DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%: Pharmaceutical manufacturers, suppliers, and wholesalers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%	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 0.075%	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 pharmaceutical industry relies heavily on a robust supply chain to ensure the availability and quality of essential intravenous (IV) solutions such as Dextrose 5% and Potassium Chloride 0.075%. These compounds are vital in clinical settings, supporting hydration, electrolyte balance, and energy provision. Securing reliable suppliers for these medications is critical for healthcare providers, distributors, and manufacturers aiming to maintain consistent product supply and meet regulatory standards. This report offers a comprehensive overview of key suppliers, market dynamics, quality considerations, and strategic insights pertinent to procurement professionals.

Overview of Dextrose 5% and Potassium Chloride 0.075%

Dextrose 5% (D-glucose) is a isotonic carbohydrate solution used primarily for caloric supplementation, fluid replacement, and nutritional support. As a sterile, aqueous solution prepared under stringent GMP conditions, it must meet pharmacopeial standards, including USP or EP requirements.

Potassium Chloride 0.075% functions as a vital electrolyte supplement, often administered concurrently with dextrose solutions to correct hypokalemia or supplement electrolyte balance during IV therapy.

Both substances are categorized as sterile pharmaceuticals requiring specialized manufacturing, quality controls, and distribution channels.

Global Major Suppliers of Dextrose 5% and Potassium Chloride

1. Leading Manufacturers of Dextrose 5%

a. Baxter International Inc.
Baxter offers a range of dextrose solutions, including Dextrose 5%, with a global footprint in sterile IV solutions. Known for high-quality manufacturing standards compliant with FDA and EMA regulations, Baxter supplies to hospitals and distributors worldwide [1].

b. Fresenius Kabi
A prominent player in sterile solutions, Fresenius produces Dextrose 5% with a focus on product purity, stability, and regulatory compliance across continents, growing its market share in both developed and developing countries [2].

c. B. Braun Melsungen AG
B. Braun manufactures and supplies Dextrose 5% solutions, emphasizing innovation, consistency, and safety. Its extensive distribution network ensures reliability for large health systems [3].

d. SNF Flotek Industries
Specializing in excipients and specialty chemicals, SNF supplies pharmaceutical-grade dextrose solutions, primarily to North American and European markets [4].

e. Hikma Pharmaceuticals
Hikma produces sterile IV solutions, including Dextrose 5%, with GMP compliance and a broad distribution network, particularly in Middle Eastern and North African regions [5].

2. Prominent Suppliers of Potassium Chloride 0.075%

a. Merck KGaA (EMD Serono)
A global leader in active pharmaceutical ingredients (APIs), Merck supplies high-purity potassium chloride suitable for IV formulations, adhering to rigorous quality standards [6].

b. Pfizer Inc.
Pfizer manufactures potassium chloride, often as part of larger IV electrolyte solutions, with stringent regulatory approvals for international markets [7].

c. Sanofi
A major global pharma, Sanofi produces and supplies potassium chloride APIs and formulations with robust quality management practices and extensive distribution channels [8].

d. Akorn, Inc.
Specializes in sterile solutions and APIs, including potassium chloride, primarily serving North American markets with high-quality production standards [9].

e. PharmaEssentia
Emerging Asian API provider, offering potassium chloride with competitive pricing and compliant manufacturing processes serving both regional and global customers [10].

Regional and Niche Suppliers

Beyond multinational corporations, regional suppliers often serve local markets, providing cost-effective and rapid procurement options. These may include:

Ind-Swift Laboratories (India)
Lupin Limited (India)
Hetero Labs Ltd. (India)
NB Group (China)

Such suppliers typically focus on bulk API manufacturing for global pharmaceutical firms or local formulation. Critical for supply chain redundancy, they often meet WHO GMP standards but require due diligence regarding quality and regulatory compliance.

Supply Chain Considerations and Supplier Evaluation

Regulatory Compliance and Certifications:
Suppliers must demonstrate adherence to cGMP, ISO 9001, and relevant pharmacopeial standards. This mitigates risks of contamination, substandard quality, or regulatory sanctions.

Quality Assurance:
Stringent testing for endotoxins, sterility, and stability is imperative. Suppliers' quality documentation and audit histories influence procurement decisions.

Production Capacity and Scalability:
Ensuring suppliers have scalable manufacturing capacity avoids shortages due to demand surges or supply disruptions.

Geopolitical Stability and Logistics:
Political stability, transportation infrastructure, and customs procedures influence supply reliability, especially for international suppliers.

Price and Payment Terms:
Cost competitiveness without sacrificing quality is critical, along with flexible payment and delivery terms.

Regulatory and Compliance Landscape

The procurement landscape must align with regional regulatory bodies:

FDA (USA): Ensures compliance with cGMP, 21 CFR Part 211.
EMA (Europe): Oversees EMA-approved manufacturing and distribution.
WHO GMP: Recognized for international procurement, particularly for developing countries.
National Regulatory Authorities: Such as CDSCO India, SFDA China, etc.

It is vital for importers and distributors to perform due diligence and supplier audits to maintain compliance.

Market Trends and Future Outlook

Global Demand Growth: Rising hospitalizations, aging populations, and expanding healthcare infrastructure drive demand for IV solutions.
Manufacturing Consolidation: Major players increasingly acquire regional manufacturers to optimize supply chains.
Quality and Safety Focus: Enhanced regulatory scrutiny emphasizes pathogen control and traceability.
Emerging Markets: Rapid growth in Asia-Pacific presents opportunities for local API manufacturers.
Bioequivalence and Innovation: Development of alternative formulations and delivery systems could modify demand patterns.

Strategic Recommendations for Procurement

Establish relationships with multiple approved suppliers to mitigate risks.
Prioritize suppliers with proven regulatory compliance and robust quality data.
Incorporate quality audits and periodic reviews into procurement protocols.
Leverage regional suppliers for diversification and cost optimization.
Stay abreast of regulatory changes affecting import/export and manufacturing standards.

Key Takeaways

Global pharmaceutical suppliers like Baxter, Fresenius, and Merck are primary sources of Dextrose 5% and Potassium Chloride 0.075%, backed by high regulatory compliance and manufacturing excellence.
Regional and emerging-market suppliers play a vital role in supplementing supply chains, offering cost advantages and rapid delivery.
Rigorous supplier evaluation, including compliance, quality assurance, and capacity, is essential to maintain consistent supply.
The evolving regulatory landscape and technological advancements necessitate continual supplier and market monitoring.
Diversification and strategic supplier partnerships enhance resilience against disruptions, ensuring uninterrupted access to essential IV solutions.

FAQs

1. How do I identify reliable suppliers for Dextrose 5% and Potassium Chloride 0.075%?
Conduct comprehensive supplier audits, verify regulatory compliance (cGMP, WHO GMP), review quality management systems, and evaluate production capacity. Partner with suppliers who demonstrate consistent quality, reliable delivery, and transparent documentation.

2. Are regional suppliers as reliable as multinational corporations?
Regional suppliers can be reliable if they meet international standards like WHO GMP and maintain rigorous quality controls. Their proximity can improve lead times and reduce costs. Due diligence is essential to validate capabilities and compliance.

3. What are the key quality parameters for these solutions?
Sterility, endotoxin levels, stability, correct potency, and absence of particulate contamination are critical quality parameters. Certificates of Analysis (CoA), batch records, and regulatory certifications are fundamental documentation.

4. How can supply chain disruptions for these drugs be mitigated?
Diversify suppliers across regions, establish long-term contracts, maintain safety stock, and implement supply chain monitoring. Regular supplier audits and contingency planning are also vital.

5. What is the future for these pharmaceutical ingredients in global markets?
Demand is expected to grow driven by expanding healthcare services and aging populations. Innovations in manufacturing and stricter regulatory standards will shape supplier strategies, emphasizing quality and compliance.

References

[1] Baxter International. Official website. "IV Solutions Portfolio," 2023.
[2] Fresenius Kabi. Product catalog, 2023.
[3] B. Braun Melsungen AG. Annual Report 2022.
[4] SNF Flotek Industries. Corporate data sheets, 2023.
[5] Hikma Pharmaceuticals. Annual review, 2022.
[6] Merck KGaA. API manufacturing standards, 2023.
[7] Pfizer Inc. IV Solutions & APIs overview, 2023.
[8] Sanofi. Product specifications, 2023.
[9] Akorn, Inc. Quality and compliance documentation, 2022.
[10] PharmaEssentia. API production quality certifications, 2023.

Suppliers and packagers for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%