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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320	NDA	Galderma Laboratories, L.P.	0299-5908-00	1 TUBE in 1 BLISTER PACK (0299-5908-00) / 2 g in 1 TUBE	2008-12-08
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320	NDA	Galderma Laboratories, L.P.	0299-5908-02	2 g in 1 TUBE (0299-5908-02)	2008-12-08
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320	NDA	Galderma Laboratories, L.P.	0299-5908-25	1 BOTTLE, PUMP in 1 CARTON (0299-5908-25) / 45 g in 1 BOTTLE, PUMP	2008-12-08
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320	NDA	Galderma Laboratories, L.P.	0299-5908-45	1 TUBE in 1 CARTON (0299-5908-45) / 45 g in 1 TUBE	2008-12-08
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Epiduo is a combination topical medication indicated primarily for the treatment of acne vulgaris. It combines adapalene, a retinoid derivative, with benzoyl peroxide, an antimicrobial agent, offering a dual mechanism to reduce acne lesions. As a high-demand dermatological product, the supply chain for Epiduo involves multiple stakeholders, including active pharmaceutical ingredient (API) manufacturers, finished dosage form (FDF) producers, and distribution companies. Understanding the key suppliers and supply dynamics is critical for stakeholders aiming to optimize sourcing strategies, anticipate market shifts, and ensure uninterrupted product availability.

Overview of Epiduo’s Composition

Epiduo contains:

Adapalene (0.1%): A third-generation synthetic retinoid with anti-inflammatory properties, improving keratinization and reducing acne severity.
Benzoyl Peroxide (2.5%): An antimicrobial and keratolytic agent that reduces C. acnes bacteria and promotes skin cell turnover.

The formulation’s topical nature demands adherence to strict manufacturing standards, with suppliers globally involved in producing high-quality APIs.

API Suppliers for Epiduo

Adapalene Suppliers

Adapalene is a highly specialized synthetic retinoid. The primary API producers are concentrated in select regions, mainly in Asia and Europe:

Sun Pharmaceutical Industries Ltd. (India): Sun Pharma is among the leading global API producers, offering adapalene at large volume capacities. Their R&D focuses on improving purity and stability, meeting international regulatory standards.
Jiangsu Hengrui Medicine Co., Ltd. (China): Hengrui provides high-grade adapalene APIs and has expanded capabilities to supply to global markets. Their focus lies in cost-effective manufacturing while maintaining quality.
Glenmark Pharmaceuticals Ltd. (India): With a robust API portfolio, Glenmark supplies adapalene with strict adherence to cGMP standards, serving both domestic and export markets.
Santee Chemical Limited (China): A mid-sized supplier providing adapalene to various finished product manufacturers, emphasizing affordability and reliable supply.

Benzoyl Peroxide Suppliers

Benzoyl peroxide is fabricated through a classic benzoyl peroxide synthesis route, with key suppliers:

AkzoNobel (Netherlands): A recognized leader in chemical manufacturing, AkzoNobel produces high-purity benzoyl peroxide used in pharmaceutical, cosmetic, and other industrial applications.
Clariant (Switzerland): Clariant supplies pharmaceutical-grade benzoyl peroxide to manufacturers globally, emphasizing product consistency and compliance with pharmacopeial standards.
Arkema (France): Arkema offers benzoyl peroxide with particular expertise in producing fineness and stability, crucial for dermatology products.
Tokyo Chemical Industry Co., Ltd. (Japan): Providing benzoyl peroxide for various applications, including pharmaceuticals, with a focus on purity and safety.

Alternative API Sources

Some pharmaceutical companies source adapalene and benzoyl peroxide from multiple suppliers, creating a diversified supply base to mitigate risks such as shortages or geopolitical disruptions. Such strategies are common among large dermatology product manufacturers.

Finished Dosage Form (FDF) Manufacturers

Once APIs are acquired, pharmaceutical companies outsource or develop in-house manufacturing of Epiduo’s cream formulation. Key players include:

Galderma:
As the patent holder and marketer, Galderma oversees the entire supply chain, including the procurement of APIs and formulation production. They manage multiple manufacturing facilities worldwide.
Contract Manufacturing Organizations (CMOs):
Several CMOs globally produce Epiduo under licensing agreements with Galderma, with notable plants in Europe, Asia, and North America. These organizations ensure compliance with cGMP and regulatory standards.

Distribution and Market Sourcing

Post-production, Epiduo is distributed via authorized wholesalers and pharmacies globally. The supply chain depends on:

Regional distributors: Ensuring accessibility in diverse markets.
Regulatory approvals: Which influence import/export channels.
Inventory management: To prevent shortages caused by supply disruptions from primary API sources.

Supply Chain Challenges and Risks

Certain market factors affect Epiduo’s supply stability:

Raw material shortages: Global API shortages can delay production, especially amid increased demand or during pandemics.
Regulatory shifts: Changing quality standards may impact supplier qualification.
Manufacturing bottlenecks: Transitioning between suppliers or scaling production can create temporary shortages.
Pricing pressures: Cost competition in API markets might influence procurement strategies and supplier loyalty.

Emerging Trends and Solutions

Diversification of API sources: Companies increasingly diversify suppliers to mitigate risks.
Vertical integration: Some large pharmaceutical firms invest directly in API manufacturing.
Onshoring and regional manufacturing: To reduce dependency on distant markets, especially significant in the post-COVID era.
Advanced procurement strategies: Use of quality-focused, long-term supplier agreements to ensure supply resilience.

Conclusion

The supply landscape for Epiduo involves a strategically coordinated network of high-quality API producers, discrete manufacturing partners, and global distribution entities. Sun Pharma, Jiangsu Hengrui, AkzoNobel, and Clariant are among the prominent suppliers of adapalene and benzoyl peroxide, forming the backbone of Epiduo’s supply chain. Continuous monitoring of geopolitical, regulatory, and market dynamics remains vital to maintaining a stable supply of this essential dermatological therapy.

Key Takeaways

Diversification reduces risk: Multiple API suppliers enable manufacturers to avoid shortages and meet global demand effectively.
Quality compliance is paramount: Suppliers must adhere to cGMP and pharmacopeial standards, especially for dermatological indications.
Market trends favor regional sourcing: Increased regional API manufacturing aims to enhance supply resilience.
Supply chain agility is critical: Flexibility in sourcing and inventory management minimizes disruptions.
Strategic partnerships matter: Long-term agreements with reputable suppliers ensure consistent quality and supply continuity.

FAQs

Who are the primary API suppliers for adapalene used in Epiduo?
Key suppliers include Sun Pharmaceutical Industries (India), Jiangsu Hengrui Medicine (China), and Glenmark Pharmaceuticals (India), all recognized for high-quality adaptation in APIs.
What companies produce benzoyl peroxide suitable for Epiduo?
Leading producers are AkzoNobel (Netherlands), Clariant (Switzerland), and Arkema (France), providing pharmaceutical-grade benzoyl peroxide.
Are there alternative suppliers for Epiduo’s APIs?
Yes, multiple regional and smaller API producers provide adaptable sources, allowing manufacturers to diversify their supply chain.
What risks threaten Epiduo’s supply chain?
Potential risks include raw material shortages, regulatory changes, geopolitical instability, and manufacturing disruptions.
How is the supply chain for Epiduo evolving?
Trends include diversification of suppliers, regional manufacturing growth, and strategic supplier partnerships to enhance resilience and quality.

Sources

[1] European Medicines Agency - Epiduo Summary of Product Characteristics.
[2] GlobalData Healthcare Reports on Dermatology Market and API Supply Chains.
[3] Clinical Pharmacology and Manufacturing Standards for Topical Acne Medications.
[4] Company Websites of Sun Pharma, Jiangsu Hengrui, AkzoNobel, and Clariant.

Suppliers and packagers for EPIDUO

EPIDUO

Suppliers for the Pharmaceutical Drug: Epiduo