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Last Updated: December 12, 2025

Suppliers and packagers for DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER


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DEXTROSE 5% AND SODIUM CHLORIDE 0.33% 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
B Braun DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631 NDA B. Braun Medical Inc. 0264-7608-00 12 CONTAINER in 1 CASE (0264-7608-00) / 1000 mL in 1 CONTAINER 1988-02-24
B Braun DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631 NDA B. Braun Medical Inc. 0264-7608-10 24 CONTAINER in 1 CASE (0264-7608-10) / 500 mL in 1 CONTAINER 1988-02-24
B Braun DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631 NDA B. Braun Medical Inc. 0264-7610-00 12 CONTAINER in 1 CASE (0264-7610-00) / 1000 mL in 1 CONTAINER 1988-02-24
B Braun DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631 NDA B. Braun Medical Inc. 0264-7610-10 24 CONTAINER in 1 CASE (0264-7610-10) / 500 mL in 1 CONTAINER 1988-02-24
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Last updated: August 10, 2025

ppliers for the Pharmaceutical Drug: Dextrose 5% and Sodium Chloride 0.33% in Plastic Container

Introduction
Dextrose 5% combined with Sodium Chloride 0.33% in a plastic container represents a critical intravenous (IV) fluid formulation extensively used for hydration, electrolyte balance, and nutritional support in clinical settings. Reliable supplier sources ensure pharmaceutical quality, regulatory compliance, consistent supply, and cost-effectiveness. This article explores leading global and regional suppliers manufacturing Dextrose 5% and Sodium Chloride 0.33% solutions in plastic containers, highlighting their manufacturing capabilities, certifications, and market presence.

Overview of Dextrose 5% and Sodium Chloride 0.33% in Plastic Containers
The combination fluid, often administered via IV infusion, requires strict adherence to pharmaceutical standards, including sterility, stability, and compatibility. These solutions typically come in polyethylene or polypropylene plastic containers, chosen for their inertness, durability, and cost efficiency. The formulations support various medical uses, including volume expansion, metabolic needs, and electrolyte replenishment, especially in outpatient and inpatient care.

Key Suppliers for Dextrose 5% and Sodium Chloride 0.33% in Plastic Containers

1. Baxter International Inc.
Baxter is a leading provider of IV fluids with a comprehensive product portfolio. Their manufacturing facilities worldwide adhere to cGMP standards and ISO certifications, ensuring high-quality sterile solutions. Baxter offers Dextrose 5% and Sodium Chloride formulations in various container types, including plastic. The company's global supply chain supports consistent availability across markets. Baxter’s commitment to innovation and quality positions it as a top supplier for hospitals and distributors.

2. Pfizer Inc.
Pfizer manufactures a range of sterile infusion solutions, including dextrose and saline-based products. With extensive manufacturing facilities compliant with FDA, EMA, and WHO standards, Pfizer supplies stable, high-purity solutions in plastic containers. Their distribution network ensures wide regional coverage, making Pfizer a preferred choice for large healthcare providers seeking compliance and reliability.

3. B. Braun Melsungen AG
B. Braun specializes in infusion therapy and offers a broad portfolio of IV fluids. Their products undergo rigorous testing and comply with international quality standards such as ISO 13485. B. Braun's Dextrose and sodium chloride solutions are available in prefilled plastic containers, serving both hospital and home healthcare segments. Their emphasis on innovation and patient safety underscores their status as a trusted supplier.

4. Fresenius Kabi AG
Fresenius Kabi is renowned for its extensive IV fluids lineup, including glucose-saline solutions. With manufacturing sites certified under GMP and ISO standards, they supply high-quality sterilized solutions in plastic containers. Their global footprint ensures procurement flexibility for healthcare providers seeking reliable sources of Dextrose 5% and Sodium Chloride 0.33% solutions.

5. Hospira (A Pfizer Company)
Hospira focuses on sterile injectable drugs and infusion solutions, providing a robust range of IV fluids. Their manufacturing adheres to strict quality regulations, with products available in plastic containers designed for safe and sterile delivery. Their global distribution channels enable continuous availability in various healthcare markets.

Regional and Emerging Suppliers

6. Hua Company (China)
Chinese pharmaceutical companies such as Huasun Pharmaceutical have ramped up their production of IV fluids, including Dextrose and sodium chloride solutions in plastic containers, to meet regional demand. These companies have increasingly obtained international certifications (e.g., ISO 9001, GMP), expanding their acceptance in global markets and providing cost-effective options.

7. Wockhardt Ltd. (India)
Wockhardt manufactures sterile infusion fluids catering to domestic and export markets. Their facilities are compliant with international standards, and they offer Dextrose and sodium chloride solutions in plastic containers with competitive pricing.

8. Zhejiang Tianyuan Pharmaceutical Co., Ltd.
This Chinese firm specializes in sterile infusion products, including dextrose and saline solutions in plastic containers. They emphasize quality management and have achieved various international standards, positioning them as emerging players in the global supply chain.

Criteria for Selecting Suppliers

  • Regulatory Compliance: Ensure suppliers meet local and international standards such as FDA, EMA, WHO GMP, and ISO certifications.
  • Product Quality: Confirm sterility, stability, and packaging integrity of solutions. Molecular testing, endotoxin testing, and stability data are vital.
  • Manufacturing Capabilities: Evaluate production capacity, scalability, and quality control processes.
  • Supply Reliability: Assess the supplier’s ability to maintain consistent supply volumes and delivery timelines.
  • Cost Effectiveness: Consider pricing in relation to quality and service levels, especially for large-volume procurement.

Market Dynamics and Future Outlook

The global demand for IV fluids like Dextrose 5% and Sodium Chloride 0.33% persists, driven by healthcare infrastructure expansion, aging populations, and the rising prevalence of chronic diseases requiring infusion therapies. Manufacturers are increasingly investing in automation and advanced sterilization techniques to ensure product quality. Emerging regional suppliers from Asia and Eastern Europe contribute to a diversified supply chain, offering competitive pricing and geographic flexibility.

Furthermore, regulatory harmonization efforts aim to streamline approval processes for suppliers seeking international markets, encouraging new entrants with compliant and innovative offerings. As healthcare systems prioritize patient safety and cost control, suppliers with robust quality systems and flexible production capabilities will dominate the market.

Conclusion

Reliable sourcing of Dextrose 5% and Sodium Chloride 0.33% in plastic containers demands thorough vetting of suppliers based on regulatory adherence, product quality, manufacturing capacity, and supply chain robustness. Leading global manufacturers such as Baxter, Pfizer, B. Braun, Fresenius Kabi, and Hospira remain dominant due to their extensive certifications and production excellence. Emerging regional players from China and India offer cost-effective alternatives with increasing regulatory compliance.

To optimize procurement strategies, healthcare organizations should prioritize supplier audits, compliance verification, and ongoing quality assurance to ensure uninterrupted, safe infusions for patient care.


Key Takeaways

  • Major global suppliers of Dextrose 5% and Sodium Chloride 0.33% in plastic containers include Baxter, Pfizer, B. Braun, Fresenius Kabi, and Hospira.
  • Regulatory compliance and product quality are critical selection criteria among international standards such as GMP, ISO, and FDA approvals.
  • Regional suppliers in China and India are expanding their footprint, offering cost-effective and compliant alternatives.
  • Supply chain resilience and consistent quality assurance are vital for healthcare providers relying on these solutions.
  • Emerging technologies and harmonized regulatory frameworks will influence future supplier competitiveness and product availability.

5 FAQs

1. Are all Dextrose 5% and Sodium Chloride 0.33% solutions in plastic containers equivalent?
No. While formulations may be similar, product quality, sterilization methods, purity levels, and packaging standards differ among manufacturers. Ensuring compliance with relevant pharmacopeial standards is essential.

2. What certifications should I look for when selecting a supplier?
Manufacturers should hold GMP (Good Manufacturing Practice), ISO 13485, and country-specific regulatory approvals such as FDA or EMA certifications. These assure product quality and regulatory compliance.

3. How can supply chain risks be mitigated for critical IV fluids?
Establish relationships with multiple approved suppliers, monitor inventory levels, and include contractual provisions for contingency supply during shortages or disruptions.

4. What are the benefits of sourcing from regional suppliers in emerging markets?
Regional suppliers often offer competitive pricing, shorter lead times, and adapt faster to local regulatory updates, aiding in reducing costs and supply risks.

5. Will regulatory standards evolve to accommodate new suppliers?
Yes. Regulatory agencies are working towards harmonized standards, facilitating international approvals for compliant new entrants, though rigorous approval processes remain in place.


References
[1] Baxter International Inc. Official Product Catalog, 2023.
[2] Pfizer Inc. Product Overview, 2023.
[3] B. Braun Melsungen AG Compliance and Quality Standards, 2023.
[4] Fresenius Kabi AG. Global Quality Certifications, 2023.
[5] World Health Organization. Good Manufacturing Practices for Pharmaceuticals, 2022.

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