Cidazo is a sterile injectable combination of Ceftazidime (250mg) and Tazobactam (31.25mg), formulated to enhance therapeutic efficacy against resistant bacterial strains. The formulation leverages Ceftazidime’s broad-spectrum coverage against Gram-negative bacteria, complemented by Tazobactam’s beta-lactamase inhibition, which preserves antibiotic activity. The product is designed for compatibility with aqueous solutions, ensuring stability during storage and reconstitution. The formulation adheres to pharmaceutical standards for solubility, pH balance, and osmolarity, ensuring consistency in manufacturing. The active pharmaceutical ingredients (APIs) are combined in a precise ratio to optimize pharmacokinetic profiles, while excipients are selected to maintain sterility and prevent degradation during storage. The vial design allows for easy reconstitution with WFI, ensuring user-friendly handling for downstream applications.
Manufacturing Capability
Our manufacturing infrastructure is engineered to meet the stringent demands of pharmaceutical production, with a focus on sterile processing and compliance with global GMP standards. The facility is equipped with advanced isolators, autoclaves, and aseptic filling lines to ensure contamination-free production. Each batch undergoes rigorous validation to maintain sterility, with dedicated cleanrooms classified at ISO 7 and ISO 5 standards. The production process includes precise API blending, filtration, and filling into vials, followed by terminal sterilization or aseptic closure. Scalability is a core strength, enabling seamless transitions from small-scale trials to large-volume commercial production. Quality systems are integrated throughout the manufacturing lifecycle, with real-time monitoring and data integrity protocols to ensure consistency and traceability.
Available Strengths and Packaging
Cidazo is available in a single strength: Ceftazidime 250mg + Tazobactam 31.25mg Injection. The product is packaged in 1 vial with WFI (Water for Injection), ensuring compatibility with reconstitution protocols and maintaining sterility during storage and transport.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing, private label production, and third-party manufacturing services tailored to pharmaceutical buyers. Our capabilities include full-cycle solutions from API sourcing to final packaging, with flexibility to meet specific regulatory and quality requirements. Clients benefit from our expertise in custom formulation development, label compliance, and scalable production for global markets. Whether seeking private-label branding or outsourced manufacturing, we provide end-to-end support while maintaining strict adherence to GMP and regulatory guidelines.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and compliance with international pharmaceutical standards. Each batch undergoes comprehensive testing, including HPLC for API quantification, microbial limit testing, and endotoxin analysis. Stability studies are conducted to ensure product integrity under varied storage conditions. Traceability is maintained through detailed batch records, with all documentation compliant with FDA, EMA, and WHO guidelines. Advanced analytical tools, such as mass spectrometry and UV spectroscopy, ensure precision in quality control. This systematic approach guarantees consistent product performance and regulatory readiness.
Regulatory Compliance
Cidazo manufacturing adheres to global GMP standards, WHO guidelines, and ISO 9001:2015 quality management systems. Our processes comply with FDA 21 CFR Part 211, EMA Good Manufacturing Practice, and ICH guidelines, ensuring alignment with international regulatory frameworks. Documentation is maintained to meet audit requirements, including batch records, deviation investigations, and validation protocols. Compliance with ISO 14644-1 for cleanroom classification and ISO 11135 for sterilization validation further reinforces our commitment to quality. These measures ensure seamless regulatory approval and market access across regions.
Global Supply Capability
With a robust international distribution network, we provide reliable bulk supply to markets worldwide. Our export capabilities are supported by advanced logistics infrastructure, including temperature-controlled shipping and customs compliance services. Bulk supply capacity is scalable to meet large-volume orders, with inventory management systems ensuring timely delivery. Supply chain reliability is guaranteed through redundant manufacturing hubs and real-time tracking systems, minimizing disruptions. Partners benefit from our ability to navigate regional regulatory landscapes and maintain consistent product availability.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our unwavering commitment to quality, regulatory compliance, and operational excellence. Our expertise in sterile injectable manufacturing, combined with global supply chain capabilities, ensures seamless integration into client operations. We offer competitive pricing without compromising on standards, supported by dedicated account management and technical support. With a proven track record of meeting stringent regulatory requirements, we empower partners to achieve market success while maintaining compliance and operational efficiency.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com to discuss customization, pricing, and logistics.
FAQs
What is the composition of Cidazo?
Cidazo contains Ceftazidime 250mg and Tazobactam 31.25mg in an injectable formulation, designed for sterile administration.
What packaging options are available for Cidazo?
The product is packaged in 1 vial with WFI (Water for Injection), ensuring compatibility with reconstitution protocols.
Can Cidazo be customized for specific regulatory requirements?
Yes, our contract manufacturing services allow customization to meet regional regulatory standards and labeling specifications.
What quality control measures are in place for Cidazo?
Each batch undergoes rigorous testing, including HPLC, microbial limit tests, and endotoxin analysis, ensuring compliance with GMP and WHO guidelines.
Is Cidazo suitable for export to international markets?
Yes, our global supply capabilities and compliance with ISO and FDA standards enable seamless export to regulated markets worldwide.
What is the shelf life of Cidazo?
The product maintains stability for up to 24 months when stored under recommended conditions (2–8°C), as validated through stability studies.
Can you provide bulk supply for large-volume orders?
Yes, our scalable manufacturing infrastructure supports bulk supply to meet high-volume demands while maintaining quality consistency.
What documentation is provided for regulatory compliance?
Full documentation, including batch records, analytical reports, and certificates of analysis, is provided to meet audit and regulatory requirements.
How do you ensure sterility during manufacturing?
Sterility is maintained through ISO-classified cleanrooms, aseptic filling lines, and terminal sterilization processes, with continuous monitoring for contamination risks.
What support is available for pharmaceutical partners?
We offer dedicated technical support, regulatory guidance, and logistics coordination to ensure smooth integration of Cidazo into client operations.
