CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
B Braun	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	cefoxitin sodium	INJECTABLE;INJECTION	065214	NDA	B. Braun Medical Inc.	0264-3123-11	24 CONTAINER in 1 CASE (0264-3123-11) / 50 mL in 1 CONTAINER	2006-03-10
B Braun	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	cefoxitin sodium	INJECTABLE;INJECTION	065214	NDA	B. Braun Medical Inc.	0264-3125-11	24 CONTAINER in 1 CASE (0264-3125-11) / 50 mL in 1 CONTAINER	2006-03-10
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 3, 2025

Introduction

Cefoxitin combined with dextrose in duplex containers represents a crucial antiseptic and antibiotic formulation used primarily for surgical prophylaxis and intraoperative infections. The delivery format—dual-compartment containers—serves to stabilize components separately, ensuring efficacy until the point of administration. Identifying reliable suppliers for this pharmaceutical combination is pivotal for healthcare providers, distributors, and procurement agencies aiming to uphold quality standards, regulatory compliance, and cost-efficiency.

This analysis explores the key global suppliers manufacturing and distributing cefoxitin and dextrose in duplex containers, examines their product offerings, regulatory standing, and logistical capabilities, and provides insights for informed procurement decisions.

Overview of Cefoxitin and Dextrose in Pharmaceutical Duplex Containers

Cefoxitin

Cefoxitin is a second-generation cephalosporin antibiotic effective against a broad spectrum of bacteria, including anaerobes and Gram-negative bacteria. It is commonly administered via intravenous infusion, often prepared in combination with other solutions for enhanced therapeutic efficacy.

Dextrose

Dextrose (glucose) solutions are widely used as carriers, diluents, or fluid replacement during infusion therapy. When combined with antibiotics like cefoxitin, dextrose solutions serve as a vehicle for intravenous delivery, especially in hospital settings.

Duplex Container Technology

The duplex container involves a dual-chamber system that segregates incompatible components, preserving drug stability. For cefoxitin and dextrose, this format prevents drug degradation or precipitation, ensuring safe and effective administration.

Key Global Suppliers of Cefoxitin and Dextrose in Duplex Containers

1. Fresenius Kabi

Overview: A leading global healthcare company specializing in infusion solutions, IV medicines, and clinical nutrition products, including duplex containers.

Product Offerings:

Cefoxitin in Duplex Containers: Fresenius offers sterile cefoxitin solutions compatible with duplex systems, primarily for hospital use across Europe, Americas, and Asia-Pacific.
Dextrose Solutions: Widely available in various concentrations (5%, 10%, 20%) in duplex containers designed for infusion therapy, ensuring stability and ease of use.

Regulatory & Quality Standards:
Fresenius Kabi adheres to cGMP and holds multiple certifications (FDA, EMA, MHRA), ensuring compliance with international standards.

Distribution & Logistics:
Extensive global distribution network, supported by regional manufacturing sites facilitating timely supply.

Intended Markets:
Hospitals and clinics in North America, Europe, Asia-Pacific, Middle East.

2. B. Braun Melsungen AG

Overview:
A leader in infusion therapy and clinical nutrition, B. Braun supplies a broad portfolio including antibiotics and infusion solutions in duplex packaging.

Product Offerings:

Cefoxitin: Available as sterile solutions, often customized for duplex containers in partnership with regional manufacturers.
Dextrose Solutions: Multiple concentrations available, with duplex packaging for stability and safety.

Regulatory & Quality:
Stringent adherence to ISO 13485, FDA approvals, and European CE marking; operates within high-quality standards.

Distribution & Supply Chain:
Global footprint with regional manufacturing units and dedicated logistical channels.

Market Focus:
Hospitals, surgical centers, outpatient clinics worldwide.

3. Baxter International Inc.

Overview:
Baxter is a prominent player in hospital infusion solutions and pharmaceuticals, including antibiotics and carrier solutions.

Product Portfolio:

Cefoxitin: Sourced through partnerships and specialized manufacturing for duplex containers.
Dextrose: Renowned for its extensive range of infusion solutions, available in duplex formats across markets.

Regulatory Standards:
Complies with US FDA, EU CE, and other international standards; specializes in sterile, ready-to-use infusion products.

Logistics & Distribution:
Robust global distribution network supporting timely delivery to hospitals and clinics.

4. Pfizer Inc.

Overview:
While primarily known for pharmaceutical innovation, Pfizer supplies antibiotics including cefoxitin through authorized distributors, often in duplex containers.

Product Focus:

Cefoxitin: Available in multi-dose vials and infusion formats, some tailored in duplex packaging in specific markets.

Distribution Networks:
Extensive worldwide reach, leveraging regional partnerships to serve hospitals and procurement agencies.

Note:
Dextrose solutions are primarily supplied by third-party manufacturers adhering to Pfizer standards.

5. Local and Regional Manufacturers

Apart from global giants, several local manufacturers cater to regional markets, particularly in emerging economies, providing cost-effective duplex container options for cefoxitin and dextrose:

Shanghai United Imaging Healthcare (China)
Serum Institute of India (India)
Biocon (India)

These manufacturers often hold domestic regulatory approvals and, in some cases, FDA or EMA approvals for export.

Regulatory and Quality Considerations

Procurement of duplex container pharmaceuticals mandates rigorous compliance with local and international regulatory bodies, such as the FDA (USA), EMA (Europe), and CDSCO (India). Suppliers must demonstrate adherence to cGMP, validated manufacturing processes, and stability certifications for duplex packaging.

Certification standards and documentation—including batch testing, sterile processing, and stability studies—are critical for ensuring product safety during procurement.

Supply Chain and Logistical Factors

The stability advantages of duplex containers reduce risks associated with drug degradation, making them suitable for widespread distribution, especially in remote or resource-limited settings. Leading suppliers maintain cold chain and temperature-controlled logistics, ensuring product integrity throughout transportation.

Timely procurement depends on supplier inventory, regional manufacturing capacity, and regulatory approvals. Establishing long-term partnerships with certified suppliers mitigates supply disruptions.

Pricing and Cost-Effectiveness

Pricing varies significantly based on geographical location, procurement volume, and contractual agreements. Bulk purchasing and negotiation with global suppliers like Fresenius Kabi or B. Braun yield economies of scale. Additionally, considering local manufacturers in emerging markets may reduce costs but necessitate thorough quality assessments.

Key Considerations for Procurement

Regulatory compliance: Select suppliers with necessary certifications and validated manufacturing processes.
Product compatibility: Confirm duplex container design matches hospital infusion systems.
Supply reliability: Prioritize companies with proven logistics and inventory management.
Cost efficiency: Balance quality assurance with budget constraints; consider long-term contracts.
Local sourcing potential: Evaluate regional manufacturers for cost advantages, bearing in mind quality standards.

Key Takeaways

Leading global suppliers like Fresenius Kabi, B. Braun, and Baxter dominate the market for cefoxitin and dextrose in duplex containers, ensuring adherence to international quality standards.
Regulatory compliance, including cGMP, FDA, and CE certifications, remains vital for safe procurement and use.
Duplex technology enhances drug stability, facilitating safer storage, transportation, and administration across diverse healthcare settings.
Supply chain robustness depends on manufacturers’ logistics capabilities, regional presence, and existing inventory management practices.
Cost considerations warrant a balance between high-quality international suppliers and regional manufacturers, especially in emerging markets.

FAQs

1. How do duplex containers improve the stability of cefoxitin and dextrose formulations?
Duplex containers segregate incompatible components, preventing interactions that can cause degradation or precipitation, thus maintaining drug efficacy over extended storage periods.

2. Are duplex containers suitable for all healthcare settings?
Yes, especially in settings requiring secure, sterile, and stable infusion solutions. However, compatibility with existing infusion equipment should be verified.

3. What regulatory approvals should suppliers possess for international procurement?
Suppliers should hold certifications such as FDA approval (US), EMA CE marking (Europe), and ISO 13485 standards, ensuring compliance with rigorous safety and quality benchmarks.

4. Can regional manufacturers supply duplex containers meeting international standards?
Yes, several regional firms adhere to local and international regulations, offering cost-effective options with appropriate certifications, though due diligence is essential.

5. How can healthcare providers verify the authenticity and quality of duplex container products?
Providers should review batch documentation, certification papers, and perform audits or third-party testing when feasible. Establishing partnerships with reputable suppliers is advisable.

Sources

[1] Fresenius Kabi Product Catalogs, 2022.
[2] B. Braun Group Safety and Quality Standards, 2022.
[3] Baxter International Infusion Solutions Data Sheets, 2022.
[4] Global Regulatory Guidelines for Parenteral Solutions, WHO, 2021.
[5] Market Analysis Reports on Infusion Solutions, 2022.

Suppliers and packagers for CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER