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

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Valeant Intl	BENZAMYCIN	benzoyl peroxide; erythromycin	GEL;TOPICAL	050557	NDA	Bausch Health US, LLC	0187-5205-46	1 KIT in 1 BOX (0187-5205-46) * 1.6 g in 1 VIAL, PLASTIC * 40 g in 1 JAR	1984-10-26
Valeant Intl	BENZAMYCIN	benzoyl peroxide; erythromycin	GEL;TOPICAL	050557	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-900-23	1 KIT in 1 CARTON (68682-900-23) * .8 g in 1 VIAL, PLASTIC (68682-924-08) * 20 g in 1 JAR (68682-923-23)	1984-10-26
Valeant Intl	BENZAMYCIN	benzoyl peroxide; erythromycin	GEL;TOPICAL	050557	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-901-46	1 KIT in 1 CARTON (68682-901-46) * 40 g in 1 JAR (68682-922-46) * 1.6 g in 1 VIAL, PLASTIC (68682-925-16)	1984-10-26
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

The global pharmaceutical landscape relies heavily on a robust supply chain to meet the demand for active pharmaceutical ingredients (APIs). Benzoyl peroxide and erythromycin are two prominent drugs with wide-ranging applications—benzoyl peroxide as a topical treatment for acne vulgaris and erythromycin as a broad-spectrum antibiotic used for various bacterial infections. Ensuring reliable sourcing from qualified suppliers is critical for manufacturers, healthcare providers, and stakeholders aiming to maintain compliance, quality, and supply continuity.

This article provides a comprehensive overview of key suppliers for benzoyl peroxide and erythromycin, highlighting manufacturing capacities, geographies, regulatory compliance, and market dynamics.

Benzoyl Peroxide Suppliers

Global Manufacturing Landscape

Benzoyl peroxide (C14H10O4) has a well-established manufacturing base primarily concentrated in Asia, with significant production also occurring in Europe and North America. Its synthesis involves the benzoyl radical reacting with peroxide sources, necessitating high-purity processes to meet pharmaceutical standards.

Major Suppliers

Gansu Jinbei Pharmaceutical Co., Ltd. (China)
As one of the largest producers of benzoyl peroxide globally, Gansu Jinbei supplies pharmaceutical-grade APIs as well as OTC-grade products. The company adheres to GMP standards, with exports to North America, Europe, and Asia.
Capacity & Certifications: GMP-certified, annual production capacity exceeding 500 tons.
Hubei Jade Pharma Co., Ltd. (China)
A key supplier specializing in dermatological ingredients, Jade Pharma offers high-purity benzoyl peroxide APIs suitable for pharmaceutical formulations. They comply with international quality standards, including ISO and GMP compliance.
Capacity & Certifications: Approximate annual capacity of 200 tons, with certifications aligned to WHO-GMP.
Chongqing Yuancheng Pharmaceutical Development Co. (China)
Focused on both APIs and intermediates, Yuancheng supplies benzoyl peroxide to global pharmaceutical firms. Their operations are FDA-registered and cGMP-compliant.
Capacity & Certifications: Capacity around 150–200 tons per year.
TRICOL PHARMA (India)
A prominent Indian bulk API manufacturer specializing in benzoyl peroxide alongside other dermatological ingredients. TRICOL PHARMA emphasizes quality control and distribution within India, with export capabilities to multiple regions.
Certifications: ISO, cGMP, and US-FDA registered facilities.
BASF SE (Germany)
While primarily known for chemical intermediates and specialty chemicals, BASF produces benzoyl peroxide for industrial use, with pharmaceutical grade production capacity primarily serving European and North American markets under strict regulatory standards.

Market Trends and Supply Dynamics

China remains the dominant supplier, accounting for over 80% of global benzoyl peroxide production due to its manufacturing scale and cost advantages.
Recent supply chain disruptions—such as regulatory changes and COVID-19 economic impacts—have prompted pharmaceutical companies to diversify suppliers or establish strategic partnerships.
Regulatory compliance with international standards (e.g., US-FDA, EMA, WHO-GMP) remains a primary factor in supplier selection.

Erythromycin Suppliers

Global Manufacturing Landscape

Erythromycin (C37H67NO13) is a macrolide antibiotic naturally derived from Saccharopolyspora erythraea (formerly Streptomyces erythraeus). Its production involves fermentation processes, making the choice of fermentation strains, purification, and downstream processing crucial for quality and yield.

Major Suppliers

Pfizer Inc. (USA)
Historically a significant producer, Pfizer supplies erythromycin with high standards of quality and regulatory compliance. Their US and international facilities adhere to GMP standards, supplying APIs to global markets.
Market Role: Leading in high-quality erythromycin API manufacturing.
Hisun Pharma (China)
One of the largest Chinese pharmaceutical manufacturers, Hisun produces erythromycin derivatives and salts, including erythromycin ethylsuccinate and stearate, complying with international regulatory standards.
Certifications: GMP, ISO, and US-FDA registration.
Yarooba International (India)
An emerging supplier specializing in macrolide antibiotics, Yarooba offers erythromycin API and related formulations, targeting both domestic and export markets.
Certifications: WHO-GMP and ISO certifications.
China National Pharmaceutical Group (Sinopharm)
A state-owned enterprise with significant fermentation capacity, Sinopharm produces erythromycin with consistent batch quality compliant with international standards.
Strengths: Cost-effective large-scale fermentation, strategic government backing.
AbbVie (USA/Europe)
Through licensing and strategic partnerships, AbbVie supplies erythromycin derivatives, ensuring compliance with stringent regulatory standards and distribution to developed markets.

Emerging and Regional Suppliers

Several regional producers in Eastern Europe, Southeast Asia, and Latin America are increasing capacity for erythromycin, driven by demand for affordable antibiotics in developing regions.
Regulatory hurdles and quality assurance remain key considerations for these suppliers, impacting market access.

Supply Chain Considerations

Fermentation-based processes necessitate reliable sourcing of raw materials, robust strain development, and controlled downstream processing.
The global erythromycin supply chain has experienced volatility due to regulatory changes, patent expirations, and pandemic-related disruptions, pushing companies to diversify sources and invest in biosynthesis innovations.

Regulatory and Quality Considerations

For both benzoyl peroxide and erythromycin, suppliers must meet stringent regulatory standards, including GMP compliance, quality certifications (ISO, FDA registration, EMA approval), and stability data supporting pharmaceutical-grade use. Ensuring supplier transparency, adherence to Good Manufacturing Practices, and continuous quality verification is essential for downstream formulation and distribution.

Conclusion

The supply of benzoyl peroxide and erythromycin depends on a global network of manufacturers, predominantly led by Chinese and Indian companies with significant capacities. While Chinese suppliers dominate benzoyl peroxide production, multinational corporations such as Pfizer and AbbVie are major global suppliers of erythromycin APIs. Given the complexities — from manufacturing standards to regulatory compliance — pharmaceutical manufacturers must conduct thorough due diligence, favoring established suppliers with proven track records.

Key Takeaways

Chinese suppliers dominate benzoyl peroxide manufacturing, with certifications from GMP and ISO standards; diversification is advised due to geopolitical and supply chain risks.
Erythromycin manufacturing is led by major pharmaceutical companies and robust fermentation processes, with regional suppliers expanding capabilities, especially in Asia and Eastern Europe.
Regulatory compliance is critical; suppliers must demonstrate adherence to international standards, including GMP, ISO, and registration with relevant authorities.
Supply chain resilience can be enhanced through multi-sourcing and strategic partnerships, particularly for critical antibiotics and dermatological ingredients.
Emerging biosynthesis methods may influence future supply dynamics, improving yields and reducing dependency on fermentation raw materials.

FAQs

How can I verify the compliance of a supplier for benzoyl peroxide or erythromycin?
Confirm certifications such as GMP, ISO, and registration with regulatory bodies like the US-FDA or EMA. Request detailed audit reports and batch quality documentation.
Are there regional differences in the quality of benzoyl peroxide suppliers?
Yes, while Chinese suppliers dominate, quality varies. Choosing suppliers with certified manufacturing standards and proven compliance minimizes risks.
What are the primary risks associated with erythromycin supply chain disruptions?
Manufacturing interruptions due to fermentation variability, raw material shortages, regulatory hurdles, and geopolitical factors.
Is there an increasing trend toward biosynthesis of erythromycin?
Yes. Advances in genetic engineering and fermentation technologies are aiming to improve yield, stability, and cost-effectiveness, potentially altering future supplier landscapes.
How do geopolitical factors influence supplier choices for these APIs?
Trade policies, tariffs, and export restrictions can impact supply reliability, prompting companies to establish multiple supplier relationships or develop in-house manufacturing capabilities.

Sources

[1] Global Industry Analyst Reports on API manufacturing landscapes.
[2] Gansu Jinbei Pharmaceutical official website.
[3] Hubei Jade Pharma Co., Ltd. Certifications and capacity details.
[4] BASF Product Portfolio and Manufacturing details.
[5] Pfizer Annual Report and API manufacturing overview.
[6] Industry analysis papers on fermentation-based antibiotic production.

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