Suppliers and packagers for DEXTROSE 20% IN PLASTIC CONTAINER

DEXTROSE 20% 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
Otsuka Icu Medcl	DEXTROSE 20% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	018564	NDA	ICU Medical Inc.	0990-7935-19	12 POUCH in 1 CASE (0990-7935-19) / 1 BAG in 1 POUCH / 500 mL in 1 BAG	2019-10-01

Last updated: August 29, 2025

ppliers for the Pharmaceutical Drug: Dextrose 20% in Plastic Container

Introduction

Dextrose 20% in plastic containers is a vital intravenous (IV) fluid widely used for hydration, energy supplementation, and metabolic support in clinical settings. The global demand for this pharmaceutical product necessitates a reliable supply chain comprising manufacturers specializing in sterile solutions, typically delivering them in secure, contamination-proof plastic containers. This article provides a comprehensive review of primary suppliers globally engaged in manufacturing and distributing Dextrose 20% in plastic containers, emphasizing market offerings, compliance standards, and strategic considerations for procurement.

Market Overview

The pharmaceutical-grade Dextrose 20%, also known as dextrose monohydrate or glucose injection, must meet stringent regulatory approvals, including compliance with United States Pharmacopeia (USP), European Pharmacopoeia (EP), and equivalent standards. The product is commonly supplied in polyethylene, polypropylene, or multilayer plastic containers designed to maintain sterility, stability, and compatibility with medical applications.

Key suppliers span North America, Europe, and Asia, driven by robust manufacturing capacities, quality assurance standards, and global distribution networks. Several multinational corporations dominate the landscape, supported by smaller regional manufacturers specializing in sterile solutions.

Major Suppliers of Dextrose 20% in Plastic Containers

1. Baxter International Inc.

Overview: Baxter is a global leader in sterile intravenous solutions, including Dextrose 20%. Their portfolio encompasses a broad range of infusion products in varied container formats, including plastic bags and bottles. Baxter adheres to ISO standards, GMP practices, and FDA regulations, ensuring high-quality products.

Product Features:

• Sterile, pyrogen-free, and preservative-free formulations.
• Packaged in sterile, rigid plastic containers suitable for infusion procedures.
• Available in various volume capacities, including 250 mL, 500 mL, and 1000 mL.

Global Reach: Baxter supplies through direct distribution and authorized regional affiliates across North America, Europe, and Asia-Pacific.

2. Fresenius Kabi

Overview: Fresenius Kabi specializes in sterile infusion solutions, notable for their extensive array of dextrose solutions, including 20% Dextrose. They maintain manufacturing facilities compliant with international regulatory standards, guaranteeing product quality.

Product Features:

• Packaged in transparent, polypropylene plastic vials and bottles.
• Sterility maintained throughout the manufacturing process.
• Meets pharmacopeial standards, with detailed support documentation.

Distribution Network: They operate globally, serving hospitals, clinics, and distributers in over 100 countries.

3. Becton, Dickinson and Company (BD)

Overview: BD offers a portfolio of sterile infusion solutions, including Dextrose 20%, especially in prefilled plastic containers. Their emphasis on innovation ensures integrations with advanced container closure and sterilization processes.

Product Features:

• Packaging includes plastic bottles designed for stability and ease of use.
• Compliant with USP, EP, and other regulatory standards.
• Suitable for IV infusion therapy with integrated safety features.

Market Placement: BD supplies hospitals, pharmaceutical manufacturers, and bulk distributors globally.

4. Hospira (now part of Pfizer)

Overview: Hospira, acquired by Pfizer, is known for its reliable sterile infusion products, including Dextrose 20% solutions. Their manufacturing complies with US FDA cGMP guidelines, ensuring sterile integrity and stability.

Product Features:

• Available exclusively in plastic containers such as bottles or flexible bags.
• High standards of quality control, with batch-specific documentation.
• Compatibility with various infusion devices.

Distribution: Centralized in North America and Europe, with expansion into emerging markets.

5. Otsuka Pharmaceutical Co., Ltd.

Overview: Otsuka supplies a variety of IV solutions, including Dextrose 20%, tailored for markets in Asia and Europe. Their manufacturing facilities meet global quality standards, ensuring product consistency.

Product Features:

• Packaged in polyethylene or polypropylene containers.
• Emphasis on sterile, preservative-free formulations.
• Compatible with hospital infusion systems.

Regional Focus: Strong presence in Japan, China, and India, with growing export channels.

6. Local and Contract Manufacturers

Numerous regional and contract manufacturing organizations (CMOs) supply Dextrose 20% in plastic bottles, often catering to specific banked supply pools or private-label arrangements. These suppliers typically adhere to national regulatory standards and are valuable options for procurement in emerging markets.

Regulatory and Quality Considerations

Suppliers must demonstrate Good Manufacturing Practice (GMP) compliance, ensure sterility, and provide Certificates of Analysis (CoA) validating each batch against pharmacopeia standards. Additionally, container compatibility, material safety, and stability profiles are critical factors influencing supplier selection.

Procurement Strategies

To secure a dependable supply chain, companies must evaluate suppliers based on:

• Product quality and regulatory compliance.
• Manufacturing capacities aligned with demand.
• Global distribution capabilities and lead times.
• Pricing and contractual flexibility.
• Previous audit and compliance history.

Partnerships with reputed suppliers such as Baxter, Fresenius Kabi, and BD typically provide assured quality, regulatory support, and logistical reliability, which are paramount for pharmaceutical end-users.

Emerging Trends and Opportunities

Innovation in container technology, such as multi-layer plastics and smart infusion systems, presents opportunities to enhance stability, safety, and traceability. Moreover, increasing regulatory harmonization is facilitating easier global procurement channels and expanding supplier options.

Conclusion

The global landscape for Dextrose 20% in plastic containers is predominantly led by established multinational firms renowned for pharmaceutical quality and compliance. Baxter, Fresenius Kabi, BD, Hospira, and Otsuka are considered primary suppliers, though regional manufacturers also contribute significantly to the supply chain, especially in emerging markets. Strategic supplier selection, emphasizing regulatory adherence, quality assurance, and supply reliability, remains fundamental to ensuring seamless procurement of this critical IV solution.

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Key Takeaways

• Major global suppliers like Baxter, Fresenius Kabi, and BD dominate the Dextrose 20% in plastic container market, offering proven quality and regulatory compliance.
• Regulatory adherence (USP, EP, cGMP) is critical to ensure product safety and efficacy.
• Container material and packaging design influence product stability and usability in clinical settings.
• Regional and contract manufacturers serve as supplementary sources, especially in emerging markets, but require rigorous validation of quality standards.
• Innovations in container technology and supply chain digitalization can enhance product safety, traceability, and efficiency.

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FAQs

1. Are Dextrose 20% in plastic containers suitable for long-term storage?
Yes, when manufactured and stored under proper conditions, these solutions maintain stability for approved shelf lives outlined by manufacturers and regulatory standards.

2. What regulatory approvals should suppliers provide?
Suppliers should provide Certificates of Analysis, batch documentation, and demonstrate compliance with USP, EP, and cGMP standards, along with relevant regional regulatory approvals.

3. How does container material impact drug stability?
Polypropylene and polyethylene are commonly used, offering chemical inertness and barrier properties that preserve dextrose solution stability and prevent leaching or contamination.

4. Can regional suppliers meet global quality standards?
Yes, many regional manufacturers meet international standards, but extensive validation and regulatory compliance verification are advised before procurement.

5. What are emerging innovations in IV container technology?
Smart infusion systems, multi-layer plastics, and integrated safety features are emerging to improve medication safety, stability, and supply chain traceability.

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Sources:

1. Baxter International Inc. Product Portfolio, baxter.com
2. Fresenius Kabi Product Catalog, fresenius-kabi.com
3. Becton, Dickinson and Company (BD). Infusion Solutions, bd.com
4. Hospira, a Pfizer Company. Product Details, hospira.com
5. Otsuka Pharmaceutical Co., Ltd. Product Information, otsuka.co.jp