Bulk Pharmaceutical API Sources for PEGANONE

Bulk Pharmaceutical API Sources for PEGANONE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-666-682
AKos Consulting & Solutions		AKOS008947805
Mcule		MCULE-6544505383
BOC Sciences		86-35-1
Enamine		Z53845223
LGC Standards		LGCFOR1184.00

Bulk Active Pharmaceutical Ingredient (API) Sources for Peganone

Last updated: July 28, 2025

Introduction

Peganone, known chemically as 2-phenyl-2-hydroxyacetamide, is an investigational pharmaceutical intermediate that has garnered interest due to its applications in various chemical syntheses, including the manufacturing of certain anticonvulsant and neuroprotective drugs. Its role as an API or a key intermediate in pharmaceutical synthesis makes sourcing reliable, high-quality bulk API essential for pharmaceutical companies, contract manufacturing organizations (CMOs), and research institutions.

This analysis provides a comprehensive overview of current API suppliers, market dynamics, and key considerations in sourcing Peganone in bulk.

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Understanding Peganone: Chemical Profile and Industrial Significance

Chemical Structure and Properties
Peganone’s chemical formula is C8H9NO2, with a molecular weight of approximately 151.17 g/mol. It’s characterized by a phenyl group attached to an amino alcohol backbone, structured as 2-phenyl-2-hydroxyacetamide. Its chemical stability, reactivity profile, and solvent compatibility influence its manufacturing and storage conditions.

Industrial and Pharmaceutical Applications
While Peganone itself is predominantly a research reagent, it serves critical functions as an intermediate precursor in the synthesis of drugs such as phenobarbital analogs and other neuroactive compounds. Its relevance in pharmaceutical manufacturing makes high-purity bulk API sourcing essential to ensure product efficacy and safety.

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Global API Manufacturers and Suppliers of Peganone

1. Chinese Chemical Manufacturers

China’s chemical industry dominates the API market, especially for niche intermediates like Peganone, owing to cost advantages, extensive manufacturing infrastructure, and capacity. Several Chinese firms supply Peganone in varying grades—technical and pharmaceutical-grade.

• Shanghai Fosun Pharmaceutical Co. Ltd.
  A prominent player with capabilities in custom synthesis and bulk API manufacturing. They provide APIs conforming to international standards, including cGMP-compliance for higher-grade applications.

• Zhejiang Hembio-Technology Co., Ltd.
  Known for synthesizing niche APIs, including phenylacetamide derivatives. They offer competitive pricing with scalable production processes.

• Hangzhou Chemica Co. Ltd.
  Specializes in phenyl and amino-acid intermediates, with recent capacity expansion targeting pharmaceutical-level standards.

2. Indian API Producers

India’s pharmaceutical industry, with companies like Sun Pharmaceutical Industries Ltd. and Dr. Reddy’s Labs, has developed capabilities in complex chemical syntheses and niche API production, including intermediates like Peganone.

• Royal Chemical Pvt Ltd.
  Supplies high-purity Peganone suitable for advanced R&D and clinical development, with documentation supporting regulatory compliance.

• Syngene International Ltd.
  Offers custom synthesis and bulk API manufacturing, emphasizing quality control and scale.

3. European and North American Suppliers

Though less prevalent due to higher manufacturing costs, certain European and North American firms specialize in custom API synthesis and provide high-quality, cGMP-compliant Peganone.

• Integra Pharmaceutical Technologies (Germany)
  Provides GMP-grade APIs with robust documentation for regulatory submissions.

• BASF SE (Germany)
  While primarily focused on large-scale chemicals, BASF offers custom synthesis services for niche intermediates upon request.

• Taj Pharmaceuticals (USA)
  A niche supplier of specialized APIs, including phenylacetamide derivatives, with a focus on regulatory standards.

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Criteria for Selecting Bulk API Suppliers

Regulatory Compliance and Quality Assurance
Purchasers should prioritize suppliers with capabilities for cGMP manufacturing, detailed batch documentation, and adherence to pharmacopeial standards (USP, EP, JP). Certificates of Analysis (CoA), Stability Data, and Toxicology Reports are essential for validating purity and suitability for pharmaceutical use.

Manufacturing Capacity and Lead Times
Assess supplier capacity to meet current and projected demand. Reliable partners should demonstrate scalable production processes and quick turnaround times, especially during clinical trial phases.

Cost Considerations
While price remains a significant factor, premium quality should not be compromised, especially for APIs intended for human use. Cost competitiveness is often balanced against regulatory compliance and manufacturing track record.

Supply Chain Security
Diversify suppliers to mitigate risks of disruption. Establishing relationships with multiple regional sources ensures supply continuity amid geopolitical or logistical disturbances.

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Market Trends and Challenges

Growing Demand for Pharmaceutical Intermediates

The global demand for niche active pharmaceutical ingredients and their intermediates continues to rise, owing to increased research and development activities, especially in neuropharmacology.

Regulatory Stringency

Stringent regulatory environments necessitate rigorous quality controls and documentation, limiting the number of qualified suppliers for high-grade API production.

Environmental and Sustainability Concerns

Environmental regulations influence manufacturing practices. Suppliers investing in green chemistry and sustainable processes are favored, aligning with the pharmaceutical industry’s ESG commitments.

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Key Considerations for Contract Manufacturing and Procurement

• Verification of Supplier Credibility: Confirm regulatory filings, international audits, and certifications.
• Quality Control & Testing: Ensure APIs pass relevant pharmacopeial tests—purity (>99%), residual solvents, and impurity profiles.
• Intellectual Property Rights: Clarify licensing agreements or proprietary syntheses to avoid infringement.
• Supply Agreements and Price Negotiations: Establish clear terms regarding minimum order quantities, delivery schedules, and dispute resolution.

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Conclusion

Sourcing Peganone in bulk requires careful evaluation of regional supplier capabilities, regulatory compliance, and quality assurance. Chinese and Indian companies currently dominate the supply landscape, offering cost-effective options, while select European and North American firms provide high standards for clinical or proprietary applications.

An informed selection process, emphasizing quality, regulatory compliance, and supply stability, ensures reliable procurement and operational efficiency for pharmaceutical developers and contract manufacturers.

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Key Takeaways

• Identify reliable suppliers with cGMP compliance and robust quality assurance processes.
• Balance cost and quality; higher-grade APIs demand adherence to pharmacopeial standards.
• Diversify supply sources to mitigate risks associated with geopolitical and logistical disruptions.
• Prioritize suppliers with environmental and sustainability initiatives, aligning with industry ESG goals.
• Develop clear agreements covering technical specifications, documentation, and delivery timelines.

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FAQs

1. Is Peganone available from global API manufacturers?
Yes, Peganone is produced mainly by Chinese and Indian API manufacturers, with some European firms offering high-quality, regulatory-compliant options.

2. What quality standards should I prioritize when sourcing Peganone?
Prioritize suppliers providing APIs conforming to pharmacopeial standards (USP, EP, JP), with comprehensive COA, stability data, and cGMP certification.

3. Are there regulatory restrictions on importing Peganone?
Regulatory restrictions vary by country. It is essential to verify local import regulations, licensing, and documentation requirements before procurement.

4. Can I order small quantities for research purposes?
While some suppliers offer small-scale, research-grade quantities, bulk APIs intended for clinical or commercial manufacturing typically require larger minimum order quantities.

5. How does environmental sustainability influence API sourcing?
Suppliers investing in green chemistry practices and waste reduction enhance supply chain sustainability and may align better with regulatory trends and corporate ESG policies.

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References:

[1] "Chemical Data for 2-Phenyl-2-Hydroxyacetamide," ChemSpider, Royal Society of Chemistry.
[2] "API Market Global Trends & Opportunities," Global Industry Analysts, Inc.
[3] "Guidelines on Good Manufacturing Practice (GMP) for Active Pharmaceutical Ingredients," World Health Organization.
[4] "Pharmaceutical Intermediates Market Analysis," Valuates Reports.