Cefox CV is a dual-component antibiotic formulation combining Cefuroxime Axetil, a prodrug of the second-generation cephalosporin Cefuroxime, with Potassium Clavulanate, a beta-lactamase inhibitor. The tablet formulation ensures stable delivery of both active ingredients, leveraging excipients such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide to achieve uniformity, disintegration, and dissolution profiles. The manufacturing process involves precise blending of the active pharmaceutical ingredients (APIs) with excipients, followed by compression into tablets using high-speed tabletting machines. The formulation is designed to maintain chemical stability under standard storage conditions (25°C ± 5°C, 60% ± 10% RH) and to ensure consistent bioavailability. The combination of Cefuroxime Axetil and Clavulanate enhances efficacy against beta-lactamase-producing pathogens, making it suitable for pharmaceutical applications requiring broad-spectrum coverage.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is equipped to produce Cefox CV with precision and scalability, adhering to stringent GMP standards. The facility includes ISO-classified cleanrooms, automated blending systems, and high-speed tablet presses capable of handling large-scale production. Sterile processing capabilities are maintained through validated HVAC systems and controlled environmental parameters to prevent contamination. The manufacturing process incorporates advanced quality control measures, including in-process testing for particle size, moisture content, and API uniformity. Production scalability is ensured through modular design and flexible manufacturing lines, allowing seamless transitions between batch sizes. Quality systems are supported by ISO 9001 certification, validated process validation protocols, and continuous monitoring of critical quality attributes (CQAs) to guarantee product consistency and compliance.
Available Strengths and Packaging
Composition: Cefuroxime Axetil 500mg + Potassium Clavulanate 125mg Tab
Packaging: 10x1x6 Alu Alu
Cefox CV is available in a standardized tablet strength of 500mg Cefuroxime Axetil combined with 125mg Potassium Clavulanate. The packaging format of 10x1x6 Alu Alu denotes a blister pack containing 10 tablets per blister, with 1 blister per box, and 6 boxes per carton. This packaging design ensures tamper-evident protection, moisture resistance, and ease of distribution. The aluminum blister material provides optimal barrier properties, safeguarding the product from light, humidity, and physical damage during storage and transport.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers’ needs. Our capabilities include private label manufacturing, where we produce branded formulations under a client’s proprietary name, and contract manufacturing for generic pharmaceutical products. We support customization of dosage forms, packaging, and labeling to meet specific regulatory and market requirements. Our team collaborates with global clients to ensure compliance with local and international standards, including FDA, EMA, and WHO guidelines. With expertise in bulk production and flexible manufacturing lines, we provide scalable solutions for both small-scale trials and large-volume commercialization.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to pharmaceutical quality standards. Every production batch undergoes comprehensive testing, including high-performance liquid chromatography (HPLC) for API quantification, dissolution testing to ensure bioavailability, and microbial limit checks for sterility. Analytical validation protocols are aligned with ICH and USP guidelines to ensure method robustness and reproducibility. Traceability is maintained through batch-specific documentation, including raw material certificates of analysis (CoAs), in-process records, and finished product specifications. Our quality control systems are integrated with real-time monitoring tools to detect deviations and ensure compliance with GMP requirements.
Regulatory Compliance
Cefox CV is manufactured in full compliance with global regulatory frameworks, including GMP, WHO guidelines, and ISO 9001 standards. Our facility meets the requirements of the FDA’s Current Good Manufacturing Practice (CGMP) and the EMA’s guidelines for pharmaceutical production. We maintain detailed documentation for regulatory submissions, including process validation reports, stability data, and quality risk management (QRM) assessments. Compliance with ISO 17025 accreditation ensures that our analytical testing methods are validated and reliable. Additionally, we adhere to the International Council for Harmonisation (ICH) guidelines to support global market access and regulatory approval processes.
Global Supply Capability
Our global supply capability is supported by an extensive international distribution network and robust logistics infrastructure. We provide bulk supply options to meet the demands of pharmaceutical distributors, exporters, and contract manufacturers worldwide. Our export experience includes compliance with customs regulations, documentation for international shipments, and adherence to pharma-specific trade standards. The facility is equipped for large-scale bulk production, with capacity to fulfill orders ranging from small batches to high-volume commercial runs. Supply chain reliability is ensured through partnerships with trusted logistics providers and real-time tracking systems to guarantee timely delivery.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in high-quality, compliant production. Our commitment to GMP standards, regulatory compliance, and scalable manufacturing ensures reliable supply chains and product consistency. With a focus on innovation and customer-centric solutions, we deliver tailored services that align with global market demands. Our partnerships with leading pharmaceutical companies and adherence to international quality benchmarks position us as a preferred supplier for bulk supply and contract manufacturing needs.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com to discuss customization, pricing, and logistics for Cefox CV.
FAQs
What manufacturing standards does Cefox CV adhere to?
Cefox CV is manufactured in compliance with GMP, WHO guidelines, and ISO 9001 standards, ensuring quality and consistency.
Can Cefox CV be produced in different packaging formats?
Yes, we offer flexible packaging options, including the standard 10x1x6 Alu Alu format, to meet diverse market requirements.
What is the shelf life of Cefox CV under standard storage conditions?
The product has a shelf life of 24 months when stored at 25°C ± 5°C and 60% ± 10% RH.
Does your facility support private label manufacturing?
Yes, we provide private label manufacturing services to produce branded formulations under a client’s proprietary name.
How do you ensure compliance with international regulatory frameworks?
Our facility meets FDA, EMA, and WHO guidelines, with documented processes for regulatory submissions and quality assurance.
What is the minimum order quantity for bulk supply?
Minimum order quantities are flexible and can be customized based on production capacity and client requirements.
Can you provide documentation for export compliance?
Yes, we supply complete documentation, including COAs, batch records, and regulatory compliance certificates for international shipments.
How do you ensure the stability of the Cefuroxime Axetil and Clavulanate combination?
The formulation is validated for stability through accelerated testing and real-time monitoring to ensure long-term efficacy.
What quality control measures are in place for batch testing?
Each batch undergoes rigorous testing, including HPLC, dissolution, and microbial limit checks, with results documented for traceability.
How do you handle supply chain disruptions?
We maintain buffer stock, diversified supplier networks, and contingency planning to ensure uninterrupted supply chain reliability.
