Cefadel O Dry Syp is a dual-ingredient dry syrup formulation combining Cefixime and Ofloxacin in a 1:1 ratio (50mg/5ml). The product is engineered for pharmaceutical manufacturers requiring a versatile, stable, and easily scalable formulation. The active ingredients are combined with excipients such as sucrose, citric acid, and flavoring agents to ensure compatibility, solubility, and palatability. The dry syrup format allows for precise dosing and storage convenience, while the formulation’s pH balance and excipient selection enhance shelf-life and chemical stability. The product is designed for reconstitution with Water for Injection (WFI) to produce a ready-to-use solution, ensuring consistency in pharmaceutical applications. The formulation adheres to strict pharmaceutical standards, ensuring uniformity in active ingredient dispersion and minimal degradation risk during storage.
Manufacturing Capability
Our manufacturing infrastructure is equipped to produce Cefadel O Dry Syp at scale, with dedicated facilities for sterile processing and non-sterile bulk production. The facility includes state-of-the-art equipment such as high-speed dry mixers, fluid bed dryers, and precision tabletting machines, ensuring consistent quality and efficiency. Sterile processing is conducted in ISO Class 7 cleanrooms, with validated aseptic techniques to prevent microbial contamination. The manufacturing process complies with current Good Manufacturing Practices (cGMP) and includes rigorous quality control checkpoints at every stage. The facility’s scalable design supports bulk production for global markets, with capacity to meet large-volume orders without compromising product integrity. Advanced quality systems, including real-time monitoring and automated data collection, ensure traceability and compliance with regulatory requirements.
Available Strengths and Packaging
Composition: Cefixime 50mg + Ofloxacin 50mg / 5ml Dry Syp
Packaging: 30ml with WFI With Outer
Cefadel O Dry Syp is available in a 30ml package with WFI (Water for Injection) and an outer carton, designed for efficient storage and transportation. The formulation’s 50mg/5ml strength ensures precise dosing flexibility, making it suitable for a range of pharmaceutical applications. The packaging is engineered to maintain product stability during transit and storage, with compliance to international pharmaceutical packaging standards.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer third-party manufacturing services, private label production, and contract manufacturing solutions tailored to pharmaceutical buyers’ needs. Our facility is equipped to produce Cefadel O Dry Syp under private label agreements, allowing clients to brand the product while leveraging our expertise in formulation development and regulatory compliance. Contract manufacturing capabilities include batch customization, API sourcing, and packaging integration, ensuring seamless collaboration with buyers. We prioritize flexibility, offering scalable production options to meet diverse market demands. Our team works closely with clients to align formulations with specific regulatory requirements and quality specifications, ensuring a smooth transition from development to commercialization.
Quality Assurance
Our quality assurance systems are designed to meet the highest pharmaceutical standards, with rigorous testing at every production stage. Batch testing includes analytical validation for active ingredient content, dissolution testing, and microbial limit checks to ensure product safety and efficacy. Advanced analytical techniques such as HPLC (High-Performance Liquid Chromatography) and UV spectrophotometry are employed to confirm potency and purity. Quality control protocols adhere to ICH (International Council for Harmonisation) and USP (United States Pharmacopeia) guidelines, ensuring consistency and reliability. All batches undergo stability testing to confirm shelf-life compliance, while raw material sourcing is strictly controlled to meet GMP requirements. Our commitment to quality is reinforced by continuous improvement programs and third-party audits to maintain compliance with global pharmaceutical benchmarks.
Regulatory Compliance
Cefadel O Dry Syp is manufactured in full compliance with GMP, WHO (World Health Organization) guidelines, and ISO 9001:2015 quality management standards. Our facility is certified by regulatory authorities in multiple jurisdictions, ensuring adherence to international pharmaceutical regulations. The product meets WHO prequalification criteria for quality, safety, and efficacy, enabling export to markets with stringent regulatory frameworks. Compliance with ISO 14001 environmental management standards further demonstrates our commitment to sustainable manufacturing practices. Additionally, our processes align with FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency) guidelines, facilitating global market access for pharmaceutical buyers.
Global Supply Capability
We provide robust global supply capabilities, including export services, international distribution networks, and bulk supply solutions. Our logistics partners ensure timely delivery to over 50 countries, with compliance to customs regulations and pharma-specific shipping requirements. Bulk supply capacity is supported by a scalable production model, enabling large-volume orders without compromising quality or timelines. Our supply chain is designed for reliability, with redundant systems to mitigate disruptions and ensure consistent delivery. We offer customized export solutions, including documentation support for regulatory approvals and compliance with import restrictions. This infrastructure positions us as a reliable partner for pharmaceutical distributors and exporters seeking dependable, high-quality supply chain solutions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in developing and supplying high-quality products like Cefadel O Dry Syp. Our facility’s compliance with global standards ensures seamless market access, while our scalable manufacturing capabilities support large-volume production. As a trusted supplier, we offer end-to-end solutions, from formulation development to global distribution, reducing time-to-market for clients. Our commitment to quality, regulatory compliance, and customer collaboration sets us apart, making us a preferred partner for businesses seeking reliable, compliant, and scalable pharmaceutical solutions.
Bulk Supply Inquiry
For bulk supply inquiries or to discuss customization options, please contact us at info@delwishealthcare.com. Our team is dedicated to supporting your pharmaceutical needs with precision and reliability.
FAQs
What is the manufacturing process for Cefadel O Dry Syp?
Cefadel O Dry Syp is manufactured using a dry blending technique, combining Cefixime and Ofloxacin with excipients in a controlled environment. The formulation is then packaged in a 30ml container with WFI, ensuring stability and ease of reconstitution.
Can Cefadel O Dry Syp be customized for private labeling?
Yes, we offer private label manufacturing services, allowing clients to brand the product while leveraging our expertise in formulation and compliance.
What regulatory standards does Cefadel O Dry Syp comply with?
The product adheres to GMP, WHO, ISO 9001, and FDA guidelines, ensuring compliance with global pharmaceutical regulations.
What is the shelf-life of Cefadel O Dry Syp?
The shelf-life is determined through stability testing and typically ranges from 24 to 36 months, depending on storage conditions.
Can the packaging be modified to meet specific export requirements?
Yes, our packaging solutions are customizable to meet regional regulatory and logistical requirements, including tamper-evident seals and child-resistant designs.
What is the minimum order quantity for bulk supply?
We accommodate bulk orders starting from 1,000 units, with flexibility to scale production based on client needs.
How does your quality assurance process ensure product consistency?
Rigorous batch testing, including HPLC analysis and microbial testing, ensures consistency. All batches are validated against ICH and USP standards.
What export documentation is provided for international shipments?
We provide complete documentation, including COA (Certificate of Analysis), GMP compliance certificates, and pharma-specific export permits.
Can you support contract manufacturing for other formulations?
Yes, our contract manufacturing services extend to a wide range of formulations, with expertise in API integration and dosage form development.
How do you ensure supply chain reliability?
Our supply chain is supported by redundant logistics systems, real-time tracking, and partnerships with global distributors to ensure timely and reliable delivery.
