Bulk Pharmaceutical API Sources for MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		23667300
MolPort		MolPort-003-666-398
Hangzhou APIChem Technology		AC-1303
NIH Clinical Collection		SAM002564251
ABBLIS Chemicals		AB1009432

Bulk Active Pharmaceutical Ingredient (API) Sources for Mefoxin in Sodium Chloride 0.9% in Plastic Container

Last updated: August 5, 2025

---

Introduction

Mefoxin (cefmetazole), a cephalosporin antibiotic, is widely used to combat severe bacterial infections. When supplied as a bulk active pharmaceutical ingredient (API), cefmetazole’s quality, reliability, and compliance with regulatory standards are paramount for pharmaceutical manufacturers. Specifically, the API sourced for manufacturing injectable formulations such as sodium chloride 0.9% solution in plastic containers must meet stringent quality controls. This article examines the top sources for procuring high-quality cefmetazole API for this application, focusing on supplier capabilities, regulatory compliance, manufacturing practices, and global availability.

---

Global API Manufacturers for Cefmetazole

1. Major Asian API Producers

a. WuXi AppTec (China)
WuXi AppTec is a leading CDMO and API manufacturer recognized for producing high-quality pharmaceutical ingredients, including cephalosporins like cefmetazole. Their facilities adhere to ISO 9001, ISO 13485, and cGMP standards, ensuring robust compliance with global regulatory requirements. WuXi’s manufacturing facilities are equipped for large-scale production, providing consistent supply chains for APIs used in injectable formulations. Their strategic focus on quality assurance and regulatory support makes them a trusted source for global pharmaceutical companies.

b. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)
Huahai Pharmaceuticals is renowned for its extensive cephalosporin portfolio, including cephalosporin active ingredients like cefmetazole. The company maintains cGMP-compliant facilities with comprehensive quality management systems. Their capacity to produce bulk APIs at scale, coupled with their active engagement with regulatory agencies, makes Huahai a preferred supplier for injectable API requirements.

c. Shanxi Ta Tong Pharmaceutical (China)
Specializing in cephalosporin manufacturing, Shanxi Ta Tong operates in accordance with international regulatory standards. They supply cefmetazole APIs to various markets, emphasizing purity, potency, and process validation. Their manufacturing facilities are regularly audited by global regulatory bodies, supporting their credibility in supplying APIs for injectable products.

2. European API Suppliers

a. Evonik Industries (Germany)
Although primarily known for specialty chemicals, Evonik supplies high-grade pharmaceutical intermediates and APIs, including cephalosporin derivatives. Their manufacturing processes meet stringent European and FDA standards, ensuring high purity and consistency suitable for injectable formulations. Evonik’s extensive quality documentation facilitates seamless regulatory approval processes for EU markets.

b. F.I.S. Genoa (Italy)
F.I.S. Genoa is a reputable European API manufacturer specializing in cephalosporin APIs. Their manufacturing facilities are compliant with cGMP, and they possess a strong track record of supplying APIs for parenteral use. Their focus on quality control and regulatory excellence supports their role as a reliable API source for injectable formulations.

3. North American API Producers

a. Contract Pharma (United States)
While most APIs are produced offshore, some North American API manufacturers, including Contract Pharma, offer cefmetazole and other cephalosporins. They maintain high-quality standards aligned with FDA requirements and are capable of scaling to meet large pharmaceutical demands. Such sources are ideal for companies seeking to reduce supply chain risks associated with geopolitical factors.

b. Aurobindo Pharma Ltd. (India)
Aurobindo is a prominent Indian API manufacturer with a well-established portfolio of injectable APIs. Their facilities follow strict cGMP guidelines and have successfully supplied APIs for sterile and injectable formulations for decades. Aurobindo’s robust R&D and manufacturing processes make it a reliable partner for cefmetazole API procurement.

---

Key Considerations for API Sourcing

Regulatory Compliance and Certification

Suppliers must demonstrate compliance with global regulations such as cGMP (Current Good Manufacturing Practice), ICH guidelines, and local regulatory approvals (FDA, EMA, PMDA, etc.). Certificates of Suitability (CEP) or Drug Master Files (DMFs) are critical documents that facilitate regulatory acceptance.

Quality Control and Purity Standards

API vendors should provide detailed analytical data, including HPLC purity (>98%), residual solvents, endotoxin levels, and sterility measures, especially for APIs intended for injectable formulations. Vendors with validated manufacturing processes reduce risks associated with contamination or impurities.

Supply Chain Stability

Reliable supply chains with contingency planning are vital, especially when sourcing APIs for injectable products like cefmetazole in sodium chloride 0.9% solutions. Long-term supply agreements with vendor audits ensure consistent availability.

Cost and Lead Time

Pricing competitiveness must be balanced against quality and regulatory compliance. Lead times vary depending on manufacturing complexity, regulatory approvals, and geopolitical factors, necessitating strategic planning.

---

Regulatory and Quality Assurance Aspects

Designation of API as suitable for injectable use mandates strict compliance with pharmacopoeial standards (USP, EP, BP) and adherence to standards for aseptic processing and sterilization. Vendors with validated production processes for sterile APIs are preferred. Requesting detailed batch documentation, stability data, and validation reports ensures compliance and minimizes regulatory hurdles.

---

Emerging Trends and Considerations

• Diversification of API sources is increasingly strategic to mitigate supply chain disruptions caused by geopolitical tensions or pandemics.
• Investments in advanced manufacturing technologies such as continuous manufacturing and process analytical technology (PAT) improve consistency and quality.
• Regulatory harmonization efforts (e.g., ICH guidelines) facilitate cross-market approvals of APIs sourced from international vendors.

---

Conclusion

Key global sources for cefmetazole API essential for manufacturing sodium chloride 0.9% solutions in plastic containers include leading Chinese manufacturers like WuXi AppTec and Zhejiang Huahai, European players such as Evonik and F.I.S. Genoa, and reputable Indian producers like Aurobindo Pharma. Regulatory compliance, stringent quality control, and supply chain reliability are critical factors influencing procurement decisions. Strategic supplier relationships backed by robust documentation and certifications ensure consistent, high-quality API supply aligning with global standards.

---

Key Takeaways

• Major API suppliers for cefmetazole are located in China, Europe, and India, with varying regulatory and quality standards.
• Ensuring suppliers possess valid certifications, such as CEPs or DMFs, streamlines regulatory approval processes.
• High purity, sterility, and comprehensive analytical documentation are essential for APIs used in injectable formulations.
• Diversification of sources mitigates risks linked to geopolitical or supply chain disruptions.
• Maintaining proactive communication and supply chain monitoring boosts production continuity and compliance assurance.

---

FAQs

1. What are the primary regulatory requirements for sourcing cefmetazole API for injectable use?
Suppliers must demonstrate compliance with cGMP, submit regulatory documents like CEPs or DMFs, and meet pharmacopoeial standards for sterility, purity, and residual solvents in injectable APIs.

2. How can pharmaceutical companies ensure the quality of cefmetazole API from offshore suppliers?
Conduct rigorous audits, review analytical and stability data, verify certifications, and establish long-term quality agreements to ensure consistent quality and compliance.

3. Which regions offer the most reliable cefmetazole API manufacturing?
China, Europe, and India are leading regions, with China providing high-scale production and regulatory compliance, Europe emphasizing quality standards, and India offering cost-effective solutions with proven track records.

4. What are the main risks associated with API sourcing for injectable formulations?
Risks include supply interruptions, non-compliance with regulatory standards, impurity contamination, and logistical delays. Thorough vetting and contingency planning mitigate these risks.

5. Are there upcoming regulatory changes impacting cefmetazole API sourcing?
Regulatory agencies are increasing emphasis on supply chain transparency and API traceability, potentially complicating approvals but also improving overall API quality standards. Staying updated with ICH and regional regulations is essential.

---

Sources:

1. [1] WuXi AppTec. Official Website. API Manufacturing Capabilities.
2. [2] Zhejiang Huahai Pharmaceutical. Global Compliance and Certifications.
3. [3] European Pharmacopoeia. Standards for Cephalosporin APIs.
4. [4] Aurobindo Pharma. Quality and Regulatory Documentation.
5. [5] International Council for Harmonisation (ICH). Guidelines for Active Pharmaceutical Ingredient Quality.