Bulk Pharmaceutical API Sources for PHEBURANE

Bulk Pharmaceutical API Sources for PHEBURANE

Vendor	Vendor Homepage	Vendor Sku	API Url
Calbiochem		567616
Hangzhou Trylead Chemical Technology		TL8001350
HDH Pharma		IN1087
NovoSeek		5258

Bulk Active Pharmaceutical Ingredient (API) Sources for PHEBURANE

Last updated: August 3, 2025

Introduction

PHEBURANE (sodium phenylbutyrate), developed and marketed by Recordati Rare Diseases, addresses the rare metabolic disorder urea cycle disorder (UCD). As an essential therapeutic agent, the supply chain integrity of its active pharmaceutical ingredient (API) is crucial. Securing reliable sources of bulk API ensures continuous manufacturing, regulatory compliance, and market stability. This article explores the global API sourcing landscape for PHEBURANE, emphasizing key suppliers, supply chain considerations, manufacturing standards, and emerging trends relevant to stakeholders.

Understanding PHEBURANE API Composition

PHEBURANE's API is sodium phenylbutyrate, a nitrogen-scavenging agent that facilitates ammonia detoxification in UCD patients. The API is synthesized through well-established chemical processes involving phenylbutyric acid derivatives. Ensuring high purity, consistent quality, and compliance with pharmacopeial standards is paramount to patient safety and regulatory approval.

Global API Manufacturing Landscape

The API market for sodium phenylbutyrate is characterized by limitedmanufacturers possessing specialized expertise and quality assurance frameworks. Major global supplier concentrations exist within regions with well-developed chemical manufacturing infrastructure, primarily in Western countries and parts of Asia.

Key API Suppliers for Sodium Phenylbutyrate

1. Indian Manufacturers

   India’s pharmaceutical sector is a significant contributor to global API production, including niche and rare APIs like sodium phenylbutyrate. Prominent players include:

   • Sun Pharmaceutical Industries Ltd.
   • Granules India Ltd.
   • Jubilant Life Sciences

   These companies leverage robust chemical synthesis capabilities, stringent quality controls, and cost advantages. Indian suppliers often meet international regulatory standards such as USFDA, EDQM, and Japanese PMDA certifications, vital for global distribution.

2. Chinese Suppliers

   China remains a pivotal hub for API manufacturing owing to economies of scale and extensive chemical industries. Leading Chinese API producers include:

   • North China Pharmaceutical Group (NCPC)
   • Hengkang Pharmaceutical
   • Jilin Shuangyang Pharmaceutical

   Chinese manufacturers demonstrate growing compliance with international standards, although ensuring consistent quality remains a priority for buyers.

3. European and North American Suppliers

   European firms like BASF and Evonik have minimal, specialized operations in rare API synthesis, often serving as high-quality, high-cost suppliers for niche markets. North American sources are limited but include boutique firms with advanced manufacturing capabilities.

Supply Chain Considerations

Regulatory Compliance: Suppliers must adhere to Good Manufacturing Practices (GMP) outlined by authorities such as the FDA, EMA, or WHO. Certificates of Suitability (CEP) and Drug Master Files (DMF) are critical documentation for regulatory approval.

Quality Assurance: Consistent API purity (typically ≥99%) and impurity profiles are mandatory. Suppliers are subject to rigorous quality audits, including in-process controls and final product testing, encompassing impurity limits and pharmacopoeial standards.

Supply Reliability: Given UCD’s necessity for life-long management, sourcing from multiple qualified suppliers mitigates supply risks. Lead times, production capacity, and geopolitical stability influence procurement planning.

Pricing Dynamics: API cost fluctuations impact overall treatment affordability. Indian and Chinese manufacturers often offer competitive prices, but regulatory barriers or quality assurance concerns can influence purchasing decisions.

Emerging Trends in API Sourcing for PHEBURANE

• Vertical Integration: Larger pharmaceutical companies increasingly develop in-house APIs or acquire API manufacturers to secure supply chains for rare APIs like sodium phenylbutyrate.

• Regulatory Harmonization: International efforts aim to streamline approval pathways, reducing market fragmentation and facilitating cross-border API sourcing.

• Quality Standard Enhancements: Advances in analytical chemistry enhance API quality control, including spectroscopic and chromatographic techniques for impurity profiling.

• Sustainability and Green Chemistry: Suppliers adopting environmentally friendly processes and waste reduction influence future API sourcing practices.

Challenges in API Sourcing for PHEBURANE

• Limited Supplier Pool: The niche nature of sodium phenylbutyrate constrains alternative sourcing avenues, magnifying supply risks.

• Regulatory Barriers: Variations in regulatory requirements across regions complicate supplier qualification and batch approval processes.

• Manufacturing Complexity: Maintaining high purity and consistent quality requires sophisticated chemical synthesis and rigorous controls, limiting small-scale or new entrants.

• Intellectual Property (IP): While sodium phenylbutyrate synthesis is well-established, IP considerations may influence licensing or sourcing agreements, especially from proprietary producers.

Conclusion

The procurement of bulk sodium phenylbutyrate API for PHEBURANE hinges on a select cohort of reliable, compliant manufacturers across India, China, and select Western regions. Navigating the complexities of quality assurance, regulatory compliance, and supply security remains paramount for pharmaceutical companies. Strategic supplier diversification and adherence to rigorous quality standards ensure uninterrupted production, critical for patient outcomes in UCD management.

Key Takeaways

• Indian and Chinese manufacturers dominate the global sodium phenylbutyrate API market, offering a balance of cost and compliance.
• Regulatory adherence, quality assurance, and supply continuity are essential criteria for selecting API suppliers for PHEBURANE.
• Emerging trends in green chemistry and supply chain harmonization could reshape future sourcing strategies.
• Limited supplier diversity underscores the importance of thorough due diligence and contingency planning.
• Strategic partnerships with GMP-certified manufacturers facilitate smoother regulatory approval and market access.

FAQs

1. What are the primary regions for sourcing sodium phenylbutyrate API?
India and China are the leading sources, offering established manufacturing capabilities, cost advantages, and an increasing number of GMP-compliant suppliers.

2. How do suppliers ensure the quality of sodium phenylbutyrate API?
Through rigorous GMP adherence, comprehensive quality testing (purity, impurities, stability), and regulatory certifications such as FDA or EMA approval.

3. What are the risks associated with API sourcing for PHEBURANE?
Supply disruptions, quality inconsistencies, regulatory non-compliance, and geopolitical factors pose risks that require mitigation via supplier diversification and thorough qualification processes.

4. How does regulatory compliance influence API sourcing?
Regulatory standards determine supplier eligibility, batch acceptance, and market access; non-compliance can delay approvals and impact drug safety.

5. Are there any new developments impacting API availability for sodium phenylbutyrate?
Yes, advances in green chemistry reduce environmental impact, and international harmonization efforts facilitate cross-border procurement, potentially expanding sourcing options.

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References

[1] Urea Cycle Disorder. Orphanet. Available at: https://www.orpha.net/consor/cgi-bin/OC_Exp.php?Lng=EN&Expert=16472
[2] US Food and Drug Administration. Guidance for Industry – API Quality Standards. 2021.
[3] Global API Market Dynamics. Pharma Intelligence. 2022.
[4] Chinese and Indian API Manufacturers’ Certification Profiles. GMP Compliance Reports. 2022.

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Disclaimer: This analysis synthesizes publicly available information and industry insights. For specific sourcing decisions, consult directly with manufacturers and regulatory bodies.