Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Otsuka Icu Medcl	NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER	dextrose; magnesium acetate; potassium acetate; sodium chloride	INJECTABLE;INJECTION	017610	NDA	ICU Medical Inc.	0990-7965-09	12 POUCH in 1 CASE (0990-7965-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG	2021-02-08
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 9, 2025

Introduction

The demand for intravenous (IV) solutions such as NORMOSOL-M and Dextrose 5% in Plastic Containers (PVC bottles) remains high across hospitals, clinics, and pharmaceutical distributors worldwide. These solutions are integral for fluid therapy, parenteral nutrition, and electrolyte management. Identifying reliable suppliers for these products involves understanding market dynamics, key manufacturers, and regulatory considerations. This report provides a comprehensive analysis of the primary suppliers, supply chain considerations, and the strategic outlook for these essential IV solutions.

Overview of NORMOSOL-M and Dextrose 5%

NORMOSOL-M is an isotonic, balanced electrolyte solution containing sodium, potassium, magnesium, chloride, and acetate, designed for volume repletion, electrolyte correction, and as a vehicle for medication delivery. It is manufactured by Pfizer and other manufacturers conforming to pharmaceutical standards.

Dextrose 5% in Plastic Container (D10W) is a glucose solution primarily used for caloric supplementation, hydration, and as a carrier for medications. It’s produced by numerous pharmaceutical firms globally, with high-volume demand in clinical settings.

Leading Suppliers and Manufacturers

1. Pfizer Inc.

Product Portfolio: Pfizer is the original manufacturer of NORMOSOL-M. Their production facilities meet strict regulatory standards worldwide, certifying product quality and compliance.
Market Reach: Pfizer’s distribution network ensures global availability, including North America, Europe, Asia, and Latin America.
Supply Chain Strength: Pfizer’s extensive manufacturing capacity and logistics capabilities ensure consistent supply.

2. Baxter International Inc.

Equivalent Products: While Baxter does not manufacture NORMOSOL-M specifically, they produce similar balanced electrolyte solutions, such as Plasma-Lyte.
Dextrose Solutions: Baxter offers Dextrose 5% in Plastic Containers, widely used in hospital systems, especially in North America.
Regulatory Compliance: Baxter’s products are FDA-approved and CE-marked, ensuring access to diverse markets.

3. B. Braun Melsungen AG

Product Range: B. Braun supplies electrolyte solutions and Dextrose 5% through their Isolyte and Dextrose series.
Global Presence: B. Braun operates manufacturing facilities across Europe, North America, and Asia, with a comprehensive distribution system.
Quality Assurance: Known for high-quality standards and adherence to international pharmaceutical regulations.

4. Fresenius Kabi

Product Portfolio: Offers a range of IV fluids, including balanced electrolyte solutions similar to NORMOSOL-M and Dextrose 5% solutions.
Certifications: Complies with European Medicines Agency (EMA) and FDA standards.
Supply Reliability: Large manufacturing footprint in Europe and Asia ensures steady availability.

5. Hospira (a Pfizer company)

Extended Product Line: Hospira produces Dextrose solutions and electrolyte products, compatible with NORMOSOL-M formulations.
Market Integration: Integrated with Pfizer’s global supply chain, ensuring high standards for product consistency.

6. Local and Regional Suppliers

In addition to global giants, regional pharmaceutical manufacturers and distributors across Asia, Europe, and Latin America supply these IV solutions. Countries such as India, China, and Brazil have several domestic manufacturers meeting GMP standards, often offering cost-effective options.

Supply Chain and Regulatory Considerations

Regulatory Approvals: Suppliers must possess certifications such as FDA approval, EMA certification, or national regulatory authority licenses to operate legally and distribute pharmaceutical IV solutions.

Manufacturing Standards: Compliance with Good Manufacturing Practices (GMP) is critical. Suppliers must regularly audit manufacturing facilities to ensure sterile processing, proper labeling, and quality control.

Distribution Channels: Global suppliers utilize a network of warehousing and logistics providers to maintain cold chain integrity and timely delivery, especially for sensitive products like IV solutions.

Emerging Trends and Market Dynamics

Consolidation of Suppliers: Major pharmaceutical firms are consolidating to streamline supply chains, affecting availability and pricing.
Regulatory Harmonization: International regulations increasingly harmonize, simplifying procurement for global healthcare organizations.
Supply Chain Disruptions: Recent global events have stressed supply chains, emphasizing the importance of diversified supplier bases.
Innovation in Packaging: Transition to safer, more sustainable plastic containers and dual-chamber bags is affecting supplier offerings.

Strategic Recommendations

Supplier Qualification: Healthcare providers should prioritize suppliers with stringent regulatory compliance, consistent quality, and robust logistics.
Diversified Procurement: To mitigate supply risks, diversify sourcing strategies across multiple regional and global vendors.
Long-term Partnerships: Establishing strategic alliances with key manufacturers ensures priority access and potential pricing benefits.
Regulatory Monitoring: Keep abreast of regulatory changes affecting imported or locally produced IV solutions for compliance efficiency.

Conclusion

The supply of NORMOSOL-M and Dextrose 5% in Plastic Containers is dominated by global pharmaceutical players such as Pfizer, Baxter, B. Braun, and Fresenius Kabi. These entities are supported by regional manufacturers, ensuring broad market coverage. Central to procurement success are compliance with regulatory standards, reliable supply chains, and adaptable sourcing strategies. As the healthcare landscape evolves, stakeholders should emphasize supplier qualification, diversification, and ongoing regulatory vigilance to meet consistent demand.

Key Takeaways

Major global suppliers supply NORMOSOL-M and Dextrose 5% solutions, with Pfizer and Baxter leading in market share.
Regulatory compliance (GMP, FDA, EMA) remains a critical factor in supplier qualification.
Supply chain resilience involves leveraging regional manufacturers to mitigate disruptions.
Emerging packaging technologies and process innovations influence supplier offerings and market dynamics.
Diversification and strategic partnerships are vital for securing reliable access to these essential IV solutions.

FAQs

1. Are there generic alternatives to NORMOSOL-M internationally?
Yes, numerous regional manufacturers produce electrolyte solutions similar to NORMOSOL-M that meet GMP standards, offering cost-effective options without compromising quality.

2. What quality certifications should suppliers hold?
Suppliers should have FDA approval, CE marking, or equivalent certifications from recognized authorities, alongside adherence to GMP standards.

3. How does regional regulation impact the availability of these products?
Regulatory differences can influence product registration, approval timelines, and importation processes, affecting availability in certain markets.

4. Are plastic containers the most common packaging for IV fluids?
Yes, PVc bottles and flexible bags are standard due to safety, sterility maintenance, and ease of handling, with ongoing innovations towards sustainable packaging.

5. How can healthcare providers ensure supply continuity during global disruptions?
By establishing diversified supplier networks, maintaining safety stock, and engaging in long-term procurement agreements with multiple approved vendors.

Sources:
[1] Pfizer Official Website, Pharmaceutical Product Catalog.
[2] Baxter International Product Portfolio.
[3] B. Braun Melsungen AG Product Catalogue.
[4] Fresenius Kabi IV Solutions Range.
[5] Global Pharmaceutical Supply Chain Reports, 2022.

Suppliers and packagers for NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER

NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER

Suppliers for Pharmaceutical Drug: NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER