Cefoper - S 1.5gm is a dual-component injectable formulation combining Cefoperazone (a third-generation cephalosporin) and Sulbactam (a broad-spectrum beta-lactamase inhibitor). The formulation ensures stability and solubility through precise pH adjustment and the use of water for injection (WFI) as the solvent. Cefoperazone provides coverage against Gram-positive and Gram-negative bacteria, while Sulbactam enhances its activity by inhibiting beta-lactamase enzymes, thereby extending its spectrum to resistant strains. The product is manufactured using advanced lyophilization techniques to maintain sterility and potency, with excipients selected for compatibility and minimal interference with therapeutic efficacy. The formulation’s physicochemical properties, including dissolution rate and shelf life, are optimized for consistent performance in clinical and manufacturing environments.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is designed to meet the stringent demands of injectable drug production. The facility is equipped with state-of-the-art aseptic filling and lyophilization lines, ensuring sterile processing at every stage. Production adheres to current Good Manufacturing Practices (cGMP) and includes validated processes for raw material handling, formulation, and final product packaging. The facility supports scalable production, enabling seamless transitions from small batches to bulk supply while maintaining quality consistency. Advanced quality systems, including real-time monitoring and automated data collection, ensure compliance with regulatory standards. Our infrastructure also supports customization for third-party manufacturers, allowing flexibility in formulation adjustments and packaging specifications.
Available Strengths and Packaging
Composition: Cefoperazone 1000mg + Sulbactam 500mg Inj.
Packaging: 1 vial with WFI
The product is available in a single strength of 1.5gm (1000mg Cefoperazone + 500mg Sulbactam) in a single-dose vial containing water for injection. This packaging ensures stability during storage and transport while maintaining sterility for clinical use.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers. Our capabilities include private label manufacturing, where we produce under a client’s brand name, and contract manufacturing, where we supply finished products for resale. We support customization of formulations, packaging, and labeling to meet specific market requirements. Our team collaborates closely with clients to ensure compliance with regulatory standards and to optimize production timelines. Whether you require a single product or a portfolio of injectable solutions, our scalable infrastructure and expertise in sterile manufacturing enable efficient, high-quality production for global markets.
Quality Assurance
Our quality assurance framework is built on rigorous testing and analytical validation to ensure product consistency and safety. Each batch undergoes comprehensive testing, including high-performance liquid chromatography (HPLC) for active ingredient quantification, microbial contamination checks, and particulate matter analysis. We validate critical processes such as lyophilization and filling to ensure reproducibility and adherence to specifications. All raw materials and finished products are tested for potency, purity, and stability, with documentation traceable to regulatory requirements. Our quality control systems are aligned with international standards, ensuring that every vial meets the highest benchmarks for pharmaceutical excellence.
Regulatory Compliance
We maintain full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and international standards such as ISO 9001 and ISO 14001. Our facility is certified by regulatory authorities in multiple regions, including the FDA, EMA, and PIC/S, ensuring adherence to global quality frameworks. All manufacturing processes are validated to meet regulatory expectations, and documentation is maintained to support audits and inspections. We also comply with environmental and safety regulations, ensuring sustainable and ethical production practices. This regulatory alignment positions us as a reliable supplier for markets with stringent compliance requirements.
Global Supply Capability
Our global supply chain is designed to deliver bulk pharmaceutical products to international markets with reliability and speed. We maintain a robust distribution network spanning key regions, including North America, Europe, Asia-Pacific, and Latin America, supported by strategic partnerships and logistics providers. Our bulk supply capacity is scalable to meet large-volume orders, with inventory management systems ensuring timely delivery. We prioritize supply chain resilience through diversified sourcing and localized storage solutions, minimizing delays and ensuring uninterrupted access to critical medications. Our commitment to compliance and quality ensures that products meet regional regulatory standards, enabling seamless export and global market entry.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in sterile injectable production, regulatory compliance, and scalable manufacturing. Our facility’s advanced infrastructure and adherence to GMP standards ensure consistent, high-quality output, while our global supply network enables efficient distribution. We offer tailored solutions, from private-label manufacturing to bulk supply agreements, with competitive pricing and transparent communication. Our commitment to innovation, sustainability, and customer satisfaction positions us as a strategic partner for businesses seeking reliable, compliant pharmaceutical solutions.
Bulk Supply Inquiry
We provide bulk supply capabilities for Cefoper - S 1.5gm, supporting large-volume orders for global markets. For inquiries, contact our team at info@delwishealthcare.com to discuss customization, pricing, and supply timelines.
FAQs
What manufacturing standards does Cefoper - S 1.5gm adhere to?
Our product is manufactured under cGMP guidelines, with compliance to WHO, FDA, and ISO standards, ensuring quality and safety.
Can the product be customized for specific packaging requirements?
Yes, we offer flexible packaging options, including vial sizes and labeling, to meet client specifications.
What is the shelf life of Cefoper - S 1.5gm?
The product has a shelf life of 24 months when stored under recommended conditions (2–8°C).
Is the product suitable for export to international markets?
Yes, our compliance with global regulatory frameworks enables seamless export to regions with stringent quality standards.
What quality control measures are in place for batch testing?
Each batch undergoes HPLC, microbial testing, and particulate analysis to ensure potency, purity, and sterility.
Can you provide bulk supply for large-volume orders?
Yes, our scalable production capacity supports bulk supply for global pharmaceutical buyers.
What is the minimum order quantity for Cefoper - S 1.5gm?
Minimum order quantities are customizable based on client needs and production schedules.
How do you ensure supply chain reliability?
We maintain a diversified distribution network and localized storage solutions to ensure timely, uninterrupted supply.
Can you assist with regulatory documentation for international markets?
Yes, our team provides compliance support, including documentation for FDA, EMA, and other regulatory bodies.
What is the typical lead time for production and delivery?
Lead times vary based on order volume and customization requirements, but we prioritize efficient timelines to meet client deadlines.
