DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER: 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% AND POTASSIUM CHLORIDE 0.3% 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

In the pharmaceutical industry, sourcing reliable suppliers for critical components like dextrose solutions combined with potassium chloride in plastic containers requires meticulous evaluation. These solutions are vital for medical procedures such as IV therapy, electrolyte correction, and nutritional support. Due to their significance, ensuring the quality, compliance, and dependable supply chain of these formulations is paramount for healthcare providers worldwide.

This article explores the leading global and regional suppliers specializing in Dextrose 5% and Potassium Chloride 0.3% in plastic containers, highlighting their market positioning, regulatory compliance, manufacturing capabilities, and strategic advantages to aid procurement decisions for pharmaceutical companies, hospitals, and distributors.

Market Overview of Dextrose 5% and Potassium Chloride Solutions

Dextrose 5% (D5) is a parenteral carbohydrate source used extensively in IV therapy, providing hydration and caloric intake. Potassium Chloride (KCl) is a key electrolyte supplement used to correct hypokalemia. The combined formulation addresses immediate electrolyte imbalances and nutritional needs.

Manufacturing and distribution of these solutions necessitate adherence to strict Quality Control (QC) and Good Manufacturing Practices (GMP), with suppliers often holding certifications from regulatory bodies such as the FDA, EMA, or WHO.

Leading Suppliers of Dextrose 5% and Potassium Chloride in Plastic Containers

1. Baxter International Inc.

Overview: Baxter is a global leader in intravenous solutions, including dextrose-based fluids containing electrolytes. The company’s extensive manufacturing capabilities and robust supply chain ensure a consistent supply of Dextrose 5% and Potassium Chloride in various container sizes.

Product Quality & Compliance: Baxter’s products are FDA-approved, compliant with USP, EP, and JP standards, and produced under rigorous GMP protocols.

Container Offerings: Their solutions are available predominantly in polyethylene (PE) and polypropylene (PP) plastic bags and bottles, with sterile, ready-to-use formats suitable for hospital settings.

Strategic Advantage: Global manufacturing footprint facilitates high-volume supply and rapid distribution, making Baxter a primary supplier for large healthcare organizations.

2. Fresenius Kabi

Overview: Fresenius Kabi specializes in infusion therapies, including electrolyte-specific formulations. Their Dextrose 5% with added potassium chloride solutions are widely used across hospitals worldwide.

Product Range & Quality: Their formulations conform to international standards (USP, EP, JP, ISO) and are available in flexible plastic bottles and bags ensuring stability and sterility.

Certifications & Compliance: They hold WHO-GMP, FDA, and EMA approvals, emphasizing quality assurance.

Container Formats: They offer ready-to-use IV bags and bottles made of medical-grade plastics, designed for easy integration into clinical workflows.

3. B. Braun Melsungen AG

Overview: B. Braun offers a comprehensive portfolio of infusion solutions, including Dextrose 5% with Potassium Chloride in plastic containers. Their focus on innovation and quality compliance positions them as key suppliers.

Product Line & Certification: Their solutions meet USP/EP/IP standards, with containers designed for compatibility and safety. They are approved by major regulatory agencies for global distribution.

Supply Capabilities: B. Braun’s extensive manufacturing infrastructure supports large-scale supply and customization options for healthcare providers.

4. Fresenius Kabi India Pvt Ltd.

Overview: As part of its global network, this division supplies Dextrose 5% and Potassium Chloride solutions in plastic containers to the Asian and Middle Eastern markets.

Compliance & Quality Management: They adhere to international standards and have strong supply chain systems ensuring timely delivery.

Container Details: Products are available mainly in plastic IV bags and bottles, sterile and suitable for clinical use.

5. Hospira (a Pfizer company)

Overview: Hospira specializes in sterile injectables and electrolyte solutions, including Dextrose 5% with Potassium Chloride.

Quality & Standards: Their products are approved by FDA and other regulatory agencies, aligning with global GMP standards.

Distribution Reach: Their international footprint ensures wide availability, especially in North America, Europe, and emerging markets.

6. Local and Regional Manufacturers

Several regional manufacturers produce comparable solutions, often at lower costs, catering to local markets. These include:

Indoco Remedies (India): Supplies Dextrose and KCl solutions conforming to Indian Pharmacopeia standards.
K Hospital Supply (Mexico): Offers electrolyte solutions in plastic containers with regulatory approval in Latin America.
Teva Pharmaceuticals: Provides a variety of IV solutions with a focus on cost-effective formulations for global markets.

Note: Procurement should prioritize suppliers with validated manufacturing facilities, ISO certifications, and proven track records for GMP compliance.

Regulatory and Quality Considerations

Suppliers must demonstrate adherence to relevant standards, including:

United States Pharmacopeia (USP): For formulation quality.
European Pharmacopoeia (EP): For European market approval.
WHO-GMP standards: For global procurement, especially in emerging markets.
FDA/EMA approval: For countries with stringent regulatory requirements.

Proper sterilization methods (such as aseptic filtration or terminal sterilization), container compatibility, stability data, and traceability are also critical factors influencing supplier selection.

Supply Chain and Logistics

Effective supply chain management involves:

Inventory management: Ensuring availability during supply disruptions.
Cold chain logistics (if applicable): Maintaining product integrity.
Regulatory compliance documentation: Certificates of Analysis (CoA), batch records.
Distribution network: Strategic regional warehouses and logistics partners.

Emerging Trends influencing supplier selection

Sustainable Packaging: Increasing demand for eco-friendly plastics and recyclable containers.
Digital Tracking: Adoption of serialization and electronic traceability.
Customization: Flexibility in container sizes and formulations to meet specific clinical needs.
Bioequivalence and Cost-Effectiveness: Balancing quality with competitive pricing.

Conclusion

Selecting the right supplier for Dextrose 5% and Potassium Chloride in plastic containers requires a holistic assessment of quality standards, regulatory compliance, manufacturing capabilities, and supply chain robustness. Industry leaders such as Baxter, Fresenius Kabi, B. Braun, and Hospira offer extensive product lines suitable for global health needs, backed by rigorous quality assurance. Regional manufacturers may provide viable alternatives for local markets but demand thorough validation.

A strategic procurement approach aligned with regulatory requirements will ensure uninterrupted access to essential IV solutions, ultimately supporting patient safety and clinical outcomes.

Key Takeaways

Top global suppliers such as Baxter, Fresenius Kabi, and B. Braun lead the market with proven quality and compliance standards.
Regulatory adherence (FDA, EMA, USP, EP, WHO-GMP) remains paramount when selecting suppliers.
Supply chain resilience reduces risk of shortages; consider supplier geographical footprint and logistics capabilities.
Sustainable packaging innovations are becoming increasingly influential in procurement decisions.
Regional manufacturers can be cost-effective options, provided they meet international quality standards.

FAQs

Q1: What regulatory standards should I verify when sourcing Dextrose 5% and Potassium Chloride solutions?
A1: Verify compliance with USP, European Pharmacopoeia (EP), WHO-GMP, and local regulatory agencies such as the FDA or EMA, depending on the target market.

Q2: Are plastic containers suitable for all IV solutions?
A2: Yes, provided the containers are made from medical-grade plastics designed for compatibility, sterility, and stability of IV solutions.

Q3: How can I ensure supplier quality and manufacturing reliability?
A3: Review their certifications (ISO, GMP), audit their manufacturing facilities if possible, and request validated documentation such as Certificates of Analysis and stability data.

Q4: What are typical container types for these solutions?
A4: Common containers include sterilized plastic IV bags and bottles, often made of polyethylene (PE) or polypropylene (PP).

Q5: Is regional sourcing advisable over international suppliers?
A5: Regional sourcing can reduce lead times and costs but requires thorough validation of quality assurance practices and regulatory compliance.

References

[1] Baxter International Inc. – Product catalog and quality certifications.
[2] Fresenius Kabi – Global product specifications.
[3] B. Braun Melsungen AG – Quality standards and regulatory approvals.
[4] WHO – Good Manufacturing Practices guidelines.
[5] U.S. Pharmacopeia – Standards for injectable solutions.

Suppliers and packagers for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER