Ceftidel - S 1.5gm is a sterile, ready-to-use injectable formulation combining Ceftriaxone (1gm) and Sulbactam (500mg) in a single vial. The formulation leverages advanced pharmaceutical engineering to ensure compatibility, stability, and optimal solubility of the active ingredients. Ceftriaxone, a third-generation cephalosporin, is combined with Sulbactam, a beta-lactamase inhibitor, to enhance antibiotic efficacy against beta-lactamase-producing pathogens. The product is prepared using purified water for injection (WFI) to maintain sterility and prevent degradation of the active pharmaceutical ingredients (APIs). The formulation process involves precise blending, filtration, and aseptic filling to meet stringent quality standards. The resulting product exhibits a neutral pH, ensuring compatibility with intravenous administration and minimizing patient-related adverse effects. The combination of APIs is designed to provide a broad-spectrum antibacterial profile, making it suitable for use in hospital and clinical settings requiring rapid therapeutic intervention.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities designed to produce high-quality injectable pharmaceuticals. The facility adheres to current Good Manufacturing Practices (cGMP) and employs advanced sterile processing technologies, including isolator systems and laminar airflow workstations, to ensure product sterility. The production line is capable of handling large-scale manufacturing while maintaining consistency in formulation and quality. Our facility is certified under ISO 9001 and ISO 14001 standards, reflecting our commitment to quality management and environmental sustainability. The production process includes rigorous validation of equipment, processes, and materials to ensure compliance with regulatory requirements. Scalability is a core strength, with the ability to adjust production volumes to meet global demand without compromising product integrity. Additionally, our quality systems include real-time monitoring, automated data collection, and comprehensive documentation to support traceability and regulatory audits.
Available Strengths and Packaging
Composition: Ceftriaxone 1gm + Sulbactam 500mg Inj. (DPCO)
Packaging: 1 vial with WFI
Ceftidel - S 1.5gm is available in a single vial formulation containing 1gm of Ceftriaxone and 500mg of Sulbactam, dissolved in WFI. The vial is designed for single-dose administration, ensuring optimal stability and sterility. The packaging is engineered to meet global pharmaceutical standards, with a focus on safety, ease of use, and compliance with regulatory requirements.
Contract Manufacturing / Third Party Manufacturing
As a leading manufacturer, we offer comprehensive contract manufacturing, private label, and third-party manufacturing services tailored to the needs of pharmaceutical buyers. Our capabilities include formulation development, API sourcing, and full-scale production of injectable products, ensuring flexibility in branding and packaging. We support clients in navigating regulatory landscapes by providing documentation compliant with GMP, WHO, and ISO standards. Our team of experts collaborates closely with clients to design customized solutions, from small-scale trials to large-volume commercial production. Whether you require a private label product or a turnkey manufacturing partnership, we deliver scalable, cost-effective solutions that align with your business goals.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to international pharmaceutical standards. Every batch of Ceftidel - S 1.5gm undergoes comprehensive testing, including HPLC (High-Performance Liquid Chromatography) for API quantification, microbial limit testing, and particulate matter analysis. We employ advanced spectroscopic techniques to ensure the purity and potency of the active ingredients. The product is validated against pharmacopoeial standards (USP, EP, BP) to guarantee consistency and safety. Our quality control systems are integrated with real-time data monitoring and automated reporting to ensure transparency and traceability. Additionally, we conduct stability studies to determine shelf life and storage conditions, ensuring product efficacy throughout the supply chain.
Regulatory Compliance
Ceftidel - S 1.5gm is manufactured in full compliance with GMP, WHO guidelines, and ISO 9001/14001 standards. Our facility is registered with regulatory authorities in multiple jurisdictions, including the FDA, EMA, and WHO, ensuring global market access. The product meets the requirements of ICH (International Council for Harmonisation) guidelines for quality, safety, and efficacy. All documentation, including batch records, analytical reports, and stability data, is prepared in accordance with regulatory expectations. Our compliance framework extends to environmental and safety standards, ensuring sustainable manufacturing practices. By adhering to these global benchmarks, we provide pharmaceutical buyers with confidence in the product’s regulatory standing and market readiness.
Global Supply Capability
We specialize in bulk supply and international distribution, with a robust network spanning over 50 countries. Our export capabilities are supported by strategic partnerships with logistics providers, ensuring timely and secure delivery of products to global markets. The facility is equipped to handle large-volume orders, with a minimum order quantity (MOQ) tailored to meet the needs of distributors and exporters. Our supply chain is designed for reliability, with redundant systems to mitigate disruptions and ensure continuous availability. We offer flexible packaging options and customized shipping solutions to accommodate diverse market requirements. Whether you need short-term supply or long-term contracts, our global supply capability ensures seamless integration into your distribution network.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in high-quality injectable production, regulatory compliance, and global supply chain management. Our commitment to GMP standards, advanced manufacturing technologies, and sustainability practices ensures that your products meet the highest quality benchmarks. We provide end-to-end solutions, from formulation to global distribution, enabling you to focus on market expansion and customer satisfaction. Our scalable production capacity and cost-effective manufacturing model allow you to optimize operational efficiency while maintaining product integrity. By partnering with us, you gain access to a reliable, compliant, and innovative manufacturer dedicated to your success.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our team at info@delwishealthcare.com. Our dedicated sales and technical support team is available to assist with order placement, customization, and regulatory documentation.
FAQs
What is the manufacturing process for Ceftidel - S 1.5gm?
Ceftidel - S 1.5gm is manufactured using aseptic filling technology, with Ceftriaxone and Sulbactam dissolved in WFI. The formulation undergoes rigorous sterility testing and quality control to ensure product safety and efficacy.
Is Ceftidel - S 1.5gm compliant with GMP and WHO standards?
Yes, our manufacturing facility is certified under GMP, ISO 9001, and WHO guidelines. All production processes and documentation meet international regulatory requirements.
What are the packaging specifications for Ceftidel - S 1.5gm?
The product is packaged in a single vial containing 1gm Ceftriaxone and 500mg Sulbactam, dissolved in WFI. The vial is designed for single-dose administration and meets global pharmaceutical packaging standards.
Can Ceftidel - S 1.5gm be customized for private label manufacturing?
Yes, we offer private label manufacturing services, allowing clients to brand the product under their own label while maintaining compliance with regulatory standards.
What is the minimum order quantity for bulk supply?
Our minimum order quantity is flexible and tailored to meet the needs of distributors and exporters. Please contact us for customized bulk supply options.
How does your quality assurance process ensure product consistency?
Every batch undergoes rigorous testing, including HPLC, microbial limit testing, and stability studies. Our quality control systems ensure consistency in potency, purity, and sterility.
Can you support export to international markets?
Yes, we have a global distribution network and regulatory expertise to support exports to over 50 countries. Our compliance framework ensures seamless market access.
What documentation is provided for regulatory compliance?
We provide complete documentation, including batch records, analytical reports, and regulatory filings, to support compliance with FDA, EMA, and WHO requirements.
How do you ensure supply chain reliability?
Our supply chain is designed with redundant systems and strategic partnerships to ensure timely delivery. We offer flexible shipping solutions and real-time tracking for order transparency.
Can you handle contract manufacturing for other formulations?
Yes, we offer contract manufacturing services for a wide range of injectable formulations. Our team collaborates closely with clients to develop customized solutions.
