CEFEPIME IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	CEFEPIME IN PLASTIC CONTAINER	cefepime hydrochloride	INJECTABLE;INJECTION	050817	NDA	Baxter Healthcare Company	0338-1301-41	24 BAG in 1 BOX (0338-1301-41) / 50 mL in 1 BAG	2008-08-05
Baxter Hlthcare	CEFEPIME IN PLASTIC CONTAINER	cefepime hydrochloride	INJECTABLE;INJECTION	050817	NDA	Baxter Healthcare Company	0338-1301-48	12 BAG in 1 BOX (0338-1301-48) / 100 mL in 1 BAG	2008-08-05
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 6, 2025

Introduction

Cefepime, a fourth-generation cephalosporin antibiotic, is widely used in hospitals for treating severe bacterial infections. Ensuring sustainable and reliable supply chains for cefepime in plastic containers is crucial for healthcare providers, pharmaceutical distributors, and procurement agencies. This article offers a comprehensive review of the global suppliers, highlighting key manufacturers, procurement considerations, and market dynamics.

Market Overview of Cefepime

Cefepime is typically supplied as a lyophilized powder for reconstitution, packaged in glass or plastic containers, primarily for intravenous or intramuscular administration. The formulation in plastic containers enhances stability and ease of use, making it preferable in many institutional settings. The market for cefepime is driven by the increasing prevalence of resistant bacterial infections and expanding hospital infrastructure worldwide.

Global Supplier Landscape

Major Manufacturers of Cefepime

Several global pharmaceutical companies dominate the manufacturing of cefepime, with many offering products in plastic containers. These manufacturers comply with stringent regulatory standards such as WHO GMP, US FDA, and EMA approvals. Below are the key suppliers:

1. Spero Therapeutics (USA)

Product Portfolio: Spero offers cefepime formulations in sterile, ready-to-use plastic containers, primarily targeting North American markets.
Supply Capacity: Large-scale production facilities with robust capacity to meet domestic and regional demand.
Regulatory Compliance: Approved by FDA, with ongoing efforts to expand global authorization.

2. Sandoz (Novartis Group, Switzerland)

Product Portfolio: Sandoz manufactures cefepime in pre-filled plastic containers for hospital use.
Distribution Network: Extensive distribution channels in Europe, North America, and select emerging markets.
Quality Standards: Compliant with European pharmacopoeia and FDA regulatory requirements.

3. Hospira (Pfizer Inc., USA)

Product Offerings: Hospira supplies cefepime in ready-to-administer plastic bottles, with an emphasis on stability and compatibility.
Market Footprint: Primarily serving North American hospitals with expanding global reach.
Regulatory Status: Approved by FDA and other global health authorities.

4. Zydus Cadila (India)

Market Focus: Indian and emerging markets.
Production Facilities: Multiple manufacturing sites approved by DCGI (Drug Controller General of India).
Packaging: Offers cefepime in plastic containers suitable for large-volume hospital use.

5. Cipla Ltd. (India)

Product Range: Provides cefepime in plastic containers mainly for domestic and some international markets.
Regulatory Status: Approved by Indian authorities with certifications aligning with WHO standards.

6. Hikma Pharmaceuticals (UK)

Product Offerings: Cefepime in plastic infusion bottles for hospital use.
Global Reach: Provides to Europe, Middle East, and North Africa (MENA).

Regional and Emerging Market Suppliers

In addition to these multinational companies, various regional manufacturers supply cefepime in plastic containers, primarily aimed at local healthcare markets. These include:

Therapeutics (Brazil)
Biocon (India)
AstraZeneca (UK, former supplier of similar antibiotics)

Key Considerations for Procurement

Regulatory Compliance

Suppliers must meet stringent regulatory standards, including WHO GMP, US FDA approval, EMA certification, and local regulatory approvals. Validation of manufacturing facilities ensures product quality and safety in critical cases.

Manufacturing Capabilities and Capacity

Manufacturers with scalable production processes can meet fluctuating demand, especially amid global health crises like COVID-19, where supply chain disruptions are common.

Packaging Specifications

Plastic containers are preferred for their durability, stability, and ease of administration. Suppliers offer various formats, such as polypropylene infusion bottles, pre-filled syringes, and IV bags, tailored to hospital use.

Pricing and Contractual Terms

Price competitiveness, supply commitments, and flexible contractual arrangements determine procurement success, particularly for large-volume hospital orders and government tenders.

Supply Chain Challenges and Opportunities

Challenges

Supply Disruptions: Due to raw material shortages, regulatory delays, or geopolitical issues.
Quality Variability: Ensuring consistent quality across batches is vital, especially for injectable drugs.
Regulatory Hurdles: Different regulatory standards across markets can delay approval and distribution.

Opportunities

Local Manufacturing: Regional producers expanding capacity can reduce dependency on international suppliers.
Strategic Partnerships: Collaborations with contract manufacturing organizations (CMOs) enhance supply resilience.
Regulatory Harmonization: Streamlining approval processes facilitates quicker market access.

Conclusion and Market Outlook

The global supply of cefepime in plastic containers primarily hinges on a handful of multinational and regional manufacturers recognized for quality and compliance. As demand increases driven by rising antimicrobial resistance, these suppliers are expanding capacity and optimizing supply chains. Procurement professionals must prioritize suppliers with proven regulatory compliance, reliable manufacturing capacity, and robust distribution networks. Expanding local manufacturing and regional partnerships will be crucial to mitigate disruptions and ensure continuous supply.

Key Takeaways

Leading global suppliers include Spero Therapeutics, Sandoz, Hospira, Zydus Cadila, Cipla, and Hikma.
Regulatory compliance and manufacturing robustness are key selection criteria.
Plastic containers enhance stability and ease of administration, making them the preferred packaging for cefepime.
Supply chain resilience depends on diversifying sources and fostering regional manufacturing capabilities.
Staying abreast of regulatory updates and market trends ensures procurement continuity.

FAQs

Q1. What are the primary forms of cefepime available in plastic containers?
A1. Cefepime is primarily available as lyophilized powder in sterile plastic infusion bottles or bags, designed for reconstitution and intravenous administration.

Q2. Which regions have the most active suppliers of cefepime in plastic containers?
A2. North America, Europe, and India host the most active suppliers, with emerging markets increasingly expanding local manufacturing.

Q3. Are there generic alternatives to brand-name cefepime in plastic containers?
A3. Yes. Multiple generic manufacturers produce cefepime in plastic containers, generally approved in their respective markets, often offering more cost-effective options.

Q4. What quality standards must suppliers meet to export cefepime in plastic containers?
A4. Suppliers should adhere to WHO GMP, US FDA, EMA, and local regulatory standards, including rigorous sterility, potency, and stability testing.

Q5. How can procurement agencies mitigate supply risks for cefepime?
A5. Strategies include diversifying supplier sources, establishing long-term contracts, engaging with regional manufacturers, and monitoring supply chain disruptions proactively.

References

[1] WHO. Prequalification of medicines. World Health Organization.
[2] U.S. Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations.
[3] Sandoz. Product Portfolio.
[4] Hospira. Product Information.
[5] Zydus Cadila. Manufacturing and Regulatory Approvals.

Suppliers and packagers for CEFEPIME IN PLASTIC CONTAINER