Cefadel - CV is a dual-component antibiotic formulation combining cefixime, a third-generation cephalosporin, with potassium clavulanate, a beta-lactamase inhibitor. The tablet formulation ensures optimal dissolution and bioavailability, leveraging advanced excipient compatibility testing to maintain stability during manufacturing. Cefixime provides coverage against Gram-positive and Gram-negative bacteria, while clavulanate enhances efficacy by neutralizing enzymatic resistance. The formulation employs a direct compression technique, ensuring uniform active pharmaceutical ingredient (API) distribution and consistent tablet hardness. Excipients such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide are incorporated to ensure flowability, disintegration, and tablet integrity. The product’s design supports long-term shelf stability, with minimal risk of degradation under standard storage conditions.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is equipped to produce Cefadel - CV at scale, adhering to current Good Manufacturing Practices (cGMP) and ISO 9001 quality management standards. The facility includes a dedicated tablet compression line with automated weight control, ensuring precise dosing accuracy. Sterile processing capabilities are maintained through ISO Class 7 cleanroom environments, with validated HVAC systems to prevent contamination. Production scalability is achieved through modular manufacturing units, allowing seamless transitions from small batches to large-scale commercial runs. Quality systems include real-time monitoring of critical process parameters (CPPs) and robust validation protocols for equipment and processes. The facility also supports batch record traceability, ensuring compliance with regulatory audits and documentation requirements.
Available Strengths and Packaging
Composition: Cefixime 200mg + Potassium Clavulanate 125mg Tab
Packaging: 10x6 Alu Alu
Cefadel - CV is available in a 200mg/125mg strength, formulated as a compressed tablet. The packaging consists of a 10x6 blister pack made of aluminum foil, offering tamper-evident protection and extended shelf life. This format is ideal for retail and hospital distribution, with secure sealing to maintain product integrity during transportation and storage. The aluminum-aluminum (Alu Alu) construction provides resistance to moisture, light, and physical damage, ensuring compliance with pharmaceutical packaging standards.
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 private label manufacturing capabilities allow clients to produce branded or generic versions of Cefadel - CV under their own regulatory frameworks. We support full end-to-end manufacturing, from API sourcing to finished dosage form production, ensuring compliance with local and international regulations. Our team provides technical expertise in formulation development, process optimization, and regulatory documentation, enabling seamless integration into global supply chains. Whether you require small-scale trial batches or large-volume commercial production, our flexible manufacturing solutions cater to diverse market demands.
Quality Assurance
Quality assurance for Cefadel - CV is anchored in rigorous analytical validation and batch testing protocols. Each production batch undergoes stability testing, dissolution profiling, and microbial contamination checks to ensure consistency and safety. Advanced techniques such as High-Performance Liquid Chromatography (HPLC) and UV spectrophotometry are employed for API quantification and impurity detection. Microbial limit testing, including tests for *E. coli*, *Salmonella*, and *Pseudomonas aeruginosa*, is conducted to meet pharmacopoeial standards. Our quality control systems are ISO 17025 accredited, ensuring data integrity and traceability. All batches are validated against ICH and USP guidelines, guaranteeing compliance with global pharmaceutical quality benchmarks.
Regulatory Compliance
Cefadel - CV is manufactured in full compliance with Good Manufacturing Practices (GMP), WHO guidelines, and ISO 9001:2015 standards. Our facility is routinely audited by regulatory bodies, including the FDA, EMA, and MHRA, to ensure adherence to international quality frameworks. The product meets the requirements of the WHO Pharmacopoeia and is registered under relevant regulatory authorities for export to over 50 countries. Documentation includes batch records, stability data, and compliance certificates, enabling seamless regulatory submissions. Our commitment to transparency and compliance ensures that Cefadel - CV meets the stringent requirements of global markets, from Asia-Pacific to Europe and the Americas.
Global Supply Capability
Our global supply chain is designed to deliver reliable, high-quality Cefadel - CV to international markets. With a network spanning over 60 countries, we provide bulk supply capabilities to meet large-volume demand from pharmaceutical distributors and exporters. The facility’s logistics infrastructure supports efficient export operations, including customs compliance, documentation, and temperature-controlled shipping for sensitive batches. Bulk supply capacity is scalable, with storage facilities capable of holding up to 50,000 kg of finished product. Our supply chain reliability is further enhanced by partnerships with trusted logistics providers and real-time tracking systems, ensuring timely delivery without compromising product quality.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturers choose us for our expertise in scalable, compliant production and global supply solutions. Our GMP-certified facility ensures consistent quality, while our flexible manufacturing capabilities allow customization to meet specific market needs. As a trusted supplier, we offer end-to-end support, from formulation development to regulatory submissions, reducing time-to-market for clients. Our commitment to innovation, combined with a proven track record in pharmaceutical manufacturing, positions us as a reliable partner for businesses seeking to expand their product portfolios.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is dedicated to providing tailored solutions for pharmaceutical buyers seeking reliable, high-quality antibiotic formulations.
FAQs
What certifications does your facility hold for manufacturing Cefadel - CV?
Our facility is certified under GMP, ISO 9001:2015, and WHO GMP guidelines, ensuring compliance with international standards.
Can you produce Cefadel - CV in different packaging formats?
Yes, we offer flexibility in packaging, including blister packs, bottles, and cartons, to meet diverse market requirements.
What is the minimum order quantity for bulk supply?
Minimum order quantities are customizable based on production schedules and client needs.
Does your manufacturing process ensure stability for long-term storage?
Yes, Cefadel - CV is formulated with excipients and packaging that ensure stability under standard storage conditions (25°C/60% RH).
Can you provide documentation for regulatory submissions?
We supply comprehensive documentation, including batch records, stability data, and compliance certificates for global regulatory submissions.
What is the production capacity for Cefadel - CV?
Our facility can produce up to 50,000 kg per month, with scalability to meet large-volume demands.
How do you ensure quality control during manufacturing?
We implement real-time monitoring, HPLC analysis, and microbial testing to ensure consistent quality across all batches.
Can you support private label manufacturing for Cefadel - CV?
Yes, we offer private label manufacturing services to help clients brand and distribute the product under their own regulatory frameworks.
What is the shelf life of Cefadel - CV?
The product has a shelf life of 24 months when stored under recommended conditions.
How do you handle export logistics and customs compliance?
Our logistics team ensures compliance with customs regulations, providing all necessary documentation for smooth international shipments.
