Suppliers and packagers for generic pharmaceutical drug: difluprednate

difluprednate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	DIFLUPREDNATE	difluprednate	EMULSION;OPHTHALMIC	211526	ANDA	Amneal Pharmaceuticals NY LLC	69238-1380-3	1 BOTTLE in 1 CARTON (69238-1380-3) / 5 mL in 1 BOTTLE	2021-11-18
Caplin	DIFLUPREDNATE	difluprednate	EMULSION;OPHTHALMIC	219441	ANDA	Caplin Steriles Limited	65145-161-01	1 BOTTLE in 1 CARTON (65145-161-01) / 5 mL in 1 BOTTLE	2024-12-26
Caplin	DIFLUPREDNATE	difluprednate	EMULSION;OPHTHALMIC	219441	ANDA	Leading Pharma, LLC	69315-329-05	1 BOTTLE in 1 CARTON (69315-329-05) / 5 mL in 1 BOTTLE	2025-02-18

Suppliers for the Pharmaceutical Drug: Difluprednate

Last updated: July 28, 2025

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Introduction

Difluprednate is a potent topical corticosteroid primarily used in ophthalmic formulations to treat inflammation and intraocular conditions. Its therapeutic efficacy and safety profile have positioned it as a critical component in ophthalmology. As demand grows, identifying reliable suppliers for difluprednate becomes essential for pharmaceutical companies, healthcare providers, and distributors seeking quality and consistent supply.

Overview of Difluprednate

Difluprednate is a synthetic fluorinated corticosteroid with a high affinity for glucocorticoid receptors, providing anti-inflammatory effects. It is marketed under various brand names such as Durezol, primarily by Alcon Laboratories. Due to its complex synthesis and specialized manufacturing process, a limited number of suppliers produce difluprednate, emphasizing the importance of sourcing from verified and compliant manufacturers.

Key Suppliers in the Global Market

1. Alcon Laboratories, Inc.

Market Leader and Original Manufacturer
As the patent holder for Durezol, Alcon remains the predominant supplier of difluprednate ophthalmic solutions globally. The company's manufacturing facilities are FDA-approved, adhering to Good Manufacturing Practices (GMP), ensuring high-quality standards.

• Distribution & Supply: Alcon supplies difluprednate directly to hospitals, pharmacies, and multinational distributors worldwide.
• Note: Given its proprietary status, Alcon's supply is primarily concentrated around branded formulations, although generic production is underway from other manufacturers.

2. Sandoz (Novartis)

Generic Manufacturer
Sandoz, a division of Novartis, is developing and producing generic formulations of difluprednate, aiming to expand access and reduce costs.

• Market Focus: Sandoz’s production caters to regions where patent exclusivity has expired or is nearing expiration.
• Regulatory Status: Sandoz’s generics are approved in various markets, including Europe and parts of Asia.

3. Sun Pharmaceutical Industries Ltd.

Emerging Producer
Sun Pharma has begun manufacturing generic ophthalmic corticosteroids, including difluprednate, leveraging advanced synthetic chemistry.

• Supply Chain: Focuses on rapid global distribution, particularly in emerging markets such as India, Southeast Asia, and South America.
• Compliance: Maintains GMP standards aligned with local regulatory agencies.

4. Lunan Pharmaceutical Group

Regional Supplier (China)
Lunan Pharmaceutical specializes in ophthalmic pharmaceuticals, including corticosteroids like difluprednate, for the Chinese market and international export.

• Production Capacity: Capable of large-scale production, meeting regional demand with quality products conformant to international standards.
• Certifications: Holds certifications from Chinese NMPA and international regulatory bodies.

5. Other Notable Suppliers

• Teva Pharmaceutical Industries: Known for producing a broad range of ophthalmic corticosteroid generics, including difluprednate formulations.
• Molecular and Contract Manufacturers: Several smaller-scale manufacturers produce difluprednate active pharmaceutical ingredient (API) for OEMs and generic companies under contract manufacturing agreements.

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Challenges in Sourcing Difluprednate

Limited Production Facilities:
The specialized synthesis of difluprednate requires advanced chemical processes, limiting the number of qualified manufacturers.

Regulatory Barriers:
Variations in approval status across countries constrain global distribution. Manufacturers must navigate complex regulatory landscapes to expand market access.

Patent Expirations & Market Entry:
Patent expiry for Durezol may open opportunities for generic manufacturers, though patent litigation and exclusivity rights vary by region.

Supply Chain Risks:
Any disruption in API production or formulation manufacturing can impact availability. Ensuring diversified sourcing reduces dependency on a single supplier.

Criteria for Selecting a Difluprednate Supplier

• Regulatory Compliance: Suppliers must adhere to GMP standards and possess necessary certifications (FDA, EMA, NMPA).
• Product Quality: Consistency, stability, and validated pharmacological potency are critical.
• Capacity & Scalability: Ability to meet demand fluctuations without compromising quality.
• Supply Chain Transparency: Clear documentation and traceability of raw materials and manufacturing processes.
• Pricing & Contract Terms: Competitive pricing aligned with quality standards.

Emerging Trends in the Difluprednate Market

• Expansion of Generics: Increased interest from generic producers following patent expirations, potentially reducing costs.
• Localized Manufacturing: Growth of regional suppliers in Asia, particularly India and China, to serve local and export markets.
• Development of Alternative Formulations: Advances in drug delivery systems, such as sustained-release formulations, could shift supplier requirements.
• Regulatory Harmonization: Facilitating easier approval processes, enabling broader supplier participation.

Strategic Considerations for Buyers

• Diversify Suppliers: Avoid dependence on a single source to mitigate supply chain risks.
• Verify Regulatory Approvals: Ensure suppliers’ products are approved in target markets.
• Conduct Ongoing Quality Audits: Maintain robust quality assurance processes.
• Negotiate Flexible Contracts: Accommodate future capacity expansions or modifications.

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Key Takeaways

• Primary Market Leader: Alcon remains the dominant supplier of branded difluprednate, with extensive global distribution channels.
• Growing Generic Market: Companies like Sandoz and Sun Pharma are expanding supply options, creating competitive pricing and increased availability.
• Regulatory Navigation: Success depends on adherence to regional approvals and documentation.
• Supply Chain Resilience: Diversification and rigorous supplier qualification are critical to stable procurement.
• Regional Expansion: Chinese and Indian manufacturers are increasingly vital, particularly in emerging regions.

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FAQs

1. Who are the main manufacturers of difluprednate API globally?
Major API producers include Lunan Pharmaceutical Group (China), Sun Pharmaceutical Industries (India), and smaller contract manufacturers, with Alcon primarily handling finished formulations.

2. Can I source difluprednate from generic manufacturers?
Yes, several generics companies like Sandoz and Sun Pharma supply difluprednate formulations, especially post-patent expiry.

3. What quality standards should I look for in a difluprednate supplier?
Suppliers should comply with GMP, possess certifications such as FDA or EMA approval, and demonstrate consistent batch-to-batch quality.

4. Are there regional differences in difluprednate availability?
Yes; regional regulatory approvals, patent laws, and manufacturing capacities influence availability, with North America, Europe, and Asia being primary markets.

5. How does patent status affect suppliers and market dynamics?
Patent protections limit generic entry; upon expiration, numerous manufacturers can produce generics, increasing competition and reducing prices.

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References

1. [1] U.S. Food and Drug Administration (FDA). "Durezol (difluprednate ophthalmic emulsion) — Approved Drug Details."
2. [2] Novartis Sandoz. "Generic Ophthalmic Products Portfolio."
3. [3] Sun Pharmaceutical Industries Ltd. “Product Catalogue and Manufacturing Capabilities.”
4. [4] Chinese NMPA Database. "Lunan Pharmaceutical Ophthalmic Products.”
5. [5] Market analysis reports on ophthalmic corticosteroids by GlobalData and IQVIA.