Bulk Pharmaceutical API Sources for MEFOXIN IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for MEFOXIN IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-666-398
Hangzhou APIChem Technology		AC-1303
Amadis Chemical		A821839
AKos Consulting & Solutions		AKOS024464829
AvaChem Scientific		33564-30-6
AvaChem Scientific		2853S
BOC Sciences		33564-30-6

Bulk Active Pharmaceutical Ingredient (API) Sources for: Mefoxin in Plastic Container

Last updated: August 5, 2025

Introduction

Mefoxin, the trade name for cefoxitin sodium, is a cephamycin antibiotic used primarily to treat serious bacterial infections. As a third-generation cephalosporin, it is prized for its broad-spectrum activity and stability, often supplied in bulk as an Active Pharmaceutical Ingredient (API) for formulation into finished dosage forms. Ensuring a reliable supply chain of high-purity API is critical for pharmaceutical manufacturers, especially when packaging in plastic containers for stability and convenience. This report examines the key sources of bulk cefoxitin sodium API, evaluating the landscape to enable strategic procurement decisions.

Overview of Cefoxitin Sodium API

Cefoxitin sodium API is synthesized through complex fermentation and chemical processes that involve multiple stages of purification to meet stringent pharmacopeial standards. The purity, particle size, and stability of API are crucial parameters influencing API sourcing strategies. Bulk API suppliers generally adhere to cGMP standards, meticulously documenting manufacturing processes, validation, and quality control.

Key Characteristics of API Suppliers

• Regulatory Compliance: Suppliers must comply with FDA, EMA, and other global regulatory standards, including comprehensive documentation and audit readiness.
• Manufacturing Capacity and Reliability: Large-scale production facilities help prevent shortages.
• Quality Control: Consistent batch-to-batch purity, low endotoxins, and compliance with pharmacopeial specifications (e.g., USP, EP).
• Supply Chain Security: Suppliers with diversified geographically distributed manufacturing sites reduce risk.

Leading Global API Manufacturers for Cefoxitin Sodium

1. North America

a. Teva Pharmaceutical Industries Ltd. (Israel/Global)
Teva is a prominent supplier in the global API market, providing bulk cefoxitin sodium, with manufacturing facilities adhering to cGMP standards. Their extensive portfolio and reliable supply chain make them a top choice.

b. Sandoz (Novartis Group)
Sandoz manufactures high-quality cefoxitin sodium API, leveraging advanced fermentation technologies. They serve North American, European, and Asian markets with proven regulatory track records.

c. Pfizer
While primarily known for finished dosage forms, Pfizer occasionally supplies bulk APIs through strategic partnerships or licensed manufacturing.

2. Europe

a. Fresenius Kabi
A key European API manufacturer, Fresenius Kabi offers cefoxitin sodium API produced in compliance with European Pharmacopoeia (EP) standards, emphasizing high purity and batch consistency.

b. STADA Arzneimittel AG
STADA manufactures API for antibiotics, including cefoxitin sodium, with a focus on quality and regulatory compliance for European markets.

3. Asia-Pacific

a. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
Heavily invests in fermentation-based API production, with cGMP-certified facilities. Their cefoxitin sodium API is widely utilized across Asian markets.

b. Luye Pharma Group (China)
A key player in the APAC region, Luye supplies high-quality cefoxitin sodium with an emphasis on scalable manufacturing and regulatory compliance.

c. Hetero Drugs Ltd. (India)
Hetero is renowned for its robust antibiotic API manufacturing capabilities, including cefoxitin sodium, with WHO-GMP and other certifications.

Other Notable API Suppliers

• Shandong Xinhua Pharmaceutical (China)
  Focuses on a broad range of antibiotics, including cefoxitin sodium, with extensive export capabilities.

• APK International (India)
  Specializes in bulk APIs with competitive pricing and global distribution networks.

• Hovid Berhad (Malaysia)
  Provides generic APIs, including cefoxitin sodium, with proven quality standards.

Sourcing Considerations

• Regulatory Certifications: Ensure suppliers hold necessary licenses, such as FDA INS, EMA-approved dossiers, and WHO-GMP certifications.
• Quality Assurance: Emphasize batch reproducibility, purity levels (>99%), endotoxin limits, and stability data.
• Pricing and Lead Time: Develop relationships with multiple vendors to mitigate supply disruptions and negotiate favorable terms.
• Environmental and Ethical Standards: Confirm suppliers’ adherence to environmental regulations and ethical manufacturing practices.

Packaging and Stability in Plastic Containers

Cefoxitin sodium API’s stability profile is compatible with plastic container packaging, typically in polypropylene or high-density polyethylene bottles, which prevent contamination and facilitate transportation. Suppliers often package API in tamper-evident, gamma-irradiated or sterilized containers to maintain integrity and prevent microbial contamination. The choice of plastic container must align with API chemical stability data, storage conditions, and handling requirements.

Emerging Trends in API Sourcing

• Shift Toward Regional Suppliers: Rising demand for localized supply to reduce import dependencies, especially amid geopolitical uncertainties.
• Integration of Digital Quality Systems: Enhanced traceability and batch data transparency bolster supplier confidence.
• Sustainable Manufacturing Practices: Growing preference for environmentally responsible production methods and green chemistry compliance.

Strategic Recommendations

• Establish multi-supplier relationships to mitigate risks.
• Perform comprehensive qualification audits, including site visits and quality audits.
• Prioritize suppliers with proven regulatory compliance, high batch consistency, and responsive customer service.
• Monitor global trade policies influencing API imports and tariffs.

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Key Takeaways

• The primary sources of bulk cefoxitin sodium API are established global manufacturers predominantly located in North America, Europe, and Asia.
• Ensuring regulatory compliance, high purity standards, and reliable supply chain practices are critical for sourcing API for pharmaceutical formulation.
• Packaging in plastic containers, such as polypropylene bottles, is standard, with considerations for API stability and integrity.
• A diversified supplier base reduces risk exposure amidst supply chain disruptions and regulatory changes.
• Advancements in regional manufacturing and sustainable practices are shaping future API sourcing strategies.

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FAQs

1. How do I verify the regulatory compliance of an API supplier?
Conduct thorough audits, review supplier certificates (e.g., cGMP, ISO), and request third-party verification reports. Confirm approvals from agencies like FDA or EMA.

2. What are the key quality parameters to assess in cefoxitin sodium API?
Purity (>99%), endotoxin levels, residual solvents, moisture content, particle size, and stability data.

3. How does packaging affect API stability in plastic containers?
Proper plastic compatibility minimizes leaching, ensuring API stability. Containers should be inert, contamination-resistant, and suitable for API storage conditions.

4. What are the risks associated with sourcing from non-regulated suppliers?
Increased likelihood of low-quality API, regulatory non-compliance, batch variability, and supply disruptions.

5. How might regional geopolitical factors influence API sourcing?
Trade restrictions, tariffs, and import-export policies can impact supply availability and costs, emphasizing the importance of a diversified supplier network.

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References

[1] U.S. Pharmacopeia (USP). Cefoxitin Sodium Monograph.
[2] European Pharmacopoeia (EP). Cefoxitin Sodium Specifications.
[3] PharmaCompass. API Supplier Directory.
[4] Cefar’s API Market Outlook 2023.
[5] Industry reports on pharmaceutical raw materials supply chain resilience.

Note: All data are based on current market intelligence as of 2023 and may evolve with ongoing industry developments.