Bulk Pharmaceutical API Sources for MASOPROCOL

Bulk Pharmaceutical API Sources for MASOPROCOL

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		71398
ABI Chem		AC1L2G35
ABI Chem		AC1Q7ACC

Bulk Active Pharmaceutical Ingredient (API) Sources for: Masoprocol

Last updated: July 30, 2025

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Introduction

Masoprocol, also known as N-phenylpropionyl-N'-phenylurea, is an orphan drug primarily utilized in the management of precancerous conditions, notably actinic keratosis. While its clinical application is limited, its synthesis and sourcing remain relevant for pharmaceutical development, research, and potential personalized applications. As an API, sourcing masoprocol requires comprehensive knowledge of reliable suppliers, quality standards, and regulatory compliance.

This report explores the global landscape for bulk API sources of masoprocol, analyzing key manufacturers, geographic distributions, quality standards, and procurement considerations vital for pharmaceutical entities seeking reliable supply chains.

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1. Overview of Masoprocol as an API

Originally developed in the mid-20th century, masoprocol functions as a lipoxygenase inhibitor, with mechanisms contributing to its clinical effects in specific dermatological conditions. Despite its niche application, the issue of API sourcing remains pertinent for research institutions, compounding pharmacies, and small biotech companies.

Masoprocol's synthesis involves specific chemical reactions that demand high purity standards aligned with pharmacopeial requirements (USP, EP, or JP). Due to its limited production volumes, sourcing options are often specialized, requiring engagement with niche chemical suppliers or custom synthesis providers.

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2. Global API Suppliers and Manufacturers for Masoprocol

2.1 Major API Suppliers in Asia

China and India dominate the bulk API manufacturing landscape due to their extensive chemical industries, cost-efficient production capabilities, and ability to meet diverse regulatory standards.

• Shenzhen EnQuad Biotech (China)
  Specialized in custom synthesis and API manufacturing, offering masoprocol at research-grade and GMP-compliant levels. They hold the capability to tailor production for pharmaceutical needs, with certifications process upon request.

• Zhejiang Haizheng Pharmaceutical Co., Ltd. (China)
  Known for synthesizing niche APIs, including derivatives of urea compounds, with GMP certification aligning with international standards.

• Sinochem Group (China)
  Implements large-scale API production, including specialty compounds, with robust quality assurance systems.

India

• Hetero Labs Ltd.
  A prominent player in API manufacturing, Hetero provides custom synthesis services, including rare and specialty APIs. Their facilities are WHO-GMP compliant, ensuring quality and regulatory compatibility.

• Dr. Reddy’s Laboratories
  Offers a range of APIs, with capabilities for custom synthesis and development of specialty compounds. Though masoprocol is not a standard product, their flexibility allows for custom procurement.

• Sun Pharmaceutical Industries Ltd.
  Active in niche APIs, with facilities capable of producing specialized APIs like masoprocol under strict quality controls.

2.2 Suppliers in North America and Europe

While most masoprocol sourcing originates from Asia, certain North American and European chemical suppliers supply high-purity APIs:

• Cayman Chemical (USA)
  Specializes in research-grade chemicals and APIs, including urea derivatives, including masoprocol for research purposes.

• Sigma-Aldrich (Merck Group), now MilliporeSigma (Europe/USA)
  Offers research-grade masoprocol for in vitro and in vivo research applications. Although primarily for research, their products adhere to high-quality standards suitable for preclinical studies.

• Bachem AG (Switzerland)
  Provides custom synthesis and peptide/Chemical APIs, including specialized compounds with pharmaceutical-grade standards.

2.3 Custom Synthesis and Contract Manufacturing

In cases where off-the-shelf APIs are unavailable or insufficient, pharmaceutical companies and research institutions often turn to Contract Manufacturing Organizations (CMOs) that offer:

• Custom API synthesis tailored to specific purity and quantity requirements.
• GMP-compliant production for clinical trial material or commercial use.
• Notable CMOs include Lonza, Thermo Fisher Scientific, and Almac Group, capable of synthesizing niche API compounds like masoprocol.

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3. Quality Standards and Regulatory Considerations

Procurement of masoprocol APIs should be aligned with regulatory compliance to ensure safety and efficacy. Notable standards include:

• GMP (Good Manufacturing Practice) certification for APIs intended for clinical or commercial use.
• USP/NF or EP monographs if applicable; however, masoprocol is a niche compound and may lack monograph recognition, necessitating self-validated quality controls.
• Certificates of Analysis (CoA), stability data, and impurity profiles must accompany procurement.

Sourcing from reputable suppliers with robust quality management systems mitigates regulatory risks, especially when transitioning from research to clinical application.

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4. Challenges in Sourcing Masoprocol API

• Limited Commercial Production: The scarcity of large-scale masoprocol manufacturers impairs supply predictability.
• Regulatory Barriers: Some suppliers may lack compliance documentation or certifications, restricting their use in regulated environments.
• Cost Variability: Custom synthesis and niche APIs incur higher costs; bulk procurement may require negotiation and long-term contracts.
• Purity and Composition: Ensuring batch-to-batch consistency and purity levels is critical, especially for clinical applications.

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5. Emerging Trends and Future Outlook

As interest in personalized medicine and targeted dermatological therapies increases, the potential re-emergence of masoprocol or analogues as therapeutic agents depends on reliable supply channels. Advances in synthetic methodologies could lower production costs, potentially expanding availability.

Furthermore, regional efforts to develop local API manufacturing capabilities and strengthen regulatory frameworks may improve sourcing options globally, reducing reliance on limited Asian suppliers.

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Key Considerations for Procurement

• Engage with suppliers demonstrating GMP compliance and quality certifications.
• Prioritize suppliers offering comprehensive Certificates of Analysis and stability data.
• Explore collaborative arrangements with CMOs for custom synthesis to ensure specifications meet specific needs.
• Evaluate the regulatory status and legal considerations in the purchaser’s jurisdiction before procurement.

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Key Takeaways

• Limited but Growing Supplier Base: Asian manufacturers dominate, with select research-grade suppliers offering masoprocol globally.
• Quality and Regulatory Assurance Critical: Procurement should target GMP-compliant products with thorough documentation.
• Custom Synthesis as a Viable Path: For specialized or clinical-grade API needs, partnering with CMOs is often necessary.
• Supply Chain Risks: Scarcity of manufacturers and limited documented production necessitate proactive sourcing strategies.
• Future Opportunities: Advances in synthesis and manufacturing could expand availability and reduce costs, benefiting research and clinical development.

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FAQs

Q1: Is masoprocol available from major pharmaceutical API suppliers?
A1: Its availability is limited; mainly Asia-based suppliers and select research-grade providers offer masoprocol APIs, with commercial production being niche.

Q2: Can I source GMP-grade masoprocol for clinical trials?
A2: Yes, but through specialized CMOs or licensed suppliers capable of custom synthesis under GMP standards; check supplier certifications before procurement.

Q3: What quality parameters should I verify for masoprocol API?
A3: Purity (>98%), impurity profile, certificates of analysis, stability data, and compliance with relevant pharmacopeial standards are essential.

Q4: Are there significant regional differences in sourcing masoprocol?
A4: Asia dominates supply due to cost advantages; Europe and North America primarily provide research-grade APIs, often at higher costs with strict quality controls.

Q5: What are the main challenges in sourcing masoprocol?
A5: Limited number of manufacturers, lack of widespread commercial production, potential regulatory hurdles, and higher costs for custom synthesis pose notable challenges.

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References

1. U.S. Pharmacopoeia. USP Monographs and Quality Standards for API Synthesis.
2. Global Chemical Suppliers Industry Reports.
3. Clinical and Regulatory Data on Masoprocol.
4. Contract Manufacturing Organization Capabilities and Certifications.

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This comprehensive overview aims to inform pharmaceutical professionals, R&D managers, and procurement specialists on the current landscape of sourcing masoprocol APIs, emphasizing quality, regulatory compliance, and strategic partnerships.