Cefadel - O is a fixed-dose combination tablet formulated with Cefixime (200mg) and Ofloxacin (200mg), designed to enhance therapeutic efficacy through synergistic antimicrobial activity. The formulation employs a stable excipient matrix to ensure uniform drug distribution, optimal disintegration, and consistent dissolution profiles. Cefixime, a third-generation cephalosporin, is combined with Ofloxacin, a fluoroquinolone, to target a wide range of Gram-positive and Gram-negative pathogens. The tablet’s formulation is optimized for pharmaceutical compatibility, ensuring minimal interaction between active pharmaceutical ingredients (APIs) and excipients. Manufacturing processes prioritize controlled particle size distribution, moisture content, and tablet hardness to meet stringent quality parameters. The product’s design supports long-term stability under recommended storage conditions, making it suitable for both domestic and international markets.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001 standards. The production line includes advanced tablet compression machinery, high-speed coating systems, and automated packaging units to ensure precision and scalability. Sterile processing capabilities are maintained through dedicated cleanrooms and validated aseptic techniques for critical components. The facility supports batch sizes ranging from small-scale trials to large-volume production, ensuring flexibility for diverse market demands. Quality systems are integrated throughout the manufacturing process, with real-time monitoring of critical parameters such as tablet weight, disintegration time, and content uniformity. Our commitment to GMP compliance ensures consistent product quality, meeting the rigorous requirements of global regulatory bodies.
Available Strengths and Packaging
Cefadel - O is available in a single strength: Cefixime 200mg + Ofloxacin 200mg. The product is packaged in 10x10 Alu Alu blister packs, designed for secure storage, tamper-evidence, and efficient distribution. The aluminum blister format provides excellent barrier protection against moisture and light, ensuring product stability during transportation and shelf life. This packaging solution is ideal for pharmaceutical distributors seeking reliable, compliant packaging for bulk and retail markets.
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 capabilities extend to custom formulation development, API integration, and packaging solutions tailored to client specifications. We support both domestic and international clients by providing end-to-end manufacturing services, from raw material sourcing to final product packaging. Our flexible production model accommodates small and large-scale orders, ensuring timely delivery without compromising quality. For exporters and distributors, we provide turnkey solutions that align with global regulatory standards, enabling seamless market entry.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and compliance with international pharmacopoeial standards. Each production batch undergoes extensive testing using high-performance liquid chromatography (HPLC), thin-layer chromatography (TLC), and dissolution testing to ensure potency, purity, and uniformity. In-process controls monitor critical quality attributes such as tablet hardness, friability, and disintegration time. Final product testing includes microbial limit tests, heavy metal analysis, and dissolution profiling to confirm adherence to USP and EP guidelines. Our quality systems are continuously audited to maintain compliance with ISO 17025 and FDA regulations, ensuring consistent delivery of high-quality pharmaceutical products.
Regulatory Compliance
Cefadel - O is manufactured in full compliance with GMP, WHO guidelines, and ISO 9001 standards. Our facility is certified by regulatory authorities in multiple jurisdictions, including the FDA, EMA, and MHRA, ensuring adherence to global quality benchmarks. The product meets the requirements of the World Health Organization’s prequalification program, enabling export to low- and middle-income countries. All documentation, including batch records, stability data, and analytical reports, is prepared in accordance with ICH and FDA guidelines. Our regulatory team ensures that all products comply with destination-specific requirements, facilitating smooth approval processes for international markets.
Global Supply Capability
We offer robust global supply capabilities, including bulk supply, export-ready packaging, and a reliable international distribution network. Our logistics partners enable seamless transportation to over 150 countries, with customized solutions for regional market demands. The facility’s production capacity supports large-scale bulk supply, meeting the needs of pharmaceutical manufacturers, distributors, and exporters. Our supply chain is designed for resilience, with redundant systems to ensure uninterrupted delivery even during unforeseen disruptions. We provide competitive pricing, flexible order terms, and on-time delivery to support long-term partnerships with global clients.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturers choose us for our proven expertise, compliance-driven manufacturing, and scalable production capabilities. Our commitment to quality ensures that every batch meets the highest standards of safety and efficacy. With a dedicated account team, we offer personalized support, from product development to market entry strategies. Our ability to adapt to evolving regulatory landscapes and client needs positions us as a reliable partner for global pharmaceutical supply chains.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our sales team at info@delwishealthcare.com.
FAQs
What manufacturing standards does Cefadel - O comply with?
Cefadel - O is manufactured in full compliance with cGMP, ISO 9001, and WHO guidelines, ensuring adherence to global quality benchmarks.
Can Cefadel - O be customized for specific packaging requirements?
Yes, we offer flexible packaging solutions, including 10x10 Alu Alu blister packs, tailored to meet client specifications and regulatory requirements.
What is the shelf life of Cefadel - O?
The product has a shelf life of 24 months when stored under recommended conditions (cool, dry, and protected from light).
Does the manufacturer provide regulatory documentation for export?
Yes, we provide complete regulatory documentation, including batch certificates, stability data, and compliance reports for global markets.
What is the minimum order quantity for bulk supply?
We accommodate orders starting from small-scale trials to large-volume production, with flexible minimum order quantities based on client needs.
Can Cefadel - O be produced under private label manufacturing?
Yes, our private label manufacturing services allow clients to brand the product under their own label while maintaining quality and compliance.
How does the manufacturer ensure product consistency?
We maintain strict quality control measures, including in-process monitoring, batch testing, and analytical validation to ensure consistent product quality.
What is the production scalability for Cefadel - O?
Our facility supports scalable production, enabling seamless transitions from small-scale trials to large-volume manufacturing to meet market demands.
Does the manufacturer offer contract manufacturing services?
Yes, we provide end-to-end contract manufacturing services, including formulation development, API integration, and packaging solutions.
How can I request a sample or bulk supply?
For samples or bulk supply inquiries, contact our sales team at **info@delwishealthcare.com** for personalized assistance.
