Bulk Pharmaceutical API Sources for KEFUROX IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for KEFUROX IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C4417_SIGMA
Molport		MolPort-002-885-814
Hangzhou APIChem Technology		AC-15028
Oakwood Products		036518

Bulk Active Pharmaceutical Ingredient (API) Sources for Kefuorox in Plastic Containers

Last updated: August 6, 2025

Introduction

Kefuorox, whose generic name is Kefurox or Cefuroxime, is a broad-spectrum cephalosporin antibiotic used extensively in the treatment of bacterial infections. Its effectiveness hinges on the stability and purity of its active pharmaceutical ingredient (API). When supplied in bulk, particularly in plastic containers, sourcing high-quality Cefuroxime API is critical for pharmaceutical manufacturers to ensure product efficacy, safety, and regulatory compliance.

This article explores the global API sourcing landscape for Kefurox, highlighting reputable suppliers, logistical considerations for API in plastic containers, quality standards, and industry trends.

Overview of Kefurox API Requirements

The pharmaceutical-grade Cefuroxime API must meet strict quality standards, including:

• Purity: Typically ≥ 99%
• Impurity profiles: Must comply with pharmacopeial standards (USP, EP, JP)
• Stability: Adequate stability in storage and transport, particularly in plastic containers
• Regulatory compliance: Certificates of Analysis (CoA), Good Manufacturing Practices (GMP) adherence

The supply chain for API involves multiple stages from synthesis to packaging, with considerations for maintaining product integrity, especially when stored or transported in plastic containers that are chosen for their convenience and cost-effectiveness.

Leading API Suppliers for Kefurox

1. Global API Manufacturers

Several established pharmaceutical ingredient manufacturers deliver Cefuroxime API in bulk, catering to diverse regional markets:

• HIKAL Ltd. (India):
  Recognized for high-quality cephalosporin APIs, HIKAL provides Cefuroxime API with GMP certifications, offering reliable supply chains tailored for global markets. Their facilities adhere to stringent quality standards, supporting API storage in plastic containers with stability data to ensure API integrity.

• Aurobindo Pharma (India):
  A major player in generic APIs, Aurobindo produces Cefuroxime with a focus on quality and regulatory compliance. Their APIs are compatible with packaging in plastic containers, provided stability parameters are considered.

• Lupin Limited (India):
  Known for extensive API manufacturing, Lupin supplies Cefuroxime approved under various international standards. Their APIs are suitable for bulk encapsulation and in-plant use.

• Sandoz (Novartis):
  A global leader with certified GMP facilities, Sandoz offers Cefuroxime APIs primarily for institutional buyers. Their products are often supplied with comprehensive stability data that support storage in plastic containers.

• TEVA Pharmaceuticals:
  As a leading generic API supplier, TEVA provides Cefuroxime with high purity levels, suitable for formulations stored in plastic containers.

2. Regional and Niche Suppliers

In addition to large conglomerates, several regional suppliers serve niche markets:

• Zhejiang Huahai Pharmaceutical (China):
  Produces Cephalosporin APIs including Cefuroxime, with robust QC protocols suitable for storage in polyethylene or polypropylene containers.

• Biochemie (Czech Republic):
  Offers pharmaceutical APIs tailored for European markets, with a focus on quality and stability.

• Jiangsu Hengrui Medicine (China):
  Notable for cost-effective Cefuroxime APIs, suitable for export with documentation for stability in plastic packaging.

3. Contract Manufacturing and Custom API Suppliers

Many pharmaceutical companies engage contract manufacturing organizations (CMOs) that provide custom synthesis, batch supply, and private labeling options. Partnerships with CMOs like Celab (India) or PharmaZell (Germany) enable tailored solutions for API in plastic containers, including stability studies and packaging validation.

Supply Chain and Packaging Considerations

1. Packaging in Plastic Containers

Bulk Cefuroxime API is often stored in high-density polyethylene (HDPE), polypropylene (PP), or polyethylene terephthalate (PET) bottles or drums. These plastics are preferred for their chemical resistance, weight savings, and operational flexibility. However, the following factors must be prioritized:

• Compatibility: API should not undergo sorption, leaching, or degradation in plastic materials.
• Stability enhancement: Use of inert plastics, proper sealing, and inert atmospheres to prevent moisture ingress or oxidative degradation.
• Shelf-Life: Stability data should support storage durations of up to 24 months under specified conditions; manufacturers often perform accelerated stability studies to confirm this.

2. Logistics and Storage

Transporting Cefuroxime API in plastic containers necessitates adherence to temperature and humidity controls. Adequate documentation, including CoAs, stability data, and certificates of origin, is essential for regulatory submission in multinational markets.

3. Regulatory Compliance

Suppliers must demonstrate compliance with international standards such as:

• US Pharmacopeia (USP)
• European Pharmacopoeia (EP)
• Japanese Pharmacopoeia (JP)

This assures the API's suitability for pharmaceutical manufacturing and storage in various packaging configurations, including plastics.

Emerging Trends and Industry Insights

• GMP Certification and Traceability: Increasingly stringent quality controls, with traceability from synthesis to packaging.
• Stability Data in Plastic Containers: Growing demand for comprehensive stability data specific to API in plastics to ensure compliance during transportation and storage.
• Regional Supply Diversification: Pharmaceutical companies are diversifying suppliers to mitigate geopolitical risks and ensure supply continuity.
• Sustainability Initiatives: Preference for recyclable plastics and environmentally friendly packaging solutions, influencing supplier options and practices.

Key Considerations for Buyers

• Verify supplier certifications, including GMP, ISO, and regulatory approvals.
• Request detailed stability data pertinent to plastic storage conditions.
• Confirm availability of Certificates of Analysis, Pharmacopoeial compliance, and batch records.
• Assess logistics capabilities for temperature-sensitive API specifications.
• Engage in contractual arrangements that specify packaging material, stability parameters, and quality standards.

Conclusion

Sourcing high-quality Cefuroxime API for pharmaceutical manufacturing in plastic containers entails careful selection among reputable global and regional suppliers. Ensuring compliance with quality standards, maintaining stability in plastic packaging, and managing supply chain logistics are essential for uninterrupted production and regulatory adherence. As industry trends favor sustainability and stricter quality control, buyers must prioritize certifications, stability data, and comprehensive documentation to support their supply chain resilience.

Key Takeaways

• Leading API suppliers for Cefuroxime include HIKAL, Aurobindo, Lupin, Sandoz, and TEVA, each offering GMP-compliant products suitable for plastic container storage.
• Proper packaging in inert plastics like HDPE or PP, combined with stability data, is essential to maintain API integrity during storage and transport.
• Suppliers must provide detailed documentation, including CoAs and stability profiles specific to plastic containers, to ensure regulatory compliance.
• Regional and niche suppliers expand choices and enable diversification, reducing supply disruption risks.
• Emerging trends emphasize sustainability, enhanced stability data, and rigorous quality certifications to meet evolving industry and regulatory standards.

---

FAQs

1. What are the primary quality standards to consider when sourcing Cefuroxime API for plastic container storage?
Prioritize suppliers with GMP certification and compliance with pharmacopoeial standards (USP, EP, JP). Verify that certificates of analysis and stability data support storage in plastics under specified conditions.

2. How does plastic container choice influence the stability of Cefuroxime API?
Inert plastics like HDPE and PP are commonly used due to their chemical resistance and minimal interaction with API. Proper sealing, inert atmospheres, and validated stability profiles are crucial for maintaining API efficacy in these containers.

3. Are there regional differences in Cefuroxime API sourcing?
Yes. Indian manufacturers such as HIKAL, Aurobindo, and Lupin dominate exports to international markets, while European and Chinese firms cater to regional demands with varying regulatory oversight and supply chain considerations.

4. How can buyers ensure the stability of Cefuroxime API in plastic containers during transportation?
Request comprehensive stability studies, utilize temperature-controlled logistics, and choose reliable suppliers with proven track records. Proper packaging and handling protocols also mitigate degradation risks.

5. What sustainability practices are emerging in API packaging for Cefuroxime?
Growing adoption of recyclable plastics, biodegradable packaging, and eco-friendly manufacturing practices are aligning with global sustainability initiatives, influencing supplier selection and industry standards.

---

Sources

1. [1] U.S. Pharmacopeia Convention. Pharmacopoeial Standards for Cefuroxime.
2. [2] HIKAL Ltd. Product Data Sheet. Cefuroxime API.
3. [3] Aurobindo Pharma Product Catalogue. Cephalosporin APIs.
4. [4] Sandoz Manufacturing Certifications. Global API Supply Chain.
5. [5] Industry Reports on API Logistics and Packaging Trends, 2022.