CEFOXITIN IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Samson Medcl	CEFOXITIN IN PLASTIC CONTAINER	cefoxitin sodium	POWDER;INTRAVENOUS	200938	ANDA	SAMSON MEDICAL TECHNOLOGIES LLC	66288-4100-1	1 BAG in 1 BAG (66288-4100-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BAG	2016-03-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 4, 2025

Introduction

Cefoxitin, a broad-spectrum cephamycin antibiotic, plays an essential role in treating various bacterial infections, notably intra-abdominal and gynecological infections. Its commercial manufacturing involves sourcing high-quality raw materials, aseptic filling, and containerization, especially in plastic containers to ensure stability, safety, and convenience. Given the criticality of supplier reliability in the pharmaceutical supply chain, identifying reputable sources for cefoxitin in plastic containers is paramount for healthcare providers, distributors, and pharmaceutical companies.

Market Landscape for Cefoxitin Manufacturing

Cefoxitin is manufactured through complex fermentation and chemical synthesis processes, requiring specialized raw ingredient suppliers, sterile manufacturing facilities, and packaging providers. The drug’s production adheres to strict regulatory standards such as Good Manufacturing Practice (GMP) by agencies like the FDA, EMA, and WHO.

The key segments in the supply chain include:

Active Pharmaceutical Ingredient (API) Suppliers: Companies that produce high-purity cefoxitin API.
Formulation and Filling Facilities: Entities responsible for sterile compounding and aseptic filling.
Packaging Suppliers: Providers specializing in plastic containers that maintain drug stability.

Leading Cefoxitin API Suppliers

Numerous global firms produce high-grade cefoxitin API, with several holding substantial market shares. Notably:

1. Zhenjiang Le Guang Pharmaceutical Co., Ltd. (China)

A prominent player in cephalosporin APIs, Le Guang offers competitively priced cefoxitin API, adhering to international GMP standards. They supply pharmaceuticals to North America, Europe, and Asia, with extensive export experience.

2. Zhejiang University First Hospital (China)

While primarily a research institution, Zhejiang University collaborates with manufacturing units to develop high-quality APIs, including cefoxitin, emphasizing biosynthesis processes to ensure purity.

3. Sandoz (Novartis) – Global

As a global generic pharmaceutical leader, Sandoz supplies sterile-grade cefoxitin API conforming to USP and EP standards, with robust compliance and supply chain integrity.

4. Teva Pharmaceuticals (Israel)

Teva offers high-quality cefoxitin API to finished product manufacturers worldwide, with a focus on strict quality control measures.

5. WuXi AppTec (China)

A contract development and manufacturing organization (CDMO), WuXi supplies cefoxitin API for custom synthesis under GMP conditions.

Plastic Container Suppliers for Cefoxitin

Stable, safe, and regulatory-compliant plastic containers are critical in pharmaceutical packaging. The suppliers of medical-grade plastic containers for cefoxitin must meet stringent standards, including USP <660> compliance, extractable and leachable assessments, and compatibility with the drug compound.

Leading Plastic Container Suppliers

1. Schott AG (Germany)

A pioneer in pharmaceutical glass and plastic containers, Schott offers pre-filled plastic syringes, vials, and cartridges suitable for sterile injectables, with extensive experience in aseptic filling.

2. Bilcare Ltd. (India)

Bilcare supplies blister packs, and plastic containers designed for sterile injectables, with proven compatibility with cephalosporins and proven barrier properties.

3. West Pharmaceutical Services (USA)

Specializes in the manufacture of plastic and elastomeric components, including primary plastic containers such as Ampuls and Syringes, with proven track record for sterile drug packaging.

4. AptarGroup Inc. (USA)

Offers innovative sterile packaging solutions, including plastic ready-to-use containers and closures, emphasizing barrier properties and patient safety.

5. Nipro Corporation (Japan)

A key supplier of medical plastics and prefilled syringes, Nipro's containers are designed for stability and compatibility with sensitive antibiotics like cefoxitin.

Key Criteria for Supplier Selection

When sourcing cefoxitin in plastic containers, stakeholders should evaluate:

Regulatory Compliance: GMP, FDA approval, or other certifications.
Quality Assurance: Validation reports, microbiological testing, stability data.
Supply Chain Reliability: Capacity to meet demand, lead times, and contingency plans.
Technical Compatibility: Material compatibility (e.g., polypropylene or polyethylene) with cefoxitin.
Cost and Contract Flexibility: Competitive pricing aligned with quality standards.

Emerging Trends and Innovations

The industry is witnessing advancements in:

Pre-Filled Syringe Technologies: Combining API stability with user safety.
Barrier Packaging: Enhanced protection against moisture and oxygen, essential for cefoxitin stability.
Sustainable Materials: Use of recyclable plastics aligning with environmental mandates.

Manufacturers are increasingly opting for contract manufacturing organizations (CMOs) with integrated API sourcing and packaging capabilities to streamline supply chains.

Regulatory Considerations

Suppliers must maintain compliance with stringent global regulations:

FDA: 21 CFR Part 211, Part 820.
EMA: EudraLex Volume 4.
WHO GMP: Ensures worldwide acceptance and licensing standards.
ISO Certifications: ISO 9001, ISO 13485.

Distributors should actively validate supplier certifications and conduct periodic audits to ensure ongoing compliance for cefoxitin in plastic containers.

Conclusion

The procurement of cefoxitin in plastic containers hinges on a reliable ecosystem of API manufacturers and packaging providers who meet high-quality and regulatory standards. Prominent API suppliers include Sandoz, Teva, WuXi AppTec, and domestic Chinese producers, while leading container providers like Schott, West Pharmaceutical, and Aptar offer validated solutions for sterile pharmaceutical products.

Partnerships with suppliers demonstrating robust compliance, proven quality, and supply chain resilience will underpin the secure and effective delivery of cefoxitin to healthcare providers worldwide.

Key Takeaways

The global supply chain for cefoxitin involves specialized API producers primarily in China and established multinational firms.
High-quality plastic container providers offer sterile, compliant packaging solutions, emphasizing material compatibility and regulatory adherence.
Due diligence, including validation of certifications, manufacturing processes, and supply capacity, is vital in supplier selection.
Advances in packaging technology enhance drug stability and patient safety, shaping future procurement strategies.
Strategic partnerships with reputable suppliers mitigate risks linked to shortages, regulatory non-compliance, and quality failures.

FAQs

1. How do I verify the legitimacy and quality of suppliers for cefoxitin in plastic containers?
Confirm certifications such as GMP compliance, FDA approval, ISO standards, and conduct supplier audits or third-party validations. Reviewing batch records, stability data, and quality assurance processes is also essential.

2. Are there regional preferences for suppliers of cefoxitin API and containers?
Yes. Asia-Pacific, especially China and India, is a major hub for API production due to cost efficiencies, whereas North America and Europe often dominate high-quality packaging solutions. Balancing cost and quality is critical.

3. What regulatory challenges exist in sourcing plastic containers for antibiotic drugs like cefoxitin?
Potential challenges include ensuring containers meet biocompatibility standards, prevent drug leaching, and maintain stability under storage conditions. Navigating regional regulatory approvals can also pose hurdles.

4. Can existing supply chains handle fluctuations in demand for cefoxitin?
Lead times and capacity vary among suppliers. Establishing strategic partnerships with multiple qualified suppliers and maintaining safety stocks can mitigate supply disruptions.

5. What emerging innovations should I consider for future sourcing of cefoxitin packaging?
Investing in pre-filled syringes, barrier packaging with enhanced stability, and environmentally sustainable plastics can improve safety, convenience, and sustainability.

Sources

[1] U.S. Food and Drug Administration (FDA). Guide to Good Manufacturing Practices (GMP) for medications.
[2] European Medicines Agency (EMA). Guidelines on Good Manufacturing Practice.
[3] WHO. WHO GMP guidelines for pharmaceuticals.
[4] Industry reports on cephalosporin API manufacturers and pharmaceutical packaging trends.
[5] Corporate websites: Sandoz, Teva, WuXi AppTec, Schott, West Pharmaceutical, Aptar, Nipro.

[End of article]

Suppliers and packagers for CEFOXITIN IN PLASTIC CONTAINER