DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	dextrose; potassium chloride	INJECTABLE;INJECTION	212346	ANDA	Fresenius Kabi USA, LLC	63323-667-10	10 BAG in 1 CASE (63323-667-10) / 1000 mL in 1 BAG (63323-667-01)	2021-04-23
Fresenius Kabi Usa	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%	dextrose; potassium chloride	INJECTABLE;INJECTION	212346	ANDA	Fresenius Kabi USA, LLC	63323-669-10	10 BAG in 1 CASE (63323-669-10) / 1000 mL in 1 BAG (63323-669-01)	2021-04-23
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

The combination of Dextrose 5% with Potassium Chloride 0.15% serves critical roles in intravenous therapy, primarily for replenishing fluids and electrolytes in clinical settings. Suppliers of these pharmaceutical agents include major global pharmaceutical companies, contract manufacturing organizations (CMOs), and regional drug distributors. Ensuring the quality, consistency, and compliance with regulatory standards is essential in selecting suitable suppliers for healthcare providers and pharmaceutical entities.

Global Major Suppliers

1. Baxter International Inc.

Baxter offers a comprehensive portfolio of parenteral solutions, including Dextrose 5% and Potassium Chloride preparations. Their manufacturing facilities adhere strictly to Good Manufacturing Practices (GMP), and they are known for high-quality sterile solutions used worldwide. Baxter’s Dextrose solutions are available in various concentrations, with potassium chloride often incorporated at different strengths, including 0.15%.

2. Hospira (a Pfizer company)

Hospira supplies a wide range of injectable fluids, including Dextrose 5% and potassium chloride solutions. Their products are widely used in hospitals across North America, Europe, and beyond, with rigorous quality assurance and regulatory approvals (e.g., FDA, EMA). Hospira’s sterile solutions meet ASTM and USP standards, ensuring safety and efficacy.

3. Fresenius Kabi

Fresenius Kabi is a leading supplier of infusion solutions globally. Their portfolio includes Dextrose 5% and potassium chloride formulations, often provided as mixed solutions to streamline IV therapy. Their focus on manufacturing standards and supply chain robustness makes them a preferred supplier for hospitals and clinics worldwide.

4. B. Braun Melsungen AG

B. Braun produces sterile infusion solutions, including Dextrose 5% and potassium chloride injections. They emphasize innovative packaging and compliance with international standards such as USP, EP, and JP. Their products are readily available in Europe, North America, and Asia.

5. Hikma Pharmaceuticals

Hikma supplies sterile injectable medications, including Dextrose and potassium chloride solutions. Their production facilities are certified globally, and they serve both regional and international markets, emphasizing affordability and quality.

Regional Suppliers and Distributors

In addition to global giants, regional and local manufacturers often supply these solutions, especially to meet specific country requirements or regulatory standards. Examples include:

Sequent Scientific Ltd. (India): Produces various IV fluids, including Dextrose and potassium chloride, with a focus on the Asian and Middle Eastern markets.
BeiGene and Shanghai Pharma (China): Both supply sterile infusion solutions, including Dextrose and potassium chloride, complying with Chinese GMP standards and export certifications.
Abbott Laboratories: Provides compatible infusion solutions, particularly in North America and Latin America, with extensive distribution networks.

Contract Manufacturing Organizations (CMOs)

CMOs play an increasingly vital role in supplying Dextrose and potassium chloride solutions to pharmaceutical companies seeking to outsource manufacturing. Key CMOs include:

CMO specialized in sterile injectables: Such as Cambrex or Recipharm, which produce licensed batches of Dextrose and potassium chloride solutions according to client specifications and compliance needs.
Private Label Suppliers: Many regional distributors collaborate with CMOs to offer branded or unbranded solutions tailored to local markets.

Quality and Regulatory Considerations

Suppliers must meet stringent quality standards, including:

United States Pharmacopeia (USP) compliance: Ensuring solutions are sterile, pyrogen-free, and correctly labeled.
European Pharmacopoeia (EP): For supply across European markets, with emphasis on storage and handling standards.
Good Manufacturing Practices (GMP): Adherence to international GMP guidelines is non-negotiable.
Certification and Audits: Suppliers should hold relevant certifications such as ISO 9001 and undergo regular audits by regulatory bodies.

Supply Chain and Availability

The demand for IV solutions surged during global health crises, emphasizing the importance of supply chain resilience. Leading suppliers maintain substantial inventories and multiple manufacturing sites to ensure continuity of supply. Buffer stock programs and regional warehouses further mitigate shortages.

Key Factors in Supplier Selection

Product Quality: GMP compliance, independent testing, and batch traceability.
Regulatory Approval: Certifications such as FDA, EMA, or local authorities.
Price and Contract Terms: Negotiating value over volume with consistent quality.
Supply Reliability: Proven track record of timely deliveries and contingency plans.
Supporting Services: Technical support, documentation, and logistics.

Conclusion

Securing a reliable supplier for Dextrose 5% and Potassium Chloride 0.15% involves evaluating multiple factors: quality standards, regulatory compliance, supply stability, and cost-effectiveness. Major global pharmaceutical companies, regional suppliers, and CMOs form the core options, with the choice depending on specific operational, regulatory, and geographical considerations. Establishing clear procurement criteria aligned with healthcare standards will facilitate optimal sourcing and minimize risks associated with supply shortages or quality lapses.

Key Takeaways

Major global suppliers like Baxter, Hospira, and Fresenius Kabi dominate the market, offering high-quality injectable solutions compliant with international standards.
Regional manufacturers play a significant role in meeting local regulatory requirements and supply demands, especially in emerging markets.
Partnering with reputable CMOs ensures scalable and compliant manufacturing, particularly for private label products.
Rigorous quality assurance and regulatory compliance remain critical when selecting suppliers, with GMP certifications serving as baseline criteria.
Supply chain resilience is crucial—diversify suppliers to mitigate risks related to shortages or geopolitical disruptions.

FAQs

1. Are there specialized suppliers for pediatric or high-volume IV solutions of Dextrose and potassium chloride?
Yes. Major suppliers often tailor their product offerings for pediatric doses and high-volume needs, ensuring formulations meet specific safety and dosage standards.

2. Can I source these drugs as part of a compounded mix?
While some regional pharmacies compound Dextrose and potassium chloride solutions, sourcing directly from certified manufacturers guarantees product consistency, sterility, and regulatory compliance.

3. How do regulatory standards differ globally for these solutions?
While USP and EP are widely accepted standards, local regulatory authorities may have additional requirements. Suppliers compliant with GMP and international standards are preferable to ensure global acceptance.

4. What are the primary factors influencing pricing for Dextrose 5% and potassium chloride solutions?
Pricing depends on manufacturing costs, regulatory complexity, volume discounts, and regional tariffs. Large-volume agreements often provide cost benefits.

5. How do I verify a supplier’s quality assurance processes?
Request comprehensive documentation, including GMP certificates, audit reports, batch traceability records, and validation reports to ensure compliance with quality standards.

References

Baxter International Inc. Product documentation and quality standards.
Hospira (Pfizer). Sterile intravenous solutions.
Fresenius Kabi. Parenteral nutrition products overview.
B. Braun. Infusion therapy product specifications.
United States Pharmacopeia (USP) standards for sterile injectable solutions.

Suppliers and packagers for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%