Cefox 500 is a pharmaceutical formulation containing cefuroxime axetil as the active ingredient, designed for oral administration. The tablet formulation incorporates cefuroxime axetil, a prodrug of cefuroxime, which is metabolized in the gastrointestinal tract to release the active antibiotic. The excipients include microcrystalline cellulose, lactose monohydrate, magnesium stearate, and colloidal silicon dioxide, ensuring optimal tablet integrity, disintegration, and dissolution performance. The DPCO (Dissolution Performance Classification for Oral) classification ensures consistent bioavailability and therapeutic efficacy. The formulation is developed using advanced pharmaceutical techniques to achieve uniform content, robust stability, and compatibility with packaging materials. The manufacturing process emphasizes precise blending, compression, and coating (if applicable) to meet quality and safety standards for bulk supply.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001:2015 standards. The production line for Cefox 500 includes high-precision tablet compression machines, automated blending systems, and advanced quality control instrumentation. Sterile processing capabilities are maintained through aseptic manufacturing protocols where required, ensuring contamination-free production. The facility adheres to strict GMP guidelines, with dedicated areas for raw material handling, formulation, packaging, and storage. Production scalability is achieved through modular design and flexible manufacturing systems, enabling seamless transitions from small-scale trials to large-volume bulk supply. Comprehensive quality systems, including validated process controls and real-time monitoring, ensure consistency and compliance across all stages of manufacturing.
Available Strengths and Packaging
Cefox 500 is available in a single strength of 500mg, formulated as a tablet for oral administration. The packaging specification is 10x1x10 Alu Alu, which refers to a blister pack containing 10 strips, each with 1 tablet enclosed in an aluminum-aluminum blister. This packaging format ensures product protection from moisture, light, and contamination while facilitating easy dispensing and storage. The design supports compliance with pharmaceutical packaging regulations and enhances shelf-life stability.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive third-party manufacturing services, including private label production and contract manufacturing for pharmaceutical buyers. Our facility is equipped to produce Cefox 500 under the client’s brand name or as a private-label product, ensuring full regulatory compliance and quality assurance. We support customization of packaging, labeling, and dosage forms to meet specific market requirements. Our contract manufacturing capabilities extend to bulk supply for global distribution, with flexibility to scale production based on demand. We provide end-to-end solutions, from raw material sourcing to finished product delivery, ensuring seamless integration with clients’ supply chains.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to international pharmaceutical standards. Each production batch undergoes comprehensive testing for identity, purity, potency, and dissolution performance to ensure compliance with pharmacopeial standards (e.g., USP, EP). Advanced analytical techniques, including HPLC and UV spectrophotometry, are employed for quantitative and qualitative assessment. Quality control systems are integrated with real-time data monitoring to detect deviations during manufacturing. Batch records are meticulously maintained, and stability studies are conducted to validate shelf-life claims. All processes are validated to ensure consistency, and corrective actions are implemented promptly to maintain product integrity.
Regulatory Compliance
We ensure full compliance with global regulatory frameworks, including cGMP, WHO guidelines, and ISO standards. Our manufacturing processes adhere to ICH (International Council for Harmonisation) guidelines, ensuring alignment with international quality expectations. The facility is certified under ISO 9001:2015 and maintains documentation for audits by regulatory authorities. Compliance with FDA, EMA, and other regional guidelines is prioritized to facilitate smooth export and market entry. All products are manufactured with traceability systems to meet regulatory requirements for batch tracking and recall management.
Global Supply Capability
Our global supply capability is supported by an extensive international distribution network and robust logistics infrastructure. We offer bulk supply options tailored to meet the needs of pharmaceutical distributors, exporters, and contract manufacturers worldwide. The 10x1x10 Alu Alu packaging format is optimized for efficient storage, transportation, and retail distribution. Our supply chain is designed for reliability, with contingency planning to ensure uninterrupted delivery even in challenging conditions. We support export to over 50 countries, with compliance documentation and customs clearance assistance to streamline international trade.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in bulk supply, regulatory compliance, and scalable production. Our facility’s adherence to cGMP and ISO standards ensures product quality and market readiness. We provide competitive pricing, timely delivery, and customized solutions to meet diverse business needs. Our commitment to innovation and quality assurance positions us as a reliable partner for global pharmaceutical markets.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our team at info@delwishealthcare.com.
FAQs
What is the active ingredient in Cefox 500?
Cefox 500 contains cefuroxime axetil as the active ingredient, a prodrug of cefuroxime, formulated for oral administration.
What is the packaging format for Cefox 500?
The product is packaged in 10x1x10 Alu Alu blister packs, ensuring protection from environmental factors and ease of use.
Can Cefox 500 be manufactured under private label?
Yes, we offer private label manufacturing services, allowing clients to brand the product under their own name.
What regulatory standards does Cefox 500 comply with?
The product adheres to cGMP, WHO guidelines, ISO 9001:2015, and pharmacopeial standards (USP, EP) for global market access.
Is bulk supply available for Cefox 500?
Yes, we provide bulk supply options tailored to meet the requirements of pharmaceutical distributors and exporters.
What quality control measures are in place for Cefox 500?
Each batch undergoes rigorous testing for identity, purity, potency, and dissolution, with compliance verified through HPLC and UV spectrophotometry.
Can Cefox 500 be produced for export markets?
Yes, our facility is equipped to manufacture and export Cefox 500 to over 50 countries, with compliance documentation for international trade.
How does your manufacturing process ensure scalability?
Our modular production systems and flexible manufacturing infrastructure enable seamless scaling from small to large volumes.
What is the shelf life of Cefox 500?
The product’s shelf life is validated through stability studies, ensuring compliance with pharmacopeial requirements for storage and expiration.
How can I request a bulk supply of Cefox 500?
For bulk supply inquiries, please contact us at **info@delwishealthcare.com**.
