Cefox Dry Syrup is a sterile, dry syrup formulation containing cefuroxime axetil as the active ingredient, equivalent to 125mg of cefuroxime. The product is formulated using high-purity excipients and water for injection (WFI) to ensure stability, compatibility, and shelf-life extension. The formulation is designed for ease of reconstitution, with a focus on maintaining the chemical integrity of cefuroxime axetil during storage and preparation. The dry syrup format minimizes microbial contamination risks while ensuring consistent dosing accuracy. From a manufacturing perspective, the formulation leverages advanced excipient compatibility testing and process validation to meet pharmaceutical grade standards. The product’s physicochemical properties, including pH stability and solubility, are optimized for compatibility with various reconstitution media, ensuring versatility in clinical and industrial applications.
Manufacturing Capability
Our manufacturing infrastructure is built on ISO 9001 and ISO 17025-certified facilities, equipped with state-of-the-art equipment for sterile processing, high-speed mixing, and precision packaging. The facility adheres to current Good Manufacturing Practices (cGMP) and maintains a Class 10,000 cleanroom environment for dry syrup production, ensuring microbial and particulate control. The manufacturing process includes rigorous process validation, including stability testing, homogeneity analysis, and dissolution profiling, to guarantee product consistency. Scalability is achieved through modular production lines capable of handling bulk supply demands without compromising quality. Quality systems are integrated throughout the manufacturing lifecycle, with real-time monitoring and automated data collection to ensure traceability and compliance.
Available Strengths and Packaging
Composition: Cefuroxime Axetil equivalent to Cefuroxime 125mg
Packaging: 30 ml Dry Syrup with WFI
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer end-to-end contract manufacturing services, including private label production, third-party manufacturing, and API-based formulation development. Our capabilities extend to custom packaging solutions, label compliance, and regulatory documentation support, enabling pharmaceutical buyers to meet regional and international market requirements. We provide flexible manufacturing options, including small-batch trials and large-scale production, with full transparency on raw material sourcing, process parameters, and quality control metrics. Our team collaborates closely with clients to align formulations with specific therapeutic needs, ensuring compliance with local regulatory frameworks while maintaining cost-efficiency and scalability.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch-specific testing, and adherence to pharmacopeial standards. Each batch undergoes comprehensive testing for identity, potency, purity, and microbial limits, using advanced techniques such as HPLC, UV spectrophotometry, and microbial culture analysis. Quality control systems are integrated with automated data integrity protocols to ensure traceability and audit readiness. We maintain a robust analytical validation program, including method development, validation, and routine performance qualification, to ensure accuracy and reproducibility. Compliance with USP, EP, and BP standards is a core component of our quality assurance strategy, ensuring product suitability for global markets.
Regulatory Compliance
We ensure full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and ISO 17025 standards for laboratory accreditation. Our manufacturing processes align with regulatory requirements from the FDA, EMA, and PIC/S, enabling seamless export to over 150 countries. We maintain detailed documentation for regulatory submissions, including batch records, stability data, and deviation investigations, to support audits and inspections. Our quality management system (QMS) is continuously updated to reflect evolving global standards, ensuring regulatory alignment for both domestic and international markets.
Global Supply Capability
With a proven track record in global pharmaceutical exports, we offer reliable bulk supply capabilities through a well-established international distribution network. Our logistics partners ensure timely delivery to key markets in Asia, Africa, Latin America, and Europe, with compliance to import regulations and customs protocols. We support both small and large-scale orders, with flexible packaging options and storage conditions tailored to regional requirements. Our supply chain is designed for resilience, with redundant inventory management and real-time tracking systems to minimize delays and ensure product availability.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our combination of regulatory compliance, scalable production, and global supply expertise. Our commitment to quality ensures products meet stringent market requirements, reducing time-to-market and compliance risks. As a manufacturer, we offer competitive pricing without compromising on standards, supported by a dedicated account management team. Our ability to deliver bulk supply with consistent quality and timely delivery positions us as a strategic partner for businesses seeking reliable, compliant pharmaceutical solutions.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our sales team at info@delwishealthcare.com.
FAQs
What is the active ingredient in Cefox Dry Syrup?
The active ingredient is cefuroxime axetil, equivalent to 125mg of cefuroxime.
Is Cefox Dry Syrup suitable for sterile compounding?
Yes, the dry syrup format is designed for sterile reconstitution and is compatible with aseptic processing.
What regulatory standards does Cefox Dry Syrup comply with?
The product adheres to GMP, WHO guidelines, ISO 17025, and regional pharmacopeial standards.
Can Cefox Dry Syrup be customized for private label manufacturing?
Yes, we offer private label manufacturing services with full regulatory documentation support.
What is the shelf life of Cefox Dry Syrup?
The shelf life is typically 24 months when stored under recommended conditions.
Does the product support bulk export to multiple countries?
Yes, our global supply network enables export to over 150 countries with compliance to local import regulations.
What quality control measures are in place for batch testing?
Each batch undergoes identity, potency, purity, and microbial testing using HPLC and UV spectrophotometry.
Can you accommodate small-scale production trials?
Yes, we support small-batch trials for product validation and market entry.
What is the packaging format for Cefox Dry Syrup?
The product is packaged in 30 ml dry syrup vials with WFI, ensuring stability and sterility.
How do you ensure supply chain reliability?
Our logistics network includes real-time tracking, redundant inventory management, and compliance with global customs protocols.
