Bulk Pharmaceutical API Sources for CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C7912_SIGMA
Sigma-Aldrich		C7039_SIGMA
NovoSeek		10695961
NovoSeek		23703285

Bulk Active Pharmaceutical Ingredient (API) Sources for Claforan in Sodium Chloride 0.9% in Plastic Container

Last updated: July 30, 2025

Introduction

The pharmaceutical industry’s reliance on robust, compliant sources of Active Pharmaceutical Ingredients (APIs) is critical to maintaining supply chain integrity, regulatory compliance, and ensuring product quality. Cefotaxime sodium, marketed as Claforan, is a third-generation cephalosporin antibiotic utilized globally for its broad-spectrum activity. Its formulation in Sodium Chloride 0.9% infusion containers demands high purity APIs sourced from validated and reputable manufacturers. This article analyzes the key API suppliers for Cefotaxime sodium, providing insights into their manufacturing profiles, compliance standards, and strategic considerations for pharmaceutical companies seeking reliable sources.

Overview of Cefotaxime Sodium API

Cefotaxime sodium is synthesized via complex chemical processes involving multiple steps to ensure high purity and stability. Its production requires strict adherence to Good Manufacturing Practices (GMP), comprehensive analytical validation, and rigorous quality control to meet pharmacopeial standards, such as USP, EP, and BP.

The API’s source is pivotal for manufacturing sterile infusions such as Claforan in Sodium Chloride 0.9%. Ensuring the API’s compliance with pharmacopeial monographs guarantees pharmaceutical efficacy, safety, and regulatory approval.

Major API Suppliers for Cefotaxime Sodium

1. Farmanguinhos / Oswaldo Cruz Foundation (Fiocruz), Brazil

• Profile: Farmanguinhos is a leading Latin American pharmaceutical manufacturer authorized to produce and export Cefotaxime sodium API.
• Capabilities: Certified GMP compliant, with extensive experience in producing sterile injectable APIs.
• Certifications: ISO 9001, ISO 13485, and ANVISA licensing.
• Strategic advantage: Long-standing reputation in South America and emerging markets; offers competitive pricing due to local manufacturing.

2. Zydus Cadila, India

• Profile: Zydus Cadila has established a robust API division specializing in cephalosporin APIs, including Cefotaxime sodium.
• Capabilities: State-of-the-art facilities with GMP compliance; extensive R&D and process optimization.
• Certifications: WHO-GMP, US FDA, and CDSCO approvals.
• Strategic advantage: Large-scale manufacturing capabilities ensure supply stability; recognized quality standards cater to both domestic and international markets.

3. Sandoz / Novartis, Switzerland

• Profile: Sandoz, a division of Novartis, is globally reputed for high-quality pharmaceuticals and active pharmaceutical ingredients.
• Capabilities: Advanced manufacturing plants with rigorous quality controls; extensive regulatory approvals in multiple jurisdictions.
• Certifications: cGMP, EMA, FDA approvals.
• Strategic advantage: Established global distribution network, consistent supply, and high standards of API purity.

4. Teva Pharmaceuticals, Israel

• Profile: Teva, a global generic pharmaceutical leader, supplies Cefotaxime sodium API through its powder division, with facilities adhering to strict quality norms.
• Capabilities: GMP-certified manufacturing plants, with a focus on sterile APIs.
• Certifications: FDA, EMA, and local regulatory licenses.
• Strategic advantage: Extensive API portfolio, reliable supply chain, and proven regulatory compliance track record.

5. Jiangsu Hengrui Pharmaceutical, China

• Profile: Hengrui is an emerging Asian API supplier with rapidly expanding capabilities in cephalosporin APIs.
• Capabilities: GMP-certified facilities; cost-competitive manufacturing.
• Certifications: China GMP, with some facilities approved by WHO and regulatory agencies.
• Strategic advantage: Cost-effective manufacturing; increasing international acceptance of Chinese pharmaceuticals.

Criteria for Selecting API Sources

When sourcing Cefotaxime sodium API, manufacturers and procurers evaluate several critical parameters:

• Regulatory compliance: GMP certification, regional approvals (FDA, EMA, WHO-GMP).
• Product purity and specifications: Consistency with pharmacopeial standards.
• Manufacturing capacity: Ability to meet demand fluctuations.
• Supply chain reliability: Proven track record of timely deliveries.
• Cost competitiveness: Balancing quality with affordability.
• Traceability and documentation: Robust documentation for regulatory audits.

Supply Chain Considerations

Given the sensitive nature of sterile APIs, companies should prioritize sourcing from suppliers with validated supply chains and transparent quality assurance processes. Establishing long-term partnerships with Tier 1 suppliers minimizes risks associated with production delays, quality deviations, and regulatory non-compliance.

Conclusion

Reliable sourcing of Cefotaxime sodium API for Claforan in Sodium Chloride 0.9% infusion formulations hinges on choosing manufacturers with proven GMP compliance, consistent quality, and robust supply chain capabilities. Leading suppliers such as Zydus Cadila, Sandoz, Teva, and Farmanguinhos provide globally recognized APIs compliant with stringent standards, ensuring the safe, effective production of sterile infusions. The strategic selection of API sources directly influences product quality, regulatory clearance, and commercial success.

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Key Takeaways

• Prioritize suppliers with GMP certification, including FDA, EMA, and WHO approvals.
• Larger, well-established manufacturers tend to offer more consistent supplies and higher quality.
• Cost considerations should balance with regulatory compliance and quality assurance.
• Establish transparent communication pathways and detailed documentation for regulatory audits.
• Emerging markets and Chinese API suppliers offer cost advantages, but due diligence is essential for quality assurance.

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FAQs

1. What are the primary factors influencing API supplier selection for Cefotaxime sodium?
Regulatory compliance, product purity, manufacturing capacity, supply chain reliability, and cost are key considerations in selecting Cefotaxime sodium API suppliers.

2. Are Chinese API manufacturers suitable for producing APIs for sterile injectables?
Yes, many Chinese API manufacturers, such as Jiangsu Hengrui, comply with GMP standards and are gaining international trust, but thorough qualification and audits are essential.

3. How do regulatory standards impact API sourcing decisions?
Regulatory standards such as FDA, EMA, and WHO-GMP ensure APIs meet quality and safety benchmarks, which is critical for approval, especially for sterile injectable formulations.

4. What role does cost play in sourcing Cefotaxime sodium API?
While cost is important, compromising on quality can lead to regulatory issues and manufacturing setbacks. Balancing cost and compliance is key to sustainable sourcing.

5. How can pharmaceutical companies mitigate risks associated with API supply disruptions?
Establishing relationships with multiple qualified suppliers, maintaining safety stock, and conducting regular supplier audits can mitigate supply chain risks.

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References

[1] United States Pharmacopeia (USP) Monograph for Cefotaxime Sodium.

[2] European Pharmacopoeia (EP) Monograph.

[3] WHO Guidelines on GMP for Cephalosporin APIs.

[4] Company websites and public regulatory submissions of Farmanguinhos, Zydus Cadila, Sandoz, Teva, and Jiangsu Hengrui.