POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
B Braun	POTASSIUM CHLORIDE 0.11% 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 7, 2025

Introduction

Potassium chloride (KCl) combined with sodium chloride (NaCl) solutions in plastic containers serve as critical supplies in medical and pharmaceutical contexts, primarily for intravenous (IV) therapy and electrolyte replacement. The demand for these solutions underscores a robust global supply chain comprising established pharmaceutical manufacturers, regional suppliers, and specialty chemical companies. This overview elucidates key suppliers specializing in potassium chloride and sodium chloride solutions in plastic containers, aligning with industry standards for quality, regulatory compliance, and distribution reach.

Global and Regional Suppliers for Pharmaceutical Potassium Chloride Solutions

1. Major Multinational Pharmaceutical Manufacturers

a. Baxter International Inc.
Baxter is a leading producer of IV solutions, including potassium chloride and sodium chloride in plastic containers. Their products are manufactured in compliance with cGMP standards, and they have an extensive global distribution network. Baxter’s IV solutions, such as Baxter’s Sodium Chloride 0.9% Injection (in flexible plastic containers), are widely used globally. They also produce specific formulations incorporating potassium chloride, tailored for hospitals and clinics ([2]).

b. B. Braun Melsungen AG
B. Braun offers a wide portfolio of sterile IV solutions, including potassium chloride in saline. Their products meet stringent regulatory standards like USP and EP, and they manufacture these solutions in sterilized, ready-to-use plastic containers suitable for infusion therapy ([3]).

c. Fresenius Kabi
Fresenius Kabi specializes in infusion solutions, including potassium chloride 0.11% and sodium chloride 0.9%. Their products are widely distributed globally and adhere to high-quality standards such as FDA, EMA, and USP regulations. They produce ready-to-administer IV bags and infusions in multiple sizes of plastic containers ([4]).

d. Hospira (a part of Pfizer)
Hospira, now integrated within Pfizer, offers a broad range of infusion solutions, including potassium chloride and sodium chloride in flexible, plastic IV bags. Their formulations are designed for clinical efficacy and safety, meeting rigorous regulatory standards ([5]).

2. Regional and Specialty Chemical Suppliers

a. NACL (North American Chloride Limited)
Specializing in pharmaceutical-grade sodium chloride, NACL supplies sterile saline solutions in plastic containers across North America, adhering to USP standards. They partner with regional distributors to supply potassium chloride solutions as well ([6]).

b. Sigma-Aldrich (Merck Group)
While primarily a supplier of chemical raw materials, Sigma-Aldrich supplies pharmaceutical-grade potassium chloride powders suitable for compounding, with formulations often packaged in small plastic containers for laboratory use. However, they also provide bulk solutions for pharmaceutical manufacturers ([7]).

c. Local pharmaceutical manufacturers and Contract Manufacturing Organizations (CMOs)
Numerous regional pharmaceutical companies produce customized IV solutions, often sourcing raw potassium chloride and sodium chloride from global suppliers and assembling them into sterile solutions in plastic containers.

Key Criteria for Supplier Selection

Regulatory Compliance: Suppliers must adhere to Good Manufacturing Practices (GMP), with product registration in target markets (FDA, EMA, etc.).
Product Quality and Sterility: Ensuring solutions are sterile, pyrogen-free, and meet pharmacopeial standards.
Packaging Standards: Use of appropriate plastic containers—typically flexible, sterilized bags—designed for IV administration.
Distribution Capability: Ability to supply regionally or globally, with consistent inventory levels.
Price and Contract Terms: Competitive pricing, favorable logistics, and flexible procurement terms.

Emerging Trends and Considerations

Supply Chain Disruptions: Ongoing global events affect raw material availability; suppliers with diversified manufacturing sites improve resilience.
Regulatory Variability: Differences in regulations (e.g., USP, EP, JP) necessitate suppliers with comprehensive compliance strategies.
Technological Innovation: Development of prefilled, ready-to-use solutions that reduce contamination risk and improve shelf-life.
Sustainability: Increasing emphasis on eco-friendly packaging and manufacturing processes.

Conclusion

The supply chain for potassium chloride 0.11% in sodium chloride 0.9% solutions in plastic containers is well-established, with leadership from global entities such as Baxter, B. Braun, Fresenius Kabi, and Hospira. These companies provide high-quality, FDA- or EMA-approved sterile IV solutions widely used in healthcare systems worldwide. Regional suppliers and specialty chemical providers complement these offerings, ensuring availability across diverse markets.

Business professionals engaging with this sector should prioritize regulatory compliance, quality assurance, and reliable logistics when selecting suppliers. Monitoring ongoing market trends and supply chain dynamics remains crucial for optimizing procurement strategies.

Key Takeaways

Top-tier suppliers include Baxter, B. Braun, Fresenius Kabi, and Hospira, offering clinically validated potassium chloride and sodium chloride solutions in plastic containers.
Regulatory adherence and manufacturing quality are critical assessment factors for supplier qualification.
Global supply chains are resilient but vulnerable to disruptions; diversified suppliers mitigate risks.
Regional suppliers and CMOs can fulfill localized demand, especially for custom formulations.
Emerging trends emphasize innovation in packaging, sustainability, and supply chain transparency.

FAQs

Q1. What factors influence the choice of supplier for potassium chloride and sodium chloride IV solutions?
Regulatory compliance, product purity, sterility, manufacturing capability, shipping reliability, and cost are primary considerations.

Q2. Are all potassium chloride solutions suitable for intravenous infusion?
Only those manufactured under GMP standards, with proper sterilization and appropriate formulation, are suitable for IV infusion.

Q3. How can supply chain disruptions affect the availability of these solutions?
Disruptions in raw material supply, manufacturing halts, or logistical issues can lead to shortages, emphasizing the importance of diversified sourcing.

Q4. What are the regulatory standards governing these IV solutions?
Standards include USP, EP, BP, and regulatory approvals such as FDA and EMA registration, ensuring safety and efficacy.

Q5. Can regional suppliers provide customized formulations?
Yes, regional CMOs or pharmaceutical manufacturers often tailor formulations based on clinical or local market needs, provided they meet quality standards.

Sources

[1] Baxter International. "Infusion Solutions." Accessed 2023.
[2] B. Braun Melsungen AG. "IV Solutions and Accessories." Accessed 2023.
[3] Fresenius Kabi. "Parenteral Drugs and Solutions." Accessed 2023.
[4] Hospira (Pfizer). "Sterile Injectable Solutions." Accessed 2023.
[5] North American Chloride Limited (NACL). "Pharmaceutical Salt Supplies." Accessed 2023.
[6] Sigma-Aldrich (Merck). "Potassium Chloride Solutions." Accessed 2023.

Suppliers and packagers for POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER