DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	211194	ANDA	Fresenius Kabi USA, LLC	63323-867-10	10 BAG in 1 CASE (63323-867-10) / 1000 mL in 1 BAG (63323-867-01)	2020-10-26
Fresenius Kabi Usa	DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	211194	ANDA	Fresenius Kabi USA, LLC	63323-867-74	20 BAG in 1 CASE (63323-867-74) / 500 mL in 1 BAG (63323-867-05)	2020-10-26
Fresenius Kabi Usa	DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	211194	ANDA	Fresenius Kabi USA, LLC	63323-867-75	30 BAG in 1 CASE (63323-867-75) / 250 mL in 1 BAG (63323-867-15)	2020-10-26
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 3, 2025

Introduction

The combination of Dextrose 5% and Sodium Chloride 0.3% in plastic containers is a common intravenous (IV) fluid used for hydration, nutritional support, and electrolyte balance in clinical settings. The global demand for these solutions has driven pharmaceutical manufacturers and suppliers to establish a robust supply chain comprising bulk manufacturers, contract manufacturers, and specialty chemical suppliers.

This article provides an in-depth analysis of key suppliers for this medication, focusing on their manufacturing capacities, geographic presence, regulatory compliance, and market share. As the healthcare industry emphasizes quality assurance and regulatory adherence, understanding the landscape of reliable suppliers becomes paramount for pharmaceutical companies and healthcare providers.

Market Overview

The Dextrose 5% and Sodium Chloride 0.3% solution is classified as a sterile, injectable, or infusion-grade pharmaceutical, typically supplied in plastic (polyethylene or polypropylene) containers such as bottles or bags. Its production involves high-quality standards to maintain sterility, stability, and compatibility with infusion systems.

Top suppliers are often large-scale pharmaceutical manufacturers with established GMP (Good Manufacturing Practice) facilities, ensuring compliance with international regulatory standards such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and WHO (World Health Organization).

Leading Suppliers of Dextrose 5% and Sodium Chloride 0.3% in Plastic Containers

1. Baxter International Inc.

Overview: A global leader in IV solutions, Baxter manufactures numerous sterile infusion products, including Dextrose and Sodium Chloride solutions. Their products are extensively used in hospitals and clinics worldwide.

Manufacturing & Capabilities: Baxter operates multiple manufacturing plants across North America, Europe, and Asia, with extensive sterile production lines compliant with GMP standards. They produce pre-filled plastic bottles and bags, ensuring sterility and stability.

Regulatory Compliance: Baxter maintains certifications from FDA, EMA, and other regulatory bodies, facilitating their products’ approval in numerous markets.

Market Presence: Their strong distribution network and reputation for quality make Baxter a primary choice for hospitals needing reliable Dextrose and Sodium Chloride solutions.

2. B. Braun Melsungen AG

Overview: B. Braun is a leading European pharmaceutical and medical device manufacturer specializing in infusion therapies, including IV fluids.

Manufacturing & Capabilities: Their production facilities in Germany and other locations focus on sterile solutions, packaging in plastic containers designed for ease of use and compatibility with infusion devices.

Regulatory Compliance: B. Braun’s production adheres to GMP, ISO 13485, and other international quality standards, earning approvals for global markets.

Market Presence: B. Braun’s extensive global footprint and reputation for high-quality infusion solutions make it a reliable supplier in this sector.

3. Fresenius Kabi AG

Overview: A prominent player in infusion solutions and clinical nutrition, Fresenius Kabi supplies Dextrose and Sodium Chloride solutions in various container formats.

Manufacturing & Capabilities: Their global manufacturing network includes sites with advanced aseptic processing capabilities, producing in plastic containers suitable for hospital use.

Regulatory Compliance: Certified under GMP and other international standards; their products are approved for distribution across Europe, North America, and Asia.

Market Presence: They have a significant market share in Europe and Asia, maintaining a focus on quality, safety, and supply reliability.

4. Pfizer Inc.

Overview: Pfizer offers a comprehensive range of injectable fluids, including Dextrose and Sodium Chloride solutions, primarily in plastic containers, predominantly for North American markets.

Manufacturing & Capabilities: Their sterile manufacturing facilities are GMP-certified, producing high-purity solutions for hospitals and clinics.

Regulatory Compliance: Pfizer’s rigorous quality systems ensure compliance with FDA and international standards, facilitating rapid market access.

Market Presence: Pfizer’s broad distribution ensures availability across multiple regions, often favored for its brand reliability.

5. Negotiating Suppliers: Regional and Local Players

While the above companies dominate the global stage, regional and local suppliers play vital roles, especially in emerging markets. Examples include:

Hema Bayer (India): Provides a range of IV solutions, including Dextrose and Sodium Chloride solutions in plastic containers, complying with local regulatory standards.
Shanghai Hengkang Pharmaceutical (China): Manufactures similar infusion fluids catering to the Asian market, with increasing compliance with international GMP standards.
Jiangsu Hengrui Medicine (China): Engages in the production of various infusion solutions, continuously expanding its global footprint.

Supply Chain Considerations

Regulatory Approval and Certification: Suppliers must hold valid GMP certificates and regulatory approvals for their markets. This ensures product safety, consistent quality, and compliance with pharmacopoeial standards (USP, EP, JP).

Manufacturing Quality: The production of solutions in plastic containers requires high aseptic processing standards, reliable sterilization methods (e.g., autoclaving, sterile filtration), and rigorous quality control.

Capacity and Scalability: Given fluctuating demand, suppliers with scalable manufacturing capacity and supply chain resilience are preferable to prevent shortages.

Traceability and Validation: Transparent supply chains with batch traceability and validated supply systems are critical for risk mitigation and regulatory audits.

Emerging Trends and Future Outlook

Localization of Production: Increasing regional manufacturing capabilities to meet local demand, reduce supply chain disruptions, and navigate import restrictions.
Innovation in Packaging: Transition toward advanced plastics and integrated infusion systems that improve safety and ease of use.
Regulatory Harmonization: Efforts toward global harmonization of standards may streamline supplier selection and product approval processes.
Supply Chain Disruptions: Ongoing geopolitical challenges, pandemic-related disruptions, and raw material shortages influence supplier reliability, emphasizing the importance of diversified supplier bases.

Key Takeaways

Leading global suppliers for Dextrose 5% and Sodium Chloride 0.3% in plastic containers include Baxter, B. Braun, Fresenius Kabi, and Pfizer, among others, each with extensive manufacturing capacity and regulatory compliance.
Regional manufacturers represent significant sources in emerging markets, offering localized supply solutions aligned with regional standards.
Ensuring regulatory compliance, manufacturing quality, supply chain resilience, and scalable capacity are essential criteria for selecting reliable suppliers.
The healthcare industry’s evolving landscape demands suppliers that innovate in packaging, enhance traceability, and adapt to regulatory harmonization efforts.
Diversification of supplier sources and vigilant quality monitoring mitigate risks associated with supply chain disruptions, ensuring uninterrupted patient care.

FAQs

1. What criteria should healthcare providers consider when selecting a supplier for Dextrose and Sodium Chloride solutions?
Providers should evaluate regulatory compliance (GMP certifications), manufacturing quality, supply chain stability, product availability, and the supplier’s global or regional presence.

2. Are there significant differences between products from different suppliers?
While formulation standards are generally consistent, differences can arise in container quality, stability, and manufacturing practices. Certification and batch testing are key to ensuring product equivalence.

3. How does regulatory approval impact the choice of suppliers?
Regulatory approval ensures product safety and quality, enabling market acceptance and legal distribution. Suppliers with multiple approvals facilitate easier market access and reduce compliance risks.

4. What role do regional manufacturers play in the supply of these solutions?
Regional manufacturers help meet localized demand, reduce logistics costs, and mitigate supply disruptions. They often adapt products to regional standards and market needs.

5. How does the ongoing global supply chain situation affect sourcing for these solutions?
Disruptions due to geopolitical, pandemic, or raw material shortages can impact availability. Diversifying suppliers and increasing regional manufacturing capacity help mitigate these risks.

References

Baxter International Inc. Product Portfolio [Online]. Available at: https://www.baxter.com
B. Braun Melsungen AG. Infusion Solutions [Online]. Available at: https://www.bbraun.com
Fresenius Kabi. IV Solutions Manufacturer [Online]. Available at: https://www.fresenius-kabi.com
Pfizer Inc. Enterprise Portfolio [Online]. Available at: https://www.pfizer.com
World Health Organization (WHO). Good Manufacturing Practices (GMP) Guidelines.

Suppliers and packagers for DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER