CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER: 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
B Braun	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	cefuroxime sodium	INJECTABLE;INJECTION	050780	NDA	B. Braun Medical Inc.	0264-3112-11	24 CONTAINER in 1 CASE (0264-3112-11) / 50 mL in 1 CONTAINER	2001-02-21
B Braun	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	cefuroxime sodium	INJECTABLE;INJECTION	050780	NDA	B. Braun Medical Inc.	0264-3114-11	24 CONTAINER in 1 CASE (0264-3114-11) / 50 mL in 1 CONTAINER	2001-02-21
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 6, 2025

Introduction

The pharmaceutical industry’s supply chain for injectable formulations such as Cefuroxime and Dextrose in duplex containers plays a pivotal role in healthcare delivery. Duplex containers, recognized for their sterile barrier and stability, are integral to intravenous therapy, particularly when precise dosing and stability are critical. This article offers a comprehensive overview of the leading suppliers specializing in the production and distribution of Cefuroxime and Dextrose in duplex containers, emphasizing quality, regulatory compliance, and geographic coverage.

Understanding Cefuroxime and Dextrose in Duplex Containers

Cefuroxime is a second-generation cephalosporin antibiotic used in treating bacterial infections. It is often supplied as a sterile solution, formulated for intravenous or intramuscular administration.

Dextrose solutions, commonly Dextrose 5% in water (D5W), provide a carbohydrate source for patients needing parenteral nutrition or hydration. When combined in duplex containers, these solutions facilitate synchronized administration, ensuring stability and sterility.

Duplex containers are pre-sterilized, dual-compartment infusion systems that keep incompatible drugs separate until use, thereby improving stability and reducing contamination risks. They are produced under strict ISO or cGMP standards and are essential in hospital and clinical settings.

Leading Global Suppliers

1. Fresenius Kabi

Fresenius Kabi is a global leader in infusion therapies and sterile pharmaceuticals, including antibiotics like Cefuroxime. They manufacture a wide range of duplex containers tailored for pediatric and adult use.

Product Range: Cefuroxime injections in duplex containers, Dextrose solutions.
Regulatory Approvals: WHO GMP, FDA, EMA.
Markets: North America, Europe, Asia, Africa.

Strengths: Robust supply chain, established manufacturing facilities adhering to international standards, and extensive distribution network.

2. B.Braun Melsungen AG

B.Braun specializes in infusion technology, including duplex infusion systems. Their portfolio includes Cefuroxime formulations and Dextrose solutions.

Product Range: Cefuroxime in duplex infusions, Dextrose 5% in duplex containers.
Compliance Certifications: ISO 13485, FDA approvals.
Markets: Global, with a strong presence in Europe, North America, and Asia.

Strengths: Innovative delivery systems and focus on device integrity, ensuring drug stability within duplex containers.

3. Hospira (A Pfizer Company)

Hospira has historically provided sterile injectable drugs, including antibiotics. Their expertise extends into high-quality duplex container formulations.

Product Range: Cefuroxime injections, Dextrose solutions.
Regulatory Approvals: US FDA, EMA.
Markets: North America, Europe, Asia-Pacific.

Strengths: Extensive manufacturing capacity and advanced quality management systems.

4. Sun Pharma

An Indian multinational, Sun Pharma supplies a wide array of injectable antibiotics and compatible dextrose solutions in duplex containers, especially targeting emerging markets.

Product Range: Cefuroxime in sterile duplex formulations, Dextrose in flexible containers.
Certifications: WHO GMP, Indian CFR regulations.
Markets: India, Southeast Asia, Middle East, Africa.

Strengths: Cost-effective solutions with compliance to global standards; expanding international footprint.

5. PharmaSynth

A mid-sized manufacturer specializing in sterile injectable drugs, including Cefuroxime and Dextrose solutions in duplex packaging.

Product Range: Cefuroxime sodium, Dextrose solutions.
Certifications: cGMP, ISO 9001.
Markets: Regional, with growing exports to Europe and North America.

Strengths: Customized duplex solutions, flexible manufacturing capacity.

Regional and Niche Suppliers

Several regional companies cater specifically to local markets but may lack extensive international certification. Notable examples include:

Vifor Pharma: Known for sterile infusion solutions, including duplex container formulations, primarily in Europe.
Aurobindo Pharma: A major Indian pharmaceutical producer with a growing portfolio of injectable antibiotics and dextrose solutions.
Shanghai Fosun Pharmaceutical: Focused on Asian markets, providing affordable duplex container medications.

Key Considerations When Selecting Suppliers

Regulatory Compliance: ISO, cGMP, FDA, EMA approvals.
Quality Assurance: Sterility, stability, and compatibility testing of Cefuroxime and Dextrose solutions within duplex containers.
Manufacturing Capacity: Ability to meet large-volume demands.
Distribution Reach: Global vs. regional availability.
Pricing Strategies: Cost competitiveness without compromising quality.

Regulatory and Quality Standards

Suppliers must adhere to rigorous international standards due to the critical nature of injectable medications. Compliance with ISO 13485, cGMP, and certifications from FDA and EMA ensures product safety and efficacy. Due to the sensitive nature of duplex containers, aseptic processing, sterilization, and validation are paramount.

Supply Chain Dynamics

Global disruptions, such as those caused by the COVID-19 pandemic, highlight the importance of diversified supplier bases. Suppliers with multiple manufacturing sites and robust logistics networks can mitigate risks associated with supply delays or quality issues.

Emerging Trends and Innovations

Bi-layer and multi-chamber systems: Enhancing stability for incompatible drugs.
Advanced sterilization techniques: Such as gamma irradiation or ethylene oxide.
Sustainable packaging: Reducing environmental impact while maintaining quality.
Digital tracking: Enhancing traceability and quality assurance.

Key Takeaways

Global manufacturers such as Fresenius Kabi, B.Braun, and Hospira dominate the supply of Cefuroxime and Dextrose solutions in duplex containers, driven by rigorous quality standards and extensive distribution networks.
Regional firms offer cost-effective options, primarily serving local markets, but may require careful verification of regulatory compliance.
Regulatory alignment with agencies like FDA, EMA, and ISO is critical for international procurement to ensure safety and efficacy.
Supply chain resilience is enhanced through diversification, strategic inventory management, and technological innovations.
Quality assurance processes including validation, sterility testing, and stability assessments guarantee product integrity.

FAQs

1. What are the primary advantages of duplex containers for Cefuroxime and Dextrose?
Duplex containers maintain drug stability, prevent incompatibility reactions, and minimize contamination risks by segregating incompatible substances until administration.

2. Which suppliers are best suited for procurement in emerging markets?
Sun Pharma, Aurobindo Pharma, and Shanghai Fosun Pharma offer affordable, regulation-compliant duplex solutions tailored to these markets.

3. How do regulatory standards impact supplier selection?
Suppliers with certifications such as WHO GMP, FDA, or EMA demonstrate compliance, ensuring product safety and facilitating regulatory approvals in target markets.

4. What logistical considerations should buyers evaluate?
Manufacturing capacity, distribution network, lead times, and contingency planning are crucial, especially amid global supply chain disruptions.

5. Are there sustainable options in duplex container formulations?
Yes, advances include biodegradable materials and minimal packaging designs, aiming to reduce environmental impact without compromising sterility and stability.

Conclusion

The supply of Cefuroxime and Dextrose in duplex containers is a critical component of intravenous therapy infrastructure. Leading global manufacturers such as Fresenius Kabi, B.Braun, and Hospira deliver high-quality, regulation-compliant solutions with extensive reach. Regional players address local needs with cost-effective options. Strategic supplier selection hinges on compliance standards, product quality, capacity, and logistics resilience. Staying abreast of technological advancements and regulatory updates will ensure reliable procurement, ultimately supporting optimal patient outcomes.

References

[1] World Health Organization. WHO Good Manufacturing Practices (GMP) Guidelines.
[2] US Food and Drug Administration. Drug Establishments Current Good Manufacturing Practice (CGMP) Regulations.
[3] European Medicines Agency. Guidelines on Stability Testing of Medicines.
[4] Pharmaceutical Technology. Innovations in Duplex Container Packaging.
[5] MarketWatch. Leading Global Manufacturers of Injectable Drugs.

Suppliers and packagers for CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER