Suppliers and packagers for NORMOSOL-R IN PLASTIC CONTAINER

NORMOSOL-R IN PLASTIC CONTAINER

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Otsuka Icu Medcl	NORMOSOL-R IN PLASTIC CONTAINER	magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate	INJECTABLE;INJECTION	017586	NDA	ICU Medical Inc.	0990-7670-03	24 BAG in 1 CASE (0990-7670-03) / 500 mL in 1 BAG	2019-09-01
Otsuka Icu Medcl	NORMOSOL-R IN PLASTIC CONTAINER	magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate	INJECTABLE;INJECTION	017586	NDA	ICU Medical Inc.	0990-7670-09	12 BAG in 1 CASE (0990-7670-09) / 1000 mL in 1 BAG	2019-09-01
Otsuka Icu Medcl	NORMOSOL-R IN PLASTIC CONTAINER	magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate	INJECTABLE;INJECTION	017586	NDA	ICU Medical Inc.	0990-7967-09	12 POUCH in 1 CASE (0990-7967-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG	2019-09-18

Suppliers for the Pharmaceutical Drug: Normosol-R in Plastic Container

Last updated: July 27, 2025

Introduction

Normosol-R, a balanced electrolyte solution, has gained widespread adoption in clinical settings, particularly for volume resuscitation, blood transfusions, and perioperative fluid management. Its formulation mimics plasma electrolyte composition, thus supporting physiological stability. As demand for Normosol-R in plastic containers—primarily prefilled or bulk packaging—rises, identifying reliable suppliers becomes crucial for healthcare providers, pharmaceutical distributors, and OEMs (Original Equipment Manufacturers). This article provides a comprehensive overview of suppliers producing Normosol-R in plastic containers, outlining manufacturing sources, supply chain considerations, and market dynamics.

Overview of Normosol-R

Normosol-R (also known as Normosol-R or Normosol-R in clinical practice) is a sterile, pyrogen-free, isotonic solution primarily comprising sodium chloride, potassium chloride, magnesium chloride, phosphate, and acetate buffered in water for injections. It is comprehensive in electrolyte content, intended for parenteral administration. Major manufacturers formulate and package Normosol-R in various container types, including glass bottles and plastic containers, with the latter favored for its convenience, safety, and compatibility with modern infusion systems.

Key Manufacturers and Supply Sources

1. Hospira (Part of Pfizer)

Product Overview: Hospira, now a Pfizer company, is one of the primary suppliers of Normosol-R in the United States. Its production facilities manufacturing electrolyte solutions employ advanced sterile processing technology, adhering to FDA and European Medicines Agency (EMA) standards.

Packaging: Hospira primarily supplies Normosol-R in plastic containers such as polyethylene bottles and prefilled bags designed for compatibility with infusion pumps. Their focus on flexible bag systems aligns with hospital needs for ease of handling.

Distribution: As a major pharmaceutical manufacturer, Hospira’s distribution network covers North America, Europe, and select Asian markets. Their logistics ensure consistent supply and adherence to quality standards.

Regulatory Status: Pfizer maintains strict compliance with Good Manufacturing Practices (GMP), ensuring product safety and potency.

2. B. Braun Melsungen AG

Product Overview: B. Braun is a key player in infusion solutions, offering electrolyte formulations, including Normosol-R equivalents or proprietary balanced electrolyte solutions packaged in plastic containers.

Packaging and Innovation: B. Braun specializes in prefilled infusion bags made of multilayer polymer materials designed for stability and biocompatibility. These containers are designed for infusion devices and compatibility with hospital pipelines.

Market Reach: B. Braun’s manufacturing sites in Germany and the U.S. enable broad distribution in European and North American markets. They also supply custom packaging solutions for institutional clients.

3. ICU Medical (Vectra® Brand)

Product Overview: ICU Medical offers a line of infusion products, including electrolyte solutions in plastic containers. Although Vectra® solutions are not always branded as Normosol-R, comparable electrolyte solutions are supplied in PVC or polyolefin bags.

Packaging: ICU Medical emphasizes prefilled, ready-to-use infusion bags with advanced barrier properties, facilitating stability during storage and transport.

Distribution: Their extensive global network ensures timely availability, particularly in North American and European markets.

4. Local and Regional Suppliers/Contract Manufacturers

In addition to major international manufacturers, numerous regional pharmaceutical companies and contract manufacturing organizations (CMOs) supply electrolyte solutions in plastic containers, often tailored to specific hospital or health system needs.

Many of these suppliers source bulk API (Active Pharmaceutical Ingredient) electrolytes from international chemical producers and perform sterile filling under cGMP conditions, exporting products globally.

5. Chemical and Raw Material Suppliers

While not directly providing finished pharmaceutical products, chemical suppliers like Thermo Fisher Scientific, Merck KGaA, and Sigma-Aldrich supply high-purity electrolytic salts used in manufacturing Normosol-R. These companies are integral to the supply chain, supporting downstream manufacturers.

Supply Chain and Quality Considerations

Given the critical nature of electrolyte solutions, procurement decisions hinge on several factors:

• Regulatory Compliance: Suppliers must meet cGMP, FDA, EMA, and other regional standards. Certifications like ISO 9001, ISO 13485, and batch-specific documentation are essential.
• Container Compatibility and Material Safety: Plastic containers are designed to prevent leaching, maintain stability, and allow for compatibility with infusion devices. Polyethylene and multilayer polymer bags are common.
• Shelf Life and Stability: Packaging must ensure stability over the product's intended shelf life, especially considering the electrolyte composition's susceptibility to pH shifts and microbial contamination.
• Supply Reliability: Ensuring steady production capacity and supply chain resilience is vital during global disruptions such as pandemics.

Emerging Trends and Market Dynamics

• Shift Toward Plastic Containers: Hospitals and clinics favor flexible, lightweight, and safe plastic containers over glass bottles, which are fragile and pose contamination risks.
• Bespoke Packaging Solutions: Manufacturers increasingly offer customized bag configurations, ports, and integrated filters to optimize infusion therapy and reduce waste.
• Global Supply Simplification: Companies aim to streamline sourcing by consolidating suppliers or developing regional manufacturing hubs, reducing lead times and mitigating geopolitical risks.

Market Challenges

• Regulatory Hurdles: Differing regional standards may necessitate multiple packaging variants or certifications.
• Pricing and Competition: Surge in demand and patent expirations lead to increased competition, influencing pricing strategies.
• Supply Chain Disruptions: Raw material shortages, geopolitical instability, and logistical challenges impact delivery schedules.

Conclusion

The primary suppliers of Normosol-R in plastic containers are established pharmaceutical manufacturers such as Pfizer's Hospira, B. Braun, and ICU Medical, supported by regional CMOs. Key considerations for stakeholders include adherence to quality standards, container compatibility, supply chain robustness, and regulatory compliance. As the healthcare sector continues to favor advanced plastic container systems, suppliers investing in innovation and logistics efficiency will maintain competitive advantages.

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Key Takeaways

• Major suppliers of Normosol-R in plastic containers include Pfizer’s Hospira, B. Braun, and ICU Medical.
• Packaging innovations favor prefilled, multilayer polymer infusion bags tailored for clinical convenience and safety.
• Supply chain resilience depends on regulatory compliance, raw material sourcing, and manufacturing capacity.
• Regional CMOs play a significant role in meeting local market demands and customizing container formats.
• The trend toward safer, more flexible plastic containers aligns with hospital preferences for reducing contamination risk and improving handling.

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FAQs

1. Who are the primary global manufacturers of Normosol-R in plastic containers?
Pfizer’s Hospira, B. Braun Melsungen, and ICU Medical are the leading global manufacturers providing Normosol-R in plastic infusion containers, with regional CMOs supporting localized supply.

2. Are there any regional or generic suppliers offering alternatives to brand-name Normosol-R?
Yes, regional pharmaceutical companies and CMOs often supply comparable electrolyte solutions in plastic containers, typically branded as "balanced electrolyte solutions" or "plasma-lyte," suitable for institutional use.

3. What are the benefits of using plastic containers for electrolyte solutions?
Plastic containers are lightweight, less fragile than glass, equipped with advanced barrier properties, and compatible with modern infusion systems, enhancing safety and operational efficiency.

4. How do regulatory standards influence supplier selection for Normosol-R?
Suppliers must demonstrate compliance with GMP, obtain relevant certifications, and ensure strict quality controls to meet regional regulatory requirements, vital for safety and efficacy.

5. What emerging trends are shaping the supply of Normosol-R in plastic containers?
Increasing adoption of prefilled, multilayer polymer bags, regional manufacturing hubs to reduce lead times, and innovations in container design to improve stability and patient safety are key trends.

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References

1. [1] Pharmaceutical Packaging News. “Advances in Parenteral Container Technologies.” 2022.
2. [2] FDA. “Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics.” 2020.
3. [3] Pfizer. “Hospira Infusion Solutions Product Portfolio.” 2023.
4. [4] B. Braun. “Solutions for Parenteral Nutrition and Electrolyte Therapy.” 2022.
5. [5] ICU Medical. “Infusion Therapy Products Overview.” 2023.