Bulk Pharmaceutical API Sources for CEFUROXIME SODIUM IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for CEFUROXIME SODIUM 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
Amadis Chemical		A830968

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

Last updated: November 21, 2025

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Introduction

Cefuroxime sodium, a second-generation cephalosporin antibiotic, is widely used for treating respiratory, urinary tract, bone, joint, and skin infections. Its efficacy depends on high-quality bulk API sourcing, especially for formulations requiring stability in plastic containers. The integrity of cefuroxime sodium during storage and the consistency of supply are paramount for pharmaceutical manufacturers. This report details the primary global API suppliers specializing in cefuroxime sodium, their manufacturing capabilities, quality standards, and considerations for sourcing in plastic container applications.

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Global API Manufacturing Landscape

The procurement of cefuroxime sodium API involves sourcing from established manufacturers adhering to Good Manufacturing Practices (GMP), complying with pharmacopoeial standards such as USP, EP, or BP, and possessing robust quality assurance. Notable regions include India, China, the European Union, and the United States, with India and China leading due to cost advantages and manufacturing capacities.

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Key API Suppliers for Cefuroxime Sodium

1. Sandoz (Novartis Group)

• Overview: Sandoz, a division of Novartis, is a global leader in generic pharmaceuticals, including antibiotics.
• Capabilities: Their manufacturing facilities in Europe and North America produce cefuroxime sodium API, complying with stringent GMP standards and offering high purity API suitable for sterile and non-sterile formulations.
• Strengths: Proven track record of regulatory compliance, extensive quality documentation, and reliable worldwide supply chains.
• Suitability for Plastic Containers: Their API exhibits excellent stability profiles and high batch consistency, fit for storage in plastic containers designed for oral or injectable forms.

2. Hubei Hualong Pharmaceutical Co., Ltd. (China)

• Overview: Specializes in cephalosporin APIs, including cefuroxime sodium.
• Capabilities: GMP-certified with ISO9001 certification, possessing capacity for large-scale production.
• Quality Standards: Meets Chinese pharmacopoeial requirements, with exported products often compliant with USP and EP standards.
• Suitability: Their cefuroxime sodium API is widely used in oral powder and injectable formulations stored in plastic containers, demonstrating stability in PE and PVC packaging under recommended conditions.

3. Huangshan Sunhere Pharmaceutical Co., Ltd. (China)

• Overview: Known for producing cephalosporin APIs with a focus on quality and cost-efficiency.
• Capabilities: GMP-certified plant, with an emphasis on high-grade cefuroxime sodium suitable for export.
• Quality Assurance: Regular audits by international regulatory bodies and adherence to strict quality protocols.
• Application in Plastic Containers: API exhibits兼 exceptional stability, making it suitable for storage in various plastics, especially for oral formulations.

4. Wockhardt Ltd. (India)

• Overview: A globally recognized pharmaceutical manufacturer with extensive experience in cephalosporin APIs.
• Capabilities: Their cefuroxime sodium API complies with international pharmacopoeial standards, supplied to multiple markets.
• Quality and Supply: Wockhardt maintains a comprehensive quality management system and scalable manufacturing, ensuring supply consistency.
• Plastic Storage Compatibility: The API demonstrates stable performance in plastic containers during storage and transport.

5. Teva Pharmaceutical Industries Ltd.

• Overview: An established leader in generic pharmaceuticals with API manufacturing units globally.
• Capabilities: Production of cefuroxime sodium adhering to GMP, with high purity and batch-to-batch consistency.
• Standards: Meets USP, EP, and other international standards.
• Storage Considerations: API's stability profile supports storage in flexible plastic containers for both oral and injectable forms.

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Quality and Regulatory Considerations

Regulatory Compliance: Sourcing from suppliers with recognized GMP certification, high-quality documentation, and regulatory approvals (FDA, EMA, PMDA) ensures API quality and mitigates regulatory risk.

Purity Profile: An API suitable for plastic container storage must have high purity (>98%), low endotoxin levels, and minimal residual solvents to prevent contamination or degradation effects.

Stability in Plastic Containers: Cefuroxime sodium demonstrates standard stability in suitable plastics; however, proper container selection (e.g., polyethylene, polypropylene) and storage conditions (temperature, humidity) are crucial for maintaining API integrity.

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Challenges in API Sourcing for Cefuroxime Sodium

• Supply Chain Disruptions: Geopolitical issues and global pandemics can impact supply availability from certain regions.
• Quality Variability: Variations in manufacturing standards across regions necessitate rigorous supplier qualification processes.
• Cost and Lead Time: Balancing cost-effectiveness with regulatory compliance and quality standards influences supplier selection.
• Regulatory Approvals for API in Plastic Storage: Ensuring that the API's stability profile aligns with container compatibility and regulatory expectations for storage in plastics.

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Sourcing Strategies for Pharmaceutical Manufacturers

• Supplier Qualification: Rigorous auditing, validation of GMP compliance, and review of quality documentation.
• Stability Data Review: Require comprehensive stability studies of cefuroxime sodium in relevant plastics under anticipated storage conditions.
• Contractual Agreements: Include quality, delivery timelines, penalties, and regulatory commitments.
• Regulatory Due Diligence: Confirm API registration statuses with targeted markets and ensure batch record traceability.

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Conclusion

The procurement of cefuroxime sodium API for formulations stored in plastic containers necessitates sourcing from reliable, GMP-compliant manufacturers with proven quality standards. Leading global suppliers such as Sandoz, Wockhardt, and Chinese API producers like Hubei Hualong and Sunhere offer high-quality APIs suitable for various plastic storage applications. A thorough qualification process, including stability data assessment, is vital to ensure API integrity throughout the product lifecycle. Strategic sourcing aligned with regulatory and quality requirements will optimize supply chain robustness, product efficacy, and patient safety.

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Key Takeaways

• Global sourcing from established GMP-certified manufacturers, with a focus on quality assurance, is essential for cefuroxime sodium APIs intended for plastic container storage.
• Leading suppliers include Sandoz, Wockhardt, Hubei Hualong, and Sunhere, with manufacturing capabilities aligning to international standards.
• API stability in plastics depends on container material selection, storage conditions, and comprehensive stability data.
• Rigorous supplier qualification and quality audits minimize regulatory, safety, and efficacy risks.
• Collaborate closely with suppliers to obtain stability profiles and ensure compliance with regional pharmacopoeial standards and regulatory requirements.

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FAQs

1. What are the main quality standards to consider when sourcing cefuroxime sodium API?
Manufacturers should provide API meeting USP, EP, or BP standards, with certifications demonstrating GMP compliance, low endotoxin levels, and high purity.

2. How does the choice of plastic container affect cefuroxime sodium stability?
Materials like polyethylene or polypropylene are generally compatible; however, stability depends on storage conditions, container integrity, and corrosion resistance. Stability studies should confirm compatibility.

3. Are Chinese API manufacturers suitable for pharmaceutical-grade cefuroxime sodium?
Yes. Several Chinese manufacturers hold GMP certification and export high-quality cefuroxime sodium APIs certified for international regulatory standards when properly qualified.

4. Can cefuroxime sodium API be stored long-term in plastic containers without degradation?
Under appropriate storage conditions (controlled temperature, humidity), cefuroxime sodium API exhibits good stability in suitable plastics, supported by stability data. Regular stability monitoring is recommended.

5. How can manufacturers mitigate risks associated with API supply disruptions?
Diversify suppliers across regions, establish long-term contracts, maintain safety stock levels, and perform thorough supplier qualification audits.

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Sources:

[1] Pharmaceutical Technology. (2021). "Sourcing APIs: Ensuring Quality & Supply Chain Integrity."
[2] World Health Organization. (2020). "Prequalification of Medicines Programme."
[3] European Pharmacopoeia. (2022). "Cefuroxime Sodium Monograph."
[4] U.S. Pharmacopoeia. (2023). "Cefuroxime Sodium Monograph."
[5] Industry Reports on Cephalosporin API Manufacturers.