DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 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
Baxter Hlthcare	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 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 pharmaceutical supply chain for parenteral solutions such as Dextrose 5% and Potassium Chloride 0.15% in plastic containers is critical, especially given their widespread clinical applications in hydration therapy and electrolyte management. Identifying reliable suppliers is essential for healthcare providers, distributors, and contract manufacturing organizations seeking consistent quality, regulatory compliance, and competitive pricing.

This article explores the key suppliers manufacturing Dextrose 5% and Potassium Chloride 0.15% solutions in plastic containers, highlighting their market presence, quality standards, and supply capabilities.

Market Overview

Dextrose 5% (also known as Dextrose Injection, USP) is a sterile, concentrated glucose solution used for caloric supply and fluid replenishment, while Potassium Chloride 0.15% serves as an electrolyte replenisher. Combining these in plastic containers, typically via IV bags, caters to hospital and outpatient needs due to ease of storage, transportation, and administration.

The global market for intravenous fluids is projected to grow steadily, driven by increasing surgical interventions, rising prevalence of electrolyte imbalance conditions, and expanding healthcare infrastructure [1].

Leading Suppliers of Dextrose 5% in Plastic Containers

1. Baxter International Inc.

Overview: Baxter is a dominant player in the intravenous solutions market, offering a broad portfolio including Dextrose 5% in plastic containers. Their products meet rigorous pharmacopeial standards (USP, EP, JP) and are supplied globally.

Manufacturing & Quality: Baxter’s manufacturing facilities adhere to current Good Manufacturing Practices (cGMP) and hold multiple certifications, ensuring high product quality and regulatory compliance.

Supply Capabilities: Baxter supplies via a network of distribution centers, supporting hospitals and clinics worldwide, with reliable delivery schedules.

Regulatory Compliance: Their products are approved by the FDA, EMA, and other health authorities, certifying quality and safety.

2. B. Braun Melsungen AG

Overview: B. Braun is a key provider of infusion solutions, including Dextrose 5%. Their solutions comply with international standards and are widely used across Europe, North America, and emerging markets.

Product Features: B. Braun’s Dextrose solutions are available in various bag sizes, ensuring flexibility in clinical use.

Quality and Certifications: The company maintains ISO certifications, along with strict adherence to CGMP regulations in manufacturing.

Distribution: Strong global logistics network ensures timely supply to healthcare institutions.

3. Fresenius Kabi

Overview: Fresenius Kabi offers a comprehensive range of infusion solutions, notably Dextrose 5% in plastic IV bags, recognized for quality and innovation.

Product Offerings: They provide sterile, pyrogen-free solutions with a focus on patient safety.

Manufacturing Standards: Their production facilities comply with multiple international standards and possess certifications such as ISO 9001, ISO 13485.

Supply Chain: Extensive distribution channels ensure availability in more than 100 countries.

4. Pfizer (Hospira Division)

Overview: Pfizer’s Hospira division supplies Dextrose 5% in various container formats, emphasizing sterile manufacturing and regulatory adherence.

Partnerships & Availability: They partner with regional distributors for broad access in multiple markets.

Regulatory & Quality Assurance: As a major pharma entity, Hospira maintains cGMP compliance and FDA approvals.

Suppliers for Potassium Chloride 0.15% in Plastic Containers

1. Baxter International Inc.

Baxter is also a significant supplier of potassium chloride solutions, offering formulations in plastic IV bags suitable for infusion therapy. Their potassium chloride solutions are produced under strict quality controls with worldwide distribution.

2. B. Braun Melsungen AG

B. Braun provides potassium chloride 0.15% solutions in intravenous bags, tailored for clinical use with a focus on safety and stability.

3. Fresenius Kabi

Fresenius maintains a broad portfolio of electrolyte solutions, including potassium chloride 0.15%, approved for hospital and outpatient use globally.

4. Mylan / Viatris

Overview: Mylan, now part of Viatris, supplies a range of electrolyte solutions, including potassium chloride, available in prefilled plastic containers with consistent quality.

Regulatory Standards: Their products are aligned with USP and other pharmacopeias, meeting international standards.

5. West-Ward Pharmaceuticals

Specialized in sterile electrolyte solutions, West-Ward offers potassium chloride formulations in plastic containers adhering to high-quality standards suitable for hospital use.

Key Considerations When Selecting Suppliers

Regulatory Compliance: Ensure suppliers possess necessary certifications like FDA Approval, EMA certification, or equivalent GMP accreditations.
Quality Certifications: Look for ISO 9001, ISO 13485, and pharmacopeial adherence.
Supply Reliability: Assess their capacity for large-volume supply and geographic reach.
Product Traceability: Confirm availability of batch records, stability data, and post-market surveillance.
Pricing and Contract Flexibility: Evaluate cost competitiveness and contractual terms suited to procurement needs.

Emerging and Alternative Suppliers

In response to global demand fluctuations, regional manufacturers in India, China, and Eastern Europe are expanding their sterile product lines, including cardiovascular and electrolyte solutions. Companies such as Huadong Medicine, Zhejiang JS Pharmaceutical, and China National Pharmaceutical Group are becoming notable entrants, often offering competitive pricing, though qualification processes may vary.

Regulatory and Legal Considerations

Healthcare providers must verify that suppliers meet local regulatory requirements. Importation, customs, and approval delays can impact supply chains, making robust verification essential. Suppliers with established regulatory dossiers and strong compliance histories are preferable for minimizing legal risks.

Conclusion

The market for Dextrose 5% and Potassium Chloride 0.15% in plastic containers features a mix of established multinational corporations—Baxter, B. Braun, Fresenius Kabi, and Pfizer—who offer high-quality, regulatory-compliant solutions with global distribution networks. Emerging regional manufacturers are increasingly competitive but require thorough qualification assessments.

Strategic procurement should focus on supplier reliability, compliance standards, and logistic efficiency to mitigate supply disruptions. Regular market analysis and supplier audits will ensure continuity and quality in the supply chain for these essential parenteral solutions.

Key Takeaways

Leading global suppliers include Baxter, B. Braun, Fresenius Kabi, and Pfizer, offering proven quality and extensive distribution networks.
Supplier selection must prioritize regulatory compliance, product quality, and supply reliability.
Emerging regional manufacturers can provide cost advantages but necessitate rigorous qualification processes.
Ensuring product traceability and adherence to international standards mitigates legal and safety risks.
Expanding procurement strategies to include diversified suppliers can enhance supply chain resilience.

FAQs

Q1: What regulatory certifications should I verify when selecting suppliers for IV solutions?

A1: Confirm certifications such as FDA approval (USA), EMA certification (Europe), ISO 9001, ISO 13485, and adherence to pharmacopeial standards (USP, EP, JP). These demonstrate compliance with quality and safety standards.

Q2: How can I ensure supplier reliability for critical solutions like Dextrose and Potassium Chloride?

A2: Assess their manufacturing track record, supply chain logistics, certification history, and request audit reports. Long-standing market presence and certifications are good indicators of reliability.

Q3: Are regional or local manufacturers a viable alternative to multinational companies?

A3: Yes, provided they meet international quality standards and have appropriate regulatory approvals. Due diligence and qualification audits are essential before integration into the supply chain.

Q4: What are the main considerations in choosing plastic containers for IV solutions?

A4: Compatibility with infusion systems, container integrity, sterilization processes, and stability of the solution in the container are critical factors.

Q5: How does the choice of supplier impact clinical practice?

A5: Reliable suppliers ensure consistent product quality and availability, minimizing clinical risks related to contamination, incorrect dosing, or supply shortages, ultimately safeguarding patient safety.

References

[1] MarketsandMarkets. "Intravenous (IV) Fluid Replacement Market by Product, Application, and Geography — Global Forecast to 2027."
[2] GlobalData. "IV Fluids Market Analysis."
[3] FDA Registration Database. Product approvals and certifications.
[4] ISO Certification Registries. Certified manufacturer profiles.
[5] Company websites and product catalogs of Baxter, B. Braun, Fresenius Kabi, and Pfizer.

Suppliers and packagers for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER