Bulk Pharmaceutical API Sources for SODIUM PHENYLACETATE AND SODIUM BENZOATE

Bulk Pharmaceutical API Sources for SODIUM PHENYLACETATE AND SODIUM BENZOATE

Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical		2023-05-9C06073
RR Scientific		R6389388

Bulk Active Pharmaceutical Ingredient (API) Sources for: Sodium Phenylacetate and Sodium Benzoate

Last updated: July 31, 2025

Introduction

The pharmaceutical industry relies heavily on the procurement of high-quality Active Pharmaceutical Ingredients (APIs), which are essential for drug formulation and manufacturing. Among these, Sodium Phenylacetate and Sodium Benzoate serve critical roles in various therapeutic and preservative applications. Securing reliable sources of these APIs ensures drug safety, regulatory compliance, and cost efficiency. This article provides an in-depth overview of global bulk API sources for Sodium Phenylacetate and Sodium Benzoate, emphasizing quality standards, key suppliers, and procurement considerations.

---

Overview of Sodium Phenylacetate and Sodium Benzoate

Sodium Phenylacetate is primarily used in metabolic disorder treatments, notably as a nitrogen-scavenging agent for urea cycle disorders. It inhibits amino acid breakdown, reducing ammonia levels in patients with hepatic encephalopathy or urea cycle dysfunctions.

Sodium Benzoate functions predominantly as a preservative in food, cosmetics, and pharmaceutical products due to its antimicrobial properties. Therapeutically, Sodium Benzoate has also been explored for potential roles in neurological conditions.

Both APIs are synthesized through chemical processes and require strict quality controls aligned with pharmacopeial standards such as USP, EP, or BP.

---

Global API Manufacturing Regions

Major API manufacturing hubs include:

• India: Known for cost-effective production, large-scale facilities, and comprehensive API portfolios.
• China: Offers extensive manufacturing capabilities, rapid production cycles, and competitive pricing.
• Europe: Emphasizes high-quality standards, regulatory compliance, and advanced R&D.
• United States: Focused on high-quality, GMP-compliant API production, often for patented or specialized APIs.

The choice of supplier depends on quality requirements, regulatory frameworks, and logistical considerations.

---

Bulk API Sources for Sodium Phenylacetate

1. Indian API Manufacturers and Suppliers

India hosts several reputed API manufacturers with specialization in amino acid derivatives and specialty APIs.

• Jubilant Life Sciences: A leading producer of APIs with a manufacturing facility compliant with WHO-GMP standards. They supply Sodium Phenylacetate for clinical and commercial use, emphasizing quality and process validation.
• Sun Pharmaceutical Industries: Offers a portfolio of APIs, including amino acid-based compounds with robust quality assurance frameworks.
• Aurobindo Pharma: Known for cost-effective APIs with GMP accreditation, capable of supplying Sodium Phenylacetate in bulk quantities.

2. Chinese API Suppliers

China's API sector for amino acid derivatives is robust, with several companies capable of providing Sodium Phenylacetate:

• Hengyang City Huiyuan Pharmaceutical Co., Ltd.: Engaged in chemical synthesis and supply of specialty amino acids and derivatives, including Sodium Phenylacetate.
• Shanghai Sinyet Chemical Co., Ltd.: Focuses on pharmaceutical intermediates and APIs, offering competitive pricing and reliable logistics.
• Zhejiang Wanfeng Chemical Co., Ltd.: Provides custom synthesis and bulk APIs complying with international standards.

3. European and US API Producers

While less dominant globally, European and US manufacturers focus on high-quality, GMP-compliant Sodium Phenylacetate:

• Wuxi AppTec (US-based operations): Offers APIs with strict regulatory compliance, especially for clinical supply.
• Bachem: Specializes in peptide-related APIs but also supplies specialty chemicals, potentially including Sodium Phenylacetate for research purposes.

---

Bulk API Sources for Sodium Benzoate

1. Indian API Manufacturers and Suppliers

India remains a key global supplier for Sodium Benzoate:

• Lupin Limited: Provides high-quality Sodium Benzoate conforming to pharmacopeial standards, with extensive GMP facilities.
• Aarti Industries: Offers globally sourced and manufactured Sodium Benzoate for pharmaceutical and food applications.
• Shilpa Medicare: Produces Sodium Benzoate with a focus on pharmaceutical-grade material, adhering to international quality norms.

2. Chinese API Suppliers

Chinese manufacturing capabilities in Sodium Benzoate are significant:

• Shandong IRO Chemical Co., Ltd.: Supplies pharmaceutical-grade Sodium Benzoate, with a competitive pricing model and compliance certifications.
• Shenzhen Bright Future Pharmaceutical Co., Ltd.: Capable of producing high-purity Sodium Benzoate suitable for both pharma and food industries.
• Qingdao Zhixin Chemical Co., Ltd.: Offers bulk quantities with product purity compliant with USP/BP standards.

3. European and US API Producers

• Furx Pharmaceutical (Europe): Supplies high-purity Sodium Benzoate for pharmaceutical use, adhering to strict quality standards.
• Sigma-Aldrich (Merck): Distributes pharmaceutical-grade Sodium Benzoate, widely used in research, manufacturing, and compounding.

---

Quality and Regulatory Considerations

Securing APIs compliant with global pharmacopeial standards (USP, EP, BP) is paramount. Suppliers must provide Certificates of Analysis (CoA), stability data, and manufacturing compliance documents. Regulatory surveillance ensures APIs are manufactured under GMP conditions, with traceability and consistent quality.

International suppliers often undergo audits by clients or third-party audit firms to verify compliance with Good Manufacturing Practices (GMP). Additionally, batch-to-batch consistency and impurity profile are critical quality parameters.

---

Supply Chain and Procurement Strategies

Successful procurement of Sodium Phenylacetate and Sodium Benzoate involves:

• Vendor Qualification: Vetting suppliers based on certification, quality history, and production capacity.
• Pricing Negotiation: Balancing cost-effectiveness with quality assurance.
• Lead Time Management: Planning for manufacturing cycles, transportation, and regulatory filings.
• Regulatory Documentation: Ensuring all documentation aligns with local and international regulatory requirements for import/export.

Diversifying sources—preferably in different regions—mitigates supply chain disruptions, especially amid geopolitical or logistical challenges.

---

Emerging Trends in API Sourcing

The industry is witnessing increased adoption of:

• Contract Manufacturing Organizations (CMOs): Offering flexible sourcing solutions, often with advanced quality management systems.
• Local Manufacturing Initiatives: Governments incentivize local API production to reduce reliance on imports.
• API Granulation and Stabilization Technologies: Improving API stability for easier transportation and storage.

In addition, digital platforms and global API marketplaces streamline sourcing, with real-time capacity and quality data.

---

Key Challenges and Mitigation

• Regulatory Variations: Differences in drug registration standards require thorough supplier audits and documentation.
• Quality Assurance: Ensuring purity and consistency; reliance on accredited suppliers reduces risk.
• Supply Chain Disruptions: Geopolitical issues, pandemics, or raw material shortages can impact supply; establishing multiple vendors mitigates this risk.
• Cost Fluctuations: Global market dynamics influence API pricing; long-term contracts stabilize costs.

---

Conclusion

Securing reliable, high-quality bulk sources of Sodium Phenylacetate and Sodium Benzoate is critical for pharmaceutical manufacturers. India and China represent dominant regions for cost-effective, scalable production, while Europe and the US emphasize quality and regulatory compliance. An effective procurement strategy balances sourcing diversity, quality assurance, cost management, and compliance.

---

Key Takeaways

• Diverse global sources exist for Sodium Phenylacetate and Sodium Benzoate, spanning India, China, Europe, and the US.
• Regulatory compliance with pharmacopeial standards (USP, EP, BP) is non-negotiable for pharmaceutical APIs.
• Quality assurance protocols should include vendor audits, Certificates of Analysis, and process validation.
• Supply chain resilience benefits from multi-region sourcing and established partnership agreements.
• Emerging digital platforms facilitate transparent, real-time sourcing, boosting supply chain agility.

---

FAQs

1. What are the primary considerations when sourcing Sodium Phenylacetate and Sodium Benzoate APIs?
Prioritize quality standards (GMP compliance), regulatory approvals, supplier reputation, batch consistency, and supply chain reliability.

2. Are Chinese API manufacturers suitable for pharmaceutical-grade Sodium Phenylacetate and Sodium Benzoate?
Yes. Several Chinese manufacturers meet international quality protocols, but thorough qualification audits are essential.

3. How do I verify API purity and quality?
Request Certificates of Analysis, review impurity profiles, conduct third-party testing, and verify compliance with pharmacopeial standards.

4. Can I source these APIs directly from API producers or via distributors?
Both options are available. Direct procurement offers cost advantages but requires rigorous qualification. Distributors provide logistical support and tested batch assurance.

5. How does regional geopolitics influence API sourcing?
Geopolitical tensions may impact trade flows, tariffs, and availability. Diversifying sources and establishing regional supply agreements mitigate risks.

---

Sources:

[1] US Pharmacopeia. "USP Monographs for Specialty Chemicals."
[2] European Pharmacopoeia. "List of Approved APIs."
[3] India Brand Equity Foundation. "Pharmaceutical Sector Overview."
[4] Chinese Pharmacopoeia. "API Manufacturing Standards."
[5] MarketsandMarkets. "API Market Trends & Forecasts."