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

dextrose; sodium chloride

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
B Braun	DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	019631	NDA	B. Braun Medical Inc.	0264-7608-00	12 CONTAINER in 1 CASE (0264-7608-00) / 1000 mL in 1 CONTAINER	1988-02-24
B Braun	DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	019631	NDA	B. Braun Medical Inc.	0264-7608-10	24 CONTAINER in 1 CASE (0264-7608-10) / 500 mL in 1 CONTAINER	1988-02-24
B Braun	DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	019631	NDA	B. Braun Medical Inc.	0264-7610-00	12 CONTAINER in 1 CASE (0264-7610-00) / 1000 mL in 1 CONTAINER	1988-02-24
B Braun	DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	019631	NDA	B. Braun Medical Inc.	0264-7610-10	24 CONTAINER in 1 CASE (0264-7610-10) / 500 mL in 1 CONTAINER	1988-02-24
B Braun	DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	019631	NDA	B. Braun Medical Inc.	0264-7612-00	12 CONTAINER in 1 CASE (0264-7612-00) / 1000 mL in 1 CONTAINER	1988-02-24

Suppliers for Dextrose and Sodium Chloride Pharmaceutical Ingredients

Last updated: February 19, 2026

This report identifies key global suppliers of Dextrose and Sodium Chloride, critical excipients for pharmaceutical manufacturing. The analysis focuses on manufacturers with significant production capacity, regulatory compliance, and established supply chains to meet the demands of the global pharmaceutical industry.

Who Are the Primary Manufacturers of Pharmaceutical-Grade Dextrose?

Pharmaceutical-grade dextrose, also known as anhydrous dextrose or dextrose monohydrate, serves as an energy source and an excipient in intravenous solutions, oral rehydration salts, and tablet formulations. Key global manufacturers are characterized by their adherence to pharmacopoeial standards (USP, EP, JP) and Good Manufacturing Practices (GMP).

• Cargill, Incorporated: A major global producer of dextrose, with manufacturing facilities in North America and Europe. Cargill offers various grades of dextrose, including anhydrous and monohydrate, meeting stringent pharmaceutical quality requirements. Their production capacity is substantial, supporting large-volume pharmaceutical contracts.
• ADM (Archer Daniels Midland Company): ADM is a significant supplier of corn-derived ingredients, including pharmaceutical-grade dextrose. They operate multiple production sites globally and maintain robust quality control systems. Their product portfolio includes dextrose monohydrate and anhydrous dextrose for pharmaceutical applications.
• Roquette Frères: A French company specializing in plant-based ingredients, Roquette is a prominent European supplier of dextrose. They offer pharmaceutical-grade dextrose monohydrate and anhydrous dextrose, produced under strict GMP conditions. Roquette emphasizes its commitment to quality and supply chain security.
• Tereos: This French agricultural cooperative group is another significant producer of dextrose from starch. Tereos supplies pharmaceutical-grade dextrose monohydrate and anhydrous dextrose to markets worldwide, with manufacturing sites in Europe. They adhere to international pharmaceutical quality standards.
• Ingredion Incorporated: An American multinational ingredients solutions company, Ingredion produces dextrose derived from corn. They offer pharmaceutical-grade anhydrous dextrose and dextrose monohydrate, produced in facilities compliant with USP and EP monographs.

These suppliers compete on product purity, consistent quality, reliable supply, and regulatory documentation support. The market for pharmaceutical dextrose is driven by the demand for intravenous fluids, particularly in hospital settings and emerging markets.

What Are the Leading Sources of Pharmaceutical-Grade Sodium Chloride?

Pharmaceutical-grade sodium chloride (NaCl), or "saline," is essential for isotonic solutions, drug formulations, and as a diluent. Manufacturers must meet USP, EP, and JP standards for purity, low endotoxin levels, and controlled particulate matter.

• Cargill, Incorporated: Beyond dextrose, Cargill is also a significant producer of pharmaceutical-grade sodium chloride. They offer vacuum-evaporated and solar-evaporated salt products meeting the highest pharmaceutical specifications. Their global presence ensures broad market access.
• AkzoNobel N.V.: Through its Specialty Chemicals business (now Nouryon), AkzoNobel has been a historical supplier of high-purity sodium chloride for pharmaceutical applications. Their production is based on the electrolysis of brine, yielding exceptionally pure salt.
• Nouryon (formerly AkzoNobel Specialty Chemicals): Nouryon continues to supply pharmaceutical-grade salt products derived from its integrated salt and chlor-alkali operations. They emphasize stringent quality control and a secure supply chain for their NaCl offerings.
• US Salt, LLC (a division of Compass Minerals): A major North American producer of salt, US Salt supplies pharmaceutical-grade sodium chloride. Their refined salt products meet stringent pharmacopoeial requirements for use in injectable and oral pharmaceutical preparations.
• Weisgram GmbH (part of K+S Aktiengesellschaft): This German company is a producer of high-purity salts, including pharmaceutical-grade sodium chloride. They operate from underground salt deposits and employ advanced purification processes to meet demanding pharmaceutical standards.

The pharmaceutical sodium chloride market is characterized by high volume, relatively stable pricing, and a strong emphasis on meeting regulatory requirements for injectable products. Suppliers differentiate themselves through the consistency of their analytical data, the robustness of their regulatory support, and their capacity to handle large orders.

What Are the Key Regulatory and Quality Requirements for These Ingredients?

Pharmaceutical excipients must conform to stringent regulatory standards to ensure patient safety and drug efficacy. For dextrose and sodium chloride, these requirements are primarily defined by major pharmacopoeias.

• Pharmacopoeial Compliance:
  • United States Pharmacopeia (USP): Specifies monograph requirements for Dextrose (USP) and Sodium Chloride (USP) regarding identity, purity, assay, and limits for impurities such as heavy metals, arsenic, and other specific contaminants.
  • European Pharmacopoeia (EP): Similar to USP, the EP sets forth monographs for Dextrose (Monohydrate and Anhydrous) and Sodium Chloride, detailing acceptance criteria for quality.
  • Japanese Pharmacopoeia (JP): Provides equivalent standards for dextrose and sodium chloride for use in pharmaceutical products manufactured or sold in Japan.
• Good Manufacturing Practices (GMP): Manufacturers must operate under cGMP (current Good Manufacturing Practices) as mandated by regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This ensures that products are consistently produced and controlled according to quality standards. GMP covers all aspects of production, from raw materials, premises and equipment to the training and personal hygiene of staff.
• ICH Guidelines: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, such as ICH Q7 for GMP for Active Pharmaceutical Ingredients (which often extends to critical excipients), are universally recognized.
• Impurity Profiles: Suppliers must provide detailed documentation on impurity profiles, including residual solvents, heavy metals, microbial limits, and endotoxins, especially for parenteral-grade products.
• Supply Chain Security and Traceability: Pharmaceutical companies require assurance of supply chain integrity, including the origin of raw materials and complete traceability of the manufacturing process.
• Regulatory Filings Support: Suppliers are expected to provide comprehensive documentation to support drug product registrations, including Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and Drug Master Files (DMFs) or equivalent documentation where applicable.

The choice of supplier for dextrose and sodium chloride often hinges on a supplier's ability to consistently meet these exacting standards and provide the necessary regulatory support for drug product approval.

How Do Production Capacities and Geographic Distribution Influence Supply Chain Reliability?

The global demand for pharmaceutical-grade dextrose and sodium chloride necessitates suppliers with substantial production capacities and strategically located manufacturing facilities to ensure supply chain resilience.

• Production Capacity:
  • Leading dextrose manufacturers typically operate large-scale corn wet-milling facilities, enabling them to process millions of bushels of corn annually. This scale is critical to meeting the volume requirements of major pharmaceutical clients.
  • Sodium chloride production is often linked to large-scale salt extraction (mining, solar evaporation) and industrial chemical processes (e.g., chlor-alkali). Companies with integrated operations can achieve significant output.
• Geographic Distribution:
  • North America: A major hub for both dextrose (due to corn production) and sodium chloride. Suppliers here serve a significant portion of the U.S. and Canadian pharmaceutical markets.
  • Europe: Strong presence of dextrose producers (often from sugar beet or corn) and established salt mining operations. European manufacturers cater to the EU market and export globally.
  • Asia: Growing production capacity, particularly in China and India, for both ingredients to serve the expanding pharmaceutical industries in these regions and for export. However, quality consistency and regulatory adherence can be more variable compared to established Western suppliers.
• Risk Mitigation: A diversified supplier base across different geographic regions can mitigate risks associated with geopolitical instability, natural disasters, or localized regulatory changes. Pharmaceutical companies often qualify multiple suppliers to ensure continuity of supply.
• Logistics and Lead Times: Proximity of manufacturing sites to drug product manufacturing facilities can reduce lead times and transportation costs, improving overall supply chain efficiency.

The reliability of supply is directly correlated with a supplier's investment in scalable production technology, robust quality management systems, and a distributed manufacturing footprint.

What are the Comparative Advantages Among Top Suppliers?

Suppliers of pharmaceutical-grade dextrose and sodium chloride differentiate themselves through a combination of factors critical to drug manufacturers.

• Cargill:
  • Advantages: Broad portfolio of both dextrose and sodium chloride, significant global manufacturing footprint, strong reputation for quality and reliability, extensive regulatory support documentation.
  • Considerations: As a large conglomerate, integration and responsiveness may vary.
• ADM:
  • Advantages: Deep expertise in agricultural processing, large-scale dextrose production capacity, established global supply chain, competitive pricing.
  • Considerations: Focus is primarily on dextrose and other corn derivatives.
• Roquette Frères:
  • Advantages: Specialization in plant-based ingredients, high-purity dextrose offerings, strong commitment to pharmaceutical quality standards, European market presence.
  • Considerations: Primarily a dextrose supplier.
• Tereos:
  • Advantages: Significant sugar and starch processing capabilities, substantial dextrose production volume, European manufacturing base.
  • Considerations: Market perception relative to North American competitors may vary.
• Ingredion Incorporated:
  • Advantages: Strong focus on specialty ingredients, consistent quality for dextrose, established North American supply.
  • Considerations: Competes across a wide range of ingredient types.
• Nouryon (formerly AkzoNobel Specialty Chemicals):
  • Advantages: High-purity sodium chloride derived from advanced chemical processes, strong European market position, established quality control for pharmaceutical grade.
  • Considerations: Primarily a sodium chloride supplier with a strong chemical industry heritage.
• US Salt, LLC (Compass Minerals):
  • Advantages: Large-scale North American salt production, well-established supply for pharmaceutical sodium chloride, reliable product quality.
  • Considerations: Focus is on salt products.
• Weisgram GmbH (K+S Aktiengesellschaft):
  • Advantages: High-purity salt products from specialized extraction, strong European quality reputation, robust regulatory documentation.
  • Considerations: Primarily a sodium chloride supplier.

The selection criteria for a pharmaceutical manufacturer typically involve a rigorous assessment of quality, regulatory compliance, supply security, price, and the supplier's ability to provide ongoing technical and regulatory support.

Key Takeaways

• Global pharmaceutical-grade dextrose supply is dominated by large agricultural processors like Cargill, ADM, Roquette Frères, Tereos, and Ingredion, leveraging extensive corn and sugar beet processing infrastructure.
• Key pharmaceutical-grade sodium chloride suppliers include Cargill, Nouryon, US Salt, and Weisgram GmbH, drawing on refined salt production and chemical processing expertise.
• Adherence to USP, EP, and JP pharmacopoeial standards, alongside stringent GMP compliance, is non-negotiable for all suppliers.
• Production capacity, geographic diversification, and robust quality management systems are critical determinants of supply chain reliability for these essential excipients.
• Suppliers differentiate on product purity, consistency, regulatory support (including DMFs), and supply chain security to meet the demands of the highly regulated pharmaceutical industry.

Frequently Asked Questions

1. Are there regional differences in the quality standards for pharmaceutical-grade dextrose and sodium chloride? While the core pharmacopoeial standards (USP, EP, JP) are globally recognized, specific interpretations and enforcement can vary by regulatory agency. However, manufacturers targeting international markets generally aim to meet all major pharmacopoeial requirements.
2. What is the typical shelf life for pharmaceutical-grade dextrose and sodium chloride? Pharmaceutical-grade dextrose monohydrate and anhydrous dextrose typically have a shelf life of two to three years when stored under recommended conditions. Pharmaceutical-grade sodium chloride also maintains its quality for extended periods, often exceeding three years, provided it is stored in sealed containers to prevent moisture absorption.
3. Can suppliers provide custom specifications beyond pharmacopoeial requirements? Yes, many leading suppliers can accommodate custom specifications for parameters such as particle size distribution, specific impurity limits, or reduced endotoxin levels for parenteral applications, often requiring a dedicated qualification process and potentially impacting cost and lead time.
4. How do drug manufacturers audit their excipient suppliers? Drug manufacturers conduct rigorous audits that typically include on-site inspections of manufacturing facilities, review of quality management systems, assessment of GMP compliance, evaluation of change control procedures, and verification of supply chain traceability and security.
5. What are the primary risks associated with the supply of these excipients? Risks include raw material availability (e.g., crop yields for dextrose), geopolitical instability affecting supply chains, regulatory changes, quality deviations leading to product recalls, and increased demand from growing pharmaceutical markets, which can strain existing capacities.

Citations

[1] United States Pharmacopeial Convention. (n.d.). United States Pharmacopeia. Retrieved from https://www.usp.org/ [2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia. Retrieved from https://www.edqm.eu/ [3] Pharmaceuticals and Medical Devices Agency. (n.d.). Japanese Pharmacopoeia. Retrieved from https://www.pmda.go.jp/english/ [4] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice (CGMP) Regulations. Retrieved from https://www.fda.gov/ [5] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from https://www.ich.org/ [6] Cargill, Incorporated. (Company Information). Retrieved from various company publications and website. [7] Archer Daniels Midland Company. (Company Information). Retrieved from various company publications and website. [8] Roquette Frères. (Company Information). Retrieved from various company publications and website. [9] Tereos. (Company Information). Retrieved from various company publications and website. [10] Ingredion Incorporated. (Company Information). Retrieved from various company publications and website. [11] Nouryon. (Company Information). Retrieved from various company publications and website. [12] Compass Minerals International, Inc. (Company Information). Retrieved from various company publications and website. [13] K+S Aktiengesellschaft. (Company Information). Retrieved from various company publications and website.