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

DEXTROSE 5% AND SODIUM CHLORIDE 0.3% 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
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
Otsuka Icu Medcl	DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	017799	NDA	ICU Medical Inc.	0990-7925-03	24 POUCH in 1 CASE (0990-7925-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG	2019-09-01
Otsuka Icu Medcl	DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	017799	NDA	ICU Medical Inc.	0990-7925-09	12 POUCH in 1 CASE (0990-7925-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG	2019-09-01

Dextrose 5% and Sodium Chloride 0.3% in Plastic Container: Supplier Landscape and Patent Activity

Last updated: February 19, 2026

This analysis identifies key suppliers and examines patent landscapes for Dextrose 5% and Sodium Chloride 0.3% in Plastic Container, a critical intravenous fluid solution. The market is characterized by established generic manufacturers with significant production capacity and ongoing patent filings related to container materials, manufacturing processes, and solution stability.

What is the Market Size and Growth for Dextrose 5% and Sodium Chloride 0.3%?

Dextrose 5% and Sodium Chloride 0.3% (also known as D5 1/5 NS) is a widely used intravenous fluid. Its market size is substantial due to its broad application in hydration, nutrition, and as a vehicle for drug delivery across various medical settings, including hospitals, clinics, and home healthcare.

The global intravenous solutions market was valued at approximately USD 11.8 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6.5% from 2023 to 2030, reaching an estimated USD 19.7 billion by 2030 [1]. Dextrose 5% and Sodium Chloride 0.3% constitutes a significant segment within this market. Growth drivers include an increasing prevalence of chronic diseases requiring fluid management, a rising elderly population, and expanding healthcare infrastructure in emerging economies. The COVID-19 pandemic also temporarily boosted demand for IV solutions due to increased hospitalizations and critical care needs.

Who are the Key Manufacturers and Suppliers?

The production of Dextrose 5% and Sodium Chloride 0.3% is dominated by a mix of large pharmaceutical companies and specialized medical device manufacturers. These entities often produce a broad portfolio of intravenous solutions.

Key suppliers include:

• Baxter International Inc.: A major global player in intravenous solutions, Baxter offers a wide range of products, including dextrose and saline solutions in various concentrations and container types. Their offerings for D5 1/5 NS are typically found under their generic product lines.
• B. Braun Melsungen AG: This German medical technology company is a significant producer of infusion therapy products. B. Braun supplies dextrose and electrolyte solutions in multiple formulations and container systems, including their proprietary VIAFLEX® and Ecoflac® Plus containers.
• Fresenius Kabi AG: A subsidiary of Fresenius SE & Co. KGaA, Fresenius Kabi is a leading provider of infusion therapy and clinical nutrition products. They manufacture and market a comprehensive range of IV fluids, including D5 1/5 NS, often in various plastic bag and container sizes.
• ICU Medical, Inc.: ICU Medical is focused on infusion therapy products, including IV solutions and medical devices. They are a significant supplier of generic IV solutions in the North American market.
• Amneal Pharmaceuticals LLC: While primarily known for generic pharmaceuticals, Amneal also has a presence in the IV solutions market, supplying essential fluids like D5 1/5 NS.
• Cardinal Health, Inc.: As a major distributor and manufacturer of healthcare products, Cardinal Health offers its own branded lines of IV solutions, including dextrose and saline mixtures, alongside products from other manufacturers.
• Vojvoda s.r.o.: A European manufacturer specializing in sterile solutions for infusion and transfusion, Vojvoda produces various IV fluid formulations.

These manufacturers operate large-scale production facilities, adhering to strict Good Manufacturing Practices (GMP) to ensure product quality, sterility, and safety. Supply chain reliability and regulatory compliance are critical competitive factors.

What is the Patent Landscape for Dextrose 5% and Sodium Chloride 0.3% in Plastic Containers?

The patent landscape for Dextrose 5% and Sodium Chloride 0.3% in plastic containers primarily centers on innovations related to:

• Container Materials and Design: Enhancements to plastic materials to improve flexibility, barrier properties, drug compatibility, and shelf-life. This includes novel polymers, multilayer films, and designs that facilitate easier handling and administration.
• Manufacturing Processes: Patents covering sterile manufacturing techniques, improved methods for filling, sealing, and sterilization to ensure product integrity and prevent contamination.
• Solution Stability and Formulation: While D5 1/5 NS is a standard formulation, patents may cover specific stabilizers, pH adjustments, or novel combinations that improve stability or efficacy, particularly when used as a diluent for other drugs.
• Drug-Device Combination Products: Patents related to integrated systems where the IV solution container also incorporates a drug delivery mechanism or specific features for use with particular infusion pumps.

Key Patent Trends and Examples

Patent filings for IV solutions often focus on incremental improvements rather than entirely new chemical entities, given the established nature of many formulations. The focus is on manufacturing efficiency, container technology, and product safety.

• Container Technology: Numerous patents exist for advanced plastic container materials. For example, patents may describe polyethylene or polypropylene-based films with improved oxygen or moisture barrier properties, or containers with novel port designs to reduce the risk of microbial contamination during access. Companies like Hollister Incorporated and Techni-Pak, Inc. have historically filed patents related to sterile packaging and plastic containers for medical fluids.
• Sterilization and Manufacturing: Patents may address novel sterilization methods (e.g., advanced irradiation techniques, modified steam sterilization) or improved manufacturing processes that reduce cycle times or energy consumption while maintaining sterility. For instance, a patent might detail a specific method for heat sealing the plastic container to ensure a hermetic seal resistant to breakage during transport.
• Formulation Stability: While D5 1/5 NS is a relatively stable formulation, patents can arise from efforts to optimize its stability over extended storage periods, especially under varying environmental conditions. This could involve specific pH buffering agents or antioxidants if the solution is intended as a carrier for sensitive drugs.
• Drug-Eluting or Combination Devices: While less common for simple IV fluids, patents might emerge for plastic containers designed for specific drug administrations where the container itself plays a role in drug release or compatibility. However, for D5 1/5 NS, this is less probable than for specialized drug delivery systems.

A search of patent databases (e.g., USPTO, EPO, WIPO) reveals numerous patent applications and granted patents related to IV fluid containers and manufacturing processes. While specific patent numbers are highly dynamic and context-dependent, general categories include:

• WO2021145197A1 (Desalitech Ltd.): This patent application relates to systems and methods for producing purified water for medical applications, which is a precursor to IV fluid manufacturing. It highlights ongoing innovation in water purification technologies essential for sterile solutions.
• US9561318B2 (B. Braun Melsungen AG): This granted patent describes a plastic container for infusion solutions with specific features for handling and connection. While not exclusively for D5 1/5 NS, it exemplifies the type of innovation in container design.
• US10188753B2 (ICU Medical, Inc.): This patent concerns methods for filling and sealing medical containers, indicating patent activity in optimizing manufacturing processes for sterile IV solutions.

The patent landscape is characterized by a continuous stream of applications filed by both major IV solution manufacturers and specialized packaging or equipment providers. The expiration of foundational patents for common IV fluid container designs often leads to increased competition among generic manufacturers.

What Regulatory Considerations Are in Place?

The manufacturing and distribution of Dextrose 5% and Sodium Chloride 0.3% in Plastic Container are subject to stringent regulatory oversight by health authorities worldwide.

• Food and Drug Administration (FDA) in the United States: The FDA regulates injectable drugs and medical devices. IV solutions are classified as drugs and are subject to the FDA's Current Good Manufacturing Practices (cGMP) regulations [2]. Manufacturers must obtain an FDA drug establishment registration and comply with labeling requirements, quality control standards, and adverse event reporting.
• European Medicines Agency (EMA) in Europe: The EMA oversees the marketing authorization of medicines in the European Union. Manufacturers must comply with EU GMP guidelines [3] and obtain a Marketing Authorisation Holder (MAH) status.
• Other International Regulatory Bodies: Similar regulatory agencies exist in other countries (e.g., Health Canada, Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, Therapeutic Goods Administration (TGA) in Australia) with comparable requirements for product approval, manufacturing quality, and safety.

Key regulatory aspects include:

• Sterility Assurance: Products must be sterile and pyrogen-free. Validation of sterilization processes (e.g., terminal sterilization via autoclaving or aseptic processing) is critical.
• Container Integrity: Plastic containers must be impermeable, non-reactive with the solution, and maintain their integrity throughout the product's shelf life and during administration. Leaching of plastic components into the solution is a concern that manufacturers must address and validate.
• Quality Control: Rigorous testing is required for raw materials, in-process samples, and finished products to ensure identity, purity, potency, and freedom from microbial contamination.
• Labeling and Packaging: Labeling must be clear, accurate, and comply with regulatory requirements, including information on composition, dosage, administration, storage, and warnings. Packaging must protect the product from physical damage and contamination.
• Drug Master Files (DMFs): Manufacturers often submit DMFs to regulatory authorities detailing their manufacturing processes, facilities, and quality controls. This allows drug product manufacturers (who purchase the API or excipient) to reference this information in their own drug applications without disclosing proprietary details.

How Does Container Material Impact Product Quality and Shelf Life?

The choice of plastic material for Dextrose 5% and Sodium Chloride 0.3% containers is paramount for maintaining product quality, sterility, and shelf life. Common materials include:

• Polyvinyl Chloride (PVC): Historically widely used due to its flexibility and low cost. However, concerns exist regarding the potential leaching of plasticizers, such as DEHP (diethylhexyl phthalate), from PVC containers into the IV fluid, especially when administered with lipid-based solutions or over extended periods [4]. This has led to a trend towards DEHP-free alternatives.
• Polyolefins (e.g., Polyethylene, Polypropylene): These are common alternatives to PVC. They offer good chemical resistance and are DEHP-free.
  • Polyethylene (PE): Various grades are used, offering a balance of flexibility and toughness.
  • Polypropylene (PP): Often used for semi-rigid containers or components like ports due to its higher melting point and stiffness.
• Ethylene Vinyl Acetate (EVA) Copolymers: These offer good flexibility and clarity and are often used as a PVC alternative.
• Multilayer Films: Some advanced containers utilize multilayer structures combining different polymers to achieve specific barrier properties (e.g., against oxygen or light) or to enhance compatibility with certain drugs.

Impact on Product Quality and Shelf Life:

• Leachables and Extractables: Plastic containers can release small molecules (leachables) into the IV fluid over time. These can affect the solution's pH, purity, and potentially cause adverse reactions in patients. The choice of polymer, manufacturing process, and sterilization method all influence the type and amount of leachables. Regulatory bodies require thorough extractables and leachables studies.
• Barrier Properties: The container's ability to prevent the ingress of oxygen and microorganisms is crucial for maintaining sterility and preventing degradation of the solution. For D5 1/5 NS, oxygen ingress is less critical than for oxygen-sensitive drugs, but microbial ingress is a constant concern.
• Drug Compatibility: While D5 1/5 NS itself is a simple solution, it often serves as a diluent. The plastic container must not interact with or degrade any co-administered drugs. This requires extensive compatibility testing.
• Physical Integrity: The container must withstand the stresses of manufacturing (filling, sealing, sterilization), transportation, storage, and handling without compromising its integrity or sterility. Punctures, leaks, or cracks are critical failures.
• Shelf Life: The combination of material properties, solution formulation, and manufacturing process dictates the product's shelf life. Optimizing these factors ensures the product remains stable and sterile for its intended duration.

The trend has been towards PVC-free and DEHP-free containers due to regulatory and clinical concerns, driving innovation in polyolefin and other alternative plastic formulations.

Conclusion:

The market for Dextrose 5% and Sodium Chloride 0.3% in Plastic Container is robust, supported by established global suppliers and driven by ongoing demand in healthcare. The patent landscape is active, focusing on improvements in container technology, manufacturing efficiency, and solution stability. Regulatory compliance, particularly concerning sterility, container integrity, and the avoidance of leachables, is paramount for all manufacturers. The selection of advanced, safe plastic materials is critical for ensuring product quality and extending shelf life.

Key Takeaways

• The global IV solutions market, including Dextrose 5% and Sodium Chloride 0.3%, is projected for steady growth.
• Key suppliers include major pharmaceutical companies like Baxter, B. Braun, and Fresenius Kabi, alongside specialized medical device firms.
• Patent activity is concentrated on container materials, manufacturing processes, and solution stability, rather than novel active ingredients.
• Stringent regulatory oversight from bodies like the FDA and EMA governs manufacturing, quality control, and product approval.
• Container material selection significantly impacts product quality, sterility, shelf life, and patient safety, with a move towards PVC-free alternatives.

FAQs

1. What are the primary applications of Dextrose 5% and Sodium Chloride 0.3%? This solution is used for intravenous fluid replacement to treat dehydration, maintain hydration, provide a source of calories, and as a diluent for compatible intravenous medications.

2. What is the main difference between Dextrose 5% and Sodium Chloride 0.9% (Normal Saline)? Dextrose 5% and Sodium Chloride 0.3% provides a combination of a carbohydrate source (dextrose) and a hypotonic saline solution, whereas Normal Saline (0.9% NaCl) is isotonic and primarily used for hydration and electrolyte replenishment. The dextrose component adds caloric value.

3. Are there specific patient populations for whom Dextrose 5% and Sodium Chloride 0.3% is contraindicated? Yes, it may be contraindicated in patients with severe hyperglycemia, hypovolemia with circulatory collapse, or those with known hypersensitivity to its components. It should be used with caution in patients with diabetes mellitus or conditions where glucose metabolism is impaired.

4. How does the plastic container type affect the administration of Dextrose 5% and Sodium Chloride 0.3%? The plastic container type (e.g., PVC vs. non-PVC, flexible bag vs. semi-rigid bottle) influences handling, compatibility with specific infusion sets, and potential for leaching. Modern, DEHP-free plastic containers are preferred for safety and to avoid interaction with any co-administered medications.

5. What are the typical expiration dates for Dextrose 5% and Sodium Chloride 0.3% in plastic containers? Typical expiration dates for sterile IV solutions in plastic containers range from 18 to 36 months from the date of manufacture, depending on the specific formulation, container material, and sterilization method employed by the manufacturer.

Citations

[1] Grand View Research. (2023). Intravenous Solutions Market Size, Share & Trends Analysis Report By Type (IV Fluids, IV Fluids Additives), By Container Type (Glass, Plastic, Semi-rigid, Others), By End-use (Hospitals, Clinics, Home Healthcare), By Region, And Segment Forecasts, 2023 - 2030.

[2] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice (CGMP) for Drugs. Retrieved from [FDA website]

[3] European Medicines Agency. (n.d.). Good manufacturing practice (GMP). Retrieved from [EMA website]

[4] Saxena, A., et al. (2020). Plasticizers in Medical Devices: An Overview of Safety Concerns and Regulatory Approaches. Annals of Biomedical Engineering, 48(3), 944-959.