Ceftidel - S 375

Ceftidel - S 375 is a sterile injectable formulation combining Ceftriaxone (250mg) and Sulbactam (125mg) in a single vial, dissolved in Water for Injection (WFI). The combination leverages Ceftriaxone’s broad-spectrum activity against Gram-positive and Gram-negative bacteria, augmented by Sulbactam’s beta-lactamase inhibition, enhancing efficacy against resistant strains. The formulation is designed for stability under sterile conditions, ensuring consistent potency and safety for pharmaceutical applications. The injectable form facilitates rapid absorption and systemic distribution, making it suitable for intravenous or intramuscular administration. The use of WFI ensures compatibility with infusion systems and minimizes the risk of particulate matter, aligning with pharmaceutical standards for injectable products.

Manufacturing Capability

Our manufacturing infrastructure is built to meet the rigorous demands of pharmaceutical production, with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP). The sterile processing capability includes ISO Class 7 and Class 8 cleanrooms, equipped with advanced aseptic filling lines for injectable products. The facility supports scalable production, enabling seamless transitions from small batches to bulk supply while maintaining quality consistency. Automated systems ensure precision in formulation, while real-time monitoring and data integrity protocols uphold compliance with regulatory standards. Quality systems include validated cleaning procedures, environmental monitoring, and robust documentation to ensure traceability and adherence to pharmaceutical excellence.

Available Strengths and Packaging

Composition: Ceftriaxone 250mg + Sulbactam 125mg Inj.

Packaging: 1 vial with WFI

The product is available in a single strength, optimized for pharmaceutical manufacturers requiring standardized dosing. The 1-vial packaging with Water for Injection (WFI) ensures stability during storage and transport, while minimizing contamination risks. This formulation is ideal for bulk supply and distribution, supporting efficient inventory management and compliance with regulatory packaging standards.

Contract Manufacturing / Third Party Manufacturing

As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers’ needs. Our private label manufacturing capabilities allow clients to brand products under their own trademarks while maintaining compliance with global standards. We support contract manufacturing for injectable antibiotics, ensuring adherence to cGMP, ISO, and WHO guidelines. Our flexible production model accommodates custom specifications, including dosage forms, packaging, and labeling, enabling pharmaceutical companies to meet market demands without compromising quality.

Quality Assurance

Our quality assurance framework is designed to ensure consistency, safety, and efficacy in every batch of Ceftidel - S 375. Rigorous batch testing includes physicochemical analysis, microbial limit testing, and endotoxin detection to meet international standards. Analytical validation methods such as High-Performance Liquid Chromatography (HPLC) and UV spectrophotometry confirm potency and purity. Each product undergoes stability testing to ensure shelf-life compliance, while documentation adheres to ICH, USP, and EP guidelines. Our quality control systems are integrated with real-time data monitoring, ensuring transparency and traceability for pharmaceutical buyers.

Regulatory Compliance

Ceftidel - S 375 is manufactured in full compliance with cGMP, WHO guidelines, ISO 9001:2015, and regional regulatory frameworks such as FDA, EMA, and PIC/S. Our facility is certified for pharmaceutical production, with regular audits to maintain compliance with international standards. All documentation, including batch records, stability data, and analytical reports, is prepared in accordance with ICH Q7 and USP requirements. This ensures seamless regulatory approval processes for global markets, supporting pharmaceutical manufacturers in meeting export and distribution obligations.

Global Supply Capability

With a robust international distribution network, we provide reliable bulk supply to markets across Asia, Africa, Latin America, and Europe. Our export capability is supported by logistics partnerships that ensure timely delivery of pharmaceutical products, adhering to customs and regulatory requirements. The facility’s production scalability allows for large-scale manufacturing to meet bulk supply demands, while our quality assurance systems guarantee product integrity during transit. We prioritize supply chain reliability through contingency planning, inventory management, and real-time tracking, ensuring uninterrupted access to pharmaceutical buyers worldwide.

Why Choose Us

Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our commitment to excellence, compliance, and scalability. As a manufacturer and supplier, we offer competitive pricing, rapid turnaround, and customized solutions to meet diverse market needs. Our adherence to global standards ensures regulatory approval and market access, while our dedicated support team provides guidance on compliance, packaging, and logistics. By partnering with us, buyers gain access to a reliable source of high-quality injectable antibiotics, backed by proven quality systems and a proven track record in the pharmaceutical industry.

Bulk Supply Inquiry

We offer bulk supply capabilities for Ceftidel - S 375, tailored to meet the needs of pharmaceutical manufacturers and distributors. For inquiries regarding bulk orders, specifications, or export requirements, please contact us at info@delwishealthcare.com.

FAQs

1. What manufacturing standards does Ceftidel - S 375 comply with?

   Ceftidel - S 375 is manufactured in compliance with cGMP, WHO guidelines, ISO 9001:2015, and regional regulatory frameworks, ensuring adherence to global pharmaceutical standards.

2. Can Ceftidel - S 375 be produced in bulk for export?

   Yes, our facility supports scalable production for bulk supply, with export capabilities to over 50 countries, ensuring timely delivery and compliance with international regulations.

3. What is the shelf life of Ceftidel - S 375?

   The product has a shelf life of 24 months when stored under recommended conditions, as confirmed through stability testing and regulatory compliance.

4. Does the packaging meet pharmaceutical safety standards?

   The 1-vial packaging with Water for Injection (WFI) ensures stability, sterility, and compliance with pharmaceutical packaging regulations.

5. Can Ceftidel - S 375 be customized for private label manufacturing?

   Yes, we offer private label manufacturing services, allowing clients to brand the product under their own trademark while maintaining quality and compliance.

6. What quality control measures are in place for batch testing?

   Each batch undergoes rigorous testing, including HPLC, microbial limit tests, endotoxin detection, and potency analysis, ensuring compliance with ICH and USP standards.

7. How does your supply chain ensure reliability for global distribution?

   Our logistics partnerships and real-time tracking systems ensure timely delivery, while contingency planning and inventory management guarantee uninterrupted supply.

8. What documentation is provided for regulatory compliance?

   Comprehensive documentation, including batch records, stability data, analytical reports, and compliance certificates, is provided to meet regulatory and audit requirements.

9. Can you accommodate custom packaging specifications?

   Yes, we support custom packaging solutions, including labeling, dosage form adjustments, and packaging materials, to meet specific client requirements.

10. How do you ensure traceability and batch integrity?

    Traceability is ensured through validated documentation, real-time data monitoring, and batch-specific records, supporting compliance and quality assurance for pharmaceutical buyers.