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Suppliers and packagers for generic pharmaceutical drug: BENZOYL PEROXIDE
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BENZOYL PEROXIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mayne Pharma | EPSOLAY | benzoyl peroxide | CREAM;TOPICAL | 214510 | NDA | Galderma Laboratories, L.P. | 0299-5890-00 | 3 g in 1 BOTTLE, PUMP (0299-5890-00) | 2022-05-09 |
| Mayne Pharma | EPSOLAY | benzoyl peroxide | CREAM;TOPICAL | 214510 | NDA | Galderma Laboratories, L.P. | 0299-5890-30 | 1 BOTTLE, PUMP in 1 BOX (0299-5890-30) / 30 g in 1 BOTTLE, PUMP | 2022-05-09 |
| Mayne Pharma | EPSOLAY | benzoyl peroxide | CREAM;TOPICAL | 214510 | NDA | Mayne Pharma Commercial LLC | 51862-772-30 | 1 BOTTLE, PUMP in 1 CARTON (51862-772-30) / 30 g in 1 BOTTLE, PUMP | 2025-08-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Benzoyl Peroxide
Overview of Benzoyl Peroxide
Benzoyl peroxide is a widely used topical agent primarily in dermatology for treating acne vulgaris. It functions as an antimicrobial, keratolytic, and anti-inflammatory agent, effectively reducing Propionibacterium acnes population and promoting pore cleansing. Its pharmaceutical-grade form demands strict compliance with regulatory standards, creating a robust supply chain with numerous qualified sources globally.
Global Manufacturing Landscape
The supply chain for benzoyl peroxide involves a mix of large-scale chemical manufacturers, specialty chemical suppliers, and contract manufacturing organizations (CMOs). The compound is primarily synthesized through eco-friendly processes that involve benzoyl chloride and hydrogen peroxide, among other chemicals. The demand surges from both over-the-counter (OTC) and prescription dermatological markets, fostering a dynamic and competitive supplier environment.
Key Suppliers and Their Profiles
1. Akcros Chemicals
Headquarters: United Kingdom
Product Range: Offers pharmaceutical and cosmetic-grade benzoyl peroxide.
Capabilities: Akcros supplies high-purity benzoyl peroxide adhering to pharmacopeial standards like USP, EP, and JP. They emphasize environmentally friendly manufacturing with a focus on stable supply chains and global distribution.
Market Position: Recognized for quality consistency and comprehensive technical support in formulation development.
2. Zhejiang Wanglong Pharmaceutical Co., Ltd.
Headquarters: China
Product Range: Produces pharmaceutical and cosmetic benzoyl peroxide, with options for different packaging sizes.
Standards Compliance: Meets USP, EP, and Chinese pharmacopeial standards.
Capabilities: Possesses large manufacturing capacity, facilitating competitive pricing and supply stability to global markets, including North America and Europe.
3. Shanghai DIALL Chemical Co., Ltd.
Headquarters: China
Market Focus: Supplies pharmaceutical-grade benzoyl peroxide for both OEM and generic applications.
Certifications: GMP-certified manufacturing facilities, with adherence to international quality standards.
4. Trigon Chemie Ltd.
Headquarters: India
Product Profile: Provides pharmaceutical-grade benzoyl peroxide with reliable supply chains targeting Asia, Europe, and North America.
Certifications: GLP, GMP, ISO 9001-certified plants, ensuring high product quality fundamentals.
5. LC Laboratories
Headquarters: United States
Product Profile: Specializes in research-grade chemicals, including benzoyl peroxide, for pharmaceutical and research applications.
Market Position: Provides high-purity benzoyl peroxide; suitable for formulations requiring stringent quality controls.
Emerging and Niche Suppliers
In recent years, new entrants from emerging markets and specialized chemical producers have expanded the supplier base, emphasizing sustainability and innovative manufacturing techniques. These include:
- Jinan Baida Chemical Co., Ltd. (China): Focuses on eco-friendly synthesis routes, aiming to meet increasing demand for green pharmaceuticals.
- SCP Scientific: Provides pharmaceutical-grade benzoyl peroxide as part of a broader portfolio of dermatological active ingredients.
Selection Criteria for Suppliers
When sourcing benzoyl peroxide, pharmaceutical companies prioritize:
- Regulatory Compliance: Must comply with pharmacopeial standards (USP, EP, JP) and possess relevant certifications (GMP, ISO).
- Product Purity and Stability: High purity (>99%) and stability over shelf life.
- Manufacturing Capacity: Ability to meet demand without supply disruptions.
- Quality Assurance: Robust quality control, traceability, and adherence to Good Manufacturing Practices.
- Pricing and Lead Times: Competitive pricing with reliable delivery schedules.
Regulatory and Quality Considerations
Suppliers must provide comprehensive documentation, including Certificates of Analysis (CoA), Certificates of Compliance (CoC), and stability data. Analytical testing ensures the absence of contaminants such as heavy metals and residual solvents, critical for pharmaceutical applications. The demand for cGMP manufacturing facilities remains high, especially for products destined for prescription formulations.
Market Dynamics and Future Outlook
The benzoyl peroxide supply market exhibits notable growth driven by rising acne prevalence globally, especially in emerging economies. Innovations around sustainable synthesis and bio-based manufacturing routes are under development, aiming to improve environmental profiles and reduce costs. Additionally, regulatory pressures are increasingly emphasizing quality and traceability, challenging suppliers to enhance their standards continuously.
Supply chain resilience is a critical focus area, with companies diversifying suppliers and geographies to mitigate risks associated with geopolitical instability, raw material shortages, or regulatory changes.
Conclusion
The global supply landscape for benzoyl peroxide is characterized by a mix of well-established chemical manufacturers and emerging players, primarily located in China, India, Europe, and North America. Pharmaceutical companies seeking reliable sources should prioritize suppliers with robust quality systems, regulatory compliance, and resilient manufacturing capacities. As demand persists and evolves, so too will the supplier network, integrating sustainability and innovation as key drivers.
Key Takeaways
- Global Supplier Base: Includes top-tier manufacturers like Akcros Chemicals, Zhejiang Wanglong, and Trigon Chemie, supplemented by niche and research-focused suppliers.
- Quality & Compliance: Critical for pharmaceutical-grade benzoyl peroxide; suppliers must demonstrate GMP compliance and pharmacopeial standards.
- Supply Chain Resilience: Diversification and strategic sourcing are vital, especially amid geopolitical and raw material supply risks.
- Sustainability Trends: Emerging eco-friendly manufacturing techniques aim to meet increasing environmental regulations and corporate sustainability commitments.
- Market Growth: Driven by global dermatology markets, with innovation and regulatory pressures shaping future supply dynamics.
5 FAQs About Benzoyl Peroxide Suppliers
1. What factors should I consider when choosing a benzoyl peroxide supplier?
Prioritize regulatory compliance (GMP, pharmacopeial standards), product purity, manufacturing capacity, quality assurance measures, pricing competitiveness, and supply reliability.
2. Are there regional differences in benzoyl peroxide quality standards?
Yes. Standardized pharmacopeial requirements (USP, EP, JP) govern quality, but regional regulators may have specific regulations influencing supplier certifications and documentation.
3. How does the environmental impact influence supplier selection?
Suppliers employing eco-friendly synthesis methods and sustainable manufacturing practices are increasingly preferred, aligning with global sustainability goals and regulatory trends.
4. What global regions dominate benzoyl peroxide production?
China and India lead in manufacturing capacity, followed by Europe and North America, which often serve as centers for quality assurance and regulatory compliance.
5. Can I source benzoyl peroxide for research purposes from different suppliers?
Yes. Suppliers like LC Laboratories provide research-grade benzoyl peroxide with high purity suitable for non-pharmaceutical applications.
Sources
[1] Pharmaceutical Market Reports, Industry Data (2022).
[2] Akcros Chemicals Product Catalog (2023).
[3] Zhejiang Wanglong Pharmaceutical Co., Ltd. Certifications & Capabilities.
[4] Trigon Chemie Ltd. Regulatory Approvals.
[5] Market Analysis on Acne Treatments and Active Pharmaceutical Ingredients (2022).
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