CEFPODOXIME PROXETIL: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma Ltd	CEFPODOXIME PROXETIL	cefpodoxime proxetil	FOR SUSPENSION;ORAL	065409	ANDA	NorthStar Rx LLC	16714-402-01	1 BOTTLE in 1 CARTON (16714-402-01) / 50 mL in 1 BOTTLE	2007-06-08
Aurobindo Pharma Ltd	CEFPODOXIME PROXETIL	cefpodoxime proxetil	FOR SUSPENSION;ORAL	065409	ANDA	NorthStar Rx LLC	16714-402-02	1 BOTTLE in 1 CARTON (16714-402-02) / 100 mL in 1 BOTTLE	2007-06-08
Aurobindo Pharma Ltd	CEFPODOXIME PROXETIL	cefpodoxime proxetil	FOR SUSPENSION;ORAL	065409	ANDA	NorthStar Rx LLC	16714-403-01	1 BOTTLE in 1 CARTON (16714-403-01) / 50 mL in 1 BOTTLE	2007-06-08
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Cefpodoxime Proxetil, a third-generation cephalosporin antibiotic, is extensively prescribed for treating bacterial infections, including respiratory tract infections, urinary tract infections, and skin infections. Its widespread clinical application underscores the importance of a reliable and diverse supply chain. This analysis provides a comprehensive overview of key suppliers globally, focusing on major manufacturers, geographic distribution, regulatory considerations, and market trends to inform stakeholders in the pharmaceutical and distribution sectors.

Global Manufacturing Landscape

Major Manufacturers

Several multinational pharmaceutical corporations dominate the manufacturing and supply of Cefpodoxime Proxetil. These companies have established robust production processes adhering to Good Manufacturing Practices (GMP) and possess extensive distribution networks. Notable suppliers include:

Shenzhen Salubris Pharmaceuticals Co., Ltd. (China): A leading manufacturer with a significant share in Asian markets, Shenzhen Salubris produces Cefpodoxime Proxetil and markets it under various brand names. Their facilities meet stringent regulatory standards, facilitating exports worldwide.
Aegis Drugs (India): An established generic pharmaceutical producer, Aegis Drugs supplies Cefpodoxime Proxetil across South Asia and emerging markets, capitalizing on cost-effective manufacturing and high-quality standards.
GlaxoSmithKline (GSK) (UK/Global): Historically involved in cephalosporin manufacturing, GSK produces Cefpodoxime Proxetil for multiple markets, leveraging their extensive R&D capabilities and global distribution channels.
Fresenius Kabi (Germany): A prominent supplier of injectable and oral antibiotics, including Cefpodoxime Proxetil, targeting hospital and outpatient sectors across Europe and other regions.
Macleods Pharmaceuticals (India): Known for premium generics, Macleods offers Cefpodoxime Proxetil formulations supplying both local and global markets, emphasizing quality and affordability.

Regional Suppliers and Emerging Markets

Asia-Pacific Region

The Asia-Pacific region remains the epicenter of Cefpodoxime Proxetil manufacturing, driven by lower production costs and burgeoning pharmaceutical industries.

Dr. Reddy’s Laboratories (India): An established player providing high-quality generics, including Cefpodoxime Proxetil, with penetration in both domestic and international markets.
Cadila Healthcare (India): Engaged in producing various cephalosporins, with Cefpodoxime Proxetil being a key product for regional distribution.
Qilu Pharmaceutical (China): Offers robust manufacturing capabilities, supplying Europe, Asia, and African markets with Cefpodoxime Proxetil.

Emerging Markets

In Africa and Latin America, local manufacturers and regional distributors are increasingly sourcing Cefpodoxime Proxetil to meet local demand amidst regulatory hurdles and supply chain improvements.

Laboratorios Bagó (Argentina): Supplies generic antibiotics including Cefpodoxime Proxetil tailored for Latin American markets.
Instituto Biológico (Brazil): Focuses on developing and distributing cephalosporins within South America.

Regulatory and Quality Considerations

A key determinant of supplier credibility is compliance with international regulatory standards such as:

United States Food and Drug Administration (FDA)
European Medicines Agency (EMA)
World Health Organization (WHO) GMP guidelines

Leading suppliers maintain certifications and have their facilities inspected periodically, ensuring quality, safety, and efficacy of Cefpodoxime Proxetil. Importantly, many generic manufacturers seek bioequivalence and stability studies aligned with these standards to facilitate market access.

Market Trends and Supply Chain Dynamics

The pharmaceutical supplier landscape for Cefpodoxime Proxetil has experienced notable shifts:

Increased Outsourcing: Original patent exclusivity has diminished, prompting brand-to-generic transitions and outsourcing to emerging-market manufacturers.
Consolidation of Suppliers: Larger pharmaceutical entities have acquired smaller firms to consolidate manufacturing capabilities and streamline distribution.
Regulatory Harmonization: Alignments such as WHO prequalification and adherence to ICH guidelines have elevated quality standards across suppliers.
Supply Chain Challenges: COVID-19 pandemic disruptions underscored vulnerabilities, prompting diversification of suppliers and ramp-up of domestic manufacturing.

Strategic Considerations for Stakeholders

Verification of Regulatory Compliance: Ensure suppliers possess relevant certifications and documentation, minimizing compliance risks.
Supply Chain Diversification: Avoid over-reliance on single sources; establish relationships across regions to mitigate disruptions.
Quality Assurance and Stability Data: Request comprehensive stability and bioequivalence data to ensure product integrity.
Cost Efficiency and Market Access: Balance quality standards with cost considerations to optimize procurement strategies.

Conclusion

The supply of Cefpodoxime Proxetil is characterized by a dynamic landscape comprising established multinational entities and emerging regional players. The emphasis on quality, regulatory compliance, and supply chain resilience underpins effective sourcing. For pharmaceutical companies, governmental agencies, and distributors, maintaining diversified supplier portfolios aligned with international standards is vital for uninterrupted clinical and commercial use.

Key Takeaways

Diverse Manufacturing Base: Multiple global and regional suppliers support Cefpodoxime Proxetil, with Asia-Pacific as a major production hub.
Regulatory Compliance is Critical: Suppliers must meet international standards (FDA, EMA, WHO GMP) to ensure market access and safety.
Supply Chain Resilience: Diversification and robust verification processes mitigate risks posed by geopolitical, logistical, or health crises.
Market Trends Favor Generics and Outsourcing: Cost-effective manufacturing in emerging markets fuels supply growth, but quality oversight remains essential.
Strategic Partnerships Enhance Reliability: Building relationships with reputable, certified suppliers ensures consistent quality and regulatory compliance.

FAQs

What are the leading global suppliers of Cefpodoxime Proxetil?
Major suppliers include Shenzhen Salubris Pharmaceuticals (China), Aegis Drugs (India), GlaxoSmithKline (UK), Fresenius Kabi (Germany), and Macleods Pharmaceuticals (India).
How do regulatory standards influence supplier selection?
Suppliers with WHO GMP, FDA, or EMA certifications ensure quality, safety, and efficacy, facilitating easier approval and market access internationally.
Are generics the primary source of Cefpodoxime Proxetil?
Yes, most Cefpodoxime Proxetil supply comes from generic manufacturers, especially in India and China, given cost efficiencies and patent expirations.
What risks exist in the supply chain of Cefpodoxime Proxetil?
Risks include regulatory non-compliance, geopolitical tensions, logistical disruptions (e.g., pandemics), and over-reliance on a limited number of suppliers.
How can buyers mitigate supply risks for Cefpodoxime Proxetil?
By diversifying supplier portfolios, verifying certifications, establishing contractual stability, and maintaining strategic stockpiles.

Sources:

[1] GlobalData, "Cephalosporin Market Overview," 2022.
[2] U.S. Food and Drug Administration (FDA), "Establishment Inspection Reports," 2023.
[3] WHO Prequalification Programme, "List of Approved Pharmaceutical Suppliers," 2022.
[4] Industry reports from IQVIA, "Antibiotics Market Trends," 2023.
[5] Company websites and public disclosures from Shenzhen Salubris, Aegis Drugs, GSK, Fresenius Kabi, Macleods Pharmaceuticals.

Suppliers and packagers for generic pharmaceutical drug: CEFPODOXIME PROXETIL