Suppliers and packagers for DUREZOL

DUREZOL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sandoz	DUREZOL	difluprednate	EMULSION;OPHTHALMIC	022212	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-6000-78	1 BOTTLE in 1 CARTON (0781-6000-78) / 5 mL in 1 BOTTLE	2013-05-15
Sandoz	DUREZOL	difluprednate	EMULSION;OPHTHALMIC	022212	NDA	Sandoz Inc	66758-086-75	1 BOTTLE in 1 CARTON (66758-086-75) / 5 mL in 1 BOTTLE	2011-01-25

Suppliers for the Pharmaceutical Drug: Durezol

Last updated: August 4, 2025

Introduction

Durezol (difluprednate ophthalmic emulsion) is a potent corticosteroid primarily prescribed to treat postoperative ocular inflammation and pain associated with ocular surgeries, including cataract extraction. Its distinctive formulation enhances bioavailability and efficacy, making it a critical asset for ophthalmologists globally. The market for Durezol hinges on a complex network of manufacturers, distributors, and suppliers, each playing a vital role in ensuring its availability and quality. This article provides an in-depth analysis of the key suppliers, the manufacturing landscape, and factors influencing the global distribution of Durezol.

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Manufacturers and Patent Holders

Durezol is developed and marketed by Alcon, a leading pharmaceutical company specializing in eye care products. Alcon's extensive R&D infrastructure and proprietary formulations granted it exclusive rights to commercialize Durezol, positioning the drug as a premium ophthalmic corticosteroid.

Alcon's Role and Production Capacity

As the sole manufacturer for Durezol, Alcon controls the entire supply chain, from raw material procurement to final packaging. Its manufacturing facilities are located primarily in the United States and Switzerland, ensuring adherence to stringent regulatory standards (FDA and EMA compliance). The company's extensive production capacity supports global distribution, although supply constraints can occur due to production scale limitations or regulatory bottlenecks.

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Key Raw Material Suppliers

Durezol's efficacy depends on supply of high-purity difluprednate, the active pharmaceutical ingredient (API). Raw material sourcing involves multiple suppliers specializing in steroids and pharmaceutical intermediates.

Difluprednate API Suppliers

Currently, no public disclosures specify suppliers for difluprednate; it is presumed to originate from a limited pool of specialized API manufacturers due to the complex synthesis process involving multiple chemical intermediates. These suppliers typically operate under strict confidentiality agreements with Alcon or its intermediaries. Major regions supplying steroid APIs include China, India, and certain European countries, well-known for their API manufacturing ecosystems.

Excipients and Formulation Components

In addition to the API, Durezol's formulation requires high-quality excipients, such as surfactants, preservatives, and emulsifiers. Suppliers like BASF, Dow, and Ashland provide pharmaceutical-grade excipients adhering to pharmacopeial standards.

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Distribution and Distributorship

Alcon manages the distribution network directly or through authorized distributors across different regions. These distributors are responsible for warehousing, logistics, and compliance with local regulatory requirements.

Regional Distributors

• North America: Alcon’s regional subsidiaries and authorized distributors ensure timely supply to hospitals and clinics.
• Europe: Distribution is managed in accordance with EMA regulations, ensuring quality and traceability.
• Asia-Pacific: Local distributors facilitate access in populous markets such as China, India, and Japan, often supported by parallel importers.

Supply Chain Challenges

Global supply chains for Durezol can face disruptions due to raw material shortages, manufacturing delays, or regulatory changes. The COVID-19 pandemic highlighted vulnerabilities in pharmaceutical supply chains, prompting efforts for diversification and increased inventory resilience.

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Regulatory and Patent Considerations

Alcon's patent protection for Durezol was pivotal initially; however, patent expirations or challenges in certain markets could influence the entry of generic competitors. The introduction of generics would dramatically diversify the supplier landscape, fostering increased competition and potentially lowering prices.

Potential for Generic Suppliers

In jurisdictions where patents have expired or were invalidated, Indian and Chinese pharmaceutical manufacturers have shown interest in developing difluprednate formulations. Regulatory pathways via abbreviated new drug applications (ANDAs) could facilitate broader supplier participation in the future.

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Market Dynamics and Competitive Landscape

Currently, Durezol remains a marketed product largely monopolized by Alcon. However, the pipeline for generic difluprednate suggests impending competition, which could reshape the supplier network. This shift could result in:

• Increased manufacturing hubs: Emerging API producers in Asia expanding capabilities.
• Diversification of distributors: Multiple regional suppliers emerging to meet demand.
• Price competition: Potential reduction in costs and improved access.

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Key Factors Influencing Supplier Selection

1. Regulatory Compliance: Suppliers must meet global regulatory standards (e.g., FDA, EMA, CDSCO).
2. Quality Assurance: Consistent high-purity API and excipient production.
3. Supply Chain Reliability: Capacity to meet global demand without disruptions.
4. Cost Effectiveness: Competitive pricing within supply chains.
5. Intellectual Property Considerations: Patent status and regulatory approvals for generics.

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Conclusion

Durezol’s supply chain is currently streamlined under Alcon’s exclusive manufacturing and distribution network. The critical dependency on high-quality difluprednate APIs and the regulatory environment underscores the importance of strategic sourcing. Future market entrants, such as generic manufacturers, are poised to diversify the supplier landscape, potentially enhancing supply resilience and reducing prices.

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Key Takeaways

• Alcon remains the primary supplier for Durezol, controlling manufacturing and distribution channels.
• Raw material sourcing for difluprednate API is concentrated in specialized manufacturers, mainly in Asia and Europe.
• Supply chain stability is essential, with recent disruptions emphasizing the need for diversified suppliers and regional manufacturing hubs.
• Patent expiry and regulatory approvals will influence emerging suppliers, especially generic competitors.
• Manufacturers and distributors must prioritize regulatory compliance, quality, and reliability to succeed in the competitive ophthalmic corticosteroid market.

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FAQs

1. Who are the primary manufacturers of Durezol?
Alcon is the sole manufacturer and marketer of Durezol, controlling all aspects from API sourcing to distribution.

2. Are there generic versions of Durezol available?
As of 2023, no generics are widely available due to patent protections; however, patent expirations may lead to the emergence of generic suppliers.

3. Where does the active ingredient, difluprednate, typically come from?
It is manufactured by specialized API producers, predominantly in China and India, adhering to strict quality standards due to the complex synthesis process.

4. How does supply chain disruption affect Durezol availability?
Disruptions in raw material supply or manufacturing delays can lead to shortages, impacting availability especially in regions dependent on limited suppliers.

5. What regulatory factors influence supplier choice?
Suppliers must comply with local and international regulations, including FDA and EMA standards, to ensure market access and product safety.

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Sources

1. Alcon Pharmaceutical Portfolio, Official Website.
2. U.S. Food and Drug Administration (FDA) Drug Approvals.
3. Market Reports on Ophthalmic Pharmaceuticals.
4. Patent databases and regulatory filings related to Durezol.
5. Global API manufacturing industry analyses.