POTASSIUM CHLORIDE 0.3% 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 0.3% 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 3, 2025

Introduction

Potassium chloride (KCl) in sodium chloride (NaCl) saline solutions is a vital intravenous (IV) fluid used extensively in medical settings for electrolyte replenishment, dehydration, and volume expansion. The 0.3% potassium chloride in 0.9% sodium chloride solution, supplied in plastic containers, is globally in demand, prompting healthcare providers and pharmaceutical companies to seek reliable suppliers with consistent quality, regulatory compliance, and competitive pricing. This article details leading suppliers, critical factors for sourcing, and market dynamics pertinent to this segment.

Key Characteristics of the Product

Composition: A sterile, isotonic solution comprising 0.3% KCl dissolved in 0.9% NaCl solution.
Container Type: Pre-packaged in plastic (typically polyethylene or polypropylene) IV bags, suitable for infusion.
Usage: Electrolyte balance, treatment of hypokalemia, and maintenance of fluid and electrolyte concentrations.
Regulatory Standards: Must comply with pharmacopeial standards such as USP, EP, or JP, and adhere to Good Manufacturing Practices (GMP).

Major Global Suppliers

1. Baxter International Inc.

Overview: A leading global healthcare company with a robust portfolio of IV fluids and electrolyte solutions.
Product Range: Baxter supplies large-volume IV solutions, including potassium chloride in sodium chloride in plastic containers.
Certifications: GMP, FDA approval, and ISO certifications.
Distribution: Extensive global supply network, prominent in North America, Europe, and Asia-Pacific markets.

2. B. Braun Melsungen AG

Overview: A German multinational specializing in infusion therapy and healthcare solutions.
Product Range: Offers various potassium chloride infusion solutions in sterile, pyrogen-free plastic containers.
Quality Standards: Complies with European Pharmacopoeia, FDA regulations, and ISO standards.
Regional Presence: Strong in Europe, North America, and emerging markets.

3. Pfizer Inc.

Overview: A major pharmaceutical and biopharmaceutical enterprise with a substantial portfolio of intravenous fluids.
Product Offerings: Supplies potassium chloride solutions, often as part of their electrolyte therapy lines.
Global Reach: U.S., European, and Asian markets, with a focus on high-quality, GMP-compliant manufacturing.

4. Fresenius Kabi

Overview: A global healthcare company focusing on infusion therapies, clinically focused medicines, and devices.
Product Range: Supplies sterile, pre-filled polyethylene IV bags with potassium chloride in saline solutions.
Certifications: GMP, FDA approval, and compliance with European regulations.
Distribution Strength: Widespread across North America, Europe, and Asia.

5. Hospira (A Pfizer spin-off)

Overview: Specializes in injectable drugs and infusion systems.
Product Line: Provides various electrolyte infusion solutions, including potassium chloride in sodium chloride solutions.
Market Position: Known for reliable supply and compliance with pharmacopoeial standards.

Regional and Niche Suppliers

Apart from the global giants, several regional and niche manufacturers supply potassium chloride in saline solutions:

F$resenius Kabi India Pvt Ltd. — Leading supplier in the Indian subcontinent with locally manufactured products meeting WHO-GMP standards.
Baudax Bio, Inc. (via licensing) — Focuses on specialized formulations in North America and emerging markets.
Local pharmaceutical companies: Many regional companies in countries like China, India, Turkey, and Brazil manufacture these solutions under stringent regulatory standards, often providing cost-effective options for local markets.

Critical Factors in Sourcing

Regulatory Compliance and Certification

Suppliers must demonstrate adherence to relevant pharmacopeial standards (USP, EP, JP) and regulatory requirements set by agencies such as theFDA (U.S.), EMA (Europe), and PMDA (Japan). GMP compliance ensures product quality and safety.

Quality Assurance and Traceability

Stringent testing for sterility, endotoxins, pH, osmolarity, and stability is essential. Suppliers offering batch traceability, validation data, and quality certifications mitigate risks associated with contamination and compliance failures.

Supply Chain Reliability

Given the critical nature of IV solutions, suppliers with proven logistics, inventory management, and contingency planning are preferred. Disruptions in supply can directly impact patient care.

Pricing and Contract Flexibility

Cost-effective procurement depends on supplier competitiveness, volume discounts, and contractual flexibility. Large-scale buyers should negotiate terms with suppliers that have scalable manufacturing capacity.

Regional Accessibility and Distribution

Suppliers with regional distribution centers improve lead times, reduce shipping costs, and mitigate regulatory hurdles in different jurisdictions.

Market Trends and Outlook

Increased Demand: Aging populations and rising prevalence of electrolyte imbalances elevate the demand for infusion solutions globally.
Regulatory Harmonization: Streamlined approval pathways (e.g., WHO prequalification) facilitate procurement for developing countries.
Generics and Local Manufacturers: Growth in generic and locally produced solutions enhances access and decreases dependency on multinational corporations.
Technological Innovations: Advances in container materials (e.g., biodegradable plastics) and infusion device compatibility improve safety and environmental sustainability.

Conclusion

The supply ecosystem for potassium chloride 0.3% in sodium chloride 0.9% in plastic containers is predominantly characterized by well-established multinational corporations alongside regional manufacturers serving local markets. Key players like Baxter, B. Braun, Pfizer, Fresenius Kabi, and Hospira maintain dominant market shares owing to their rigorous quality standards, extensive distribution networks, and regulatory compliance. Organizations seeking reliable supply should prioritize supplier certifications, quality assurance, logistical robustness, and regional distribution capabilities for optimal procurement strategies.

Key Takeaways

Globally recognized suppliers like Baxter, B. Braun, Pfizer, and Fresenius Kabi are primary sources for potassium chloride 0.3% in saline solutions, offering consistent quality and regulatory compliance.
Regional manufacturers, notably in India and China, provide cost-effective, locally produced options that meet international standards, expanding access in developing markets.
Critical sourcing considerations include product quality certifications, supply chain resilience, regulatory adherence, and regional distribution capabilities.
The growing demand driven by aging populations and increasing healthcare infrastructure investments emphasizes the need for diversified and reliable supplier partnerships.
Advancements in container materials and regulatory harmonization are expected to further streamline procurement processes, ensuring continuous access to essential IV solutions.

FAQs

1. What are the primary quality certifications to look for in potassium chloride saline solution suppliers?
Suppliers should comply with GMP, ensure compliance with pharmacopeial standards such as USP, EP, or JP, and hold certifications like ISO, FDA approval, and regional drug authority authorizations.

2. Are there regional suppliers that specialize in low-cost potassium chloride solutions?
Yes. Many regional manufacturers in countries like India, China, and Turkey produce cost-effective solutions that meet international standards, providing an alternative for local markets and bulk procurement.

3. How do supply chain disruptions impact the procurement of potassium chloride saline solutions?
Disruptions can delay delivery, cause shortages, and compromise patient care. Engaging with multiple suppliers and maintaining safety stock helps mitigate supply risks.

4. What regulatory considerations are essential when sourcing potassium chloride solutions internationally?
Ensure suppliers meet local regulatory requirements, possess necessary certifications, and follow Good Manufacturing Practices to guarantee safety, efficacy, and compliance.

5. What emerging trends could influence the supplier landscape for IV electrolyte solutions?
Technological advances, environmental sustainability initiatives, and regulatory harmonization are shaping future offerings, with innovations like biodegradable containers and streamlined approval pathways gaining importance.

Sources:

Baxter International Inc., Official Website.
B. Braun Melsungen AG, Product Catalogs.
Pfizer Inc., Pharmaceutical Product Portfolio.
Fresenius Kabi, Global Product Listings.
World Health Organization, Prequalification of Injectable Medicines.

Suppliers and packagers for POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER