chain Challenges and Considerations

Despite a broad supplier base, supply chain disruptions can occur due to:

• Regulatory Non-Compliance: Manufacturers not meeting cGMP standards may face bans or delays, impacting supply stability.
• Raw Material Shortages: Fluctuations in active pharmaceutical ingredient (API) availability can constrain production volumes.
• Quality Variability: Variance in product quality can affect therapeutic outcomes and regulatory acceptance.
• Logistical Challenges: Cold chain requirements (for injectable formulations) and transportation disruptions affect timely delivery.

Sourcing strategies that incorporate supplier audits, quality verification, and diversified sourcing are essential to mitigate these risks.

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Regulatory Status and Market Approvals

In most markets, both the original Pfizer patent and subsequent generics are approved by regulatory authorities. For example, the FDA lists multiple approved fluconazole products, including Pfizer’s branded Diflucan and numerous generics from approved manufacturers. Similar approvals are maintained in the EMA, Health Canada, and the Therapeutic Goods Administration (TGA) of Australia.

Market approvals are continuously monitored, especially as biosimilar equivalents and combination products enter the market, requiring ongoing regulatory oversight.

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Conclusion

The supply landscape for Diflucan (fluconazole) is characterized by a combination of originator (Pfizer) and a broad spectrum of generic manufacturers spanning North America, Europe, and Asia. The globalization of pharmaceutical manufacturing has increased supply availability, improved pricing, and reduced dependency on single sources. However, global supply chain vulnerabilities underscore the need for strategic sourcing, regulatory compliance, and quality assurance.

Healthcare providers and procurement organizations must remain vigilant, ensuring supplies are obtained from validated, authorized manufacturers and distributors. Regulatory developments and market dynamics will continue to influence supplier stability and product availability in this critical antifungal segment.

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Key Takeaways

• The original branded Diflucan is manufactured solely by Pfizer, but generic fluconazole is produced by numerous global pharmaceutical firms, primarily in India and China.
• Selection of suppliers should prioritize regulatory approval, GMP compliance, and quality certifications to ensure therapeutic efficacy.
• Diversifying suppliers and engaging authorized distributors enhances supply security and mitigates risks related to disruptions.
• Market trends favor competitive tenders, transparent quality controls, and regional diversification to optimize costs and supply stability.
• Ongoing regulatory compliance and product quality monitoring are essential for maintaining a reliable Diflucan supply chain.

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Frequently Asked Questions

1. Who are the leading manufacturers of generic fluconazole?
Top producers include Sun Pharmaceutical Industries, Cipla, Dr. Reddy’s Laboratories, Lupin in India; Hepalink and Shanghai Acebright in China; and Teva and Mylan globally, all operating under strict regulatory compliance.

2. How does regulatory approval impact Diflucan supply?
Regulatory approval from authorities such as the FDA and EMA ensures that manufacturers adhere to quality standards, facilitating market access and supply stability.

3. What risks exist in sourcing Diflucan from multiple suppliers?
Risks include quality variability and compliance issues. Due diligence, validation, and supplier audits are imperative for mitigating these risks.

4. How has globalization affected Diflucan supply security?
It has increased availability and reduced costs but introduced complexities regarding regulatory harmonization, raw material sourcing, and logistical challenges.

5. What trends are shaping the future of Diflucan supply?
Emerging trends include market diversification, regulatory harmonization, contract manufacturing, and emphasis on quality assurance, all aimed at ensuring resilient and affordable supply chains.

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References

1. U.S. Food and Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
2. Pfizer Inc. (2023). Diflucan (fluconazole) product details.
3. Indian Pharmaceutical Association. (2022). Generics and manufacturing standards for antifungal agents.
4. European Medicines Agency. (2022). Summary of Product Characteristics for Fluconazole.
5. Global Data. (2023). Pharmaceutical Market Reports: Antifungal Agents.