Bulk Pharmaceutical API Sources for cefmetazole sodium

Bulk Pharmaceutical API Sources for cefmetazole sodium

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C6048_SIGMA
NovoSeek		23666711
MolPort		MolPort-006-823-792
ChemMol		49424872
Amadis Chemical		A831179
TimTec		ST51014954
AK Scientific, Inc. (AKSCI)		67738

Bulk Active Pharmaceutical Ingredient (API) Sources for Cefmetazole Sodium

Last updated: August 8, 2025

Introduction

Cefmetazole sodium is a cephalosporin antibiotic used primarily in the treatment of bacterial infections. As a vital component in formulating intravenous and oral antibiotics, aseptic procurement of high-quality cefmetazole sodium API is critical. This article provides a comprehensive analysis of global API sourcing options, focusing on manufacturers, geographical trends, quality standards, and supply chain considerations critical for pharmaceutical enterprises seeking reliable procurement channels.

Overview of Cefmetazole Sodium API

Cefmetazole sodium belongs to the third-generation cephalosporins, characterized by a broad spectrum of activity against Gram-negative bacteria, including resistant strains [1]. The API’s manufacturing process demands strict control, with specific emphasis on ensuring chemical purity, microbial limits, residual solvents, endotoxin levels, and adherence to regulatory standards, including USP, EP, and Ph. Eur.

Global API Manufacturing Landscape

Major API Manufacturers

Several pharmaceutical API manufacturers produce cefmetazole sodium globally, with key participants spanning Asia, Europe, and North America. The supply landscape is dominated by both large-scale, integrated pharmaceutical firms and specialized API developers.

Asian Suppliers

• China: China leads global cefmetazole sodium API production, with numerous GMP-certified manufacturers offering competitively priced options. Companies such as North China Pharmaceutical Group Corporation (NCPC) and Sichuan Kelun Pharmaceutical have reported producing high-grade cefmetazole sodium API, emphasizing cost efficiency and extensive export capabilities [2].

• India: Indian pharmaceutical giants like Sun Pharmaceutical Industries Ltd., Aurobindo Pharma, and Cipla are reported to engage in cefmetazole sodium API manufacturing, often catering to regional markets with stringent quality standards aligned with WHO guidelines.

European Suppliers

• Italy: Firms such as Polifarma and Chemi S.p.A specialize in cephalosporin APIs, including cefmetazole sodium, emphasizing high purity and compliance with European Pharmacopoeia standards.

• Germany: Some European companies supply cefmetazole sodium API as part of a broader cephalosporin API portfolio, primarily targeting export markets due to higher manufacturing costs domestically.

North American Providers

• North American suppliers are less prominent in cefmetazole sodium API production, often relying on imports from Asian manufacturers. However, some U.S.-based contract manufacturing organizations (CMOs) offer CDMO services for cefmetazole sodium with robust compliance and regulatory support.

Emerging Markets and Niche Suppliers

Some smaller entities and emerging Asian manufacturers increasingly focus on cefmetazole sodium, leveraging lower production costs and local regulatory pathways. Companies in South Korea and Vietnam also claim GMP-certified production, but verification and supplier audits should precede engagement.

Quality Standards and Regulatory Compliance

Ensuring API quality is paramount. Reputable API suppliers adhere to international GMP standards, and their cefmetazole sodium APIs are often certified under:

• United States Pharmacopeia (USP)
• European Pharmacopoeia (EP)
• Japanese Pharmacopoeia (JP)

Manufacturers routinely conduct batch testing for purity (>99%), residual solvents, microbiological contamination, and endotoxin levels. Suppliers should provide comprehensive Certificates of Analysis (CoA) and stability data to ensure API quality and compliance with the intended dosage form [3].

Supply Chain Considerations

Reliability and Lead Times

Suppliers with established manufacturing infrastructure and certifications typically offer more reliable supply chains. Lead times vary from 8 to 20 weeks depending on the source, with larger firms providing more consistent delivery schedules.

Pricing Trends

Pricing is influenced by regional manufacturing costs, quality certifications, and order volumes. Asian suppliers tend to offer lower prices due to lower production expenses, but purchasers must balance cost against quality, regulatory acceptance, and supply reliability.

Logistics and Export Regulations

Export policies of manufacturing countries impact API availability. Some nations impose export restrictions or require specific certifications, complicating procurement. Therefore, importers should perform due diligence regarding import licenses, tariffs, and customs procedures.

Key Players Summary

Supplier	Region	Certifications	Strengths	Notes
North China Pharmaceutical Group	China	GMP, ISO	Cost-effective, large production capacity	Export-focused, strong regulatory compliance
Sichuan Kelun Pharmaceutical	China	GMP	Advanced manufacturing	International registration underway
Aurobindo Pharma	India	WHO-GMP	Reliable quality, regional supply	Expanding global footprint
Chemi S.p.A	Italy	EP, GMP	High purity standards	Niche European supplier
Local CMOs (North America)	US	GMP	Customized manufacturing	Dependence on Asian imports

Regulatory and Sourcing Challenges

• The proliferation of API sources necessitates rigorous supplier qualification and auditing.
• Counterfeit or substandard APIs pose risks; verification of GMP certification and batch testing is critical.
• Regulatory harmonization varies; importers should verify compliance with local authorities (FDA, EMA, etc.).

Conclusion

The sourcing of cefmetazole sodium API is predominantly driven by Asian manufacturers, with reliable European and North American suppliers emerging to meet stricter quality standards. Companies must perform comprehensive supplier evaluations, focusing on regulatory compliance, quality assurance, supply stability, and cost considerations. Strategic partnerships with multi-certified API manufacturers can efficiently mitigate risks, ensure product integrity, and support sustained supply.

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Key Takeaways

• Asia dominates cefmetazole sodium API production, offering cost-effective options, primarily Chinese suppliers with large-scale GMP-compliant facilities.

• European suppliers cater to markets demanding high-quality standards, often at higher costs but with stringent regulatory compliance.

• Good Supplier Qualification Practices are essential to mitigate risks related to quality and supply disruptions.

• Regulatory alignment with local authorities enhances market access; suppliers providing comprehensive documentation streamline approval processes.

• Supply chain resilience depends on diversifying suppliers, establishing long-term relationships, and performing due diligence.

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FAQs

1. What are the primary regions manufacturing cefmetazole sodium API?
Chinese manufacturers lead globally, followed by India, Italy, and select European firms. North American production is limited, with import reliance on Asian suppliers.

2. How can I verify the quality of cefmetazole sodium API from a supplier?
Request Certificates of Analysis (CoA), GMP certifications, and batch documentation. Performing supplier audits and third-party testing enhances confidence.

3. Are there regulatory differences among API sources for cefmetazole sodium?
Yes. Suppliers compliant with GMP, CE marking, and adhering to USP or EP standards facilitate regulatory approval in respective markets.

4. What factors influence API procurement costs?
Production costs, certification standards, order volume, logistics, and regional economic factors influence pricing.

5. How can I mitigate supply risks in sourcing cefmetazole sodium API?
Diversify suppliers, establish long-term agreements, approve multiple sources, and conduct regular quality audits.

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References

[1] Levy, B., & O’Hara, S. (2019). Cephalosporins: Pharmacology and Clinical Use. Journal of Antimicrobial Chemotherapy, 74(3), 651–661.

[2] Global API Market Report, 2022. Pharma Intelligence.

[3] United States Pharmacopeia (USP). Cefmetazole Sodium API Monograph. USP.org.