Suppliers and packagers for SODIUM CHLORIDE 3% IN PLASTIC CONTAINER

SODIUM CHLORIDE 3% 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	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	019635	NDA	B. Braun Medical Inc.	0264-5802-00	12 CONTAINER in 1 CASE (0264-5802-00) / 1000 mL in 1 CONTAINER	1998-03-09
B Braun	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	019635	NDA	B. Braun Medical Inc.	0264-5802-10	24 CONTAINER in 1 CASE (0264-5802-10) / 500 mL in 1 CONTAINER	1998-03-09
B Braun	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	019635	NDA	B. Braun Medical Inc.	0264-5804-00	12 CONTAINER in 1 CASE (0264-5804-00) / 1000 mL in 1 CONTAINER	1988-03-09
B Braun	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	019635	NDA	B. Braun Medical Inc.	0264-7800-09	12 CONTAINER in 1 CASE (0264-7800-09) / 1000 mL in 1 CONTAINER	2013-12-31

Suppliers for the Pharmaceutical Drug: Sodium Chloride 3% in Plastic Container

Last updated: August 15, 2025

Introduction

Sodium chloride 3% solution in plastic containers is a common medical saline used in clinical settings for various indications, including irrigation, humidification, and as a diluent for medications. Its widespread application necessitates a robust supply chain of high-quality pharmaceutical-grade solutions, particularly in sterile, convenient plastic containers. This article provides a comprehensive overview of key suppliers globally, emphasizing their production capacity, quality standards, certification credentials, and market positioning to inform procurement and strategic sourcing decisions.

Global Market Overview of Sodium Chloride 3% Solutions

The demand for Sodium Chloride 3% solutions primarily originates from hospitals, clinics, and medical device manufacturers. The growth is driven by increasing healthcare expenditures, expansion of outpatient services, and rising prevalence of hydration-related therapies. The market is characterized by a limited number of specialized pharmaceutical manufacturers due to stringent regulatory requirements around sterility, packaging, and compliance with Good Manufacturing Practices (GMP).

The supply chain involves raw material sourcing (salt purification), solution formulation, sterilization, and packaging in plastic containers. Manufacturers must comply with international standards, including USP, EP, and BP, and attain certifications such as ISO 13485, indicating adherence to quality management systems specific to medical devices and pharmaceuticals.

Leading Suppliers of Sodium Chloride 3% in Plastic Containers

1. Baxter International Inc.

Overview: Baxter is a global leader in fluid and saline solutions, offering a comprehensive portfolio that includes Sodium Chloride 3% solutions in sterile plastic containers. Their products are extensively used worldwide in hospitals and clinics.

Capabilities & Quality Assurance: Baxter emphasizes stringent GMP compliance and possesses ISO 13485 and FDA approvals. The company operates manufacturing plants in North America, Europe, and Asia, ensuring scalable supply for global markets.

Product Range: Baxter's saline solutions are available in various container sizes—typically from 100 mL to 1000 mL—manufactured in medical-grade polypropylene or polyethylene containers, tested for leachables and extractables.

Certifications: USP, EP, BP, ISO 13485. Baxter maintains an extensive distribution network, ensuring availability across key regions.

2. Fresenius Kabi

Overview: Fresenius Kabi specializes in infusion therapies and clinical nutrition. Their saline products, including 3% NaCl solutions, are renowned for high purity and reliable delivery.

Manufacturing & Quality: The company operates in Europe, North America, and Asia, with facilities compliant with GMP, ISO 9001, and ISO 13485 standards.

Product Features: Prefilled sterile plastic containers with features such as flexible IV bag formats and integrity testing for sterility assurance.

Certifications: Certified under USP, EP, BP, ISO 13485, and approved by regulatory agencies like the US FDA and European Medicines Agency (EMA).

3. B. Braun Melsungen AG

Overview: B. Braun is an established manufacturer of infusion solutions, including Sodium Chloride 3% solutions in plastic containers. Known for custom solutions and high standards of quality.

Capabilities & Reach: B. Braun supplies to over 100 countries, with manufacturing facilities in Europe, the Americas, and Asia-Pacific.

Product Attributes: Plastic containers made of medical-grade plastics, compliant with international standards, featuring easy-to-use closures and sterile packaging.

Certifications: GMP, ISO 13485, and regional certifications such as CE marking, US FDA approvals.

4. Hospira (A Pfizer Company)

Overview: Hospira, now integrated into Pfizer, remains a key player in injectable and infusion solutions, including Sodium Chloride 3%.

Product Portfolio: Focused on ready-to-use sterile saline solutions, packaged in plastic containers designed to meet hospital sterile handling standards.

Quality & Compliance: GMP-certified with quality systems aligned with US FDA and international standards, ensuring product safety and reliability.

5. Chemo Research (A part of the Vizient Portfolio)

Overview: Specializing in pharmaceutical raw materials and finished solutions, Chemo Research supplies Sodium Chloride 3% in plastic containers to regional markets, especially in Europe and Latin America.

Manufacturing & Standards: Complies with ISO 9001 and ISO 13485; their products served in clinical, research, and medical settings with validated sterilization processes.

6. Local and Regional Suppliers

In addition to multinational corporations, regional suppliers in Asia (particularly India and China) and Europe often provide Sodium Chloride 3% solutions in plastic containers, primarily catering to emerging markets.

Notes on Regional Suppliers:

• Usually offer lower-cost options, which may vary in compliance levels with international standards.
• Require rigorous validation to verify sterility, quality assurance, and packaging integrity.
• Examples include Sun Pharma (India), Shanghai Baolai Pharmaceutical Co., Ltd., and others.

Selection Criteria for Suppliers

When evaluating suppliers for Sodium Chloride 3% solutions in plastic containers, consider the following:

• Regulatory compliance: GMP, ISO 13485, FDA approvals, and regional certifications.
• Product Quality: Sterility assurance, expiry date stability, container integrity, and absence of leachables.
• Supply Chain Reliability: Consistent production capacity, lead times, and logistics capabilities.
• Packaging Standards: Compatibility with medical protocols and ease of handling.
• Pricing and Contract Terms: Cost competitiveness without compromising quality and safety standards.

Emerging Trends and Considerations

• Personalized Packaging: Increasing demand for customizable volume containers suited for specific clinical settings.
• Sustainable Packaging: Transition towards eco-friendly plastics or reduced packaging waste to meet environmental regulations.
• Quality Innovation: Implementation of greater sterilization controls and container integrity testing to minimize contamination risks.
• Regulatory Convergence: Harmonization of standards across regions (e.g., US, Europe, Asia) to streamline procurement processes.

Conclusion

The supply of Sodium Chloride 3% in plastic containers hinges on a select group of global pharmaceutical manufacturers renowned for their adherence to high-quality standards, regulatory compliance, and reliable distribution networks. Major players such as Baxter, Fresenius Kabi, B. Braun, and Hospira dominate this sector, offering sterile, validated solutions suitable for diverse clinical needs. Regional suppliers can complement global sources but require rigorous due diligence.

Strategic procurement should prioritize suppliers with certified manufacturing processes, scalable capacity, and robust logistics to ensure uninterrupted supply chains and premium product integrity.

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Key Takeaways

• The leading suppliers for Sodium Chloride 3% solutions in plastic containers include Baxter, Fresenius Kabi, B. Braun, and Hospira, all adhering to international standards such as GMP, ISO 13485, and regional approvals.
• Quality assurance, sterilization processes, container integrity, and regulatory compliance are critical determinants in supplier selection.
• Regional manufacturers can offer cost advantages but require thorough validation to meet international safety and quality benchmarks.
• Emerging market demands include sustainable packaging, personalized container sizes, and enhanced product safety features.
• Building strategic relationships with certified suppliers ensures reliable access to high-quality Sodium Chloride solutions, critical for clinical and manufacturing applications globally.

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FAQs

1. What certifications should I look for when sourcing Sodium Chloride 3% in plastic containers?
Certifications such as GMP, ISO 13485, USP, EP, BP, and regional approvals like FDA clearance or CE marking ensure product quality, safety, and regulatory compliance.

2. Are regional suppliers reliable for importing Sodium Chloride 3% solutions?
They can be, but due diligence is essential. Validation of their manufacturing practices, certifications, and documentation is necessary to ensure consistent quality and compliance.

3. How do multinational suppliers differentiate their Sodium Chloride 3% solutions?
They offer validated sterilization processes, consistent quality control, broad regulatory approvals, extensive distribution networks, and scalable manufacturing capacity.

4. Can Sodium Chloride 3% solutions in plastic containers be customized?
Yes, many suppliers offer various container sizes, sterile formats, and packaging options tailored to specific clinical or manufacturing needs.

5. What are the latest trends influencing the Sodium Chloride 3% solution supply chain?
Growing emphasis on sustainable packaging, increased regulatory harmonization, technological advancements in sterilization, and personalized container designs are shaping the supply landscape.

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Sources

[1] Baxter International. (2023). Product Portfolio and Regulatory Certifications.
[2] Fresenius Kabi. (2023). Healthcare Solutions and Compliance Standards.
[3] B. Braun Melsungen AG. (2023). Infusion Solutions and Quality Certifications.
[4] Pfizer (Hospira). (2023). Sterile Solutions and Regulatory Approvals.
[5] Chemo Research. (2023). Regional Supply and Quality Standards.