POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% 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
Otsuka Icu Medcl	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	potassium chloride; sodium chloride	INJECTABLE;INJECTION	078446	ANDA	ICU Medical Inc.	0990-9257-39	12 POUCH in 1 CASE (0990-9257-39) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG	2020-01-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 3, 2025

Introduction

Potassium chloride (KCl) combined with sodium chloride (NaCl) solutions serve as essential intravenous (IV) fluids in clinical settings, primarily for replenishing electrolytes and managing fluid balance. The specific formulation—Potassium Chloride 0.149% in Sodium Chloride 0.45%, packaged in plastic containers—is designed to meet strict pharmaceutical standards for safety and efficacy.

Identifying reliable suppliers for this formulation is crucial for healthcare providers, distributors, and pharmaceutical companies seeking quality, compliance, and consistent supply. This article examines key global and regional suppliers, their capabilities, regulatory compliance, and factors influencing procurement decisions.

Overview of the Formulation

The specified solution comprises:

Potassium chloride (KCl): 0.149%
Sodium chloride (NaCl): 0.45%
Container: Plastic (preferably transparent, sterile, and single-use to prevent contamination and facilitate administration).

This formulation is typically classified as a sterile, aqueous IV infusion, requiring manufacturing processes adhering to Good Manufacturing Practices (GMP), and regulatory approval in respective jurisdictions.

Global and Regional Suppliers

The supply chain for such electrolyte solutions is mature, with leading pharmaceutical manufacturers and contract manufacturing organizations (CMOs) offering high-quality products globally. The availability of specific formulations in plastic containers depends on capacity, certifications, and regional regulatory approvals.

Major Pharmaceutical Manufacturers

Baxter International Inc.

Baxter is a leading supplier of IV fluids, including electrolyte solutions. Their product portfolio includes potassium chloride and sodium chloride solutions in various concentrations and container types, including plastic bags and bottles. Baxter emphasizes compliance with USP, EP, and FDA standards, making its products suitable for markets worldwide.
B. Braun Melsungen AG

B. Braun manufactures a broad range of IV solutions, including isotonic and electrolytic solutions. The company’s products are widely used in Europe, North America, and emerging markets, with strict adherence to GMP and international standards.
Fresenius Kabi

Fresenius offers extensive IV electrolyte solutions, manufactured with robust quality controls. Their formulations are designed for compatibility with infusion pumps and sterile delivery systems, with a focus on safe and precise electrolyte replenishment.
Pfizer Inc. (Hospira)

Hospira, now part of Pfizer, supplies a broad range of hospital fluids, including electrolyte solutions. Their manufacturing facilities comply with global standards, and their products are distributed in multiple countries.
Hospira (now part of Pfizer)

Hospira has been a significant provider of infusion solutions, including specific electrolyte formulations, with a focus on safety and regulatory compliance.

Contract Manufacturing Organizations (CMOs)

Many generic and private-label electrolyte solutions are produced by CMOs specializing in sterile injectable manufacturing, such as:

Recipharm
STADA Arzneimittel AG
Pliva/King’s College

These firms often produce under licensing agreements, catering to regional needs or private brands.

Regional and Local Suppliers

In addition to global giants, regional pharmaceutical companies and local suppliers may offer the required formulation, especially in markets with comprehensive regulatory approvals (e.g., India, China, Brazil).

Indo Nippon Pharma (India): Produces electrolyte IV solutions conforming to WHO GMP standards, often catering to domestic and neighboring markets.
Shanxi Yuncheng Salt Chemicals Co., Ltd. (China): Supplies bulk electrolytes, with some formulations available in ready-to-use IV containers.
EuroPharma (Brazil): Offers electrolyte solutions compliant with ANVISA standards.

Regulatory and Quality Considerations

Choosing a supplier involves evaluating:

Regulatory approvals (FDA, EMA, WHO, local authorities)
GMP compliance certifications
Batch consistency and traceability
Sterility assurance and validation processes
Container safety standards (material, compatibility, leak-proof design)

Suppliers often provide Certificates of Analysis (COA), Certificates of Suitability (COS), and compliance documentation to facilitate regulatory approval and quality assurance.

Procurement Factors

Supply Chain Reliability: Ensure long-term stability, especially during supply chain disruptions.
Pricing and Contract Terms: Competitive pricing aligned with quality standards.
Customization Capabilities: Ability to offer specific formulations, container types, and packaging.
Regulatory Compliance: Local registration and approvals for specific markets.
Volume Capabilities: Suppliers capable of high-volume production to meet hospital and distributor demands.

Emerging Trends and Recommendations

Prefilled and Ready-to-Use Solutions: Increasing adoption of prefilled plastic containers improves safety, reduces contamination risk, and enhances convenience.
Customization and Packaging Innovations: Suppliers offering customized solutions that improve stability and compatibility with infusion devices.
Supply Chain Resilience: Focusing on suppliers with diversified manufacturing facilities to mitigate geopolitical and logistical risks.

Key Takeaways

The pharmaceutical supply landscape for Potassium Chloride 0.149% in Sodium Chloride 0.45% in plastic containers is mature, with dominant global players like Baxter, B. Braun, Fresenius Kabi, and Pfizer leading the market.
Regulatory compliance, quality assurance, and supply chain reliability are critical factors when selecting suppliers.
Regional manufacturers may offer cost-effective alternatives, especially within emerging markets, provided they meet international standards.
Increasing demand for prefilled sterile solutions underscores the importance of supplier capabilities in container customization.
Businesses should conduct thorough due diligence, including regulatory validation and quality audits, to ensure supplier suitability.

FAQs

1. What are the primary factors to consider when sourcing electrolyte solutions in plastic containers?
Regulatory compliance, GMP certification, product sterility, container safety, supply chain stability, and price competitiveness.

2. Are there regional suppliers capable of meeting global standards for this formulation?
Yes. Many regional manufacturers, especially in India and China, produce electrolyte solutions that comply with international standards, but validation and certification are necessary.

3. How do global suppliers ensure the quality of their electrolyte solutions?
Through rigorous GMP adherence, comprehensive quality control protocols, certification from regulatory authorities, and batch traceability systems.

4. Is prefilled plastic containerization the future for electrolyte solutions?
Yes. Prefilled solutions reduce contamination risks, improve convenience, and are increasingly adopted in hospital settings.

5. What regulatory challenges exist for importing these solutions into different markets?
Regulatory hurdles include registration with local health authorities, demonstrating product equivalence, complying with container and sterilization standards, and adhering to label and packaging requirements.

References

Baxter International Inc. Product portfolio and regulatory filings.
B. Braun Melsungen AG product documentation and GMP certification.
Fresenius Kabi official product specifications.
Pfizer Inc. (Hospira) product registration data.
World Health Organization (WHO) guidelines on sterile injectable manufacturing standards.

This comprehensive overview enables business professionals to identify suitable suppliers for Potassium Chloride 0.149% in Sodium Chloride 0.45% in plastic containers, facilitating strategic sourcing decisions grounded in quality, compliance, and supply reliability.

Suppliers and packagers for POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER