ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632	NDA	Bausch Health US LLC	0187-0006-10	1 BOTTLE, PUMP in 1 CARTON (0187-0006-10) / 20 g in 1 BOTTLE, PUMP	2023-10-20
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632	NDA	Bausch Health US LLC	0187-0006-25	1 BOTTLE, PUMP in 1 CARTON (0187-0006-25) / 50 g in 1 BOTTLE, PUMP	2023-10-20
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632	NDA	Bausch Health US LLC	0187-0006-35	3.5 g in 1 TUBE (0187-0006-35)	2023-10-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

The global dermatology market continues to expand, driven by increasing incidences of acne vulgaris and skin ailments, necessitating reliable supply chains for key pharmaceutical ingredients. Among these, adapalene, benzoyl peroxide, and clindamycin phosphate remain pivotal due to their extensive use in acne treatments and other skin conditions. Securing reputable suppliers for these active pharmaceutical ingredients (APIs) ensures quality, compliance, and supply chain resilience for pharmaceutical companies and healthcare providers.

Adapalene: Overview and Leading Suppliers

Adapalene is a third-generation topical retinoid primarily used for acne vulgaris. Its stability, efficacy, and targeted action make it a valued compound in dermatological formulations.

Key Suppliers

Galderma: As the original developer of adapalene (marketed as Differin), Galderma supplies both the finished product and active ingredients through licensed manufacturing agreements. While primarily a pharmaceutical company, Galderma collaborates with CDMOs (Contract Drug Manufacturing Organizations) to ensure supply.
Toyo Synthetic Chemical Corporation: A prominent manufacturer of retinoid APIs, Toyo Synthetic supplies adapalene primarily to Asian markets. Their facilities comply with cGMP standards, and they hold certifications from major regulatory bodies.
Flexus Biosciences (Now part of Galderma): Previously engaged in raw material supply, Flexus/Biosn Biosciences focuses on high-purity APIs and intermediates, including adapalene.
LGC Standards: Offers high-quality reference standards of adapalene for analytical purposes; not a bulk supplier but relevant for quality control.
Other Chinese API producers: Several Chinese manufacturers, such as Zhejiang NHU and Hebei Urisense Pharmaceutical, have started producing adapalene APIs, often noted for cost competitiveness but varying in regulatory compliance and quality assurance.

Regulatory & Quality Considerations
Suppliers must adhere to cGMP protocols, possess necessary approvals (FDA, EMA, etc.), and provide comprehensive documentation, including certificates of analysis (CoA).

Benzoyl Peroxide: Overview and Leading Suppliers

Benzoyl peroxide is a widely used topical agent, recognized for its keratolytic and antimicrobial properties, making it a mainstay in acne therapy.

Key Suppliers

Johnson & Johnson: As the originator of many OTC benzoyl peroxide products, J&J often sources APIs internally or through licensed manufacturers, ensuring a high-quality product aligned with their brand standards.
BASF: A major chemical conglomerate, BASF supplies benzoyl peroxide to pharmaceutical and cosmetic markets worldwide. Their manufacturing facilities in Europe and Asia maintain ISO certifications and adhere to regulatory standards.
AkzoNobel: While primarily known for pigments and chemicals, AkzoNobel also produces benzoyl peroxide for industrial and pharmaceutical applications, with strong quality control systems.
Jiangsu Xinqiao Chemical: Chinese manufacturers such as Jiangsu Xinqiao produce benzoyl peroxide, primarily serving Asian markets. Their facilities are certified for GMP, offering competitive pricing.
MTI Biologics: Specializes in high-purity benzoyl peroxide suitable for pharmaceutical-grade applications, supplying major dermatology and OTC brands.

Supply & Quality Dynamics
Benzoyl peroxide is produced through safer, cost-effective processes, primarily via benzoyl chloride oxidation. Suppliers with advanced reactor systems and strict quality controls are preferred to mitigate risks of impurities such as benzoic acid or residual chlorides.

Clindamycin Phosphate: Overview and Leading Suppliers

Clindamycin phosphate is a prescription antibiotic used in combination with other agents or alone for bacterial skin infections and acne.

Key Suppliers

Pfizer: As the original patent holder and manufacturer of topical clindamycin formulations, Pfizer supplies pharmaceutical-grade clindamycin phosphate API globally, maintaining strict regulatory compliance.
Lupin Limited: An Indian pharmaceutical company with WHO-GMP and USFDA approval, Lupin supplies high-quality clindamycin phosphate APIs and intermediates, often serving emerging markets.
Hubei Jusheng Technology Co., Ltd.: Chinese API manufacturer with cGMP certification, specializing in antibiotics, including clindamycin phosphate, serving both domestic and international markets.
Hovione: A Portuguese API producer with a focus on high-quality, complex molecules, providing custom manufacturing of clindamycin phosphate complying with international standards.
Fukuda Denshi (Nipro): For high-purity APIs, companies like Fukuda Denshi supply pharmaceutical-grade clindamycin phosphate, prioritizing purity and stability.

Manufacturing & Regulatory Credentials
Suppliers typically hold certifications such as USFDA, EMA, or WHO-GMP to ensure that APIs meet international standards. Consistency in potency, low residual impurities, and robust analytical data are critical.

Emerging Market Dynamics and Regulatory Considerations

The market for these APIs is increasingly served by Asian manufacturers, especially in China and India, due to cost advantages and expanding manufacturing capacities. Nonetheless, regulatory hurdles, especially concerning quality standards, must be carefully navigated. Suppliers with proven track records and regulatory approvals face less scrutiny and reduce compliance risks.

Supply Chain Risks and Mitigation Strategies

Dependence on a limited supplier base increases vulnerability. Diversifying suppliers across geographies and maintaining supplier audits can mitigate risks. Establishing long-term supply agreements and ensuring comprehensive quality documentation further secures procurement channels.

Consolidated Trends in API Supply

Strong presence of Chinese and Indian manufacturers offering cost-effective APIs.
Increasing emphasis on regulatory compliance, cGMP certification, and quality assurance.
Growing importance of supply chain resilience amid global disruptions.
Technological advances enabling higher purity and better batch-to-batch consistency.

Key Takeaways

Quality Assurance Is Critical: Always verify certifications such as FDA, EMA, or WHO-GMP for API sourcing.
Diversify Suppliers: Reduce dependency risks by engaging multiple globally recognized suppliers.
Monitor Regulatory Changes: Stay updated with evolving global regulations affecting API import/export.
Align with Reputable Manufacturers: Prioritize suppliers with a proven track record of consistent quality and regulatory compliance.
Consider Cost-Efficiency and Lead Times: Balance competitive pricing with reliable delivery schedules.

FAQs

1. What are the main considerations when selecting a supplier for adapalene?
Prioritize suppliers with cGMP compliance, regulatory approvals, high purity standards, and reliable supply history. Verify their production capacities and quality documentation, especially for international regulatory submissions.

2. How does the quality of benzoyl peroxide APIs vary across regions?
While Chinese and Indian manufacturers offer cost-effective APIs, quality variation exists. Reliable suppliers possess stringent quality controls, certifications, and transparent analytical data to ensure pharmaceutical-grade quality.

3. Are Chinese manufacturers of clindamycin phosphate considered reliable?
Many Chinese suppliers possess WHO-GMP and other certifications, making them credible sources. Nonetheless, due diligence—including audits and verification of regulatory compliance—is essential before procurement.

4. How has COVID-19 affected API supply chains for these drugs?
The pandemic caused disruptions, prompting companies to diversify supply sources, increase inventory buffers, and seek alternative manufacturers to mitigate risks associated with geopolitical and logistical challenges.

5. What emerging trends are influencing API sourcing strategies?
Increasing adoption of quality-by-design principles, digital tracking, and regulatory harmonization aims to enhance supply chain transparency, reduce counterfeit risks, and ensure high-quality API availability globally.

References

[1] Galderma official website, API manufacturing partnerships.
[2] BASF chemical product catalog, benzoyl peroxide specifications.
[3] Lupin Ltd. API overview and quality standards.
[4] US Food and Drug Administration (FDA). API manufacturing requirements and certifications.
[5] Industry reports on global API manufacturing trends and supply chain dynamics.

Author’s Note: This analysis offers a comprehensive overview intended to inform procurement and strategic planning for pharmaceutical professionals seeking reliable suppliers of adapalene, benzoyl peroxide, and clindamycin phosphate.

Suppliers and packagers for generic pharmaceutical drug: ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE