DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER	dextrose; potassium chloride	INJECTABLE;INJECTION	017634	NDA	Baxter Healthcare Company	0338-0683-04	1000 mL in 1 BAG (0338-0683-04)	1979-02-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

The demand for intravenous (IV) solutions such as Dextrose 5% with Potassium Chloride 0.075% has grown significantly within healthcare sectors globally, driven by their essential role in hydration, electrolyte balance, and nutritional support. This compound combination is widely used in hospitals, clinics, and emergency settings, establishing a competitive market for reliable suppliers providing high-quality, regulatory-compliant products in plastic containers. Navigating this landscape requires an understanding of key suppliers specializing in customizable IV solutions and their regulatory adherence, reliability, and global reach.

Market Overview and Industry Landscape

The global IV fluids market is projected to surpass USD 17 billion by 2024, with a compounded annual growth rate (CAGR) of approximately 6.8% (Grand View Research, 2021). Suppliers in this domain encompass large pharmaceutical manufacturers, regional producers, and generic medication firms. Essential factors influencing supplier selection include compliance with Good Manufacturing Practices (GMP), European Medicines Agency (EMA) or Food and Drug Administration (FDA) approvals, manufacturing capacity, customization offerings, and logistical capabilities.

Key Suppliers for Dextrose 5% and Potassium Chloride 0.075% in Plastic Containers

1. Baxter International Inc.

Baxter is a leading global provider of sterile IV solutions with extensive experience in manufacturing Dextrose and electrolyte solutions. Their products include Baxter Dextrose 5% and Electrolyte Solutions, often supplied in flexible plastic containers such as polyethylene or polypropylene bottles. Their offerings are recognized for strict regulatory compliance, high safety standards, and extensive distribution networks.

Product Line: Baxter offers a range of IV solutions with customizable electrolyte compositions, including potassium chloride, in compatible plastic containers (e.g., Flexibags).
Regulatory Compliance: GMP-certified facilities, FDA approval, and compliance with ISO standards.
Regional Presence: North America, Europe, Asia-Pacific, with manufacturing facilities in the US, Ireland, and China.

2. B. Braun Melsungen AG

B. Braun is a prominent European manufacturer specializing in infusion solutions, including Dextrose 5% with potassium chloride prepared in a wide range of container formats, principally plastic bags and bottles.

Product Line: B. Braun's PremiGard and Clinimix series include electrolyte-admixed solutions in plastic containers designed for sterile, ready-to-use applications.
Regulatory and Quality Assurance: Compliance with EU GMP standards, FDA registration, and worldwide certifications.
Global Reach: Europe, North America, Asia-Pacific, with regional manufacturing plants and distribution centers.

3. West-Ward Pharmaceuticals (a subsidiary of Hikma Pharmaceuticals)

Known for manufacturing affordable, high-quality IV fluids, West-Ward supplies Dextrose 5% solutions with potassium chloride in plastic bottles, primarily targeting the North American and Middle Eastern markets.

Product Variability: Offers tailored electrolyte formulations, including potassium chloride concentrations at 0.075%, in sterile, single-use plastic bottles.
Regulatory Status: Approval from US FDA, compliance with international standards (ISO, cGMP).
Manufacturing Capabilities: Large-scale production facilities with strong focus on quality assurance.

4. Pfizer Inc.

Pfizer produces a broad spectrum of IV fluids, including dextrose solutions with electrolyte additives such as potassium chloride, in plastic containers suitable for hospital pharmacies and clinical settings.

Product Portfolio: Includes Dextrose 5% with added electrolytes in ready-to-use plastic bottles.
Regulatory Adherence: Strict adherence to FDA and global GMP standards.
Distribution Network: Extensive logistics ensuring global reach, especially in North America and Europe.

5. Fresenius Kabi

Fresenius Kabi offers a comprehensive portfolio of parenteral solutions, including Dextrose 5% with potassium chloride, packaged primarily in flexibags and bottles compatible with clinical infusion equipment.

Product Features: Compatibility with infusion pumps, preservative-free, sterilized, and pre-filled in plastic containers.
Regulatory Standards: Compliant with US and European regulations, including FDA and EMA approvals.
Market Scope: North America, Europe, Asia-Pacific, and Latin America.

6. Local and Regional Manufacturers

In emerging markets such as India, China, and Southeast Asia, numerous regional firms supply Dextrose with potassium chloride solutions in various plastic formats. Examples include:

Vedic Lifecare Limited (India)
Sino Biopharmaceutical Limited (China)

These manufacturers often provide cost-effective options but require rigorous verification of regulatory credentials and manufacturing standards.

Selection Criteria for Suppliers

Key factors in choosing the right supplier:

Regulatory Compliance: Ensure FDA, EMA, or relevant health authority approvals.
Product Customization: Ability to produce specific concentrations, including 0.075% potassium chloride.
Quality Assurance: GMP-certified manufacturing, sterile processing, and quality control measures.
Container Compatibility: Use of safe, durable plastic containers that are compatible with infusion systems.
Supply Chain Reliability: Robust logistics to ensure consistent supply, especially during high-demand periods.
Pricing and Contract Flexibility: Competitive pricing, flexible delivery options, and minimal lead times.

Emerging Trends and Future Outlook

The market for IV solutions like Dextrose and potassium chloride in plastic containers is evolving with advancements in container technology, such as pre-filled, preservative-free formulations, which improve safety and reduce contamination risks. Additionally, increased focus on regional manufacturing and supply chain resilience post-pandemic underscores the importance of diversified supplier bases.

Biopharmaceutical developments, including patient-specific electrolyte mixes, are anticipated to drive customization services from suppliers. Furthermore, regulatory harmonization efforts influence market dynamics, making compliance paramount in supplier selection.

Conclusion

The procurement landscape for Dextrose 5% with Potassium Chloride 0.075% in plastic containers is populated by established global pharmaceutical firms and regional manufacturers. Key suppliers such as Baxter, B. Braun, West-Ward Pharmaceuticals, Pfizer, and Fresenius Kabi dominate due to their extensive product portfolios, regulatory compliance, and global distribution capabilities. Careful supplier evaluation based on regulatory standards, quality assurance, reliability, and cost considerations is critical for healthcare providers and procurement professionals aiming to ensure uninterrupted supply and patient safety.

Key Takeaways

Leading global suppliers for Dextrose 5% with Potassium Chloride 0.075% in plastic containers include Baxter, B. Braun, West-Ward, Pfizer, and Fresenius Kabi.
Regulatory compliance (FDA, EMA, GMP) remains crucial in supplier selection.
Customization options, container compatibility, and supply chain robustness influence procurement decisions.
Regional manufacturers offer cost-effective solutions but require careful quality verification.
The market is increasingly driven by innovations in container technology and supply chain resilience.

FAQs

1. Are all suppliers' IV solutions compatible with standard infusion equipment?
Most major suppliers ensure their plastic containers are compatible with standard infusion pumps and IV administration systems. However, it is essential to verify product-specific compatibility and technical datasheets before procurement.

2. How do I verify the regulatory compliance of a supplier?
Request certifications like FDA approval, European CE marking, ISO certifications, and details of GMP compliance. Engaging with regulatory consultants can further validate supplier credentials.

3. Can suppliers customize the potassium chloride concentration?
Yes, many suppliers offer tailor-made electrolyte formulations, including specific potassium chloride concentrations like 0.075%, based on client requirements.

4. What are the typical container types used for these solutions?
Solutions are usually supplied in pre-sterilized plastic bottles (polypropylene or polyethylene) or flexible bags (flexibags and pouches), designed for sterile, single-use applications.

5. How critical is regional regional manufacturing in procurement strategies?
Regional manufacturing can improve supply chain resilience, reduce lead times, and mitigate logistical disruptions. Selecting suppliers with regional production capabilities can enhance supply security, especially during global crises.

Sources:

Grand View Research. (2021). Infusion Therapy Market Size, Share & Trends Analysis Report.
Baxter International Inc. Product Portfolio and Regulatory Documentation.
B. Braun Melsungen AG. Infusion Solutions Catalogue.
West-Ward Pharmaceuticals. Product and Regulatory Certifications.
Fresenius Kabi. IV Solutions Product Data Sheets.

Suppliers and packagers for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER