DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K): Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)	dextrose; potassium chloride; sodium chloride	INJECTABLE;INJECTION	018037	NDA	Baxter Healthcare Company	0338-0663-04	1000 mL in 1 BAG (0338-0663-04)	1979-02-02
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 4, 2025

Introduction

The formulation comprising Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 15 mEq (K) is commonly used in various intravenous (IV) therapy applications, including hydration, electrolyte balance, and nutritional support. Sourcing high-quality, reliable suppliers for these active pharmaceutical ingredients (APIs) and their formulations is critical for pharmaceutical companies, hospitals, and compounding pharmacies. This report provides a detailed analysis of key suppliers globally, highlighting their capabilities, compliance standards, and market positioning.

Market Overview of the Ingredients

Dextrose 5% (D-Glucose)
Dextrose is a widely used carbohydrate in IV solutions, primarily for caloric supplementation and osmotic balance. The market for pharmaceutical-grade dextrose is mature, with numerous suppliers offering USP or EP grades.

Sodium Chloride 0.2%
A dilute sodium chloride solution is standard in electrolyte therapy, with global suppliers providing sterile, certified APIs for pharmacy and hospital use.

Potassium Chloride 15 mEq (K)
Potassium chloride is essential for correcting potassium deficiencies, with strong demand in clinical settings. Its suppliers must adhere to strict quality and safety standards.

Leading Suppliers for Pharmaceutical Dextrose 5%

1. Archer Daniels Midland Company (ADM)

Overview: A global leader in carbohydrate and amino acid production with extensive capabilities in high-quality dextrose manufacturing.
Certifications: ISO 9001, cGMP, FDA approvals, and certifications for pharmaceutical-grade products.
Market Position: Known for consistent purity standards and reliable supply chains.

2. Cargill, Inc.

Overview: Offers pharmaceutical-grade dextrose monohydrate, manufactured under strict quality controls.
Certifications: Good Manufacturing Practices (GMP), cGMP, and international quality certifications.
Strengths: Extensive global distribution network catering to hospitals and pharmaceutical manufacturers.

3. Roquette Frères

Overview: A France-based global supplier focused on specialty ingredients including dextrose for parenteral applications.
Certifications: ISO, Kosher, Halal, and pharmaceutical grades.
Reputation: Recognized for purity, low endotoxin levels, and compliance with pharmacopoeial standards.

4. Merck (known as MilliporeSigma in the US)

Overview: Supplies pharmaceutical-grade dextrose (D-glucose) in various formulations.
Certifications: cGMP, ISO, FDA-approved manufacturing facilities.
Market advantage: Strong regional presence in North America and Europe.

Suppliers for Sodium Chloride 0.2%

1. Baxter International Inc.

Overview: Major provider of sterile saline solutions used in hospitals worldwide.
Certifications: cGMP, FDA approval, ISO standards.
Supply focus: Large-scale manufacturing capacity, consistent quality assurance.

2. Fresenius Kabi

Overview: Global leader in IV solutions and electrolytes, including 0.2% sodium chloride.
Certifications: GMP, ISO, verifiable quality management systems.
Market presence: Extensive supply chain for hospital and pharmacy sectors.

3. Otsuka Pharmaceutical

Overview: Known for manufacturing sterile electrolyte injections, including sodium chloride solutions.
Certifications: GMP, ISO compliance.
Specialty: Focus on purity and stability for clinical applications.

4. B. Braun Melsungen AG

Overview: Provides a broad portfolio of IV solutions, including sterile sodium chloride.
Certifications: GMP, ISO.
Strategic advantage: Regional manufacturing hubs and global distribution network.

Leading Suppliers for Potassium Chloride 15 mEq (K)

1. Sigma-Aldrich (Merck Group)

Overview: A leading provider of high-purity potassium chloride for pharmaceutical and research applications.
Certifications: ISO, GMP, and pharmacopeial grades.
Market strengths: Versatile product offerings, robust quality controls.

2. Fisher Scientific (Thermo Fisher Scientific)

Overview: Supplies potassium chloride in pharmaceutical-grade quality, suitable for IV solutions.
Certifications: ISO, GMP.
Unique selling point: Wide product catalog, reliable supply chain.

3. MolPort

Overview: A chemical marketplace offering bulk and specialty potassium chloride for pharmaceutical manufacturing.
Certifications: Verified suppliers with ISO standards.
Application: Suitable for large-scale formulation and compounding.

4. Wockhardt Ltd.

Overview: An Indian pharmaceutical manufacturer with capabilities in manufacturing potassium chloride solutions.
Certifications: WHO-GMP, ISO, major export approvals.
Key advantage: Cost-effective sourcing with high-quality standards.

Integrated Suppliers and Contract Manufacturing Organizations (CMOs)

Several organizations provide integrated solutions for formulations containing these ingredients, ensuring compliance with regulatory standards:

Baxter Healthcare – Specializes in IV solutions with integrated supply chains.
Fresenius Kabi – Offers both APIs and finished formulations, ensuring seamless supply.
CMOs such as Jubilant Cadista or WuXi AppTec – Provide custom formulation, sourcing, and packaging services.

Quality and Regulatory Considerations

Sourcing from approved suppliers requires conformity to pharmacopeial standards like USP, EP, or JP. Suppliers should demonstrate adherence to cGMP, exhibit stable quality controls, and possess necessary regulatory certifications (FDA, EMA, WHO). Traceability and reliable supply chains are paramount, especially given the critical nature of IV solutions.

Emerging Trends and Strategic Sourcing

Global supply chain diversification mitigates risks associated with geopolitical issues or manufacturing disruptions.
Increased demand for GMP-certified ingredients due to tightening pharmaceutical regulations.
Sourcing from emerging markets offers cost advantages without compromising quality when validated properly.
Technological integration: Digital sourcing platforms enhance transparency and streamline procurement processes.

Conclusion

Reliable procurement of Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 15 mEq hinges on selecting suppliers with proven quality standards, extensive capacity, and regulatory compliance. Leading global corporations such as ADM, Cargill, Roquette, and Merck supply pharmaceutical-grade dextrose. Similarly, Baxter, Fresenius, Otsuka, and B. Braun provide high-quality electrolytes. For potassium chloride, Sigma-Aldrich, Fisher Scientific, and Wockhardt are reputable sources.

Strategic sourcing should prioritize supplier certifications, supply chain stability, and adherence to international standards. Emerging trends advocate for diversification and technological enhancement of procurement processes to ensure uninterrupted supply and regulatory compliance.

Key Takeaways

Comprehensive vetting of suppliers for cGMP compliance and regulatory certifications is essential.
Leading pharmaceutical ingredient manufacturers globally have proven capabilities to provide high-quality dextrose, sodium chloride, and potassium chloride.
Strategic sourcing involves balancing quality, cost, and supply chain resilience.
Emerging markets present opportunities for cost-efficient procurement, provided quality assurances are maintained.
Integrated supply solutions from CMOs can streamline formulation production and ensure regulatory adherence.

FAQs

What criteria should be prioritized when selecting a supplier for pharmaceutical-grade Dextrose?
Suppliers must demonstrate GMP compliance, ISO certifications, consistent purity, low endotoxin levels, and a proven track record in pharmaceutical manufacturing.
Are all suppliers capable of providing sterile, injectable-grade sodium chloride at 0.2%?
Most leading suppliers like Baxter and Fresenius are certified to produce sterile, injectable-grade sodium chloride, suitable for IV applications.
What certifications are critical for potassium chloride suppliers?
GMP, ISO, and pharmacopeial approvals (USP, EP) are essential. Suppliers should also have traceability and quality control processes validated by regulatory bodies.
Can emerging markets reliably supply pharmaceutical ingredients for critical IV solutions?
Yes, with proper validation and supplier verification, many emerging market manufacturers meet international quality standards, offering cost-effective options.
How does supply chain diversification benefit pharmaceutical procurement?
It minimizes risks associated with geopolitical instability, manufacturing disruptions, and market fluctuations, ensuring a steady supply of essential ingredients.

Sources:
[1] Pharmacopoeia standards and certification guidelines (USP, EP).
[2] Major supplier websites and corporate disclosures.
[3] Industry reports on pharmaceutical ingredient market trends.

Suppliers and packagers for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)