Cefadel 100 Dry Syrup is a pharmaceutical formulation containing cefixime at a concentration of 100mg per 5ml, designed as a dry powder for reconstitution. The formulation leverages advanced pharmaceutical engineering to ensure uniform dispersion, stability, and bioavailability of the active ingredient. The dry syrup format minimizes moisture exposure during storage, preserving the potency of cefixime, a third-generation cephalosporin antibiotic. The excipient profile includes non-ionic surfactants, pH regulators, and preservatives to maintain chemical stability and enhance solubility upon reconstitution with Water for Injection (WFI). The product’s formulation adheres to strict pharmaceutical standards, ensuring compatibility with modern dosage delivery systems and compliance with regulatory requirements for oral antibiotics. The dry syrup’s compact form facilitates efficient storage and transportation while maintaining the integrity of the active pharmaceutical ingredient (API) throughout the supply chain.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities for the production of sterile pharmaceutical products, including Cefadel 100 Dry Syrup. The facility features aseptic processing lines, high-speed tablet and powder filling systems, and advanced drying technology to ensure consistent quality. The production process adheres to current Good Manufacturing Practices (cGMP) and includes rigorous quality control checkpoints at every stage. Our facility is designed for scalability, enabling seamless transitions from small-scale development to large-volume commercial production. The sterile processing capability ensures contamination-free manufacturing, while integrated quality systems support real-time monitoring of critical parameters such as temperature, humidity, and particle count. Additionally, the facility complies with international standards for pharmaceutical manufacturing, including ISO 9001 and ISO 14644-1 for cleanroom environments, ensuring consistency and reliability in every batch.
Available Strengths and Packaging
Cefadel 100 Dry Syrup is available in a single strength of 100mg/5ml, formulated as a dry powder for reconstitution. The product is packaged in 30ml vials with WFI, enclosed in an outer protective packaging to ensure sterility and stability during transit. This packaging format is ideal for pharmaceutical manufacturers requiring a reliable, ready-to-use solution for oral antibiotic delivery.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to meet the needs of pharmaceutical buyers. Our private label manufacturing capabilities allow clients to produce branded products under their own specifications, including custom packaging, labeling, and formulation adjustments. We support contract manufacturing for both small and large-scale production runs, ensuring compliance with regulatory standards and maintaining strict quality control throughout the process. Our services are designed to streamline supply chain operations, reduce development timelines, and provide cost-effective solutions for global pharmaceutical markets.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to international pharmaceutical standards. Every batch of Cefadel 100 Dry Syrup undergoes comprehensive testing for identity, purity, potency, and microbial contamination. Advanced analytical techniques such as High-Performance Liquid Chromatography (HPLC) and UV spectrophotometry are employed to ensure the consistency and accuracy of the active pharmaceutical ingredient. Microbial limit testing, endotoxin analysis, and particulate matter assessment are conducted to guarantee sterility and safety. Additionally, our quality control systems are aligned with pharmacopoeial standards (USP, EP, BP) and regulatory guidelines, ensuring that products meet the highest benchmarks for pharmaceutical excellence.
Regulatory Compliance
We ensure full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and international ISO standards such as ISO 9001 and ISO 14644-1. Our manufacturing processes are designed to meet the requirements of regulatory bodies worldwide, including the FDA, EMA, and PIC/S. Compliance with these frameworks ensures that our products are suitable for export to global markets and meet the stringent quality and safety expectations of pharmaceutical buyers. Our documentation and traceability systems support audits and regulatory inspections, providing transparency and confidence in product integrity.
Global Supply Capability
With a robust international distribution network, we offer reliable bulk supply capabilities to meet the demands of global pharmaceutical markets. Our export infrastructure is supported by partnerships with logistics providers specializing in temperature-controlled and sterile transport, ensuring the safe delivery of products to destinations worldwide. The facility’s production capacity allows for large-scale manufacturing, enabling consistent supply to meet regional and global demand. Our supply chain reliability is further enhanced by inventory management systems, real-time tracking, and contingency planning to mitigate disruptions. Whether for domestic or international markets, we provide a seamless solution for bulk supply, ensuring timely delivery and compliance with import regulations.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our expertise in sterile pharmaceutical production, compliance with global standards, and commitment to quality. Our ability to deliver bulk supply with consistent specifications ensures operational efficiency and cost-effectiveness for buyers. As a manufacturer and supplier, we prioritize innovation, scalability, and regulatory adherence, positioning ourselves as a reliable partner in the pharmaceutical industry. Our focus on quality assurance and regulatory compliance ensures that clients receive products meeting the highest international benchmarks, reinforcing trust and long-term collaboration.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com to discuss your requirements and receive a tailored quotation.
FAQs
What is the manufacturing process for Cefadel 100 Dry Syrup?
Cefadel 100 Dry Syrup is manufactured using aseptic powder filling and drying techniques to ensure sterility and stability. The process involves precise blending of the active ingredient with excipients, followed by drying to achieve a consistent, free-flowing powder suitable for reconstitution.
What excipients are used in the formulation?
The formulation includes non-ionic surfactants, pH regulators, and preservatives to ensure chemical stability, solubility, and microbial protection. Specific excipient details are provided upon request to meet regulatory and formulation requirements.
Does the product comply with WHO and FDA standards?
Yes, Cefadel 100 Dry Syrup is manufactured in compliance with WHO guidelines, FDA regulations, and international GMP standards. Our facility is regularly audited to ensure adherence to these frameworks.
Can the product be customized for private label manufacturing?
Yes, we offer private label manufacturing services, allowing clients to brand the product under their own specifications. Custom packaging, labeling, and formulation adjustments are supported to meet market-specific needs.
What is the shelf life of the product?
The shelf life of Cefadel 100 Dry Syrup is typically 24 months when stored under recommended conditions (cool, dry, and protected from light). Stability testing confirms compliance with pharmacopoeial standards.
What quality control measures are in place for batch testing?
Every batch undergoes rigorous testing for identity, purity, potency, microbial contamination, and endotoxin levels. Analytical methods such as HPLC and UV spectrophotometry ensure accuracy and consistency.
Is the product suitable for export to international markets?
Yes, Cefadel 100 Dry Syrup is formulated and manufactured to meet the regulatory requirements of global markets, including the FDA, EMA, and PIC/S. Export documentation and compliance certifications are provided upon request.
What are the packaging specifications for bulk supply?
The product is supplied in 30ml vials with WFI, enclosed in outer packaging to maintain sterility. Bulk supply options are available to meet large-scale distribution and export needs.
Can the product be produced in different strengths?
While Cefadel 100 Dry Syrup is currently available in 100mg/5ml strength, we can accommodate custom formulation requests for alternative strengths based on client specifications.
How does your supply chain ensure reliability?
Our supply chain is supported by a global distribution network, real-time tracking systems, and contingency planning to ensure timely delivery. We maintain inventory reserves and collaborate with logistics partners to minimize disruptions.
