Cefox 1.5gm is a sterile, ready-to-use injectable solution containing cefuroxime, a second-generation cephalosporin antibiotic. The formulation is designed for stability, compatibility, and ease of reconstitution, ensuring consistent pharmaceutical performance. The active ingredient, cefuroxime, is dissolved in water for injection (WFI) to achieve a 1.5gm concentration, making it suitable for intravenous or intramuscular administration. The product’s formulation adheres to pharmaceutical-grade specifications, with precise control over pH, osmolarity, and particulate matter to meet global quality standards. The use of DPCO (Drug Product Code of Origin) ensures traceability and compliance with regulatory requirements. From a manufacturing perspective, the formulation is optimized for scalability, with minimal excipient interference to maintain therapeutic efficacy and product integrity during storage and transport.
Manufacturing Capability
Delwis Healthcare’s manufacturing infrastructure is designed to meet the stringent demands of pharmaceutical production. Our facility is equipped with state-of-the-art sterile processing equipment, including isolators and laminar flow hoods, to ensure aseptic handling of cefuroxime injections. The production process adheres to current Good Manufacturing Practices (cGMP) and is validated to maintain sterility, purity, and potency throughout the manufacturing lifecycle. The facility supports scalable production, enabling seamless transitions from small batches to bulk supply without compromising quality. Advanced quality systems, including real-time monitoring and automated data collection, ensure compliance with regulatory benchmarks. Our commitment to GMP standards is further reinforced by routine internal audits, calibration of critical equipment, and rigorous documentation of all production parameters.
Available Strengths and Packaging
Composition: Cefuroxime 1.5gm Injection. (DPCO)
Packaging: 1 vial with WFI
Cefox 1.5gm is available in a single strength of 1.5gm, formulated as a sterile injection for direct use. Each vial is sealed with WFI (Water for Injection) to ensure stability and compatibility during reconstitution. The packaging is designed for pharmaceutical manufacturers requiring reliable, ready-to-use solutions for bulk supply.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, Delwis Healthcare offers comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers. Our private label manufacturing capabilities allow clients to produce high-quality cefuroxime injections under their brand, ensuring compliance with global regulatory standards. We support customized formulations, packaging, and labeling to meet specific market requirements. Our contract manufacturing division is equipped to handle large-scale production, with flexible timelines and cost-effective solutions for both domestic and international clients. Whether you require bulk supply or specialized packaging, our team provides end-to-end support to streamline your pharmaceutical operations.
Quality Assurance
Delwis Healthcare’s quality assurance framework is built on rigorous testing, analytical validation, and adherence to pharmaceutical quality standards. Every batch of Cefox 1.5gm undergoes comprehensive quality control checks, including sterility testing, endotoxin analysis, and pH/clarification assessments. Advanced analytical techniques, such as HPLC (High-Performance Liquid Chromatography), are employed to validate potency and purity. Batch testing is conducted in accordance with ICH, USP, and EP guidelines to ensure consistency and compliance. Our quality systems are designed to detect deviations early, with corrective actions implemented to maintain product integrity. Regular third-party audits and validation studies further reinforce our commitment to delivering pharmaceutical-grade products.
Regulatory Compliance
Delwis Healthcare ensures full compliance with global regulatory frameworks, including GMP, WHO guidelines, and ISO standards. Our manufacturing processes align with ICH Q7 and USP <797> for sterile drug production, ensuring adherence to international quality benchmarks. The facility is certified under ISO 9001:2015 and ISO 14001:2015 for quality management and environmental sustainability. Additionally, our products meet WHO prequalification criteria, enabling seamless export to markets requiring regulatory approval. Compliance with regional frameworks, such as the FDA’s current GMP and EMA guidelines, ensures that Cefox 1.5gm is suitable for global distribution. All documentation, including batch records and certificates of analysis, is prepared to meet the requirements of regulatory authorities worldwide.
Global Supply Capability
Delwis Healthcare is a leading exporter with a robust international distribution network, capable of supplying bulk quantities of Cefox 1.5gm to markets across Asia, Africa, Latin America, and Europe. Our logistics partners ensure timely delivery through secure, temperature-controlled supply chains, with real-time tracking for transparency. The facility’s production capacity supports large-scale bulk supply, accommodating both short-term and long-term orders. Our export capabilities are complemented by compliance with international trade regulations, including HS code classification and customs documentation. With a focus on supply chain reliability, we maintain inventory buffers and contingency planning to ensure uninterrupted delivery, even in challenging market conditions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select Delwis Healthcare for its unwavering commitment to quality, regulatory compliance, and scalable production. Our expertise in bulk supply ensures cost-effective solutions without compromising product standards. As a manufacturer and supplier, we offer end-to-end support, from formulation to global distribution, with a focus on meeting the unique needs of B2B clients. Our ISO-certified facility, combined with advanced quality systems and regulatory expertise, positions us as a reliable partner for pharmaceutical buyers seeking dependable, high-quality cefuroxime injections.
Bulk Supply Inquiry
Delwis Healthcare provides seamless bulk supply solutions for pharmaceutical manufacturers and exporters. For inquiries regarding large-scale procurement, production timelines, or customized packaging, contact us at info@delwishealthcare.com.
FAQs
What certifications does Delwis Healthcare hold for Cefox 1.5gm?
Our facility is certified under ISO 9001:2015, ISO 14001:2015, and complies with GMP, WHO, and FDA regulations.
Can Cefox 1.5gm be customized for private label manufacturing?
Yes, we offer private label manufacturing services to meet specific branding and packaging requirements.
What is the shelf life of Cefox 1.5gm?
The product has a shelf life of 24 months when stored under recommended conditions (2–8°C).
Does Delwis Healthcare support bulk supply for international markets?
Yes, we provide bulk supply solutions with a global distribution network, including export to Asia, Africa, and Europe.
What quality control tests are performed on Cefox 1.5gm?
Each batch undergoes sterility testing, endotoxin analysis, pH/clarification checks, and HPLC validation.
Can Cefox 1.5gm be produced in different packaging formats?
While the standard packaging is 1 vial with WFI, we can accommodate customized packaging upon request.
What is the minimum order quantity for bulk supply?
We offer flexible order quantities, with minimums tailored to the scale of your procurement needs.
How does Delwis Healthcare ensure regulatory compliance for exports?
Our processes adhere to WHO prequalification, FDA GMP, and EMA guidelines, with full documentation for global markets.
Is there a lead time for production and delivery?
Production timelines vary based on order size, but we prioritize efficiency to meet urgent bulk supply demands.
How can I contact Delwis Healthcare for bulk supply inquiries?
For assistance with procurement, production, or export queries, email **info@delwishealthcare.com**.
