DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K): 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%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)	dextrose; potassium chloride; sodium chloride	INJECTABLE;INJECTION	018037	NDA	Baxter Healthcare Company	0338-0663-04	1000 mL in 1 BAG (0338-0663-04)	1979-02-02
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

In the pharmaceutical sector, sourcing high-quality, reliable suppliers for critical infusion solutions like Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 20 mEq (K) is indispensable for ensuring patient safety, regulatory compliance, and operational stability. These solutions are foundational in parenteral nutrition, fluid therapy, and electrolyte replenishment, making the selection of trusted suppliers essential. This article provides a comprehensive overview of prominent suppliers globally recognized for manufacturing and distributing these infusion solutions, emphasizing their market presence, quality standards, and regulatory standings.

Market Overview of Parenteral Solutions

Parenteral solutions such as Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride serve critical functions in hospitals and clinics worldwide. The global infusion therapy market is expanding, driven by increasing cases of chronic diseases, surgical procedures, and in-hospital treatments. The complexity of pharmaceutical manufacturing and stringent regulatory standards necessitate sourcing suppliers with proven quality systems, GCP certifications, and consistent supply chains.

Key Suppliers of Dextrose 5%

1. Baxter International Inc.

Overview: A leader in the infusion therapy industry, Baxter supplies Dextrose 5%, among other fluids. Known for its extensive product portfolio and global reach, Baxter emphasizes strict adherence to Good Manufacturing Practices (GMP).
Quality Standards: FDA-approved, European Medicines Agency (EMA) certifications, and ISO quality management standards.
Market Presence: Global footprint with manufacturing facilities in North America, Europe, and Asia.

2. B. Braun Melsungen AG

Overview: A German-based healthcare company, B. Braun offers Dextrose solutions, focusing on innovative infusion technologies.
Quality and Compliance: Certified under FDA, EMA, and international standards, with comprehensive quality assurance protocols.
Supply Capabilities: Extensive distribution network across Europe, North America, and emerging markets.

3. Pfizer Inc.

Overview: Known for its pharmaceutical and biopharmaceutical expertise, Pfizer supplies sterile Dextrose solutions globally.
Certifications: GMP, ISO, and compliance with U.S. and European regulatory frameworks.
Specialization: Focuses on high-quality manufacturing for hospital-grade solutions.

Leading Suppliers of Sodium Chloride 0.2%

1. Fresenius Kabi

Overview: A key player specializing in infusion solutions, fluids, and clinical nutrition. Fresenius Kabi provides Sodium Chloride 0.2% widely used for diluents and reconstitution.
Regulatory Compliance: GMP, FDA, EMA certifications across manufacturing sites.
Global Reach: Strong presence in Europe, Asia-Pacific, and North America.

2. SN aids in Containerless Handling of Saline Solutions

Product Focus: Manufacturing sodium chloride solutions for both medical and laboratory applications.
Standards: Adheres to pharmacopeial standards (USP, BP, EP) for sterility and isotonicity.

3. Hikma Pharmaceuticals

Overview: A multinational pharmaceutical company producing sterile infusion solutions, including Sodium Chloride 0.2%.
Certifications: ISO, GMP, and other regulatory approvals.
Distribution: Wide regional distribution, especially in Middle East and Africa.

Prominent Suppliers of Potassium Chloride 20mEq (K)

1. Pfizer Inc.

Overview: One of the largest manufacturers of electrolytes, including potassium chloride solutions.
Quality Assurance: Deep compliance with international standards, robust quality testing.
Availability: Supplies to hospitals, distributors, and pharmacies globally.

2. Baxter International Inc.

Overview: Provides Potassium Chloride solutions for infusion, emphasizing safety and stability.
Regulatory Standards: Fully compliant with FDA and international approvals.
Supply Network: Capable of large-volume delivery globally.

3. Hikma Pharmaceuticals

Overview: Offers sterile potassium chloride solutions, including 20 mEq formulations.
Manufacturing Standards: Adherence to GMP standards, rigorous quality control.
Market Focus: Serves emerging markets with reliable supply.

4. Sagent Pharmaceuticals

Overview: Specializes in sterile injectable drugs, including electrolyte solutions.
Certifications: US-FDA approved manufacturing, GMP compliance.
Distribution Channels: Extensive network across North America and beyond.

Regulatory and Quality Considerations

Suppliers must meet regulatory standards to ensure patient safety and legal compliance. The primary regulatory certifications include:

FDA (U.S. Food and Drug Administration): Ensures products meet safety, efficacy, and quality standards.
EMA (European Medicines Agency): Certifies manufacturing practices for European markets.
ISO Standards (International Organization for Standardization): Encompasses quality management (ISO 9001) and manufacturing standards.
Pharmacopeial Standards: USP, BP, and EP specifications for purity, sterility, and isotonicity.

Suppliers with a proven track record of compliance and regular regulatory inspections are preferable.

Supply Chain and Market Dynamics

The global supply chain for pharmaceutical infusion solutions is highly sensitive to geopolitical, manufacturing, and logistical disruptions. Leading suppliers maintain multiple manufacturing sites, robust logistics, and contingency planning to mitigate risks. The market trends indicate a shift toward localized manufacturing, especially in Asia and emerging markets, to reduce lead times and costs.

Emerging Trends and Innovations

Formulation Enhancements: Development of ready-to-use, preservative-free solutions with improved stability.
Quality Control Technologies: Implementation of advanced sterilization and testing methods, such as PCR-based sterility testing.
Sustainability Practices: Increasing emphasis on environmentally sustainable manufacturing and supply chain recycling protocols.

Conclusion

The selection of reputable suppliers for Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 20 mEq (K) hinges on adherence to regulatory standards, supply reliability, and product quality. Baxter International, B. Braun, Pfizer, Fresenius Kabi, and Hikma are among the prominent global players providing these infusion solutions. Regional manufacturers and emerging market suppliers also contribute significantly, often offering cost-competitive options without compromising quality. Establishing solid supply agreements with validated suppliers, aligned with compliance standards, secures operational continuity and enhances patient safety.

Key Takeaways

Prioritize Regulatory Compliance: Ensure suppliers have FDA, EMA, or ISO certifications for product safety and quality.
Assess Supply Chain Reliability: Choose manufacturers with diversified manufacturing sites and robust logistics.
Match Supplier Capabilities with Market Needs: Consider regional availability and volume capacity when selecting suppliers.
Leverage Established Market Leaders: Baxter, B. Braun, Pfizer, and Fresenius Kabi set benchmarks for quality and reliability.
Stay Updated on Trends: Keep abreast of innovations in formulation and sustainability to future-proof procurement strategies.

FAQs

1. How can I verify the authenticity of suppliers for pharmaceutical infusion solutions?

Verify suppliers through official regulatory approvals, certifications (GMP, ISO), and audits. Cross-reference with regulatory databases like the FDA’s ORA (Office of Regulatory Affairs) and EMA supplier listings, and conduct site visits where feasible.

2. Are regional manufacturers suitable alternatives to global brands?

Regional manufacturers can offer cost advantages and localized supply but must meet equivalent quality standards. Confirm their compliance with international regulatory benchmarks and obtain product certifications before procurement.

3. What factors influence the choice of supplier for these infusion solutions?

Key factors include regulatory compliance, product quality, supply chain robustness, manufacturing capacity, cost efficiency, and the supplier's reputation in the healthcare industry.

4. How do supply disruptions impact the availability of these pharmaceutical solutions?

Disruptions can cause shortages, affecting patient care. Diversification of suppliers, maintaining safety stock, and establishing contingency agreements mitigate risks.

5. What are the upcoming regulations that could affect suppliers of infusion solutions?

Anticipated regulations focus on improved sterility testing, traceability, environmental impact (such as biodegradable materials), and manufacturing transparency. Keeping abreast of guidance from agencies like FDA and EMA is essential.

References

[1] MarketsandMarkets. "Infusion Therapy Market by Product, Application, End User – Global Forecast to 2026." (2022)
[2] Baxter International Inc. Official Website. "Infusion Solutions."
[3] B. Braun Melsungen AG. Product Information.
[4] Pfizer Inc. Pharmaceutical Portfolio.
[5] European Medicines Agency. "Manufacturing and Quality Standards."

Suppliers and packagers for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)