DEXTROSE 10% IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
B Braun	DEXTROSE 10% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	019626	NDA	B. Braun Medical Inc.	0264-7387-50	4 CONTAINER in 1 CASE (0264-7387-50) / 2000 mL in 1 CONTAINER	2015-02-19
B Braun	DEXTROSE 10% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	019626	NDA	B. Braun Medical Inc.	0264-7510-00	12 CONTAINER in 1 CASE (0264-7510-00) / 1000 mL in 1 CONTAINER	1988-02-02
B Braun	DEXTROSE 10% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	019626	NDA	B. Braun Medical Inc.	0264-7510-10	24 CONTAINER in 1 CASE (0264-7510-10) / 500 mL in 1 CONTAINER	1988-02-02
B Braun	DEXTROSE 10% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	019626	NDA	B. Braun Medical Inc.	0264-7510-20	24 CONTAINER in 1 CASE (0264-7510-20) / 250 mL in 1 CONTAINER	1988-02-02
B Braun	DEXTROSE 10% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	019626	NDA	B. Braun Medical Inc.	0264-7520-00	12 CONTAINER in 1 CASE (0264-7520-00) / 1000 mL in 1 CONTAINER	1988-02-02
B Braun	DEXTROSE 10% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	019626	NDA	B. Braun Medical Inc.	0264-7520-10	24 CONTAINER in 1 CASE (0264-7520-10) / 500 mL in 1 CONTAINER	1988-02-02
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This analysis identifies leading suppliers of Dextrose 10% in Plastic Container, a critical intravenous fluid. The patent landscape reveals a focus on container material, sterility, and manufacturing processes. Key players in the supply chain possess manufacturing capabilities and regulatory approvals essential for pharmaceutical product distribution.

Who are the Primary Manufacturers of Dextrose 10% in Plastic Container?

The market for Dextrose 10% in Plastic Container is served by several established pharmaceutical and medical device manufacturers. These companies operate under stringent regulatory oversight, including Good Manufacturing Practices (GMP), to ensure product quality and patient safety.

Leading suppliers include:

Baxter International Inc.
B. Braun Medical Inc.
Fresenius Kabi USA, LLC
ICU Medical, Inc.
Piramal Pharma Solutions

These entities have demonstrated consistent supply capabilities and hold the necessary Food and Drug Administration (FDA) approvals for their products. Their manufacturing infrastructure is designed to produce large volumes of sterile injectable solutions.

What are the Dominant Patent Areas for Dextrose 10% Solutions in Plastic Containers?

Patent filings related to dextrose solutions in plastic containers primarily concentrate on innovations in container design, material science, sterilization techniques, and manufacturing processes. These patents aim to enhance product stability, reduce leaching of container components, improve ease of use, and maintain sterility throughout the product's shelf life.

Key patent categories include:

Container Material Composition: Patents address the development and use of specific polymer blends or coatings for plastic containers. These innovations seek to minimize or eliminate the potential for leaching of plasticizers or other compounds into the dextrose solution, thereby improving product purity and reducing patient risk. For example, research has focused on multi-layer films and advanced polyolefins.
Sterilization Methods: Novel or improved sterilization processes for both the solution and the plastic container are a frequent subject of patenting. This includes advancements in terminal sterilization techniques that do not compromise the integrity of the plastic container or degrade the dextrose. Radiation sterilization and autoclaving efficacy under specific parameters are often detailed.
Container Design and Features: Patents also cover improvements in the physical design of the plastic container. This can include enhanced spike ports, improved hanging mechanisms, integrated infusion ports designed for reduced contamination, and container shapes optimized for stability and ease of handling in clinical settings. Bag-in-bag systems and specific valve designs have been patented.
Manufacturing Processes: Proprietary manufacturing techniques that ensure aseptic filling, precise dextrose concentration, and robust container sealing are also patented. These often relate to quality control measures integrated into the production line and methods for preventing microbial contamination during high-volume production.
Stabilization of Dextrose Solutions: While dextrose solutions are generally stable, some patents may address formulations or container interactions designed to prevent degradation or discoloration over extended storage periods, particularly under varying environmental conditions.

The expiration of foundational patents allows for generic competition, but ongoing innovation in material science and container technology continues to generate new intellectual property, particularly around enhanced safety and usability features.

How do Patent Expirations Impact Market Dynamics for Dextrose 10% Solutions?

Patent expirations have a significant impact on the market for Dextrose 10% in Plastic Container, primarily by facilitating the entry of generic manufacturers and increasing price competition.

When a patent protecting a specific formulation, manufacturing process, or container technology expires, other companies can legally produce and market their own versions of the product without infringing on the original intellectual property. This typically leads to:

Increased Supply: The number of manufacturers offering the product grows, increasing overall market supply.
Price Erosion: With more competitors, prices tend to decrease as companies vie for market share. This benefits healthcare providers and payers by reducing costs.
Innovation in Manufacturing and Delivery: While the core product may be off-patent, companies continue to innovate in areas such as improved manufacturing efficiency, more sustainable packaging, or enhanced delivery systems to differentiate their offerings.
Focus on Brand and Service: For originator companies, maintaining market share post-patent expiration often relies on strong brand recognition, established supply chain relationships, and superior customer service.

The patent landscape for dextrose solutions is characterized by a mix of expired foundational patents and newer patents focused on incremental improvements or specific technological advancements, particularly in the realm of container integrity and safety.

What Regulatory Hurdles Must Suppliers Navigate for Dextrose 10% in Plastic Containers?

Suppliers of Dextrose 10% in Plastic Container must navigate a rigorous regulatory landscape overseen by agencies such as the U.S. Food and Drug Administration (FDA) and equivalent bodies internationally. Compliance is essential for market access and continued operation.

Key regulatory considerations include:

FDA Approval: Products must receive FDA approval as a finished drug product. This involves submitting New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs) for generic versions, demonstrating safety, efficacy, and quality.
Good Manufacturing Practices (GMP): Manufacturers must adhere to stringent GMP regulations outlined in 21 CFR Parts 210 and 211. This encompasses all aspects of production, including facility design, equipment calibration, raw material sourcing, process validation, quality control testing, and record-keeping.
Sterility Assurance: Demonstrating and maintaining the sterility of the final product is paramount. This involves validated sterilization processes, aseptic filling techniques, and rigorous environmental monitoring of manufacturing areas.
Container Closure Integrity: The plastic container and its sealing mechanism must maintain product sterility and prevent contamination throughout its shelf life. Testing for container closure integrity is a critical part of the regulatory submission.
Leachable and Extractables Testing: Manufacturers must conduct comprehensive testing to identify and quantify any substances that may leach from the plastic container into the dextrose solution or be extracted from the container material. The results must demonstrate that these substances are below acceptable safety thresholds.
Labeling Requirements: Product labeling must comply with FDA regulations, providing accurate information regarding the drug, dosage, administration, warnings, and expiration date.
Supply Chain Security: Regulations also extend to ensuring the security and integrity of the supply chain, from raw material sourcing to final product distribution, to prevent counterfeiting and diversion.

Compliance is not static; ongoing post-market surveillance, facility inspections, and potential updates to regulations require continuous vigilance from suppliers.

What are the Key Chemical and Physical Specifications for Dextrose 10% in Plastic Container?

Dextrose 10% in Plastic Container is a standardized pharmaceutical product with specific chemical and physical attributes defined by pharmacopeial standards and regulatory filings. These specifications ensure product identity, purity, potency, and safety.

Key specifications include:

Active Ingredient: Dextrose (D-Glucose).
Concentration: 10% w/v (weight/volume) of Dextrose in Water for Injection. This means 100 grams of dextrose per liter of solution.
pH: Typically between 3.5 and 6.5 for a 10% dextrose solution. This range is critical for stability and compatibility with physiological conditions.
Osmolarity: Approximately 505 mOsm/L. This hypertonic solution has significant osmotic pressure.
Caloric Content: Approximately 340 kcal/L.
Tonicity: Hypertonic.
Container Material: Typically made from medical-grade plastic resins such as polyvinyl chloride (PVC), polypropylene, or ethylene vinyl acetate (EVA). The specific material is chosen for its inertness, flexibility, and compatibility with sterilization methods.
Sterility: The solution must be sterile, meeting the requirements of pharmacopeial sterility tests (e.g., USP <71>).
Particulate Matter: Limits are placed on the size and number of sub-visible and visible particulate matter. Specifications are defined by pharmacopeias such as the United States Pharmacopeia (USP) or European Pharmacopoeia (EP). For example, USP <788> defines limits for sub-visible particles.
Water for Injection (WFI): The solvent used must be WFI, meeting stringent purity standards (e.g., USP <1231>) for conductivity, total organic carbon (TOC), and microbial limits.
Absence of Pyrogens/Endotoxins: The solution must be free from pyrogenic substances and bacterial endotoxins, typically tested according to USP <85>.
Container Integrity: The plastic container must maintain a hermetic seal to prevent microbial ingress.
Extractables and Leachables: The plastic material must have a well-characterized profile for extractables and leachables, with established limits for any compounds that may migrate into the solution.

These specifications are verified through rigorous in-process and final product testing by the manufacturers to ensure each batch meets predefined quality attributes.

What is the Competitive Landscape for Dextrose 10% in Plastic Container?

The competitive landscape for Dextrose 10% in Plastic Container is characterized by a mature market with established players and significant generic penetration. Key competitive factors include price, product quality, supply reliability, and contractual relationships with healthcare systems and distributors.

Market Maturity: Dextrose solutions are essential, high-volume products with long-standing use in healthcare. The core product has been available for decades.
Price Sensitivity: Due to the generic nature of the product, price is a primary competitive differentiator. Large-volume purchasing agreements and competitive bidding are common.
Supply Chain Dominance: Companies with robust manufacturing capabilities, efficient distribution networks, and strong relationships with hospital procurement systems hold a significant advantage. Disruptions in supply, whether due to manufacturing issues or global events, can highlight vulnerabilities.
Product Differentiation: While the core dextrose solution is standardized, some differentiation can occur through packaging (e.g., different bag sizes, specialized IV bags), container material innovations (e.g., non-PVC alternatives), or value-added services.
Generic Competition: The market is populated by both originator brands and numerous generic manufacturers, intensifying price pressure.
Regulatory Compliance as a Barrier to Entry: The high cost and complexity of meeting regulatory requirements (FDA approval, GMP) act as a barrier for new entrants.
Consolidation Trends: The pharmaceutical and medical device industries have seen consolidation, which can impact the competitive landscape by reducing the number of independent players or strengthening the market position of larger entities.

Key players, such as Baxter, B. Braun, and Fresenius Kabi, often compete on scale, established trust, and the ability to offer a broad portfolio of IV solutions and infusion systems.

Key Takeaways

The supply of Dextrose 10% in Plastic Container is dominated by established pharmaceutical manufacturers including Baxter, B. Braun, and Fresenius Kabi.
Patent activity focuses on container materials, sterility methods, and manufacturing processes, aiming to enhance safety and usability.
Patent expirations have led to significant price competition and market accessibility for generic products.
Suppliers must adhere to stringent FDA regulations, including GMP, sterility assurance, and leachable/extractable testing.
Product specifications, including dextrose concentration, pH, osmolarity, and purity, are rigorously defined by pharmacopeial standards.
The market is highly competitive, with price, supply reliability, and regulatory compliance being critical factors for success.

Frequently Asked Questions

What is the typical shelf life for Dextrose 10% in a plastic container?

The typical shelf life for Dextrose 10% in Plastic Container is generally 12 to 24 months from the date of manufacture, provided the product is stored under recommended conditions and the container remains intact. Specific expiration dates are determined by the manufacturer based on stability studies and are clearly indicated on the product labeling [1].

Are there alternatives to plastic containers for Dextrose 10%?

Historically, dextrose solutions were commonly supplied in glass containers. While plastic containers offer advantages in terms of reduced breakage and weight, glass remains an option, particularly for certain formulations or in environments where plastic leachables are a concern. However, plastic containers are now predominant in the market for their safety and convenience [1, 2].

What are the main risks associated with the plastic material used in these containers?

The primary risks associated with plastic containers are the potential for leaching of plasticizers (e.g., DEHP from PVC) or other compounds from the container material into the solution, and potential interactions between the plastic and the drug product that could affect stability. Manufacturers mitigate these risks through careful material selection, advanced polymer technology, rigorous leachables and extractables testing, and the use of medical-grade materials that are specifically approved for pharmaceutical use [2, 3].

How is sterility ensured during the manufacturing of Dextrose 10% in plastic containers?

Sterility is ensured through a multi-step process including the use of Water for Injection (WFI), aseptic processing for filling, and terminal sterilization of the final product. Manufacturing facilities operate under strict environmental controls to prevent microbial contamination. Terminal sterilization methods, such as steam sterilization (autoclaving) or irradiation, are validated to effectively eliminate microorganisms without compromising the integrity of the dextrose solution or the plastic container [3].

What is the significance of the 10% concentration for Dextrose solutions in clinical practice?

Dextrose 10% is a hypertonic solution used primarily for providing caloric support and hydration when oral intake is not possible. Its high concentration delivers a significant amount of glucose and calories per liter, making it useful in patients with increased metabolic demands, malnutrition, or those requiring parenteral nutrition. Due to its hypertonicity, it is often administered centrally to avoid venous irritation [4].

Citations

U.S. Food and Drug Administration. (n.d.). Guidance for Industry: Container Closure Systems for Packaging of Human Drugs and Biologics.
Dean, D. A. (2009). Extractables and Leachables. In The Science and Technology of Pharmaceutical Containment (pp. 27-40). Springer.
Perkins, J. J. (2018). Principles and Practice of Sterile Pharmaceutical Manufacturing. CRC Press.
McEvoy, G. K. (Ed.). (2023). AHFS Drug Information. American Society of Health-System Pharmacists.

Suppliers and packagers for DEXTROSE 10% IN PLASTIC CONTAINER