DEXTROSE 5% AND SODIUM CHLORIDE 0.45%: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	dextrose; sodium chloride	INJECTABLE;INJECTION	211276	ANDA	BECTON DICKINSON AND COMPANY	17271-734-05	30 BAG in 1 CASE (17271-734-05) / 250 mL in 1 BAG	2020-10-26
Fresenius Kabi Usa	DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	dextrose; sodium chloride	INJECTABLE;INJECTION	211276	ANDA	BECTON DICKINSON AND COMPANY	17271-734-06	20 BAG in 1 CASE (17271-734-06) / 500 mL in 1 BAG	2020-10-26
Fresenius Kabi Usa	DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	dextrose; sodium chloride	INJECTABLE;INJECTION	211276	ANDA	BECTON DICKINSON AND COMPANY	17271-734-07	10 BAG in 1 CASE (17271-734-07) / 1000 mL in 1 BAG	2020-10-26
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 8, 2025

Introduction

In the pharmaceutical industry, sourcing reliable suppliers for intravenous (IV) fluids such as Dextrose 5% and Sodium Chloride 0.45% (half-normal saline) is critical to ensure drug quality, regulatory compliance, and supply chain resilience. These solutions are essential in clinical settings, used for hydration, electrolyte stabilization, and as carriers for other medications. The selection of suppliers hinges on reputable manufacturing standards, global reach, regulatory approvals, and consistent supply capabilities. This report presents a comprehensive overview of key suppliers for Dextrose 5% and Sodium Chloride 0.45%, emphasizing market leaders, manufacturing standards, and procurement considerations.

Market Overview of Dextrose 5% and Sodium Chloride 0.45% Suppliers

Dextrose 5% and Sodium Chloride 0.45% are among the most widely used intravenous fluids globally. The primary suppliers include multinational pharmaceutical companies, regional manufacturers, and contract manufacturing organizations (CMOs). Their production adheres to stringent aseptic processing, Good Manufacturing Practices (GMP), and regulatory standards such as those mandated by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regional authorities.

Leading Suppliers of Dextrose 5% and Sodium Chloride 0.45%

1. Baxter International Inc.

Overview: Baxter is a global leader in injectable and IV solutions, known for its extensive product portfolio, including Dextrose and Sodium Chloride solutions. Its manufacturing facilities follow strict GMP guidelines, with products approved by major regulatory agencies.

Key Attributes:

Global distribution network.
ISO 13485 and FDA-approved manufacturing plants.
Innovative packaging (e.g., ready-to-use bags).
Established supplier for hospitals and clinics worldwide.

Supply Capabilities: Baxter produces large volumes of IV fluids, ensuring steady supply and robust logistics support, ideal for large-scale procurement.

2. B. Braun Melsungen AG

Overview: A prominent German healthcare company specializing in infusion therapy and clinical nutrition. B. Braun’s sterile solutions for hydration are trusted for quality and safety.

Key Attributes:

GMP-certified manufacturing plants in Europe, North America, and Asia.
Price competitiveness offers value for procurement.
Focus on innovation and environmentally sustainable practices.

Supply Capabilities: Consistently maintains high production standards to meet international demand, with flexibility in supply chain logistics.

3. Fresenius Kabi

Overview: This German pharmaceutical firm is a global provider of IV solutions, including Dextrose and Sodium Chloride solutions. Known for high-quality manufacturing and a broad product range.

Key Attributes:

Extensive manufacturing facilities compliant with cGMP and FDA standards.
Strong presence in emerging markets.
Emphasis on patient safety and product reliability.

Supply Capabilities: Able to supply large volumes quickly, serving hospitals, clinics, and pharmacy networks.

4. Hospira (a Pfizer company)

Overview: Hospira has a longstanding reputation for producing sterile injectable drugs and IV fluids. Although now part of Pfizer, its legacy products remain critical procurement options.

Key Attributes:

Robust manufacturing processes.
Broad distribution and supply chain.
Adherence to global regulatory requirements.

Supply Capabilities: Known for consistent quality and supply reliability, particularly in North America.

5. Weigao Group

Overview: A leading Chinese manufacturer of infusion solutions, including Dextrose and Sodium Chloride saline solutions.

Key Attributes:

Cost-effective manufacturing options.
Growing global distributor network.
Regulatory approvals in multiple markets.

Supply Capabilities: Offers competitive pricing with increasing capacity to meet international demand.

Regional and Niche Suppliers

In addition to global giants, several regional and lesser-known suppliers serve localized markets:

Otsuka Pharmaceutical (Japan): Supplies high-quality IV solutions with a focus on Asia-Pacific.
Shanghai RAAS (China): Offers affordable saline solutions, expanding into emerging markets.
Minapharm Pharmaceuticals (Egypt): Serves Middle Eastern and African regions with GMP-compliant products.

Criteria for Selecting Suppliers

When choosing suppliers for Dextrose 5% and Sodium Chloride 0.45%, stakeholders should consider:

Regulatory Compliance: Ensure products possess requisite approvals, such as FDA, EMA, or local regulatory clearances.
Manufacturing Standards: Confirm adherence to GMP, ISO 13485, and other international quality standards.
Supply Chain Reliability: Evaluate production capacity, logistics, and contingency plans.
Pricing and Contract Terms: Balance cost-effectiveness with quality assurance.
Product Stability & Packaging: Seek formats that ensure stability, such as pre-filled bags or bottles suited to clinical settings.
Environmental and Sustainability Policies: Prefer suppliers committed to environmental sustainability.

Supply Chain and Regulatory Considerations

The global supply chain for IV solutions is susceptible to disruptions due to regulatory changes, geopolitical issues, and pandemics. Recent supply chain challenges have underscored the importance of diversified sourcing and establishing relationships with multiple reputable suppliers. Regulatory compliance remains paramount; products must meet pharmacopoeial standards (USP, BP, JP) and regional regulatory requirements, such as FDA approval, to ensure safety and efficacy.

Emerging Trends and Future Outlook

Localized Manufacturing: Moving towards regional suppliers to reduce logistics risks.
Innovation in Packaging: Development of more convenient and tamper-evident containers.
GMP Compliance in Developing Countries: Increasing capacity among regional suppliers to meet growing demand.
Supply Chain Digitization: Enhanced tracking and real-time inventory management.

Key Takeaways

Secure partnerships with established global suppliers like Baxter, B. Braun, Fresenius Kabi, and Hospira for reliable sourcing.
Evaluate suppliers based on strict adherence to GMP and regulatory standards, supply capabilities, and geographic presence.
Diversify sourcing channels to mitigate geopolitical and supply chain risks.
Prioritize suppliers with innovative packaging solutions and sustainable practices.
Keep abreast of evolving regulations and market trends to optimize procurement strategies.

FAQs

1. What are the primary regulations that suppliers of Dextrose 5% and Sodium Chloride 0.45% must comply with?
Manufacturers must comply with GMP standards, and products should have approvals from regulatory agencies such as the FDA, EMA, or regional health authorities. Compliance ensures safety, efficacy, and quality.

2. Which global suppliers produce the most reliable Dextrose and Sodium Chloride solutions?
Baxter International, B. Braun Melsungen, Fresenius Kabi, and Hospira are recognized for their reliability, adherence to standards, and extensive distribution networks.

3. Are regional suppliers suitable for large-scale international procurement?
Regional suppliers can be suitable, especially when complemented with global suppliers. Evaluating their regulatory approvals, manufacturing standards, and capacity is essential before large-scale procurement.

4. How does supply chain disruption affect procurement of IV fluids?
Disruptions can lead to shortages, delays, and increased costs. Diversification of suppliers, maintaining buffer stock, and engaging with well-established suppliers mitigate these risks.

5. What emerging trends are influencing the supplier landscape for IV fluids?
Trends include regional manufacturing, sustainable packaging, digitized supply chain management, and increased focus on regulatory compliance across emerging markets.

References

[1] Baxter International. (2022). Product Portfolio and Quality Standards.
[2] B. Braun Melsungen AG. (2022). Corporate Overview and Product Certifications.
[3] Fresenius Kabi. (2022). Global Manufacturing and Supply Chain Capabilities.
[4] Hospira (Pfizer). (2022). Compliance and Regulatory Approvals.
[5] World Health Organization. (2021). Good Manufacturing Practices for Injectable Products.

Suppliers and packagers for DEXTROSE 5% AND SODIUM CHLORIDE 0.45%