Bulk Pharmaceutical API Sources for KEFLIN IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for KEFLIN IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C4520_SIGMA
Sigma-Aldrich		C3050_SIGMA
NovoSeek		23675321
MolPort		MolPort-002-511-511
Hangzhou APIChem Technology		AC-15529

Bulk Active Pharmaceutical Ingredient (API) Sources for KEFLIN IN PLASTIC CONTAINERS

Last updated: August 5, 2025

Introduction

Keflin, known generically as cefazolin sodium, is a first-generation cephalosporin antibiotic extensively used for bacterial infections. The sourcing of bulk APIs like keflin (cefazolin sodium) is pivotal for pharmaceutical manufacturers aiming to produce high-quality injectable formulations. In particular, the use of plastic containers for storage and packaging necessitates sourcing from suppliers that guarantee API stability, compliance with regulatory standards, and supply chain integrity. This article explores the global landscape of keflin API suppliers, emphasizing quality, capacity, regulatory compliance, and considerations specific to formulations packaged in plastic containers.

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Global API Manufacturing Landscape for Keflin

Major API Production Regions

The production of cefazolin sodium as a bulk API occurs predominantly in regions with mature pharmaceutical manufacturing bases, including India, China, Europe, and the United States. These regions host recognized GMP-compliant manufacturers capable of exporting high-grade cefazolin sodium to global markets.

• India: India’s pharmaceutical sector is renowned for cost-effective manufacturing and a robust API industry. Companies like Shilpa Medicare, Lupin Ltd., and Biological E. Ltd. have established APIs with certifications aligned with international standards (e.g., USFDA, EMA).

• China: Chinese API manufacturers such as Huafeng Pharmaceutical, Jiangsu Aosaikang Pharmaceutical Co., and North China Pharmaceutical Group Corporation possess significant capacity for cefazolin sodium production, with exports to various regions adhering to global quality norms.

• Europe & North America: Established European firms like Sandoz (Novartis) and American companies such as Paragon Biosciences produce high-purity cefazolin sodium, often serving markets with stringent regulatory requirements.

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Leading API Suppliers for Keflin

1. Shilpa Medicare Ltd. (India)

• Certifications: USFDA, EMA, WHO-GMP
• Capacity & Quality: Produces cefazolin sodium APIs suitable for pharmaceutical manufacturing, with rigorous quality control and stability testing.
• Supply Focus: Strong export capability, adhering to international pharmacopoeia standards.

2. Lupin Ltd. (India)

• Regulatory Status: Authorized for export to US, Europe, and emerging markets
• API Quality: Demonstrates compliance with FDA and EMA standards, offering high purity cefazolin sodium suitable for parenteral formulations in plastic containers.

3. Huafeng Pharmaceutical (China)

• Market Footprint: Global supplier for cephalosporins, including cefazolin sodium
• Certifications: GMP, ISO 9001, and often collaborates with international regulatory agencies for compliance.

4. Jiangsu Aosaikang Pharmaceutical Co. (China)

• Production Capabilities: Extensive capacity for cephalosporin APIs with focus on sterile APIs compatible with injections stored in plastic bottles.
• Quality Assurance: Implements comprehensive QA/QC procedures for batch consistency.

5. Sandoz (Switzerland/Global)

• Premium Supplier: Offers high-purity cefazolin sodium APIs meeting strict regulatory standards, with validation data available for sterile injectable productions.

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Compliance and Regulatory Considerations

Manufacturers sourcing keflin API must prioritize suppliers with proven GMP compliance, validated manufacturing processes, and comprehensive documentation such as:

• Batch production records
• Certificates of Analysis (CoA)
• Pharmacopoeia compliance (USP, EP, JP)
• Stability and sterility assurance data
  These ensure API suitability for formulations packaged in plastic containers, especially considering the potential for leachables and extractables issues.

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API Storage & Packaging Specifics

Keflin API packaging in plastic containers—such as PE or HDPE drums and bottles—demands API stability under various conditions. Storage conditions influence API integrity, especially in terms of moisture, light, and temperature. Suppliers often provide stability data demonstrating the API's compatibility with plastic packaging, critical to maintaining efficacy and safety during shelf life.

Manufacturers should collaborate with API suppliers that provide detailed stability profiles, ensuring API remains stable when stored in plastic containers with specific material compositions.

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Supply Chain & Logistics Considerations

Ensuring a reliable supply chain for keflin API involves evaluating vendor preparedness, lead times, and logistical arrangements—particularly amid global disruptions such as COVID-19. Suppliers with a track record of punctual deliveries, flexible batch sizes, and robust excellent warehousing practices are preferable.

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Emerging Trends and Future Directions

• Synthetic Route Innovations: Companies adopting greener manufacturing routes and automated quality controls.
• Regulatory Stringency: Increasing pharmacopoeial and regulatory demands require suppliers to continuously upgrade their quality systems.
• API Stability in Packaging: Focus on developing APIs with enhanced stability profiles suitable for long-term storage in plastic containers.

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Conclusion

The sourcing of keflin (cefazolin sodium) API from reliable suppliers is critical for pharmaceutical manufacturers aiming for high-quality injectable formulations stored in plastic containers. Leading global API producers, mainly based in India, China, and Europe, offer compliant, high-purity APIs serving international markets. Due diligence in supplier qualification, compliance documentation, and stability data is essential to ensure API integrity, regulatory adherence, and supply chain robustness.

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Key Takeaways

• Indian and Chinese manufacturers dominate the cefazolin sodium API market, supported by GMP compliance and cost-effectiveness.
• European and US-based companies provide premium APIs with rigorous quality assurance, suitable for markets with stringent regulations.
• Compatibility with plastic container storage requires detailed stability and leachable data from API suppliers.
• Due diligence in supplier qualification ensures regulatory compliance and uninterrupted supply.
• Continuous innovation in manufacturing and stability testing enhances API viability for long-term storage in plastic packaging.

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FAQs

1. What are the key regulatory certifications to consider when sourcing keflin API?
GMP certification, CoA compliance with USP, EP, or JP standards, and approvals from regulatory bodies like USFDA, EMA, or WHO are essential indicators of quality.

2. How does API stability impact its storage in plastic containers?
API stability can be affected by leachables, extractables, moisture ingress, and light exposure. Suppliers should provide stability profiles indicating suitability for plastic packaging.

3. Are there differences in API quality between regional manufacturers?
Yes. European and US manufacturers often adhere to stricter standards, but Indian and Chinese producers have improved quality control, with many now meeting international regulatory requirements.

4. What factors influence the choice of API supplier for injectable cefazolin sodium?
Regulatory compliance, supply capacity, quality certifications, cost-effectiveness, stability data, and supply chain reliability are critical factors.

5. What is the impact of global supply chain disruptions on API sourcing?
Disruptions can cause shortages, delays, and increased costs. It emphasizes the importance of working with multiple qualified suppliers and maintaining safety stock levels.

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Sources:
[1] U.S. Pharmacopeia, "USP Cefazolin Sodium Monograph," 2023.
[2] European Pharmacopoeia, "Cefazolin Sodium," 2023.
[3] Indian Directorate General of Foreign Trade (DGFT), "API Manufacturing Standards," 2022.
[4] China Food and Drug Administration (CFDA), "Pharmaceutical API Regulations," 2022.
[5] Global API Market Report, EvaluatePharma, 2022.