DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER	dextrose; potassium chloride	INJECTABLE;INJECTION	017634	NDA	Baxter Healthcare Company	0338-0683-04	1000 mL in 1 BAG (0338-0683-04)	1979-02-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

The pharmaceutical market for intravenous (IV) fluids such as Dextrose 5% with Potassium Chloride 0.224%, contained in plastic containers, is vital for clinical nutrition and electrolyte management. Key to the supply chain are manufacturers and distributors that ensure consistent quality, regulatory compliance, and global availability. This report offers a detailed overview of primary suppliers specializing in this formulation, exploring their manufacturing capacity, compliance standards, geographic presence, and strategic positioning to assist healthcare providers, procurement officers, and industry stakeholders.

Market Overview and Regulatory Context

Dextrose 5% with Potassium Chloride 0.224% in plastic containers is classified as a compounded or prepackaged sterile medicinal solution used for fluid therapy, electrolyte replenishment, and caloric supplementation. The formulation must comply with stringent standards set by regulatory authorities such as the FDA (Food and Drug Administration) in the US, EMA (European Medicines Agency) in Europe, and respective national bodies globally.

Globally, the demand for sterile IV fluids continues to grow, driven by hospital requirements and outpatient care. Suppliers must meet high-quality standards, including Good Manufacturing Practices (GMP) and rigorous sterilization protocols.

Leading Suppliers of Dextrose 5% with Potassium Chloride 0.224% in Plastic Containers

1. Baxter International Inc.

Baxter is a global leader in infusion therapies, providing a comprehensive portfolio of sterile IV fluids, including Dextrose-formulated solutions combined with electrolytes like Potassium Chloride.

Product Range & Capacity: Baxter offers Dextrose 5% in plastic containers with electrolytes, including tailored formulations for different clinical needs.
Regulatory Compliance: Facilities comply with cGMP standards, U.S. FDA-approved manufacturing sites, and EMA certifications.
Geographic Presence: North America, Europe, Asia-Pacific with extensive distribution networks.
Key Strengths: Proven manufacturing quality, robust distribution channels, and extensive clinical support.

2. Baxter’s Partnered & Contract Manufacturing Options

Many regional manufacturers produce similar formulations under licensing agreements or OEM (Original Equipment Manufacturer) arrangements with Baxter or other global firms, expanding availability in local markets.

3. Fresenius Kabi

Fresenius Kabi specializes in sterile infusion solutions, with a dedicated portfolio containing Dextrose in combination with electrolytes.

Product Range & Capacity: Offers ready-to-use Dextrose 5% with potassium chloride solutions in various plastic container sizes, often pre-packaged for hospitals.
Quality & Compliance: Compliant with EU GMP standards, FDA registration in the U.S., and adherence to ISO standards.
Market Reach: Europe, North America, Latin America, Asia-Pacific, and Africa.
Strategic Advantages: Known for high product quality, innovative container designs, and comprehensive clinical support.

4. Hikma Pharmaceuticals

Hikma delivers sterile injectable solutions, including Dextrose with electrolytes, with a focus on emerging markets.

Manufacturing Capabilities: Facilities in Europe, Middle East, and North America.
Portfolio: Offers flexible solutions with customizable electrolyte mixes, including Potassium Chloride.
Compliance & Certification: Meets FDA, EMA, and local regulatory standards.

5. West-Ward Pharmaceuticals (Part of Hikma Group)

Specializes in sterile injectable production with extensive experience in electrolyte solutions combined with dextrose.

Product Offerings: Dextrose 5% with Potassium Chloride, in various plastic container sizes.
Strengths: Cost-effective manufacturing, high GMP standards, reliable supply.

Regional and Specialty Suppliers

Besides the large multinational corporations, regional suppliers and contract manufacturers cater to local markets with compliant formulations:

Pfizer: Offers certain IV solutions, including dextrose-based solutions, in strategic markets.
Lupin Pharmaceuticals: Active in India and Asia-Pacific, producing affordable hospital-grade IV fluids.
Zydus Cadila: Indian manufacturer with a growing international footprint for sterile solutions.

These regional suppliers often provide customizable formulations aligned with local regulations, reducing lead times and optimizing supply chains for localized healthcare markets.

Key Considerations in Supplier Selection

Regulatory Compliance: Suppliers must adhere to cGMP standards, FDA/EMA approvals, and local regulatory requirements for sterile injectable solutions.
Manufacturing Capacity & Supply Reliability: Capacity to meet fluctuating demand without compromising sterility or quality.
Quality Assurance: Validation of sterilization processes, container integrity, and stability.
Distribution & Logistics: Ability to deliver in sterile condition, with appropriate cold chain management if needed.
Price & Contract Terms: Competitive pricing, flexible purchasing options, and supply agreements.

Emerging Trends & Future Outlook

The demand for IV fluids continues to rise amid ongoing global health challenges. Suppliers increasingly incorporate advanced materials for plastic containers—such as ethylene-vinyl acetate (EVA)—that enhance container strength and reduce leachables. Additionally, manufacturers invest in sustainability, aiming to reduce plastic waste and carbon footprint.

Innovations such as ready-to-use multi-dose vials and pre-mixed formulations tailored for specific patient populations are expanding the market. Furthermore, regional suppliers building GMP-compliant manufacturing bases in emerging markets aim to increase local supply and reduce reliance on imported solutions.

Conclusion

Major global pharmaceutical companies such as Baxter, Fresenius Kabi, Hikma Pharmaceuticals, and West-Ward Pharmaceuticals dominate the market for Dextrose 5% and Potassium Chloride 0.224% in plastic containers, offering reliable, compliant, and high-quality options. Regional manufacturers, especially in Asia and emerging markets, serve increasingly significant roles, driven by cost advantages and localized supply chains.

Healthcare providers and procurement entities should prioritize regulatory compliance, capacity to meet demand, and quality assurance when selecting suppliers. As the global healthcare landscape evolves, suppliers investing in innovation, sustainability, and regional manufacturing are poised to maintain strategic relevance.

Key Takeaways

Leading suppliers include Baxter, Fresenius Kabi, Hikma, and West-Ward, distinguished by their manufacturing quality and regulatory compliance.
Regional manufacturers in Asia and emerging markets ensure competitive pricing and localized supply.
Ensuring supplier adherence to GMP, FDA, and EMA standards is critical for patient safety.
Innovations in container technology and formulation customization are shaping future supply options.
A diversified supplier base mitigates supply chain risks and enhances procurement resilience.

FAQs

1. What are the primary regulatory requirements for suppliers of Dextrose with Potassium Chloride in plastic containers?
Suppliers must comply with cGMP standards, obtain approval from regulatory bodies like the FDA and EMA, and adhere to local drug safety and manufacturing regulations, including sterile processing and container safety protocols.

2. How do regional suppliers compare to global pharmaceutical giants?
Regional suppliers typically offer cost advantages, faster local distribution, and regulatory compliance tailored to local laws. Global giants provide extensive quality assurance, consistent supply, and broad regulatory approvals.

3. What factors influence the choice of supplier for this IV solution?
Factors include regulatory compliance, manufacturing capacity, product quality, supply stability, pricing, and geographic reach.

4. Are there sustainability considerations among current suppliers?
Yes. Increasingly, suppliers are investing in eco-friendly packaging, reducing plastic waste, and implementing sustainable manufacturing processes to meet environmental standards.

5. What future trends are expected in the supply of Dextrose and Potassium Chloride solutions?
Anticipated trends include advanced container materials, pre-mixed formulations tailored for specific patient needs, and regional manufacturing expansions aiming for localized production and reduced logistic complexities.

Sources

Baxter International Inc. Product Portfolio, 2023.
Fresenius Kabi Annual Report, 2023.
Hikma Pharmaceuticals Official Website, 2023.
West-Ward Pharmaceuticals Product Catalog, 2023.
Regulatory Guidelines for IV Fluid Manufacturing, FDA and EMA, 2022.

Suppliers and packagers for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER