Last Updated: May 4, 2026

Suppliers and packagers for POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER


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POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
B Braun POTASSIUM CHLORIDE 0.15% 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

Suppliers for the Pharmaceutical Drug: Potassium Chloride 0.15% in Dextrose 5% in Plastic Container

Introduction
The demand for potassium chloride (KCl) in dextrose solutions is significant within hospital and clinical settings for electrolyte replenishment and parenteral nutrition. This specific formulation—potassium chloride 0.15% in dextrose 5% in plastic containers—addresses the need for safe, sterile, and stable intravenous (IV) electrolytes. Given the complex regulatory landscape and the importance of reliable supply chains, understanding the key suppliers is essential for procurement, manufacturing, and distribution stakeholders. This article systematically examines the global landscape of suppliers for this specific drug formulation, considering manufacturing capacities, regulatory compliance, and market presence.


Global Market Overview and Demand
Potassium chloride in dextrose solutions is a standard IV therapy component, with enormous demand across North America, Europe, Asia-Pacific, and emerging markets. Hospitals rely on high-quality sterile preparations, often sourced from companies holding Good Manufacturing Practice (GMP) certifications and robust supply chains.

The formulation's particular concentration—0.15% potassium chloride in 5% dextrose—in plastic containers, requires specialized sterile compounding and packaging capabilities, typically provided by multinational pharmaceutical manufacturers and contract manufacturers (CMOs).


Major Suppliers and Manufacturers

1. Baxter International Inc.

Baxter is a leading provider of IV solutions globally. Their portfolio includes sterile, pre-packaged electrolyte solutions, including potassium chloride in dextrose formulations. Baxter’s manufacturing facilities in the U.S., Europe, and Asia ensure compliance with international standards such as FDA, EMA, and WHO cGMP regulations. Its supply chain boasts high-volume production capability, ensuring ongoing availability for hospitals and distributors.

2. B. Braun Melsungen AG

This German-based company manufactures a broad spectrum of IV fluids, including potassium chloride solutions. B. Braun emphasizes quality, safety, and innovates in container technologies—including plastic bags and bottles—that meet global regulatory standards. Their market reach extends worldwide, particularly strong in Europe and North America.

3. Fresenius Kabi AG

Fresenius is renowned for its extensive portfolio of sterile infusion solutions, including potassium chloride 0.15% in 5% dextrose in plastic containers. Their manufacturing facilities in Germany, the United States, and India enable large-scale production aligned with international regulatory frameworks. Fresenius’ products are widely used in hospital settings across multiple continents.

4. Hospira, A Pfizer Company

Though now part of Pfizer, Hospira specializes in the manufacture of sterile injectable drugs, including electrolyte formulations. Their global manufacturing network ensures reliable supply chains with an emphasis on sterile processing and compliance with GMP standards.

5. Harrods Pharmaceuticals (India)

A significant regional manufacturer, Harrods supplies sterile electrolyte solutions to Asia and Africa. Their facilities adhere to WHO-GMP standards, and their products often serve as cost-effective alternatives for hospitals in developing regions.

6. Local and Contract Manufacturers

Numerous regional and contract manufacturing organizations supply potassium chloride dextrose solutions, especially in markets with logistical restrictions or specific regulatory requirements. Notable contract manufacturers include Vifor Pharma, Seqirus, and Baxter’s contract manufacturing units.


Regulatory and Quality Standards

Last updated: August 11, 2025

Suppliers of this formulation must adhere to stringent standards, notably FDA (for the U.S.), EMA (for Europe), ICH guidelines, and WHO-GMP standards. Packaging in plastic containers demands particular focus on material compatibility, stability, and leachables. Suppliers often hold certification from regulatory bodies like ISO 13485 (medical devices) and PIC/S (Pharmaceutical Inspection Cooperation Scheme).

Supply Chain Considerations
High-volume, sterile production capabilities coupled with effective cold chain logistics are critical. Disruption in manufacturing or logistics can lead to shortages, particularly during emergencies such as pandemics or geopolitical disruptions.


Market Trends and Future Outlook

  • Consolidation and Strategic Alliances: Many large firms are engaging in partnerships or acquisitions to bolster capacity.
  • Regulatory Compliance Focus: Suppliers investing in quality assurance, traceability, and compliance are better positioned to meet evolving regulations.
  • Regional Manufacturing Expansions: To address regional demands and reduce supply chain risks, companies are expanding manufacturing footprints, especially in Asia-Pacific.

Conclusion

Reliable procurement of potassium chloride 0.15% in dextrose 5% in plastic containers hinges on engaging reputable, GMP-certified manufacturers with global supply networks. Major natural choices include Baxter, B. Braun, Fresenius Kabi, and Pfizer’s Hospira. Regional and contract manufacturers augment supply in emerging markets, emphasizing regional compliance and affordability. Distributors and healthcare providers should prioritize suppliers with proven track records for quality, regulatory adherence, and logistical resilience.


Key Takeaways

  • Leading multinational companies such as Baxter, B. Braun, and Fresenius dominate the supply of potassium chloride in dextrose solutions in plastic containers.
  • Regulatory compliance, particularly GMP standards, is paramount for quality and safety assurance.
  • Supply chain robustness, including manufacturing capacity and logistics, is critical to avoiding shortages.
  • Regional manufacturers and CMOs serve emerging markets, offering cost-effective and locally compliant solutions.
  • Continuous monitoring of regulatory changes and market trends enhances procurement strategies.

FAQs

1. What are the primary factors influencing supplier selection for potassium chloride dextrose solutions?
Regulatory compliance, manufacturing capacity, quality assurance systems, supply chain reliability, and cost-effectiveness.

2. Are there regional differences in supplier availability?
Yes. North America and Europe are dominated by large multinational companies, whereas Asia-Pacific and Africa rely more on regional and contract manufacturers.

3. How do regulatory standards impact global supply chains?
Strict compliance with GMP and other standards is essential, limiting suppliers to those with verified certifications, affecting lead times and market access.

4. Can hospitals or distributors source potassium chloride dextrose solutions directly from manufacturers?
Typically, hospitals procure through authorized distributors or healthcare suppliers due to regulatory and logistic considerations.

5. What future trends could impact the supply landscape?
Increased regional manufacturing, technological innovations in container materials, and stricter regulatory requirements could shape future supply strategies.


References
[1] Baxter International Inc. – Product Portfolio and Quality Certifications.
[2] B. Braun Melsungen AG – Medical Solutions Overview.
[3] Fresenius Kabi AG – Global Manufacturing and Compliance Standards.
[4] Hospira (Pfizer) – IV Solutions and Manufacturing Capabilities.
[5] World Health Organization (WHO) – Good Manufacturing Practices for Injectables.

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