Bulk Pharmaceutical API Sources for TAZIDIME IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for TAZIDIME IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		5481173
ABI Chem		AC1NUK7U
ABBLIS Chemicals		AB1009357
ChemMol		49423380
Amadis Chemical		A839420

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

Last updated: July 31, 2025

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Introduction

Tazidime, known commercially as Tazicef among other brand names, is a broad-spectrum cephalosporin antibiotic used primarily for severe bacterial infections. Its intravenous formulation in plastic containers necessitates sourcing high-quality bulk APIs suitable for sterile manufacturing and stability in container-closure systems. Identifying reliable suppliers for Tazidime API is essential for pharmaceutical manufacturers aiming to ensure drug safety, efficacy, and regulatory compliance. This article explores global API sources specializing in Tazidime, emphasizing quality standards, supply reliability, and strategic considerations for pharmaceutical companies.

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Overview of Tazidime API Manufacturing and Specification Requirements

Tazidime is a semi-synthetic cephalosporin analog requiring complex synthesis involving multiple chemical steps. The API must adhere to stringent purity, potency, and residual solvent specifications, typically aligned with pharmacopeial standards such as USP or EP. For injectable formulations, API quality standards expand to include microbiological purity, endotoxin levels, and compatibility with plastic container systems, especially polyethylene or polypropylene used in plastic infusion bags.

Key specifications include:

• Purity: ≥ 98%
• Residual solvents: As per ICH guidelines (e.g., methanol, dichloromethane)
• Microbial limits: Sterility, endotoxin ≤ 0.5 EU/mL
• Particle size: Suitable for sterile filtration
• Physical stability: Compatibility with container materials over shelf life

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Global API Suppliers for Tazidime

1. Falcon Pharmaceutical

• Location: India
• Overview: Falcon Pharmaceutical specializes in cephalosporin APIs, including Tazidime, with a focus on high-purity standards suitable for sterile injectable formulations.
• Capabilities: Manufacturing at cGMP standards, offering comprehensive quality documentation including batch records, stability data, and regulatory dossiers.
• Certifications: WHO-GMP, ISO 9001, and ISO 14001.
• Strengths: Competitive pricing, extensive R&D for process optimization, supply stability.

2. Biocon Limited

• Location: India
• Overview: As a major biopharmaceutical issuer, Biocon is a reputable API manufacturer with a portfolio that includes beta-lactam antibiotics such as Tazidime.
• Quality Assurance: Meets international standards, offering APIs compliant with USFDA, EMA, and WHO guidelines.
• Supply Capabilities: Large-volume production, dedicated sterile manufacturing facilities, and proven track record in global markets.
• Additional Notes: Strong focus on sustainable practices and innovative synthesis pathways.

3. Sandoz (Novartis Division)

• Location: Switzerland, with regional manufacturing units
• Overview: Sandoz supplies bulk APIs for antibiotics, including third-party sourcing options for Tazidime.
• Quality and Compliance: High manufacturing standards, aligning with global pharmacopeial requirements.
• Strengths: Proven supply chain reliability and extensive regulatory support for injectable APIs.

4. Shanghai ChemPartner

• Location: China
• Overview: ChemPartner offers API manufacturing including cephalosporins, with a focus on cost-effective, high-quality production.
• Regulatory Footprint: Possesses cGMP certification and an expanding presence in global markets.
• Notes: Suitable for bulk procurement, especially for companies seeking regional API sourcing in Asia.

5. Zhejiang Yuhuan Pharmaceutical

• Location: China
• Overview: Focused on cephalosporin APIs, Yuhuan Pharmaceutical offers Tazidime API for international markets, with comprehensive quality documentation.
• Operational Strengths: Advanced synthesis techniques, robust quality control processes, and flexible batch sizes.

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Strategic Considerations for Sourcing Tazidime API

Quality Assurance and Regulatory Compliance:
Identify suppliers with confirmed compliance with pharmacopeial standards, validated manufacturing processes, and transparent documentation. Suppliers with WHO-GMP or cGMP certifications provide higher assurance of quality and consistency.

Supply Chain Reliability:
Assess historical supply performance, capacity for bulk production, and contingency plans. Long-term supply agreements reduce risks related to shortages or quality lapses.

Cost and Pricing:
While pricing is crucial, prioritize quality and compliance over low-cost sourcing to avoid regulatory issues and manufacturing delays detrimental to brand reputation and patient safety.

Documentation and Technical Support:
Ensure comprehensive technical transfer documentation, stability data, and ongoing technical support to facilitate integration into existing manufacturing lines.

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Regulatory and Quality Trends

With increasing global regulatory scrutiny, sourcing APIs from certified manufacturers becomes non-negotiable. Regulatory bodies such as the USFDA, EMA, and WHO emphasize API traceability, proper documentation, and adherence to International Conference on Harmonisation (ICH) guidelines as prerequisites for approval.

Additionally, the trend toward single-use plastic systems in sterile manufacturing amplifies the importance of API selection that guarantees stability and compatibility with plastic containers. Suppliers should provide compatibility data and stability profiles pertinent to plastic infusion bags.

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Conclusion

The search for reliable bulk API sources for Tazidime in plastic containers entails careful evaluation of supplier quality, capacity, adherence to regulatory standards, and logistical robustness. Leading producers such as Falcon Pharmaceutical, Biocon, Sandoz, ChemPartner, and Zhejiang Yuhuan represent prominent options, each with distinct strengths aligned with global pharmaceutical manufacturing demands.

Manufacturers should establish strategic partnerships with validated suppliers to secure a consistent, high-quality supply chain that supports regulatory compliance, production efficiency, and ultimately, patient safety.

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Key Takeaways

• Prioritize quality and compliance over cost to mitigate regulatory risks associated with Tazidime API sourcing.
• Evaluate supplier certifications such as WHO-GMP and cGMP to ensure adherence to international manufacturing standards.
• Assess supply chain stability and capacity for large-volume production to avoid shortages.
• Review compatibility data about API stability with plastic containers during storage and administration.
• Build long-term relationships with trusted API manufacturers to ensure continuous, compliant supply in a competitive global market.

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FAQs

1. What are the critical quality attributes to verify in Tazidime API suppliers?
Key attributes include purity (≥98%), residual solvent levels within ICH limits, sterility, endotoxin levels, and compatibility with plastic containers. Documentation of manufacturing processes and compliance certificates are essential.

2. How does regulatory compliance influence API sourcing decisions?
Regulatory compliance ensures APIs meet health authority standards, facilitating approval processes and reducing the risk of batch rejections or recalls. Certifications like WHO-GMP and cGMP are primary indicators.

3. Can regional API manufacturers in China or India reliably supply Tazidime?
Yes, many reputable manufacturers in these regions meet international standards and have extensive export experience. However, due diligence, audits, and validation are recommended before engagement.

4. What challenges exist when sourcing Tazidime API for plastic container formulations?
Challenges include ensuring API stability within plastic matrices, managing residual solvents, maintaining sterility, and preventing leaching or material interactions that could compromise drug quality.

5. How can manufacturers mitigate risks related to API supply disruptions?
Diversifying suppliers, establishing long-term contracts, maintaining safety stock, and conducting regular quality audits are effective strategies to mitigate supply chain risks.

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Sources

1. [1] U.S. Pharmacopeia. USP Monographs on Cephalosporins.
2. [2] European Pharmacopoeia. Monograph for Antibiotic APIs.
3. [3] World Health Organization. Guidance on Good Manufacturing Practices for Active Pharmaceutical Ingredients.
4. [4] Technical Data Sheets from Falcon Pharmaceutical, Biocon, Sandoz, ChemPartner, and Zhejiang Yuhuan Pharmaceutical.