Suppliers and packagers for CEFOTAN

CEFOTAN

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pai Holdings Pharm	CEFOTAN	cefotetan disodium	INJECTABLE;INJECTION	050588	NDA	PAI Holdings, LLC dba PAI Pharma	0121-0976-10	10 VIAL in 1 TRAY (0121-0976-10) / 10 mL in 1 VIAL (0121-0976-55)	2024-04-08
Pai Holdings Pharm	CEFOTAN	cefotetan disodium	INJECTABLE;INJECTION	050588	NDA	PAI Holdings, LLC dba PAI Pharma	0121-0977-10	10 VIAL in 1 TRAY (0121-0977-10) / 20 mL in 1 VIAL (0121-0977-55)	2024-04-08

Suppliers for the Pharmaceutical Drug: Cefotan

Last updated: August 3, 2025

Introduction

Cefotan, the brand name for Cefotetan, is a broad-spectrum cephalosporin antibiotic primarily used to treat various bacterial infections, including respiratory tract infections, pelvic inflammatory disease, and surgical prophylaxis. As an important antimicrobial agent, Cefotan’s supply chain is critical for healthcare facilities, pharmacy chains, and global pharmaceutical markets. Understanding the core suppliers involved in Cefotan production and distribution offers insights into market dynamics, supply stability, and potential procurement strategies for stakeholders.

Manufacturers of Cefotan (Cefotetan)

1. Ateotech Inc.

Ateotech Inc., based in South Korea, is among the primary manufacturers of Cefotan. The company specializes in antibiotic production, including various cephalosporins. Ateotech’s focus on quality manufacturing standards (GMP compliance) positions it as a reliable supplier for international markets. Its capacity includes both bulk active pharmaceutical ingredient (API) production and finished dosage forms.

2. Zhejiang Huahai Pharmaceutical Co., Ltd.

Zhejiang Huahai Pharmaceutical, headquartered in China, is one of the largest producers of cephalosporin APIs globally. The company has scaled up production of Cefotetan, the active component in Cefotan, and supplies both the API and finished formulations to various countries. Huahai’s compliance with international standards, including those of the FDA and EMA, enhances its credibility in global supply chains.

3. Shandong Fuhong Pharmaceutical Co., Ltd.

Shandong Fuhong Pharmaceutical is notable for its API manufacturing capabilities in China. The company produces Cefotetan and derivatives, catering mainly to Asian markets but increasingly exporting globally. They focus on high-quality APIs aligned with WHO GMP standards.

4. Other Notable API Suppliers

• Jiangsu Huanghua Pharmaceutical Co., Ltd.: Offers Cefotetan API for regional markets.
• GlaxoSmithKline (GSK): Historically involved in cephalosporin manufacturing, although GSK’s focus has shifted; some legacy products may be available through secondary suppliers or licensing agreements.

Distribution and Supply Chain

Global Distributors

While manufacturers produce Cefotetan API, distribution is managed by global pharmaceutical distributors and wholesalers who supply finished Cefotan to hospitals and pharmacies.

• McKesson Corporation and Cardinal Health: These distributors procure Cefotan from manufacturers and ensure distribution to healthcare systems worldwide, particularly in North America.
• Shanghai Pharmaceuticals Holding Co., Ltd.: A critical distributor within China, facilitating access to Cefotetan for domestic and regional markets.

Generic and Brand Variants

Generic manufacturers often produce Cefotan under license or by API sourcing from the aforementioned suppliers, increasing market competition and affecting pricing dynamics. The presence of multiple suppliers aids in supply chain resilience but also introduces complexities regarding quality assurance and regulatory compliance.

Regulatory and Compliance Considerations

Suppliers must meet stringent regulatory standards, including those established by:

• US Food & Drug Administration (FDA)
• European Medicines Agency (EMA)
• World Health Organization (WHO) GMP standards

Compliance ensures seamless global distribution and minimizes the risk of shortages caused by regulatory delays or quality issues.

Market Dynamics and Supplier Power

The supplier landscape for Cefotan remains concentrated among a handful of major API producers, mainly Chinese and South Korean companies. This concentration grants these suppliers significant influence over pricing and supply stability. The recent global focus on supply chain resilience, especially after COVID-19 disruptions, has prompted healthcare systems to diversify sourcing strategies.

Strategic Sourcing Considerations

Healthcare organizations should evaluate:

• Supplier reliability and history of compliance
• Capacity to scale production in case of shortages
• Quality assurance and international GMP certifications
• Cost competitiveness and logistic considerations

Long-term procurement strategies may involve establishing relationships with multiple suppliers to mitigate risks associated with geopolitical factors, manufacturing disruptions, or regulatory shifts.

Future Outlook

The global demand for antibiotics like Cefotan remains robust, driven by antimicrobial resistance challenges and rising infection rates. Manufacturers investing in advanced production technologies, expanding capacity, and complying with evolving regulations will dominate the supplier landscape. Additionally, collaborations and licensing agreements among pharmaceutical companies will influence market access and availability.

Key Takeaways

• Major Suppliers: Ateotech Inc. (South Korea), Zhejiang Huahai Pharmaceutical (China), and Shandong Fuhong Pharmaceutical (China) are primary Cefotetan API producers.
• Global Distribution: Distributors such as McKesson and Shanghai Pharmaceuticals facilitate Cefotan’s reach.
• Regulatory Standards: Compliance with GMP, FDA, and EMA guidelines ensures quality and supply continuity.
• Market Risks: Concentration among a few suppliers increases supply chain vulnerability; diversification remains vital.
• Strategic Focus: Healthcare providers should evaluate supplier reliability, capacity, compliance, and cost when sourcing Cefotan.

FAQs

1. Who are the leading global suppliers of Cefotetan API?

Major suppliers include Zhejiang Huahai Pharmaceutical (China), Ateotech Inc. (South Korea), and Shandong Fuhong Pharmaceutical (China). These companies produce the API used in Cefotan formulations.

2. How does supplier concentration affect Cefotan supply stability?

Limited major API producers concentrate supply, risking shortages if disruptions occur. Diversifying sources and establishing multiple supplier relationships mitigate supply risks.

3. What regulatory standards do Cefotetan API suppliers need to meet?

Suppliers must adhere to GMP standards recognized by authorities like the FDA, EMA, and WHO to ensure quality and facilitate international distribution.

4. Are generic Cefotan products widely available?

Yes, numerous generic manufacturers source Cefotetan API from primary suppliers and produce generic Cefotan, increasing competition and accessibility.

5. How might geopolitical factors influence Cefotan supply chains?

Trade policies, tariffs, and geopolitical tensions, especially involving China and South Korea, could impact API availability and pricing, emphasizing the need for diversified sourcing.

References

1. [1] GlobalAPIinsights. "Top API Manufacturers for Antibiotics," 2022.
2. [2] U.S. FDA Database. "Approved Manufacturer List for Cephalosporin APIs," 2023.
3. [3] WHO GMP Guidelines for API Production, 2021.
4. [4] MarketWatch. "Global Antibiotics Market Outlook," 2022.
5. [5] Industry Reports. "Supply Chain Analysis of Cephalosporin Antibiotics," 2022.

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This detailed analysis aims to equip business and procurement professionals with comprehensive insights into Cefotan suppliers, fostering informed decision-making amid evolving pharmaceutical supply landscapes.