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

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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 5MEQ (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 2, 2025

Introduction

The pharmaceutical supply chain for intravenous (IV) fluids, notably solutions containing dextrose 5%, sodium chloride 0.2%, and potassium chloride 5mEq, is extensive, spanning global manufacturers, regional distributors, and specialized suppliers. These solutions are foundational for clinical care, used in fluid replacement, electrolyte correction, and nutritional support. Ensuring a reliable and compliant supply chain is critical for healthcare providers worldwide.

Market Overview

Intravenous fluids are classified under sterile products, heavily regulated by bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national health authorities. The global IV fluids market is driven by increasing hospitalization rates, chronic disease prevalence, and advancements in infusion therapy. Suppliers must adhere to strict Good Manufacturing Practices (GMP) and undergo rigorous quality control processes.

Leading Global Suppliers

1. Baxter International Inc.

Baxter is one of the leading global providers of IV solutions, including dextrose and electrolyte solutions. Its extensive product portfolio includes Dextrose 5% in Water (D5W), Sodium Chloride 0.2%, and Potassium Chloride 5mEq solutions. Baxter's manufacturing adheres to stringent GMP standards, and its distribution network spans over 100 countries.

Key strengths:

Broad global footprint
High-quality manufacturing standards
Established relationship with hospitals and clinics

2. Becton, Dickinson and Company (BD)

BD supplies a comprehensive range of sterile IV fluids including dextrose and electrolyte solutions. They are known for innovation in drug delivery systems and maintain rigorous quality controls, making them a preferred supplier for hospitals and healthcare institutions.

Product highlights:

Dextrose 5% solutions
Electrolyte formulations including sodium chloride and potassium chloride
Focus on safety innovations, such as pre-filled syringes and infusion systems

3. B. Braun Melsungen AG

B. Braun provides a range of sterile infusion solutions, including dextrose and electrolyte products. They emphasize sustainability and quality, offering solutions compatible with various infusion devices.

Core offerings:

Dextrose 5% solutions
Electrolyte solutions with specified concentrations
Custom formulations upon request

4. Hospira, A Pfizer Company

Hospira, now part of Pfizer, is a prominent supplier of IV solutions globally, offering a variety of dextrose and electrolyte preparations. Their products are widely utilized in hospitals, and they have a robust manufacturing infrastructure.

Advantages:

Large-scale manufacturing capabilities
Global distribution
Focus on compliance and safety standards

5. Fresenius Kabi

A leading German manufacturer, Fresenius Kabi specializes in IV solutions, including dextrose, sodium chloride, and potassium chloride solutions, catering to hospitals worldwide. Their emphasis is on innovation, safety, and quality.

Strengths:

Extensive product range
Compliant with international regulatory standards
Focus on infusion therapy research

Regional and Local Suppliers

India

National Biopharma – Known for producing sterile IV solutions for domestic markets.
Cadila Pharmaceuticals – Offers a range of IV fluids, including dextrose and electrolyte solutions.
Vifor Pharma – Supplies electrolyte solutions with high quality standards.

China

Shandong Weigao Group – Major Chinese manufacturer of IV fluids, including dextrose and electrolytes.
Zhejiang Changchun Pharmaceutical – Regional supplier with GMP-certified products.

Europe

Fresenius Kabi (Germany)
B. Braun (Germany)
Baxter (Netherlands)

United States

Hospira (Pfizer)
Baxter Healthcare
Becton Dickinson

Supplier Selection Criteria

Choosing a reliable supplier involves evaluating several criteria:

Regulatory compliance: Certification under GMP, ISO standards, and local authority approvals.
Product quality: Consistency, sterility, and stability of solutions.
Supply chain reliability: Capacity to meet demand fluctuations.
Pricing and contractual terms: Competitive pricing with favorable credit terms.
Customer support: Technical support, documentation, and responsiveness.

Emerging Trends & Challenges

Supply chain disruptions: Recent global events have highlighted vulnerabilities; diversification of suppliers reduces risk.
Regulatory differences: Variability in approval processes across regions necessitates due diligence.
Sustainability concerns: Increasing regulations on packaging waste and manufacturing practices.
Innovation: Preference for ready-to-use, pre-mixed solutions to minimize contamination risks.

Conclusion

A secure supply chain for dextrose 5%, sodium chloride 0.2%, and potassium chloride 5mEq solutions hinges on partnering with globally recognized, GMP-compliant manufacturers. Institutions should prioritize supplier reliability, quality assurance, and regulatory adherence to ensure uninterrupted availability of these critical IV solutions, ultimately safeguarding patient care standards.

Key Takeaways

Leading global suppliers include Baxter, BD, B. Braun, Hospira (Pfizer), and Fresenius Kabi.
Regional suppliers are significant, especially in Asia-Pacific, with India and China hosting several GMP-compliant manufacturers.
Supplier evaluation should focus on regulatory compliance, product quality, supply capacity, and support services.
Vigilance against supply disruptions is crucial amid geopolitical and economic uncertainties.
Emphasizing innovation and sustainable practices aligns with industry trends and regulatory expectations.

FAQs

1. How can I verify the regulatory compliance of IV solution suppliers?
Verify suppliers’ certifications such as GMP accreditation, ISO standards, and local regulatory approvals through official agency databases or supplier documentation.

2. Are there regional differences in the formulations of dextrose and electrolyte solutions?
Yes. Formulations can vary by region due to regulatory standards, but major suppliers adhere to international pharmacopoeial standards ensuring consistency.

3. What are the risks associated with sourcing from multiple suppliers?
Risks include variability in product quality, differing batch-to-batch consistency, and logistical complexities. Proper qualification and oversight mitigate these risks.

4. How important is supply chain diversification for critical IV solutions?
Diversification reduces vulnerability to regional disruptions, geopolitical issues, or manufacturing delays, ensuring continuous patient care.

5. What innovations are emerging in IV solution manufacturing?
Pre-mixed, ready-to-use solutions, environmentally sustainable packaging, and integrated infusion systems are notable innovations improving safety and efficiency.

References

[1] Global IV Fluids Market Analysis, MarketsandMarkets, 2023.
[2] U.S. FDA Drug Approvals and Certifications.
[3] European Medicines Agency (EMA) Guidelines on Injectable Solutions.
[4] Baxter International Corporate Website.
[5] Becton Dickinson Official Catalogs and Product Data Sheets.

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