CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Samson Medcl	CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER	cefepime hydrochloride	POWDER;INTRAVENOUS	209408	ANDA	SAMSON MEDICAL TECHNOLOGIES LLC	66288-8100-1	1 BAG in 1 BAG (66288-8100-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BAG	2018-10-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 10, 2025

Introduction

Cefepime Hydrochloride, a fourth-generation cephalosporin antibiotic, is widely utilized for treating severe bacterial infections, including pneumonia, urinary tract infections, and skin infections. Its stable formulation in plastic containers facilitates hospital and outpatient intravenous administration. Identifying reliable suppliers for this critical pharmaceutical ingredient and finished product is essential for healthcare providers, pharmaceutical companies, and procurement agencies aiming to ensure consistent supply, regulatory compliance, and cost efficiency.

Market Overview

The global demand for Cefepime Hydrochloride has surged owing to its broad-spectrum activity and high efficacy profile. Major pharmaceutical manufacturing countries like India, China, the United States, and European nations dominate the supply chain. These regions host a mix of multinational corporations, contract manufacturing organizations (CMOs), and regional players offering Cefepime Hydrochloride in various formulations, including sterile powders and ready-to-use solutions stored in plastic containers.

Key Suppliers of Cefepime Hydrochloride in Plastic Containers

1. Major International Pharmaceutical Manufacturers

Leading pharmaceutical manufacturers consistently supplying Cefepime Hydrochloride in plastic containers rely on robust R&D, GMP compliance, and extensive distribution networks to meet global demand.

a. Hospira / Pfizer

Profile: A pioneer in sterile injectables, Hospira (now part of Pfizer) offers Cefepime Hydrochloride in ready-to-use infusion bags and plastic containers.
Supply Focus: Known for high-quality standards, Hospira delivers pre-filled and sterile multi-dose containers suitable for hospital use.
Certifications: GMP, ISO, and WHO prequalification certifications ensure global compliance.

b. Fresenius Kabi

Profile: Global leader offering a range of injectable antibiotics, including Cefepime Hydrochloride, chiefly in plastic containers.
Features: Emphasizes stability, sterility, and compatibility with infusion systems.

c. S.C. Johnson & Johnson / McGuff

Profile: Manufactures sterile injectable products, including Cefepime Hydrochloride in pre-filled or bulk containers for hospitals and pharmacies.
Distribution: Wide global footprint with availability in multiple regions.

2. Regional and Contract Manufacturers

These include CMOs and regional pharma companies adept at producing Cefepime Hydrochloride in plastic packaging, often catering to local markets or contract outsourcing.

a. Cipla Limited (India)

Profile: Indian pharmaceutical giant producing Cefepime Hydrochloride as part of its injectable range.
Packaging: Offers in plastic vials and containers tailored for hospital use.

b. Cadila Healthcare (Zydus Cadila) (India)

Profile: Supplies cefepime formulations in plastic containers, with a focus on affordability and regulatory compliance.

c. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

Profile: Expands manufacturing capabilities to include Cefepime Hydrochloride with plastic container packaging, catering to Asia and global exports.

d. Mylan / Viatris

Profile: Offers Cefepime Hydrochloride in plastic bottles as part of their injectable portfolio.
Notes: Their manufacturing standards align with international norms, including FDA and WHO certifications.

Regulatory and Quality Considerations

For procurement, adherence to regulatory requirements such as FDA approval, EU GMP standards, and WHO prequalification is paramount. Many suppliers cache their credibility through certifications, audit reports, and consistent quality controls. The presence of stability data and compatibility with infusion systems in plastic containers further influences supplier choice.

Emerging Suppliers and Market Trends

Emerging markets continue to grow with local manufacturing capabilities. Governments and organizations promoting generic medicines expect increased capacity from regional producers. Additionally, the shift toward ready-to-use solutions favors suppliers with advanced fill-finish facilities equipped for plastic container output.

Innovations like single-dose pre-filled plastic syringes and multi-dose infusion bags are also expanding supplier portfolios, offering convenience and safety advantages.

Supply Chain Considerations

Packaging Type: Plastic containers, such as polypropylene infusion bags, vials, or bottles, are preferred for stability, ease of handling, and compatibility.
Supply Stability: Long-term agreements with GMP-compliant manufacturers mitigate risks of shortages.
Cost Factors: Regional manufacturers often provide cost-effective options, though quality and compliance are critical.
Lead Times: Larger companies typically maintain higher inventories and faster dispatch, vital for urgent medical needs.

Conclusion

The supplier landscape for Cefepime Hydrochloride in plastic containers is diverse, encompassing global pharmaceutical giants, regional manufacturers, and CMOs. Leading industry players such as Pfizer/Hospira, Fresenius Kabi, and Johnson & Johnson dominate the market with high-quality standards and extensive distribution channels. Regional suppliers like Cipla, Zydus Cadila, and Zhejiang Hisun provide alternative sources, often at competitive prices.

Healthcare providers must prioritize suppliers with rigorous quality certifications, proven stability data, and reliable supply chains to ensure optimal patient care.

Key Takeaways

Global giants like Pfizer and Fresenius Kabi are reliable primary suppliers of Cefepime Hydrochloride in plastic containers, meeting international standards.
Regional manufacturers serve local markets effectively, often providing cost-effective options with appropriate certifications.
Regulatory compliance (GMP, FDA, WHO prequalification) is critical in supplier selection to ensure safety and efficacy.
Packaging innovation favors pre-filled and multi-dose plastic containers, enhancing safety and convenience.
Supply chain resilience depends on long-term agreements and diversified sourcing strategies to prevent shortages.

FAQs

1. What are the main factors to consider when sourcing Cefepime Hydrochloride in plastic containers?
Quality certifications, regulatory approvals, packaging stability, supply reliability, and cost efficiency.

2. Are regional suppliers as reliable as multinational corporations for Cefepime Hydrochloride?
Many regional suppliers meet international good manufacturing practices, but thorough qualification and certification verification are essential.

3. How does packaging in plastic containers benefit Cefepime Hydrochloride?
Plastic containers offer stability, ease of administration, compatibility with infusion systems, and reduced contamination risk.

4. What are the typical certifications to look for in suppliers?
GMP compliance, FDA approval, CE marking, WHO prequalification, and ISO certifications.

5. How can procurement professionals mitigate supply disruptions for Cefepime Hydrochloride?
By establishing relationships with multiple certified suppliers, maintaining safety stocks, and regularly auditing supply chain performance.

Sources:

[1] Industry reports on pharmaceutical manufacturing, 2022.
[2] World Health Organization Prequalification Program.
[3] FDA and EMA product registries.
[4] Company websites of Pfizer, Fresenius Kabi, Cipla, Zydus Cadila, Zhejiang Hisun, Mylan.

Suppliers and packagers for CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER