dextrose; magnesium acetate; potassium acetate; sodium chloride: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Otsuka Icu Medcl	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	dextrose; magnesium acetate; potassium acetate; sodium chloride	INJECTABLE;INJECTION	017610	NDA	ICU Medical Inc.	0990-7965-09	12 POUCH in 1 CASE (0990-7965-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG	2021-02-08
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

The pharmaceutical manufacturing landscape relies heavily on the availability and quality of active and excipient ingredients. Dextrose, magnesium acetate, potassium acetate, and sodium chloride are essential compounds used across various formulations, including IV solutions, infusion fluids, and diagnostic protocols. Securing reliable suppliers is crucial to maintaining regulatory compliance, ensuring product consistency, and meeting global demand. This article evaluates the key suppliers for these compounds, highlighting their capabilities, quality standards, and market positioning to assist pharmaceutical companies in their sourcing strategies.

Dextrose: Market Overview and Suppliers

Dextrose monohydrate (glucose) is a vital carbohydrate source in medical, nutritional, and pharmaceutical applications. It must meet rigorous pharmacopeial standards such as USP, EP, or JP.

Major Suppliers:

Cargill, Inc.
A global leader in food and pharmaceutical-grade dextrose, Cargill supplies USP-grade dextrose monohydrate suitable for intravenous use and nutritional applications. Known for high-quality standards and consistent supply, Cargill has an extensive manufacturing network across North America, Europe, and Asia. Their products comply with stringent pharmacopeial standards, supporting pharmaceutical manufacturing needs.
Roquette Frères
A French-based global supplier specializing in pharmaceutical-grade excipients, including dextrose monohydrate. Roquette maintains GMP certification and offers tailored grades aligned with pharmacopeial specifications, ensuring product purity and low endotoxin levels for injectable formulations.
Archer Daniels Midland Company (ADM)
ADM supplies pharmacopeial-grade dextrose from their global production facilities, emphasizing high purity, low microbial contamination, and compliance with international standards. Their supply chain offers robustness and flexibility across North America, Europe, and Asia.
Haryanto Utama (Indonesia)
A regional supplier offering pharmaceutical-grade dextrose, focusing primarily on Southeast Asian markets. Their products meet pharmacopeial standards and support regional pharmaceutical manufacturing.

Magnesium Acetate: Suppliers and Market Dynamics

Magnesium acetate is a key electrolyte component in IV solutions, often used for magnesium supplementation and pH adjustment. It requires high purity and compliance with pharmacopeial standards.

Leading Suppliers:

Sigma-Aldrich/Merck KGaA
Globally renowned for high-quality chemicals, Sigma-Aldrich supplies pharmaceutical-grade magnesium acetate tetrahydrate, adhering to USP and EP standards. Their extensive distribution network enables timely delivery to manufacturers worldwide.
PT. Indochemik Internusa (Indonesia)
A regional supplier providing pharmaceutical-grade magnesium acetate, complying with local and international standards. They focus on serving Southeast Asian pharmaceutical companies with reliable, GMP-compliant products.
Tatic Group (India)
A significant manufacturer offering magnesium acetate with pharmaceutical certification, catering primarily to the Indian domestic market and exports.

Potassium Acetate: Prominent Suppliers

Potassium acetate functions as a buffering agent, electrolyte, and reagent in various pharmaceutical formulations.

Key Suppliers:

BASF SE
A global chemical giant, BASF supplies high-purity potassium acetate conforming to pharmacopeial standards. Their products are widely used in intravenous solutions and diagnostic applications, supported by rigorous quality control processes.
Tinci Materials Technology Co., Ltd. (China)
An emerging supplier offering pharmaceutical-grade potassium acetate with competitive pricing and reliable quality, approved under GMP standards for pharmaceutical manufacturing.
Siegfried AG (Switzerland)
Known for its pharmaceutical excipients, Siegfried offers potassium acetate with adherence to international standards, serving primarily North American and European markets.

Sodium Chloride: Market Leaders and Supply Chain

Sodium chloride (NaCl) is a fundamental component in intravenous fluids, parenteral nutrition, and various diagnostic solutions.

Leading Suppliers:

BASF SE
As a dominant supplier, BASF provides USP-grade sodium chloride for pharmaceutical applications, with production facilities that meet global quality standards and ensure consistent supply.
Shandong Xinhua Pharmaceutical Co., Ltd. (China)
A leading producer of pharmaceutical-grade sodium chloride, complying with pharmacopeial specifications, primarily serving Asian markets.
Cargill
Cargill manufactures pharmaceutical-grade sodium chloride with a focus on purity, sterility, and compliance with international standards.
Kemira Oyj (Finland)
Supplies high-purity sodium chloride, emphasizing environmental sustainability and quality, used in critical medical formulations.

Emerging Trends and Sourcing Strategies

Quality assurance: Suppliers must demonstrate compliance with GMP, USP, EP, or JP standards, with clear documentation, batch testing, and traceability.
Regional considerations: Asia-Pacific manufacturers are increasingly sourcing from regional suppliers to mitigate supply chain disruptions, whereas North American and European firms prioritize suppliers with validated quality systems.
Supply chain resilience: Diversification across multiple suppliers diminishes risk of shortages, especially given recent global supply chain disruptions impacting pharmaceutical ingredients.
Sustainability and regulation: Suppliers adhering to environmental standards (ISO 14001) and responsible sourcing are gaining preference.

Conclusion

Securing reliable suppliers for dextrose, magnesium acetate, potassium acetate, and sodium chloride requires a balance of quality, capacity, and regulatory compliance. Leading global players such as Cargill, Roquette, BASF, and Sigma-Aldrich possess established reputations for delivering high-quality pharmaceutical ingredients. Regional suppliers can provide cost advantages and localized support, but must demonstrate adherence to international standards. Strategic diversification and rigorous qualification processes are essential to ensure consistent supply, high quality, and regulatory compliance in pharmaceutical manufacturing.

Key Takeaways

Focus on suppliers with demonstrated GMP and pharmacopeial compliance to ensure ingredient quality and regulatory acceptance.
Build relationships with diversified suppliers across regions to mitigate supply chain disruptions.
Conduct comprehensive supplier qualification, including audits, documentation review, and performance evaluations.
Prioritize suppliers with sustainable practices and environmental standards to align with corporate responsibility initiatives.
Regularly update sourcing strategies based on evolving global market dynamics and regulatory requirements.

FAQs

1. How do I verify if a supplier meets pharmaceutical-grade standards?
Validate their certifications (GMP, ISO, pharmacopeial compliance), request batch testing reports, and conduct on-site audits if possible.

2. Are regional suppliers a reliable alternative to global giants?
Yes, provided they demonstrate consistent product quality, proper documentation, and adherence to regulatory standards.

3. What are the common challenges in sourcing these compounds?
Supply chain disruptions, regulatory compliance, fluctuating raw material costs, and quality variability.

4. How can I ensure supply continuity for critical ingredients?
Establish relationships with multiple qualified suppliers, maintain safety stock, and implement rigorous qualification and monitoring protocols.

5. What impact do regulatory changes have on supplier choice?
Regulatory updates may require suppliers to meet new standards; hence, ongoing supplier qualification and monitoring are essential to ensure compliance.

References

[1] European Pharmacopoeia, General Notices.
[2] US Pharmacopeia, USP Monographs for Dextrose, Magnesium Acetate, Potassium Acetate, and Sodium Chloride.
[3] Supplier Websites: Cargill, Roquette, Sigma-Aldrich, BASF, Tinci.
[4] Market Reports: Global pharmaceutical excipients market analysis (2022).

Suppliers and packagers for generic pharmaceutical drug: dextrose; magnesium acetate; potassium acetate; sodium chloride