POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% 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
B Braun	POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	potassium chloride; sodium chloride	INJECTABLE;INJECTION	019708	NDA	B. Braun Medical Inc.	0264-7865-00	12 CONTAINER in 1 CASE (0264-7865-00) / 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 1, 2025

Introduction

Potassium chloride (KCl) in sodium chloride (NaCl) solutions, particularly at a concentration of 0.22% KCl in 0.9% NaCl (normal saline), is a vital pharmaceutical fluid used primarily for electrolyte replenishment and management of hypokalemia. The preparation typically comes in sterile plastic containers suitable for intravenous infusion. Identifying reliable suppliers is crucial for healthcare providers, distributors, and pharmaceutical manufacturers seeking high-quality, compliant products.

Market Overview

The market for intravenous (IV) electrolyte solutions is highly regulated across jurisdictions such as the United States, European Union, and Asia-Pacific. Suppliers are required to meet strict standards for sterility, stability, and regulatory compliance, including Good Manufacturing Practices (GMP). Leading suppliers operate globally, often serving hospitals, clinics, and pharmaceutical companies.

Key Suppliers for Potassium Chloride 0.22% in Sodium Chloride 0.9% in Plastic Containers

1. Baxter International Inc.

Baxter is a global leader in IV solutions, including electrolyte therapies. Their product portfolio includes sterile, pre-filled plastic containers of electrolyte solutions, ensuring consistent quality and compliance with international standards. Baxter’s KCl-infused saline solutions are widely supplied in North America, Europe, and other markets.

Product Features: Sterile, pyrogen-free, ready-to-use in flexible plastic containers; multi-dose options available.
Regulatory Status: FDA-approved, EMA-registered, and compliant with ISO standards.
Availability: Supplies both hospital and commercial segments; global distribution network.

2. Fresenius Kabi

Fresenius Kabi specializes in infusion solutions, including sodium chloride with potassium supplementation. The company offers sterile, single-use plastic containers with pre-measured electrolyte concentrations suitable for various clinical needs.

Product Features: High-purity ingredients adhering to pharmacopoeial standards; secure sterilization processes.
Regulatory Status: Approved by leading regulatory agencies (FDA, CE marking).
Availability: International distribution, notable in Europe, Asia, and North America.

3. B. Braun Melsungen AG

B. Braun provides a broad spectrum of infusion solutions, including customized electrolyte solutions in plastic containers. Their portfolio emphasizes safety, stability, and ease of administration.

Product Features: Pre-mixed sterile solutions, ready for IV administration.
Regulatory Compliance: Meets US and European standards.
Market Focus: Hospitals, clinics, and pharmaceutical manufacturing.

4. APP Pharmaceuticals (a subsidiary of Hikma Pharmaceuticals)

Known for a comprehensive range of injectable and infusion solutions, APP offers potassium chloride in sodium chloride solutions in sterile plastic containers, prioritizing quality control and regulatory adherence.

Product Features: Advanced filtration, validated stability.
Availability: Primarily in North American and Middle Eastern markets.

5. Local and Regional Suppliers

In addition to multinational corporations, regional suppliers often provide potassium chloride saline solutions at competitive prices, especially within Asia-Pacific, Latin America, and Eastern Europe. Companies such as:

Hikma Pharmaceuticals (Middle East)
Sagent Pharmaceuticals (U.S.)
Sino Biotech (China)

produce comparable products adhering to regional regulatory standards.

Emerging and Boutique Suppliers

Several smaller or emerging manufacturers focus on niche electrolyte formulations, offering customized concentrations in plastic containers. These suppliers often serve specialized hospital groups or pharmaceutical compounding entities. Their products undergo rigorous regulatory vetting prior to market entry.

Regulatory Considerations and Quality Certification

Reliability hinges on suppliers’ adherence to regulatory standards, including:

FDA Approval (U.S.)
EMA Certification (Europe)
Pharmacopeial compliance (USP, EP, JP)
ISO certifications (e.g., ISO 13485 for medical devices)

Verification of validated sterilization processes, stability data, and expiration dating is critical before procurement.

Supply Chain and Logistics

Given the critical nature of sterile electrolyte solutions, choosing suppliers with robust supply chains, reliable logistics, and contingency plans minimizes disruption risks. Many top suppliers maintain extensive warehouses and certification for cold chain logistics, ensuring product integrity from manufacturing to point-of-care.

Conclusion

Securing high-quality suppliers for potassium chloride 0.22% in sodium chloride 0.9% in plastic containers entails evaluating their regulatory compliance, product quality, global reach, and logistical capabilities. Established industry leaders such as Baxter, Fresenius Kabi, and B. Braun provide trustworthy options backed by stringent quality standards. Regional and emerging suppliers also serve niche markets, often offering cost-effective alternatives but requiring thorough due diligence.

Key Takeaways

Leading global suppliers include Baxter International, Fresenius Kabi, and B. Braun, known for their adherence to international safety and quality standards.
Regulatory compliance, including FDA and EMA approvals, is essential in supplier selection.
The supply chain resilience and logistics planning are crucial for continuous availability of sterile IV solutions.
Regional suppliers can be suitable alternatives if they meet regulatory and quality standards, often providing lower-cost options.
Due diligence on sterilization processes, stability data, and product specifications ensures safe and effective use.

FAQs

1. What factors should I consider when selecting a supplier for potassium chloride in saline solution?
Regulatory compliance, product sterility, manufacturing quality standards, logistical reliability, and price are key factors. Verification of certifications such as FDA approval, ISO standards, and pharmacopoeial compliance ensures product safety.

2. Are regional suppliers as reliable as multinational corporations for sterile electrolyte solutions?
Many regional suppliers meet rigorous standards and are capable of providing high-quality products. However, due diligence is necessary to verify their regulatory certifications, sterilization processes, and quality assurance procedures.

3. Can I find customizable electrolyte solutions from suppliers?
Yes, some suppliers offer tailored electrolyte formulations, including varying concentrations of potassium chloride, sodium chloride, and other electrolytes, especially for specialized clinical needs or compounded preparations.

4. What are the regulatory differences across regions for these products?
While the core standards for sterility and safety are similar globally, specific regulatory requirements vary. The U.S. primarily relies on FDA approvals, Europe on EMA and CE marking, while other regions may follow national pharmacopeia standards and local certifications.

5. How do supply chain disruptions affect the availability of sterile electrolyte solutions?
Disruptions can arise from manufacturing issues, logistical challenges, or geopolitical factors. Establishing relationships with multiple suppliers and maintaining inventory buffers help mitigate shortages.

References

[1] Baxter International Inc. Product literature and regulatory filings.
[2] Fresenius Kabi Product Portfolio and regulatory compliance data.
[3] B. Braun Melsungen AG official product documentation.
[4] Hikma Pharmaceuticals – Strategic overview of electrolyte solutions.
[5] World Health Organization (WHO) guidelines on sterile injectable solutions.

Suppliers and packagers for POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER