Suppliers and packagers for SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER

SODIUM CHLORIDE 0.9% IN STERILE 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
Baxter Hlthcare	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	sodium chloride	SOLUTION FOR SLUSH;IRRIGATION	019319	NDA	Baxter Healthcare Corporation	0338-0051-44	1000 mL in 1 BAG (0338-0051-44)	1985-05-17

Last updated: August 17, 2025

ppliers for the Pharmaceutical Drug: Sodium Chloride 0.9% in Sterile Plastic Container

Introduction

Sodium chloride 0.9% in sterile plastic containers, commonly referred to as normal saline, is a critical formulation in medical settings. It serves as an isotonic solution used for hydration, drug delivery, wound irrigation, and various medical procedures. As a widely utilized intravenous (IV) fluid, reliable sourcing from reputable suppliers ensures pharmaceutical quality, compliance with regulatory standards, and uninterrupted clinical supplies. This article provides an in-depth analysis of leading suppliers globally, their manufacturing capabilities, regulatory compliance, and market positioning in this essential pharmaceutical segment.

Market Overview

The global market for saline solutions is projected to grow steadily, driven by expanding hospital admissions, increased procedural interventions, and the rising prevalence of dehydration-related conditions. The demand for sterile sodium chloride 0.9% solutions is robust, both in mature healthcare markets in North America and Europe, and emerging markets across Asia-Pacific and Latin America. Suppliers must meet stringent quality standards, such as those outlined by the FDA, EMA, and WHO, to ensure patient safety and compliance.

Leading Suppliers of Sodium Chloride 0.9% in Sterile Plastic Containers

1. Baxter International Inc.

Baxter is a global leader in sterile injectable and IV solutions, including sodium chloride 0.9%. The company’s extensive manufacturing facilities in North America, Europe, and Asia enable high-volume production with rigorous quality control protocols. Baxter’s saline products are compliant with cGMP standards and have a strong reputation for safety and reliability. Their sterile plastic containers are designed for convenience, stability, and patient safety, serving hospitals, clinics, and home-care providers worldwide.

2. Hospira (now part of Pfizer)

Hospira has historically been a dominant player in sterile IV solutions, including saline solutions. Post-acquisition by Pfizer, Hospira's manufacturing footprint expanded, especially in sterile production facilities in the US and Europe. Their saline solutions adhere to stringent regulatory standards (21 CFR Part 11 and EMA guidelines), with a focus on quality assurance and traceability. Pfizer continues to leverage Hospira’s global distribution network to supply saline solutions across multiple continents.

3. Fresenius Kabi

Fresenius Kabi specializes in infusion therapies and sterile medicinal products, including sodium chloride 0.9%. The company possesses multiple manufacturing sites across Europe, Asia, and North America, emphasizing innovations in container design and sterilization techniques. Fresenius Kabi’s solutions meet international pharmacopeial standards (USP, EP, JP) and are used extensively in critical care, surgical, and outpatient settings.

4. B. Braun Melsungen AG

This German medical device and pharmaceutical manufacturer supplies a broad portfolio of IV solutions, notably sodium chloride 0.9%. B. Braun’s sterile solutions are known for high purity, stability, and compatibility with other IV therapies. Their global manufacturing footprint and commitment to quality make them a dependable supplier for large healthcare systems and distributors.

5. Baxter’s Competitors in Emerging Markets

In emerging markets, companies like Cipla (India), Indo Pharma, and Sun Pharmaceutical are increasingly manufacturing sodium chloride 0.9%. These suppliers help cater to regional demand, often offering competitive pricing while maintaining compliance with local regulatory standards. Their presence supports local healthcare infrastructure development and expands access to essential IV fluids.

Manufacturing and Regulatory Compliance

Manufacturers in this segment operate under stringent regulatory oversight. Good Manufacturing Practices (GMP) certifications, ISO standards, and adherence to pharmacopeial specifications ensure the products’ safety, efficacy, and quality. Suppliers must validate sterilization processes, container integrity, and solution sterility, typically verified through sterility testing, PYROGEN testing, and physical-chemical assessments.

Key Factors Influencing Supplier Selection

• Regulatory Compliance: Suppliers must meet local and international standards (FDA, EMA, WHO).
• Manufacturing Capacity: High-volume, reliable production is essential to prevent shortages.
• Quality Assurance: Stringent quality controls and certifications reduce risk.
• Global Footprint: An extensive distribution network ensures timely delivery across regions.
• Cost Competitiveness: Competitive pricing while maintaining quality standards is critical, especially in emerging markets.

Emerging Trends in Saline Solution Supply

The industry is witnessing innovations in container designs, such as prefilled, flexible pouches, and improved sterilization techniques to enhance safety and shelf life. There is also increased emphasis on supply chain resilience, prompted by disruptions during global crises like the COVID-19 pandemic. Manufacturers are investing in digitalization and traceability to meet regulatory and quality demands.

Conclusion

Sodium chloride 0.9% in sterile plastic containers remains a vital component of healthcare, demanding sourcing from reputable, compliant suppliers. Baxter, Pfizer (Hospira), Fresenius Kabi, and B. Braun are prominent global providers, backed by rigorous quality standards and extensive distribution networks. Emerging regional manufacturers contribute to broader access and affordability, especially in developing markets. Ensuring supply chain stability, regulatory adherence, and product quality remains paramount for healthcare providers and distributors.

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Key Takeaways

• Reliable sourcing of sodium chloride 0.9% in sterile containers requires partnering with established manufacturers adhering to GMP and international standards.
• Global leaders like Baxter, Pfizer (Hospira), Fresenius Kabi, and B. Braun dominate the supply chain, offering extensive capacities and compliance.
• Regional manufacturers expand access, particularly in emerging markets, but must meet quality standards to ensure safety.
• Supply chain resilience and innovation are vital amid global disruptions and evolving regulatory landscapes.
• Strategic procurement should include evaluation of manufacturing capacity, regulatory compliance, and regional distribution capabilities to mitigate shortages and ensure continuous supply.

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FAQs

1. What are the primary regulatory standards for sodium chloride 0.9% solutions?
Sodium chloride 0.9% solutions must comply with standards set by agencies like the FDA (21 CFR Part 211), EMA, and pharmacopeias (USP, EP, JP). These regulations cover sterility, isotonicity, manufacturing practices, and container integrity.

2. Are there differences in saline solutions supplied by different manufacturers?
While the chemical composition remains consistent (0.9% NaCl), differences may exist in container materials, sterilization methods, and manufacturing processes, impacting shelf life, stability, and compatibility.

3. How do regional regulations impact supplier choices?
Regional regulations influence manufacturing standards, labeling, and approval processes. Suppliers must demonstrate compliance with local health authority requirements to gain market entry and maintain supply continuity.

4. What considerations are critical during supplier qualification?
Assessments should include regulatory compliance, GMP certifications, manufacturing capacity, quality control protocols, supply chain stability, and cost. It’s also beneficial to evaluate past audit results and track record.

5. How is supply chain resilience enhanced in this segment?
Manufacturers are expanding regional production sites, adopting digital traceability, maintaining safety stock, and building diversified supplier networks to mitigate disruptions and ensure uninterrupted supply.

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Sources

1. Baxter International, official website, product catalogs.
2. Pfizer Inc., corporate disclosures on Hospira products.
3. Fresenius Kabi, product specifications and quality standards.
4. B. Braun Melsungen AG, manufacturing and compliance information.
5. Industry reports on global saline solution markets and supply chain dynamics.