POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% 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
B Braun	POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER	dextrose; potassium chloride	INJECTABLE;INJECTION	019699	NDA	B. Braun Medical Inc.	0264-7625-00	12 CONTAINER in 1 CASE (0264-7625-00) / 1000 mL in 1 CONTAINER	1989-09-29
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

Potassium chloride (KCl) solutions are essential in medical settings for treating hypokalemia, preventing potassium depletion during clinical interventions, and maintenance therapy. The specific formulation—0.22% potassium chloride in a 5% dextrose injection within a plastic container—is widely used for intravenous electrolyte replenishment. Ensuring a reliable supply chain for this pharmaceutical product is critical for healthcare providers, hospital pharmacies, and supply chain managers. This article delineates key suppliers, evaluates their capacities and compliance standards, and offers strategic insights for procurement.

Market Overview and Demand Drivers

The global demand for potassium chloride IV solutions is driven by an expanding healthcare sector, increased prevalence of electrolyte imbalances, and the rising need for hospital-based infusion therapies. The formulation's compatibility with dextrose solutions makes it suitable for patients unable to tolerate oral potassium. Market growth is also propelled by continuous manufacturing advancements, regulatory acceptance, and the growth of generic pharmaceutical suppliers.

Key Suppliers for Potassium Chloride 0.22% in Dextrose 5%

1. Baxter International Inc.

Overview:
Baxter is a leading global provider of innovations in medication delivery and infusion solutions. Its portfolio includes various IV electrolytes, including potassium chloride solutions.

Capabilities:

Extensive manufacturing facilities adhering to cGMP standards.
High-quality, ISO-certified products compliant with U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations.
Supply capabilities aligned with global demand, including customized formulations and packaging.

Compliance & Quality Standards:
Baxter’s products are subject to rigorous quality assurance, with certifications such as ISO 13485 and compliance with United States Pharmacopeia (USP) standards.

Availability & Distribution:
Global distribution network enables swift delivery to hospitals and pharmacies.

Website: baxter.com

2. Hospira (A Pfizer Company)

Overview:
Hospira specializes in infusion therapy, injectable drugs, and biosimilars, with a significant presence in the electrolyte solutions market.

Capabilities:

Manufacturing facilities in North America, Europe, and Asia-Pacific regions.
Proven track record in sterile solution production adhering to strict quality standards.
Expertise in developing and producing IV solutions with precise concentrations.

Compliance & Quality Standards:
Certified under ISO 9001, ISO 13485, and compliant with FDA’s cGMP regulations.

Availability & Distribution:
Large-scale production ensures consistent supply; distribution networks capture global markets.

Website: hospira.com

3. Hikma Pharmaceuticals

Overview:
Hikma is a leading manufacturer of injectable and sterile pharmaceutical products, including electrolyte solutions.

Capabilities:

Multi-site manufacturing robustly certified for quality and safety.
Strong focus on sterile injectables, including potassium chloride solutions in dextrose.
Ability to supply both branded and generic formulations.

Compliance & Quality Standards:
Compliance with EMA and FDA standards, certified ISO 9001 and 13485.

Availability & Distribution:
Operates in markets across the Middle East, Europe, and North America, ensuring broad supply channels.

Website: hikma.com

4. Fresenius Kabi

Overview:
Fresenius Kabi manufactures a broad range of infusion solutions, including electrolyte and glucose in plastic containers.

Capabilities:

Large manufacturing capacity with sterilized, ready-to-use plastic container formulations.
Focus on patient safety and convenience, delivering flexible packaging options.
Innovates in prefilled, ready-to-administer IV solutions.

Compliance & Quality Standards:
Adheres to US FDA, EMA, and international quality certifications, including ISO standards.

Availability & Distribution:
Global distribution channels ensure timely supply, especially in critical care settings.

Website: fresenius-kabi.com

Regulatory and Quality Considerations

Procurement of IV electrolytes like potassium chloride in dextrose solutions requires strict adherence to regulatory standards for sterility, stability, and compatibility. Suppliers must demonstrate GMP certification, batch validation, and compliance with pharmacopeial standards (USP, EP, JP). Additionally, documentation on shelf life, storage conditions, and endotoxin levels ensures safe application.

Emerging Suppliers and Contract Manufacturing Organizations (CMOs)

With the global pharmaceutical industry increasingly adopting outsourcing, many CMOs offer custom manufacturing of potassium chloride solutions. Notable names include:

Samsung BioLogics: Offering contract manufacturing for sterile injectable solutions with scalable capacity.
WuXi AppTec: Providing comprehensive manufacturing and quality assurance services for infusion solutions.

These partners enable rapid scaling, tailored formulations, and compliance with international standards, but require rigorous due diligence.

Strategic Sourcing Recommendations

Supplier Qualification: Prioritize suppliers holding current GMP, ISO 13485, and pharmacopeial certifications.
Supply Chain Diversification: Engage multiple suppliers across geographies to mitigate risks related to geopolitical or logistical disruptions.
Regulatory Compliance: Ensure suppliers have extensive documentation and track record for regulatory audits, especially for FDA and EMA compliance.
Quality Assurance: Implement strict incoming quality control and batch testing protocols upon receipt.

Conclusion

A reliable supply of potassium chloride 0.22% in dextrose 5% in plastic containers hinges on robust relationships with established, compliant manufacturers such as Baxter, Hospira, Hikma, and Fresenius Kabi. The choice of supplier should be driven by quality standards, capacity, regulatory adherence, and logistic capabilities. As demand grows, strategic diversification and validation are essential to ensure uninterrupted availability for critical healthcare applications.

Key Takeaways

Leading global suppliers for potassium chloride 0.22% in dextrose solutions include Baxter, Hospira, Hikma, and Fresenius Kabi.
Prioritize suppliers with ISO, GMP, and pharmacopeial certifications for quality and safety.
Contract manufacturing organizations (CMOs) expand capacity but require thorough vetting.
Diversify suppliers to mitigate supply chain risks amidst growing demand.
Continuous quality assurance, regulatory compliance, and traceability are critical for procurement success.

FAQs

1. What factors should I consider when sourcing potassium chloride in dextrose solutions?
Prioritize regulatory compliance, manufacturing quality standards, supply capacity, and reliability of distribution channels.

2. Are there regional variations in supplier availability?
Yes. While global suppliers like Baxter and Fresenius operate worldwide, regional suppliers tailored to local markets may offer more immediate access but should meet international standards.

3. How can I verify supplier compliance with regulatory standards?
Request certifications such as GMP, ISO, and pharmacopeial validation reports. Conduct audits or audits via third-party inspectors when feasible.

4. What are the lead times for manufacturing and delivery of these solutions?
Lead times vary by supplier, typically ranging from 4 to 12 weeks depending on order size, certification status, and logistics.

5. Can I procure custom formulations or packaging?
Yes. Many CMOs and large manufacturers offer customized formulations, packaging options, and supply chain solutions tailored to specific institutional needs.

References

Baxter International Inc. Product Portfolio. baxter.com
Hospira (Pfizer) Product Listings. hospira.com
Hikma Pharmaceuticals Product Details. hikma.com
Fresenius Kabi Product Catalog. fresenius-kabi.com
U.S. Pharmacopeia (USP) Standards for IV Solutions.

Suppliers and packagers for POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER