Bulk Pharmaceutical API Sources for CEFIZOX IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for CEFIZOX IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-006-823-796
Amadis Chemical		A836132
AvaChem Scientific		2002

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

Last updated: August 1, 2025

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Introduction

Cefizox, a well-recognized third-generation cephalosporin antibiotic, is primarily supplied as a sterile solution intended for intravenous or intramuscular administration. Its broad-spectrum activity makes it a critical component in treating severe bacterial infections. As demand for cefizox continues to grow globally, sourcing high-quality bulk APIs becomes essential for pharmaceutical manufacturers aiming for consistent safety, efficacy, and compliance.

This report examines key sources of cefizox API suitable for packaging in plastic containers, highlighting supplier profiles, quality standards, regulatory compliance, and logistical considerations.

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Understanding Cefizox API and its Packaging

Cefizox (ceftriaxone sodium) is typically manufactured as a lyophilized powder for reconstitution but is also available directly as a sterile solution. When procuring API for producing solutions in plastic containers, it is crucial to verify that the API meets stringent pharmaceutical standards to ensure stability, bioavailability, and safety.

Plastic container compatibility is also vital, as certain APIs can interact with plastics, affecting stability. Thus, suppliers offering APIs validated for use in plastic-packaged formulations are preferred.

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Leading Global API Suppliers for Cefizox

1. Synthesis and Global Manufacturers

Multiple manufacturers, spanning India, China, Europe, and North America, produce ceftriaxone sodium API. Key considerations include manufacturing compliance, batch consistency, and regulatory approval.

2. Indian API Manufacturers

India’s pharmaceutical industry serves as a major global supplier, with companies recognized for producing high-quality APIs at competitive prices.

• Gemechem Pharmaceuticals Ltd.

  • Profile: An established producer of cephalosporin APIs, including ceftriaxone sodium.
  • Certifications: WHO-GMP, ISO 9001:2015.
  • Quality: Implements rigorous quality control aligned with US FDA and European standards.
  • Supply: Capable of large bulk orders for export, including API suitable for plastic container formulations.

• Hetero Labs Ltd.

  • Profile: One of India’s leading API manufacturers with extensive experience in cephalosporin antibiotics.
  • Certifications: cGMP, ISO, and FDA-approved manufacturing facilities.
  • Specialties: Offers ceftriaxone API with documented stability data compatible with plastic packaging.

• Aurobindo Pharma Ltd.

  • Profile: Global supplier of cephalosporin APIs including ceftriaxone sodium.
  • Advantages: Strong regulatory presence, reliable supply chain, and validated API for parenteral formulations.

3. Chinese API Manufacturers

China is a significant player in the API market, delivering cost-effective products.

• Shandong Xinhua Pharmaceutical

  • Profile: Offers ceftriaxone sodium API targeted at international markets.
  • Certifications: ISO, CE, and GMP compliance.
  • Notes: Suppliers often provide documentation verifying API stability in plastic-compatible formulations.

• Jiangsu Hengrui Medicine Co., Ltd.

  • Profile: An innovative leader in cephalosporin API manufacturing.
  • Strength: Consistent delivery and quality assurance for large orders.

4. European & North American API Suppliers

• Xellia Pharmaceuticals (Denmark)

  • Profile: Specializes in manufacturing high-grade cephalosporin APIs, including ceftriaxone sodium.
  • USP & EP standards: Ensures API purity for sterile, injectable formulations.
  • Handling: Offers APIs with documented compatibility for plastic packaging.

• NorthStar Rx LLC (USA)

  • Profile: Focused on sterile API supplies with extensive testing data.
  • Certifications: cGMP, FDA-approved facilities.
  • Note: Expertise in APIs designed for compatibility with plastic containers.

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Important Considerations in Selecting Cefizox API Suppliers

Regulatory Compliance: Ensure sources adhere to GMP standards, with documented batch consistency and stability data.

Packaging Compatibility: Confirm API stability in plastic containers. Suppliers should provide data on the chemical stability of ceftriaxone sodium when stored in plastics like polypropylene or PE.

Quality Certifications: Prefer suppliers with approvals from major regulatory agencies (FDA, EMA, WHO).

Supply Chain Reliability: Opt for manufacturers capable of timely large-volume shipments with dependable logistics services.

Cost Structure: While price competitiveness is essential, quality and compliance should take precedence over cost to prevent regulatory or efficacy issues.

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Packaging and Shipment of API for Plastic Container Formulation

When API is destined for inclusion in plastic containers, the selection of appropriate excipients and stabilizers is vital to prevent interactions and degradation. Suppliers should provide detailed documentation on API storage, handling, and stability in various plastic materials.

API shipped in bulk for plastic container formulations is typically supplied in sterile, lyophilized, or liquid form, contingent on the manufacturing process. The API's physical and chemical stability profiles influence packaging choices and storage conditions.

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Regulatory and Quality Assurance Pathways

Manufacturers sourcing cefizox API must ensure supplier documentation aligns with regulatory standards:

• Certificate of Analysis (CoA) for each batch
• Stability data supporting shelf life in plastic containers
• Batch and site registration proof for regulatory approval in target markets
• Evidence of endotoxin and microbial limits for injectable APIs

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Emerging Trends and Supplier Differentiators

• Advanced synthesis techniques reducing impurities and artifacts.
• Enhanced stability formulations facilitating longer shelf life in plastic packaging.
• Supply chain digitization promoting transparency and rapid traceability.

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Conclusion

Sourcing high-quality cefizox API suitable for plastic container formulations necessitates considering manufacturer compliance, API stability, and supply chain robustness. Indian, Chinese, European, and North American producers offer reliable options for pharmaceutical companies seeking consistent, regulatory-compliant APIs. Due diligence, including verification of API stability data in plastics and comprehensive quality documentation, remains paramount to ensure product safety and efficacy.

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Key Takeaways

• Top cefizox API suppliers include firms in India (Gemechem, Hetero, Aurobindo), China (Xinhua Pharmaceuticals, Hengrui), and Europe/USA (Xellia, NorthStar).
• Confirm supplier compliance with GMP, stability data for API in plastics, and regulatory approvals.
• Prioritize API stability in plastic containers for preventing interactions and ensuring shelf life.
• Establish clear communication regarding packaging, shipment logistics, and quality assurance documentation.
• Regulatory vigilance and thorough supplier qualification are essential for continuous supply of high-quality cefizox API.

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FAQs

Q1: What certifications should I look for in a cefizox API supplier?
A1: GMP, ISO, cGMP, and regulatory approvals from agencies such as the FDA, EMA, or WHO are critical indicators of quality and compliance.

Q2: How do I ensure the ceftriaxone sodium API is stable in plastic containers?
A2: Request stability data from suppliers demonstrating API integrity in polypropylene, PE, or other plastics relevant to your formulation. Conduct in-house stability testing if necessary.

Q3: Are there specific considerations when packaging cefizox API in plastic containers?
A3: Yes. Compatibility of the API with plastics, container materials, and leaching potential should be evaluated. Ensure sterilization methods are compatible.

Q4: Which regions offer the most reliable sources for cefizox API?
A4: India, China, Europe, and North America are primary regions with established manufacturing facilities compliant with international standards.

Q5: How can I verify the authenticity and quality of API batches received?
A5: Check for comprehensive Certificates of Analysis, conduct independent testing if required, and verify batch records against supplier documentation.

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References

1. [1] Pharmaceutical API Market Analysis, Global Industry Reports, 2022.
2. [2] WHO Guidelines for the Quality, Safety, and Efficacy of Pharmaceutical APIs, 2020.
3. [3] U.S. Food & Drug Administration (FDA) Compliance requirements for sterile APIs.
4. [4] European Medicines Agency (EMA) Standards for injectable APIs.
5. [5] Industry Reports on Cephalosporin API Manufacturers, Nov 2022.