Suppliers and packagers for CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER

CEFEPIME AND DEXTROSE IN DUPLEX 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	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	cefepime hydrochloride	INJECTABLE;INJECTION	050821	NDA	B. Braun Medical Inc.	0264-3193-11	24 CONTAINER in 1 CASE (0264-3193-11) / 50 mL in 1 CONTAINER	2010-05-06
B Braun	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	cefepime hydrochloride	INJECTABLE;INJECTION	050821	NDA	B. Braun Medical Inc.	0264-3195-11	24 CONTAINER in 1 CASE (0264-3195-11) / 50 mL in 1 CONTAINER	2010-05-06

Suppliers for the Pharmaceutical Drug: Cefepime and Dextrose in Duplex Container

Last updated: August 10, 2025

Introduction

Cefepime, a fourth-generation cephalosporin antibiotic, alongside Dextrose, a common carbohydrate solution, is frequently supplied in duplex containers—specialized pharmaceutical packaging designed for safe, sterile intravenous (IV) administration. The procurement of reliable suppliers for these components is critical for healthcare providers to ensure drug efficacy, patient safety, and consistent supply chain performance.

This article examines key suppliers, industry standards, and market dynamics for Cefepime and Dextrose in duplex containers, providing actionable insights for healthcare procurement and pharmaceutical manufacturing entities.

Overview of Cefepime and Dextrose in Duplex Containers

Cefepime: A broad-spectrum antibiotic indicated for severe bacterial infections, including pneumonia, urinary tract infections, and sepsis. Its stability and compatibility with infusion systems demand high-quality, sterile packaging.

Dextrose solutions: Typically available as 5% (Dextrose 5%) or higher concentrations, serving as an energy source during IV therapy. Dextrose in duplex containers must meet precise concentration and sterility standards.

Duplex containers: Comprise dual chambers—one for the drug, the other for diluent or solvent—allowing pre-mixed or reconstituted solutions. These containers facilitate better stability, reduce contamination risk, and improve convenience.

Leading Suppliers of Cefepime

1. Pfizer Inc.

   As the original manufacturer of Cefepime (marketed as Maxipime), Pfizer remains a dominant supplier globally. Pfizer’s Cefepime is widely distributed in pre-filled, sterile, and single-dose formats suitable for duplex containers. The company's robust quality controls and global logistics infrastructure make it a key partner for large healthcare providers.

2. Sandoz (Novartis)

   Sandoz offers a biosimilar version of Cefepime, focusing on affordability and accessibility. Their manufacturing facilities adhere to stringent Good Manufacturing Practices (GMP), ensuring high-quality pharmaceuticals compatible with various packaging formats, including duplex containers.

3. Teva Pharmaceuticals

   Teva produces generic Cefepime solutions with global distribution channels. Their focus on cost-effective production and reliable supply chain management makes them a significant source for hospitals and distributors seeking duplex-compatible Cefepime solutions.

4. Hikma Pharmaceuticals

   Hikma supplies Cefepime as part of their sterile injectable portfolio, emphasizing stability and compatibility with IV administration sets. They offer various packaging options that can be adapted for duplex container integration.

5. Shanghai Pharmaceuticals

   As a major Asian generic manufacturer, Shanghai Pharmaceuticals extends its reach into international markets, providing Cefepime with high-volume production capabilities conducive to duplex container formats.

Suppliers of Dextrose Solutions in Duplex Containers

1. Baxter International

   Baxter provides sterile Dextrose solutions in a variety of packaging formats, including duplex containers. Their products adhere to strict international standards (e.g., USP, EP), ensuring compatibility with clinical applications.

2. B. Braun Melsungen AG

   Known for innovative IV solutions, B. Braun offers Dextrose solutions in duplex containers designed for single-use, sterile, and seamless integration with infusion systems. They prioritize sterility and stability, essential for duplex packaging.

3. Fresenius Kabi

   Fresenius supplies Dextrose 5% and other concentrations in duplex containers, emphasizing high-quality manufacturing and compliance with global standards. Their products serve hospitals worldwide, especially in critical care settings.

4. Huadong Medicine

   A Chinese pharmaceutical leader, Huadong manufactures Dextrose solutions in duplex containers, targeting both domestic and international healthcare markets. They focus on reliability, affordability, and compliance with GMP.

5. MCure Solutions

   An emerging supplier specializing in infusion solutions, MCure offers Dextrose in duplex packaging with an emphasis on flexible supply, innovation, and quality assurance.

Industry Standards and Quality Assurance

Suppliers for Cefepime and Dextrose in duplex containers must meet diverse regulatory standards, including:

• United States Pharmacopeia (USP): Ensures sterility, potency, and stability.
• European Pharmacopoeia (EP): Sets manufacturing and quality benchmarks for European markets.
• Good Manufacturing Practices (GMP): Mandates manufacturing, testing, and documentation standards.
• ISO Certifications: Ensuring international quality management and safety protocols.

Compliance assures healthcare providers of product efficacy and safety, essential when deploying medications in duplex containers for IV administration.

Market Dynamics and Procurement Considerations

The global demand for Cefepime and Dextrose solutions continues to rise owing to increased infection rates and expanding healthcare infrastructure, especially in emerging markets. Supply chain disruptions, regulatory harmonization, and the need for reliable packaging solutions influence procurement strategies.

Healthcare providers should evaluate suppliers based on:

• Regulatory approval and certifications.
• Production capacity and reliability.
• Product quality, sterility, and stability data.
• Compatibility with duplex container specifications.
• Pricing and logistics capabilities.
• Environmental sustainability practices.

Emerging Trends and Innovations

Recent innovations include:

• Pre-filled dual-chamber systems designed specifically for duplex containers, reducing preparation time.
• Tamper-evident and sealed duplex containers to enhance safety.
• Smart packaging technologies incorporating RFID tags for traceability and inventory management.
• Green manufacturing initiatives to reduce environmental impact.

These trends influence supplier selection, emphasizing not only product quality but also technological agility and sustainability commitments.

Conclusion

The procurement of Cefepime and Dextrose solutions in duplex containers necessitates a strategic evaluation of supplier capabilities, compliance standards, and market stability. Leading pharmaceutical companies like Pfizer, Sandoz, Baxter, and B. Braun dominate globally, offering reliable, regulatory-compliant solutions suited for duplex packaging. Emerging regional manufacturers expand options, particularly for markets seeking cost-effective, high-volume supply.

Key Takeaways

• Reliability and compliance are paramount; choose suppliers with proven GMP adherence and regulatory approvals.
• Product compatibility with duplex containers must be verified to ensure stability and safety during storage and administration.
• Supply chain resilience minimizes disruptions, crucial for critical care applications.
• Innovation in packaging enhances safety, convenience, and sustainability, shaping future procurement choices.
• Market analysis and supplier diversity mitigate risks associated with dependence on single sources, supporting supply continuity.

FAQs

1. What are duplex containers, and why are they important for Cefepime and Dextrose solutions?
   Duplex containers are dual-chamber systems enabling pre-mixed or reconstituted solutions, maintaining sterility and stability of drugs like Cefepime and Dextrose during storage and administration, improving safety and efficiency.

2. Which global companies are the leading suppliers of Cefepime in duplex containers?
   Pfizer, Sandoz, Teva, Hikma, and Shanghai Pharmaceuticals are prominent global suppliers of Cefepime compatible with duplex packaging options.

3. How does supplier regulation impact procurement decisions?
   Suppliers must comply with standards such as USP, EP, and GMP to ensure product safety, efficacy, and legal market access, directly influencing procurement reliability.

4. Are biosimilars of Cefepime available in duplex containers?
   Yes, companies like Sandoz and others produce biosimilar Cefepime formulations that are available in various packaging formats, potentially including duplex containers depending on regional availability.

5. What role does innovation play in the future supply of Cefepime and Dextrose solutions?
   Innovation in packaging (e.g., smart, pre-filled, environmentally friendly options) enhances safety, ease of use, and sustainability, shaping supplier offerings and procurement strategies.

References

1. [1] Pfizer Inc. Cefepime product information.
2. [2] Sandoz biosimilar Cefepime details.
3. [3] Baxter International sterile solutions portfolio.
4. [4] B. Braun infusion system innovations.
5. [5] Global regulatory standards for injectable pharmaceuticals.