Suppliers and packagers for generic pharmaceutical drug: SODIUM ACETATE

SODIUM ACETATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	SODIUM ACETATE	sodium acetate	SOLUTION;INTRAVENOUS	218469	ANDA	Amneal Pharmaceuticals Private Limited	80830-2436-2	25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (80830-2436-2) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (80830-2436-1)	2025-08-12
Amneal	SODIUM ACETATE	sodium acetate	SOLUTION;INTRAVENOUS	218469	ANDA	Amneal Pharmaceuticals Private Limited	80830-2437-2	10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (80830-2437-2) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (80830-2437-1)	2025-08-12
Fresenius Kabi Usa	SODIUM ACETATE	sodium acetate	SOLUTION;INTRAVENOUS	206687	ANDA	Fresenius Kabi USA, LLC	63323-032-00	20 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-032-00) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (63323-032-04)	2017-10-30

Suppliers for the Pharmaceutical Drug: Sodium Acetate

Last updated: July 29, 2025

Introduction

Sodium acetate, a widely used pharmaceutical excipient and active pharmaceutical ingredient (API), plays a vital role in various medical and laboratory applications. Known for its buffering capacity and solubility, sodium acetate is integral to formulations such as infusion solutions, dialysis fluids, and laboratory media. The supply chain for sodium acetate involves a diverse range of manufacturers and suppliers spanning global markets. This article provides a comprehensive overview of key suppliers, emphasizing their manufacturing capabilities, quality standards, and strategic positioning within the pharmaceutical industry.

Overview of Sodium Acetate in Pharmaceuticals

Sodium acetate (NaC₂H₃O₂) is produced through the reaction of acetic acid with sodium compounds, typically sodium hydroxide or sodium carbonate. Pharmaceutical-grade sodium acetate conforms to stringent purity standards such as USP, EP, or BP, ensuring safety and efficacy in medical applications. The demand for sodium acetate is driven by the pharmaceutical, biotechnological, and clinical sectors, with suppliers consistently expanding their product portfolios to meet evolving regulatory and quality requirements.

Major Suppliers and Manufacturers

1. Merck KGaA (MilliporeSigma)

Merck KGaA, under its MilliporeSigma division, is a prominent supplier of pharmaceutical-grade chemicals, including sodium acetate. Their offerings include analytical grade and pharmaceutical grade sodium acetate, suitable for laboratory and injectable pharmaceutical applications. Merck emphasizes quality control, complying with Good Manufacturing Practices (GMP), and adheres to global regulatory standards, making it a preferred choice among pharmaceutical companies.

2. Thermo Fisher Scientific

Thermo Fisher Scientific supplies a broad spectrum of laboratory reagents, including sodium acetate in multiple grades. Their sodium acetate solutions are used widely in bioprocessing, clinical diagnostics, and research. The company's global distribution network ensures reliable supply chains, and their products meet regulatory standards such as USP and EP.

3. Avantor (VWR, PanReac)

Avantor, through its brands VWR and PanReac, distributes sodium acetate for various pharmaceutical and laboratory applications. Avantor maintains a comprehensive product portfolio, offering both analytical and pharmaceutical grades of sodium acetate. Their focus on quality assurance and regulatory compliance makes their sodium acetate suitable for injectable and research purposes.

4. MP Biomedicals

Specializing in biochemical solutions, MP Biomedicals supplies sodium acetate with a focus on research, development, and pharmaceutical applications. Their sodium acetate products are manufactured in compliance with current Good Manufacturing Practices (cGMP) and meet international standards, making them suitable for pharmaceutical formulations.

5. Sigma-Aldrich (Merck)

While now part of Merck KGaA, the Sigma-Aldrich brand remains a key distributor of sodium acetate. Their extensive catalog includes analytical and pharmaceutical grades, supporting research laboratories, pharmaceutical manufacturers, and healthcare providers worldwide.

6. Greenfield Chemicals

Greenfield Chemicals specializes in the production of pharmaceutical and food-grade sodium acetate. Their capacity spans bulk manufacturing, and they adhere to ISO quality standards, ensuring consistent product purity. They serve regional markets across Asia, Europe, and North America.

7. local and regional manufacturers in China and India

China and India are significant hubs for sodium acetate production, featuring numerous regional suppliers such as Shandong Xinhua Pharmaceutical, Simalab Chemicals, and Vinayak Ingredients. These suppliers often cater to both pharmaceutical and industrial markets and typically offer competitive pricing. However, buyers must rigorously evaluate quality certifications and regulatory compliance for pharmaceutical-grade products.

Factors to Consider When Selecting Sodium Acetate Suppliers

• Regulatory Compliance: Ensure supplier adherence to pharmacopeial standards (USP, EP, BP) and GMP certifications.
• Quality Assurance: Verify purity levels, certificates of analysis (CoA), and validation data.
• Supply Chain Robustness: Assess the supplier's capacity for consistent supply, lead times, and contingency planning.
• Pricing and Terms: Evaluate competitive pricing, minimum order quantities, payment terms, and logistical costs.
• Geographical Reach: Consider proximity, distribution network, and import/export capabilities, especially for regional markets.

Regulatory and Quality Standards Impacting Suppliers

Pharmaceutical-grade sodium acetate must meet strict regulatory standards to ensure safety and efficacy. Suppliers operating within GMP frameworks and adhering to pharmacopoeial specifications facilitate seamless integration into pharmaceutical manufacturing processes. Certification by relevant regulatory bodies (e.g., FDA, EMA, CFDA) further enhances supplier credibility.

Emerging Trends in Sodium Acetate Supply

• Increased demand due to COVID-19: The pandemic accelerated reliance on sodium acetate in vaccine and therapeutic formulations, prompting suppliers to scale manufacturing.
• Sustainability initiatives: Suppliers are adopting greener production methods, reducing waste and energy consumption.
• Regional supply chain improvements: Countries are strengthening local manufacturing capacities to reduce dependency on imports, ensuring supply continuity amid geopolitical tensions.

Challenges in the Sodium Acetate Supply Chain

• Quality Variability: Variations in purity levels among regional suppliers necessitate thorough vetting.
• Regulatory Barriers: Import restrictions, compliance costs, and evolving standards can impede procurement.
• Price Fluctuations: Raw material costs, coupled with supply-demand imbalances, influence market pricing.
• Logistical Disruptions: Global logistics issues, such as shipping delays, impact timely procurement, especially for bulk orders.

Conclusion

The supply landscape for pharmaceutical-grade sodium acetate encompasses a mix of global corporations, regional manufacturers, and local suppliers, each delivering varying levels of quality, assurance, and reliability. Industry players must prioritize regulatory compliance and quality standards while considering logistical and cost factors. Strengthening supplier relationships with credible and compliant vendors ensures consistent supply, critical in high-demand therapeutic and research applications.

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Key Takeaways

• Globally, leading suppliers like Merck KGaA, Thermo Fisher Scientific, and Avantor provide high-quality sodium acetate suitable for pharmaceutical use.
• Regional manufacturers in China and India offer cost-effective options but require rigorous validation for quality compliance.
• Regulatory adherence and GMP certification are vital criteria in selecting pharmaceutical-grade sodium acetate suppliers.
• Supply chain resilience is increasingly important amid disruptions from geopolitical shifts, pandemics, and logistical challenges.
• Continuous monitoring of market trends, investments in quality assurance, and supplier diversification mitigate risks and ensure supply stability.

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FAQs

1. What are the main applications of pharmaceutical-grade sodium acetate?
Pharmaceutical-grade sodium acetate is primarily used as an excipient, buffering agent in infusion solutions, dialysis fluids, and laboratory media, as well as in pharmaceutical manufacturing processes requiring precise pH control.

2. How can I verify the quality of sodium acetate from a supplier?
Request comprehensive Certificates of Analysis (CoA), check for compliance with pharmacopeial standards (USP, EP, BP), and conduct in-house testing or third-party validation if necessary.

3. Are regional Chinese and Indian suppliers reliable for pharmaceutical-grade sodium acetate?
Many regional suppliers adhere to international quality standards; however, verify their certifications, quality control procedures, and regulatory compliance before procurement.

4. What factors influence the cost of sodium acetate in pharmaceuticals?
Market demand, raw material costs, purity grade, supply chain logistics, and volume discounts significantly affect pricing.

5. What trends are shaping the future of sodium acetate suppliers?
Increasing demand during health crises, adoption of sustainable manufacturing practices, and regional supply chain development are key future trends influencing suppliers.

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References

[1] USP-NF Monographs for Sodium Acetate
[2] European Pharmacopoeia, Sodium Acetate Monograph
[3] Market reports on pharmaceutical excipients supply chains (2022-2023)
[4] Industry analyses of chemical manufacturing in Asia
[5] Regulatory guidelines on pharmaceutical excipients (FDA, EMA)