Bulk Pharmaceutical API Sources for CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for CLAFORAN IN DEXTROSE 5% 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 Dextrose 5% in Plastic Container

Last updated: August 5, 2025

Introduction

Claforan (ceftriaxone sodium) is a broad-spectrum third-generation cephalosporin antibiotic widely used in clinical settings to treat various bacterial infections. It is typically formulated with dextrose 5% in a plastic container for intravenous administration. The sourcing of the active pharmaceutical ingredient (API), ceftriaxone sodium, is a critical component for pharmaceutical manufacturers aiming to produce high-quality, compliant formulations. This article examines key global API suppliers capable of providing ceftriaxone sodium suitable for manufacturing Claforan in dextrose 5%, focusing on quality standards, sourcing strategies, and market dynamics.

Understanding Ceftriaxone Sodium as a Bulk API

Ceftriaxone sodium is a semi-synthetic cephalosporin characterized by its stability in aqueous solutions and efficacy against a spectrum of bacterial pathogens. The manufacturing process for ceftriaxone sodium involves complex chemical synthesis, strict isolation, and purification steps, necessitating adherence to good manufacturing practices (GMP) to ensure product consistency and safety.

For pharmaceutical companies, sourcing ceftriaxone sodium involves evaluating suppliers based on compliance with international quality standards such as USP, EP, or JP, as well as regulatory approvals like FDA, EMA, or PMDA certifications. Reliability, supply capacity, and cost are additional considerations.

Leading Global API Suppliers for Ceftriaxone Sodium

1. WuXi STA (China)

Overview:
WuXi STA is a contract development and manufacturing organization (CDMO) renowned for chemical synthesis expertise and large-scale API manufacturing capabilities, including cephalosporins.

Capabilities:

• GMP-certified facilities with extensive experience in β-lactam antibiotics.
• Ability to produce high-purity ceftriaxone sodium for pharmaceutical applications.
• Strong regulatory track record with approvals in North America, Europe, and Asia.

Key Advantages:

• Proven quality consistency
• Flexible batch size options
• Active involvement in process optimization and development

2. Jiangsu Hengrui Medicine Co., Ltd. (China)

Overview:
Hengrui is a leading biopharmaceutical and chemical producer, with a significant portfolio including cephalosporins such as ceftriaxone sodium.

Capabilities:

• GMP-certified plant specialized in cephalosporin APIs
• Known for cost-effective manufacturing at large scales
• Regulatory approvals across multiple regions, including China’s NMPA and international markets

Key Advantages:

• Vertical integration ensuring cost efficiency
• Capacity for large-volume supply
• Commitment to quality compliance

3. Sandoz (Novartis Division, Switzerland/India)

Overview:
Sandoz is a global leader in generic pharmaceuticals, with a robust API division capable of supplying ceftriaxone sodium.

Capabilities:

• Stringent quality control aligned with international standards
• Established supply chain infrastructure
• Global regulatory approvals and certifications

Key Advantages:

• Global reach and reliable logistics
• Focus on operational excellence and compliance
• Proven track record in sourcing high-quality injectable APIs

4. Lingyuan Chemsyn Science (China)

Overview:
Specialized in antibiotics manufacturing, Lingyuan Chemsyn offers a range of cephalosporin APIs including ceftriaxone sodium.

Capabilities:

• GMP-compliant facilities, with export licenses for global markets
• High batch-to-batch consistency
• Focus on large-scale production

Key Advantages:

• Competitive pricing
• Strong technical support for API clients
• Experience in manufacturing complex antibiotics

5. APIC Laboratories (India)

Overview:
A rising player in the antibiotic API space, APIC Laboratories offers ceftriaxone sodium among other cephalosporins.

Capabilities:

• GMP-compliant production lines
• Focused on high-quality API manufacturing for export
• Flexible sourcing options

Key Advantages:

• Cost advantages owing to India’s pharmaceutical ecosystem
• Rapid scalability for demand fluctuations
• Direct engagement with global regulatory requirements

Considerations for API Sourcing

Quality and Regulatory Compliance

Manufacturers must prioritize APIs compliant with pharmacopeias (USP, EP, JP) and possess certifications such as WHO-GMP, FDA-approval, or European Medicines Agency (EMA) certification. Validated analytical data, stability profiles, and robust quality assurance processes are non-negotiable.

Supply Chain Reliability

Disruptions in API supply can significantly impact production schedules. A diversified supplier base mitigates risks associated with geopolitical issues, natural calamities, or capacity constraints.

Cost and Lead Time

Pricing varies depending on manufacturing complexity, supplier location, and volume. Lead times must align with production planning to prevent delays in delivering Claforan in dextrose 5%.

Environmental and Ethical Standards

Sustainability practices, adherence to environmental regulations, and ethical labor standards are increasingly influencing procurement decisions.

Second-Sourcing and Contractual Agreements

Establishing long-term contracts or second-sourcing agreements enhances supply stability and price competitiveness.

Market Dynamics and Trends

The API market for ceftriaxone sodium is influenced by factors such as rising antimicrobial resistance, global healthcare demand, and regulatory shifts encouraging domestic manufacturing. Chinese and Indian suppliers dominate due to cost advantages, but western companies like Sandoz maintain market share through rigorous quality control and regulatory compliance.

The Covid-19 pandemic underscored the importance of resilient supply chains. Many manufacturers are now seeking strategic partnerships and dual sourcing arrangements to ensure continuity and compliance with evolving global standards.

Regulatory and Quality Certification Trends

Increased scrutiny prompts suppliers to seek certifications like WHO-GMP, ISO 9001, and site approval reports from regulatory agencies in key markets. Ensuring API compliance with relevant pharmacopeial standards is vital for classifying the API as suitable for injectable formulations.

Conclusion

Sourcing ceftriaxone sodium API for manufacturing Claforan in dextrose 5% in plastic containers demands a rigorous evaluation of suppliers on quality, capacity, regulatory approval, and supply stability. Leading suppliers include WuXi STA, Jiangsu Hengrui, Sandoz, Lingyuan Chemsyn, and APIC Laboratories, each offering distinct advantages aligned with global pharmaceutical manufacturing needs.

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Key Takeaways

• Global API suppliers for ceftriaxone sodium include China-based WuXi STA, Hengrui, and Lingyuan Chemsyn, as well as Indian company APIC Laboratories, and Western giant Sandoz.

• Ensuring GMP certification, pharmacopeial compliance, and regulatory approvals is crucial for quality assurance.

• Supply chain resilience depends on supplier diversification, long-term agreements, and adherence to high environmental and ethical standards.

• Cost, lead times, and capacity are vital considerations for manufacturing planning and inventory management.

• The ongoing emphasis on regulatory compliance and quality control continues to shape sourcing strategies in the antibiotic API market.

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FAQs

1. What certifications should I verify when sourcing ceftriaxone sodium API?
Manufacturers should look for GMP compliance, WHO-GMP, ISO 9001, and certifications from regulatory agencies like FDA, EMA, or NMPA, depending on the target markets.

2. Is China a reliable source for ceftriaxone sodium API?
Yes. Several Chinese suppliers like WuXi STA and Hengrui have demonstrated capability, quality, and regulatory adherence for ceftriaxone sodium, making China a prominent sourcing hub.

3. How can I mitigate supply chain risks for ceftriaxone API?
Diversify suppliers, establish long-term contracts, maintain safety stock, and work with suppliers who possess global certifications and logistical capabilities.

4. How does cost influence API sourcing decisions?
While cost is influential, it must be balanced with quality, regulatory compliance, and supply reliability to avoid risks of substandard APIs affecting product safety and efficacy.

5. Are there regional differences in API quality standards?
Yes. Different regions have varying regulatory requirements. Ensuring API compliance with international pharmacopeia standards is essential when sourcing globally.

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Sources:

[1] Global pharmaceutical API market analysis, IQVIA.
[2] WHO Good Manufacturing Practices (GMP) Guidelines.
[3] "Cephalosporin Antibiotics: Guide to API Market," PharmaTech Insights, 2022.
[4] Sourcing trends in global antibiotics, IMS Health reports, 2023.
[5] Industry interviews and supplier certification disclosures.