Suppliers and packagers for generic pharmaceutical drug: SODIUM BENZOATE; SODIUM PHENYLACETATE

SODIUM BENZOATE; SODIUM PHENYLACETATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ailex Pharms Llc	SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	207096	ANDA	Ailex Pharmaceuticals, LLC	70556-100-50	1 VIAL, SINGLE-DOSE in 1 CARTON (70556-100-50) / 50 mL in 1 VIAL, SINGLE-DOSE	2016-02-24
Ailex Pharms Llc	SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	207096	ANDA	Omnivium Pharmaceuticals LLC	81665-203-01	1 VIAL, SINGLE-DOSE in 1 CARTON (81665-203-01) / 50 mL in 1 VIAL, SINGLE-DOSE	2025-02-25
Ailex Pharms Llc	SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	207096	ANDA	Omnivium Pharmaceuticals LLC	81665-204-01	1 VIAL, SINGLE-DOSE in 1 CARTON (81665-204-01) / 50 mL in 1 VIAL, SINGLE-DOSE	2025-05-15

Sodium Benzoate and Sodium Phenylacetate Supply Chain Analysis

Last updated: February 19, 2026

This report details the current global supply landscape for sodium benzoate and sodium phenylacetate, key active pharmaceutical ingredients (APIs) and excipients. It identifies major manufacturers, assesses production capacities, and outlines potential supply chain vulnerabilities relevant to pharmaceutical development and commercialization.

What are the Primary Applications of Sodium Benzoate and Sodium Phenylacetate in Pharmaceuticals?

Sodium benzoate is primarily used as a preservative in oral liquid medications, buffering agents, and as an API in the treatment of hyperammonemia. Sodium phenylacetate, often used in combination with sodium benzoate, is also a critical treatment for hyperammonemia.

• Sodium Benzoate:
  • Preservative (antimicrobial agent)
  • Buffering agent
  • API for Urea Cycle Disorders (UCDs), specifically hyperammonemia [1].
• Sodium Phenylacetate:
  • API for Urea Cycle Disorders (UCDs), specifically hyperammonemia [2].

Who are the Leading Global Manufacturers of Sodium Benzoate?

The global manufacturing base for sodium benzoate is diversified, with significant production in Asia, Europe, and North America. Production volumes are substantial, catering to both pharmaceutical and industrial-grade demand.

Manufacturer	Primary Region of Operation	Pharmaceutical Grade Production	Notes
Lanxess AG	Europe	Yes	Global specialty chemicals producer.
J.H. Gheysens NV	Europe	Yes	Focus on food and pharmaceutical grades.
Nanjing Union Chemical Co., Ltd.	Asia	Yes	Large-scale chemical producer.
Hebei Chengxin Co., Ltd.	Asia	Yes	Significant player in fine chemicals.
Sigma-Aldrich (Merck KGaA)	North America / Europe	Yes	Broad portfolio of laboratory chemicals.
Thermo Fisher Scientific	North America	Yes	Diverse chemical and lab supply.

These companies generally adhere to Good Manufacturing Practices (GMP) for pharmaceutical-grade production. Capacity can vary, but the market is generally not characterized by significant shortages, though specific purity requirements for APIs can influence availability from certain suppliers.

What is the Production Capacity and Market Size for Sodium Benzoate?

Estimates for the global sodium benzoate market size vary. In 2022, the market was valued at approximately USD 400 million to USD 500 million [3, 4]. Projections indicate a Compound Annual Growth Rate (CAGR) of 4% to 6% through 2028. Production capacity is considered robust, with significant overcapacity in certain regions, particularly in China and India, driven by demand from the food and beverage industry. Pharmaceutical-grade production represents a smaller, more specialized segment of the total output.

What are the Key Characteristics of Sodium Phenylacetate Production?

Sodium phenylacetate production is more specialized compared to sodium benzoate due to its primary role as a niche API. Manufacturing requires stringent quality controls and adherence to pharmaceutical GMP.

• Primary Production Methods: Typically synthesized through the reaction of phenylacetic acid with a sodium source, such as sodium hydroxide or sodium carbonate [2]. The synthesis pathway necessitates careful control of impurities.
• Key Manufacturers: The supply for pharmaceutical-grade sodium phenylacetate is concentrated among fewer suppliers compared to sodium benzoate. This concentration is a critical factor in supply chain risk assessment.

Manufacturer	Primary Region of Operation	Pharmaceutical Grade Production	Notes
Umanick Industries Inc.	North America	Yes	Specialized API and intermediate manufacturer.
Vink Chemicals GmbH & Co. KG	Europe	Yes	Focus on biocides and specialty chemicals for pharma.
Jubilant Pharmova Limited	Asia	Yes	Vertically integrated pharmaceutical company.
Hangzhou Dayang Chemical Co., Ltd.	Asia	Yes	Producer of pharmaceutical intermediates and APIs.

The development and qualification of new suppliers for sodium phenylacetate can be a time-consuming process, involving rigorous analytical testing and regulatory dossier submissions.

What is the Market Size and Supply Dynamics for Sodium Phenylacetate?

The market for pharmaceutical-grade sodium phenylacetate is significantly smaller than that of sodium benzoate. It is primarily driven by the demand for hyperammonemia treatments, which affects a specific patient population. The market size is estimated to be in the tens of millions of USD annually.

• Supply Chain Concentration: A smaller number of manufacturers means that supply disruptions from a single key producer can have a more immediate impact on availability.
• Pricing: Due to specialized manufacturing and smaller volumes, pharmaceutical-grade sodium phenylacetate typically commands a higher price per kilogram than industrial or food-grade sodium benzoate.

What are the Regulatory Requirements for Pharmaceutical-Grade Sodium Benzoate and Sodium Phenylacetate?

Both substances, when used as APIs or critical excipients in pharmaceuticals, must meet stringent regulatory standards.

• Pharmacopoeia Standards: Compliance with major pharmacopoeias is mandatory:
  • United States Pharmacopeia (USP)
  • European Pharmacopoeia (Ph. Eur.)
  • Japanese Pharmacopoeia (JP)
  • Other national pharmacopoeias as applicable.
• Good Manufacturing Practices (GMP): Manufacturers must operate under GMP guidelines to ensure product quality, consistency, and safety. This includes robust quality control, validated processes, and thorough documentation.
• Drug Master Files (DMFs): API manufacturers often submit DMFs to regulatory agencies (e.g., FDA in the US) to provide detailed information about their manufacturing process, facilities, and quality controls. These DMFs are then referenced by drug product manufacturers in their marketing applications.
• Impurity Profiling: Strict limits are placed on impurities, including heavy metals, residual solvents, and process-related impurities. For APIs like sodium phenylacetate, specific impurity limits are critical for patient safety.

What are the Potential Supply Chain Risks and Mitigation Strategies?

Several factors can pose risks to the reliable supply of these materials.

Supply Chain Risks:

• Geopolitical Instability: Concentration of manufacturing in specific regions can make the supply chain vulnerable to trade disputes, export restrictions, or regional conflicts.
• Raw Material Availability: Fluctuations in the cost and availability of precursor chemicals for both sodium benzoate and sodium phenylacetate can impact production.
• Regulatory Changes: Evolving regulatory requirements or unexpected enforcement actions can disrupt production or disqualify suppliers.
• Single-Source Dependence: For certain specialized grades or niche APIs like sodium phenylacetate, reliance on a limited number of suppliers creates significant risk.
• Quality Control Failures: Any lapse in GMP compliance or failure in quality testing can lead to batch rejections and supply interruptions.
• Logistical Challenges: Transportation disruptions, port congestion, or increased freight costs can impact delivery timelines and costs.

Mitigation Strategies:

• Supplier Diversification: Identify and qualify multiple suppliers across different geographical regions. For sodium phenylacetate, this is paramount.
• Dual Sourcing for Critical Raw Materials: Secure supply of key precursor chemicals from more than one source.
• Robust Quality Agreements: Establish detailed quality agreements with suppliers, clearly defining specifications, testing protocols, change control, and audit rights.
• Inventory Management: Maintain appropriate safety stock levels for critical materials, balancing inventory holding costs against the risk of stock-outs.
• Supplier Audits and Monitoring: Conduct regular on-site audits of manufacturing facilities to ensure ongoing compliance with GMP and quality standards.
• Contingency Planning: Develop detailed contingency plans for potential supply disruptions, including pre-identified alternative suppliers and expedited shipping options.
• Engage with Manufacturers Early: Collaborate with suppliers during the drug development lifecycle to understand their capacity, lead times, and potential challenges.

Key Takeaways

The global supply of sodium benzoate is characterized by broad manufacturing capacity and a diverse supplier base, primarily driven by food and industrial applications, with pharmaceutical grades meeting rigorous pharmacopoeial and GMP standards. Sodium phenylacetate, conversely, is a more specialized API with a concentrated manufacturing landscape. Its supply chain is therefore more susceptible to disruption, necessitating proactive risk management by pharmaceutical companies. Regulatory compliance, including adherence to USP, Ph. Eur., and GMP, is a fundamental prerequisite for all suppliers. Mitigation strategies should focus on supplier diversification, robust quality agreements, and proactive supply chain monitoring to ensure continuity of supply for both essential ingredients.

Frequently Asked Questions

1. What is the primary difference in manufacturing complexity between pharmaceutical-grade sodium benzoate and sodium phenylacetate? Pharmaceutical-grade sodium benzoate manufacturing complexity is moderate, driven by its widespread use and established production methods. Sodium phenylacetate production is more complex due to its niche API status, requiring highly specialized synthesis and stringent impurity control to meet pharmacopoeial and regulatory standards.

2. How does the price of pharmaceutical-grade sodium benzoate compare to industrial-grade? Pharmaceutical-grade sodium benzoate is typically more expensive than industrial-grade due to the additional costs associated with GMP compliance, rigorous quality testing, higher purity requirements, and specialized packaging.

3. Are there significant lead time differences for ordering pharmaceutical-grade sodium benzoate versus sodium phenylacetate? Yes. Due to its more diversified supply base and higher production volumes, lead times for pharmaceutical-grade sodium benzoate can be shorter and more predictable. Sodium phenylacetate, with its concentrated manufacturing and specialized production, often involves longer lead times and requires earlier ordering and closer coordination with suppliers.

4. What are the main regulatory hurdles for a new manufacturer to enter the market for pharmaceutical-grade sodium phenylacetate? Key regulatory hurdles include establishing GMP-compliant manufacturing facilities, developing and validating robust analytical methods for quality control, preparing comprehensive Drug Master Files (DMFs) for submission to health authorities, and undergoing successful facility inspections by regulatory agencies like the FDA or EMA.

5. Can the food-grade production capacity for sodium benzoate be easily converted to pharmaceutical-grade production? Conversion is not straightforward. While the basic chemical synthesis may be similar, pharmaceutical-grade production requires significant upgrades to facilities, equipment, quality management systems, and analytical testing capabilities to meet GMP and pharmacopoeial standards. This involves substantial investment and validation.

Citations

[1] National Organization for Rare Disorders. (n.d.). Hyperammonemia. Retrieved from https://rarediseases.org/rare-diseases/hyperammonemia/

[2] Summarized from typical pharmaceutical synthesis and drug labeling information for treatments of hyperammonemia. Specific source details are proprietary or within regulatory filings not publicly accessible.

[3] Grand View Research. (2023, November). Sodium Benzoate Market Size, Share & Trends Analysis Report. Retrieved from https://www.grandviewresearch.com/industry-analysis/sodium-benzoate-market

[4] Mordor Intelligence. (n.d.). Sodium Benzoate Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023 - 2028). Retrieved from https://www.mordorintelligence.com/industry-reports/sodium-benzoate-market