Bulk Pharmaceutical API Sources for CEFAZOLIN SODIUM

Bulk Pharmaceutical API Sources for CEFAZOLIN SODIUM

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C5020_SIGMA
Molport		MolPort-002-510-626
Hangzhou APIChem Technology		AC-13166
TimTec		ST024775
AKos Consulting & Solutions		AKOS015895533
AstaTech, Inc.		44015
Finetech Industry Limited		FT-0623529

Bulk Active Pharmaceutical Ingredient (API) Sources for: Cefazolin Sodium

Last updated: July 29, 2025

Introduction

Cefazolin sodium, a first-generation cephalosporin antibiotic, remains a cornerstone in treating various bacterial infections, including respiratory tract infections, skin infections, and surgical prophylaxis. As a pivotal component in injectable formulations, the supply of high-quality cefazolin sodium API is critical to ensure consistent drug efficacy, regulatory compliance, and supply chain stability. This report explores primary sources of bulk cefazolin sodium API, emphasizing manufacturing regions, key suppliers, quality standards, and strategic procurement considerations.

Global Market Overview and Manufacturing Trends

The global cefazolin sodium API market has experienced steady growth driven by the rising prevalence of surgical procedures and antibiotic-resistant bacterial infections. Major manufacturing hubs include China, India, and Europe, with a growing number of suppliers adhering to stringent quality regulations such as the US FDA, EMA, and WHO-GMP standards.

Chinese and Indian manufacturers dominate the production landscape due to lower manufacturing costs, robust pharmaceutical infrastructure, and government initiatives supporting API export growth. European manufacturers, though fewer, often focus on high-margin, high-quality APIs aligned with strict regulatory requirements.

Leading API Manufacturers and Suppliers

1. Chinese Manufacturers

   • North China Pharmaceutical Group Corporation (NCPC): A significant producer with comprehensive WHO-GMP certification, NCPC supplies cefazolin sodium APIs to global markets. They have invested in advanced synthesis technologies and quality control systems ([1]).

   • Hefei CHUANGYI Pharmaceutical Co., Ltd.: Specializing in cephalosporin APIs, CHUANGYI offers cefazolin sodium API with rigorous quality assurance programs, complying with international regulatory standards ([2]).

   • Zhejiang Hisun Pharmaceutical Co., Ltd.: Known for producing bulk antibiotics, including cephalosporins, with stringent process controls and stable supply chains.

2. Indian Manufacturers

   • Aurobindo Pharma Ltd.: Among India's top API producers, Aurobindo offers cefazolin sodium API manufactured under cGMP compliant facilities, with extensive regulatory approvals ([3]).

   • Sun Pharmaceutical Industries Ltd.: Enters the cefazolin sodium API market through contracts and subsidiaries, maintaining quality standards compliant with US and European regulations ([4]).

   • Glenmark Pharmaceuticals: Known for quality assurance and global certification adherence, Gelnark supplies cefazolin sodium APIs globally.

3. European and U.S. Suppliers

While European and US-based manufacturers primarily focus on finished formulations, some APIs are produced domestically or via partnerships. For example:

• Siegfried AG: A Swiss API manufacturer that supplies cephalosporin APIs, including cefazolin sodium, with a focus on high-quality standards.

• Nexgen Pharma (USA): Provides pharmaceutical-grade APIs and intermediates, including cephalosporin compounds, meeting all requisite regulatory standards.

Regulatory and Quality Considerations

Suppliers must meet comprehensive regulatory standards, including:

• Current Good Manufacturing Practices (cGMP): Ensures consistent quality, purity, and potency.

• WHO-GMP Certification: Facilitates international export and acceptance in emerging markets.

• USP/EP/JP Compliance: Regulatory standards for APIs in the US, Europe, and Japan.

• Batch-To-Batch Consistency and Raw Material Traceability: Critical for maintaining API quality and regulatory approval.

Supply Chain and Strategic Sourcing

Given geopolitical factors and regulatory requirements, diversification of API sources is advisable. Key strategies include:

• Establishing long-term contracts with certified suppliers.

• Ensuring supplier audits and documentation of quality systems.

• Monitoring regulatory updates impacting API imports.

• Considering regional manufacturing hubs to mitigate supply disruptions, especially post-pandemic supply chain vulnerabilities.

Emerging Trends and Future Outlook

The API manufacturing industry is witnessing:

• Technological advancements: Continuous flow synthesis and biocatalysis enhance yield and purity.

• Regulatory harmonization: Increasing global standards simplify cross-border sourcing.

• Sustainability initiatives: Emphasizing greener manufacturing practices reduces environmental impact.

• Potential biosimilar and generic competitors: Expanding market options but emphasizing quality and regulatory compliance.

Summary of Major API Suppliers

Manufacturer	Region	Certifications	Focus	Remarks
NCPC	China	WHO-GMP, cGMP	Cephalosporin APIs	Cost-effective, high-volume
Aurobindo Pharma	India	US FDA, EMA	Cephalosporin APIs	Reliable, extensive quality control
Hefei CHUANGYI	China	WHO-GMP	Cephalosporin APIs	Innovative synthesis methods
Siegfried AG	Switzerland	GMP	Cephalosporin APIs	High purity, niche applications

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Key Takeaways

• China and India remain dominant in cefazolin sodium API production, offering cost-effective and regulation-compliant options.

• Quality standards and certifications (WHO-GMP, cGMP, USP, EP) are essential criteria for supplier selection to ensure regulatory approval and product integrity.

• Diversification of supply sources enhances supply security amidst geopolitical and pandemic-related disruptions.

• Technological advancements in synthesis and environmental sustainability are shaping the future of cefazolin sodium API manufacturing.

• Regulatory compliance and documentation are critical components in establishing and maintaining supplier relationships.

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FAQs

1. What are the primary regions producing cefazolin sodium API?
The main manufacturing regions are China, India, and Europe, with China and India leading in volume and cost advantages, and Europe focusing on high-quality, regulated supply.

2. How do I verify the quality of cefazolin sodium API from international suppliers?
Verify certifications such as WHO-GMP, cGMP, USP, or EP compliance. Conduct supplier audits, request batch documentation and analytical data, and review regulatory approval status in target markets.

3. What are the risks associated with sourcing cefazolin sodium API from emerging markets?
Risks include variability in quality standards, geopolitical issues, regulatory uncertainties, and supply chain disruptions. Due diligence and strict quality assurance processes are essential.

4. How is the cefazolin sodium API market evolving?
Advancements in synthetic processes, stricter regulatory frameworks, environmentally sustainable manufacturing, and growing generic production are key trends influencing market dynamics.

5. What considerations should pharmaceutical companies keep in mind when sourcing cefazolin sodium API?
Focus on supplier certification, compliance with international standards, supply stability, manufacturing capacity, technological capabilities, and adherence to environmental and safety regulations.

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References

[1] North China Pharmaceutical Group Corporation (NCPC). Official website and certifications.
[2] Hefei CHUANGYI Pharmaceutical Co., Ltd. Product dossiers and certifications.
[3] Aurobindo Pharma Ltd. Regulatory filings and API manufacturing standards.
[4] Sun Pharmaceutical Industries Ltd. API sourcing and quality assurance reports.