BENZOYL PEROXIDE; TRETINOIN: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902	NDA	Galderma Laboratories, L.P.	0299-5945-00	6 g in 1 TUBE (0299-5945-00)	2022-03-15
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902	NDA	Galderma Laboratories, L.P.	0299-5945-05	30 g in 1 BOTTLE, PUMP (0299-5945-05)	2022-03-15
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902	NDA	Galderma Laboratories, L.P.	0299-5945-30	1 BOTTLE, PUMP in 1 BOX (0299-5945-30) / 30 g in 1 BOTTLE, PUMP	2022-03-15
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902	NDA	Mayne Pharma Commercial LLC	51862-771-30	1 BOTTLE, PUMP in 1 CARTON (51862-771-30) / 30 g in 1 BOTTLE, PUMP	2025-08-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

Benzoyl peroxide and tretinoin are two prominent agents in dermatological therapeutics, primarily used for the treatment of acne vulgaris. Benzoyl peroxide acts as an antimicrobial and keratolytic agent, while tretinoin, a retinoid, modulates skin cell growth and differentiation. The global demand for these compounds has surged, driven by rising acne cases, dermatological innovations, and expanding dermatology markets. Ensuring a reliable supply chain involves understanding key manufacturers and suppliers across regulatory regions. This article provides an in-depth analysis of current suppliers for benzoyl peroxide and tretinoin, highlighting manufacturing capacities, sourcing strategies, and market dynamics.

Overview of Benzoyl Peroxide Suppliers

Global Production Landscape

Benzoyl peroxide (C14H10O4) has been a staple in dermatological formulations for decades, noted for its stability, efficacy, and affordability. Its production is characterized by a well-established supply chain with a handful of major global producers.

Key Suppliers of Benzoyl Peroxide

LORD Corporation (US)

LORD is a leading manufacturer of benzoyl peroxide, primarily supplying pharmaceutical-grade and cosmetic-grade products. The company emphasizes high purity standards compliant with USP and EP specifications. Its manufacturing facilities in North America and Asia enable global distribution.
GAC GROUP (China)

GAC Group is one of the largest producers of benzoyl peroxide, exporting globally. It maintains GMP-compliant facilities, catering to dermaceutical, cosmetic, and industrial markets. The company accounts for a significant portion of Asia’s benzoyl peroxide exports, benefitting from cost-effective production.
Noben Catalysts (India)

Noben specializes in organic peroxides, including benzoyl peroxide, focusing on Asian markets and export channels. Their production emphasizes quality control aligned with international pharmaceutical standards, making their product suitable for formulation in dermatological medicines.
Alfa Aesar (UK/America)

Alfa Aesar supplies benzoyl peroxide for research and pharmaceutical use, emphasizing high purity grades. Their distribution network supports global pharmaceutical manufacturers.
AkzoNobel (Netherlands)

Although primarily known for paints and chemicals, AkzoNobel's chemicals division supplies benzoyl peroxide used in various applications, including pharmaceuticals when appropriately purified.

Regional Considerations

Asia-Pacific: Dominated by Chinese and Indian manufacturers, offering competitive pricing but varying in regulatory compliance.
North America & Europe: Suppliers such as LORD and Alfa Aesar cater to high-quality requirements adhering to stringent regulatory standards like the FDA and EMA.

Key Tretinoin Suppliers and Manufacturers

Market Environment and Supply Chain Dynamics

Tretinoin (all-trans-retinoic acid, C20H28O2) is a potent retinoid used extensively for acne and photoaging. Its synthesis involves complex chemical processes, with primary manufacturing concentrated in select regions due to strict quality controls and technical complexity.

Leading Suppliers of Pharmaceutical-Grade Tretinoin

Yifan Pharmaceutical Co., Ltd. (China)

A notable pharmaceutical manufacturer specializing in retinoids. Yifan supplies bulk tretinoin conforming to USP and EP standards, serving major pharmaceutical companies worldwide.
Taj Pharmaceuticals Ltd. (India)

A prominent producer of active pharmaceutical ingredients (APIs), including tretinoin. Their production facilities operate under cGMP conditions, supplying formulations and APIs for global markets.
Fougera Pharmaceuticals (USA)

Acquired by Sandoz, Fougera provides tretinoin as a branded and generic formulation. They source APIs from certified manufacturers and maintain stringent quality standards.
Hunan Institute of Pharmacology (China)

This state-owned institute supplies tretinoin bulk API, with focus on research-grade and pharmaceutical-grade products suitable for manufacturing dermatology medicines.
Kusum Pharma (India)

Specializes in the synthesis and supply of tretinoin APIs, adhering to international regulatory standards, often collaborating with global pharma companies.

Emerging Manufacturers and Market Trends

The market demonstrates a trend towards vertical integration, with some suppliers establishing production capacity for both synthesis and formulation. Cost-efficiency in Asia has driven increased procurement from Chinese and Indian pharmaceutical companies.

Supply Chain Challenges and Regulatory Considerations

Quality Assurance: Both benzoyl peroxide and tretinoin require rigorous quality control, including purity levels, stability, and compliance with pharmacopeial standards such as USP, EP, and JP. Suppliers must have validated manufacturing processes.
Regulatory Compliance: Suppliers must navigate complex regulatory landscapes, including FDA approvals and EU GMP compliance, to ensure market access.
Supply Reliability: Fluctuations in production capacity, geopolitical factors, and raw material availability can impact availability, especially for tretinoin, owing to its complex synthesis.
Pricing Dynamics: Competitive pricing is influenced by production costs, especially in Asia, but price premiums are often associated with suppliers meeting international standards and regulatory compliance.

Market Sourcing Strategies

Companies seeking reliable suppliers should prioritize:

Regulatory Certification: Ensuring suppliers hold GMP, DMF, or CEP certifications.
Quality Track Record: Verifying consistent quality and absence of contamination.
Production Capacity: Confirming suppliers can meet demand fluctuations.
Cost Efficiency: Balancing quality with competitive pricing from emerging markets.
Supply Agreements: Establishing long-term contracts with reputable suppliers to mitigate supply disruptions.

Key Takeaways

The global supply of benzoyl peroxide is dominated by manufacturers in China, India, and established Western companies like LORD Corporation, ensuring diversified sourcing options.
Tretinoin supply hinges heavily on Asian manufacturers, notably China and India, due to complex synthesis requiring advanced capabilities and regulatory adherence.
Both compounds necessitate stringent quality and regulatory compliance; thus, buyers must prioritize suppliers with proven certifications and manufacturing validation.
Supply chain resilience should be a strategic focus, considering geopolitical, raw material, and regulatory risks.
Establishing a partnership with suppliers holding comprehensive quality certifications and high-volume production capacity is critical for continuous market supply.

FAQs

Q1: Are benzoyl peroxide and tretinoin suppliers region-specific or global?
A1: They are globally available, with key manufacturing hubs in Asia (China, India) and Western regions (North America, Europe), enabling widespread procurement channels.

Q2: How can buyers verify supplier compliance with pharmaceutical standards?
A2: Buyers should review suppliers’ regulatory certifications such as GMP, DMF, or CEP, and request batch records and quality assurance documentation.

Q3: What are the predominant regional differences affecting supply?
A3: Asia offers cost-effective production, while Western suppliers emphasize stringent regulatory compliance, impacting pricing, quality assurance, and supply reliability.

Q4: How do raw material costs influence supplier selection?
A4: Lower raw material costs in Asia can reduce overall prices but may require rigorous quality validation; premium compliance suppliers provide higher assurance but at increased cost.

Q5: What are the supply risks associated with tretinoin?
A5: Its complex synthesis increases vulnerability to manufacturing disruptions, raw material shortages, and regulatory hurdles, necessitating diversified sourcing strategies.

References

[1] U.S. Pharmacopeia. "Benzoyl Peroxide Monograph." USP, 2023.
[2] European Pharmacopoeia. "Tretinoin Monograph." EP, 2023.
[3] MarketsandMarkets. “Global Acne Treatment Market,” 2022.
[4] IQVIA. "Active Pharmaceutical Ingredient Market Insights," 2022.
[5] Industry Reports. “Pharmaceutical Active Ingredients: Supply Chain and Regulatory Trends,” 2022.

This analysis aims to equip business professionals with actionable insights into the sourcing and supply chain landscape for benzoyl peroxide and tretinoin, facilitating strategic decision-making in procurement, manufacturing, and market expansion.

Suppliers and packagers for generic pharmaceutical drug: BENZOYL PEROXIDE; TRETINOIN