Cefox 250 is formulated as a 250mg tablet of Cefuroxime Axetil, a prodrug of cefuroxime, designed for oral administration. The active ingredient, Cefuroxime Axetil, is combined with excipients such as microcrystalline cellulose, calcium carbonate, and magnesium stearate to ensure optimal tablet integrity, disintegration, and stability. The formulation is engineered to maintain pharmaceutical consistency, with controlled release properties to ensure uniform bioavailability. The tablet’s physicochemical stability is achieved through precise pH adjustment and moisture barrier protection, ensuring shelf-life compliance under standard storage conditions. The manufacturing process emphasizes homogeneity, with advanced blending and compression techniques to meet stringent quality requirements.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP). The production line for Cefox 250 includes automated tablet compression systems, high-efficiency blending units, and advanced coating technologies to ensure precision in formulation. Sterile processing capabilities are maintained through ISO Class 7 cleanrooms, ensuring contamination-free environments for critical steps. The facility adheres to global GMP standards, with continuous monitoring of critical parameters such as temperature, humidity, and particle count. Scalability is achieved through modular production lines capable of handling bulk supply demands without compromising quality. Quality systems include real-time data collection, validated process controls, and rigorous documentation to ensure traceability and compliance.
Available Strengths and Packaging
Composition: Cefuroxime Axetil 250mg Tab
Packaging: 10x1x10 Alu Alu
Cefox 250 is available in a single strength of 250mg per tablet, tailored for broad therapeutic applications. The packaging consists of 10 blister packs, each containing 10 tablets, sealed in aluminum-aluminum foil to ensure moisture resistance and product integrity. This format is ideal for bulk supply and export, offering secure storage and distribution capabilities.
Contract Manufacturing / Third Party Manufacturing
As a leading manufacturer, we offer comprehensive contract manufacturing and third-party production services to pharmaceutical buyers. Our capabilities include private label manufacturing, where we produce under a client’s brand name, ensuring full customization of packaging, labeling, and formulation. We also provide contract manufacturing for generic and branded products, adhering to client specifications and regulatory requirements. Our flexible production model supports small-to-large scale orders, with dedicated project management teams to ensure timely delivery and compliance. This service is ideal for exporters and distributors seeking to expand their product portfolios while maintaining quality and cost efficiency.
Quality Assurance
Our quality control systems are designed to ensure consistency, safety, and efficacy in every batch of Cefox 250. Each production batch undergoes rigorous testing, including high-performance liquid chromatography (HPLC) for active ingredient quantification, dissolution testing to confirm bioavailability, and microbial limit tests to ensure sterility. Analytical validation is conducted to verify method accuracy, precision, and reproducibility. All processes are documented to meet ISO 9001 and FDA guidelines, with continuous improvement initiatives to enhance product quality. Batch-specific records are maintained for traceability, ensuring compliance with global pharmaceutical standards.
Regulatory Compliance
Cefox 250 is manufactured in full compliance with GMP, WHO guidelines, and ISO 9001:2015 standards. Our facility is routinely audited by regulatory authorities, including the FDA, EMA, and WHO, to ensure adherence to international quality frameworks. The product meets specifications for active pharmaceutical ingredients (APIs) as outlined in the International Pharmacopoeia and is registered with relevant regulatory bodies for export. Compliance with ISO 14001 environmental management standards ensures sustainable manufacturing practices, while adherence to Good Distribution Practices (GDP) guarantees safe and efficient supply chain operations.
Global Supply Capability
As a trusted exporter, we offer robust global supply capabilities, with a well-established international distribution network spanning key markets in Asia, Africa, Latin America, and Europe. Our bulk supply capacity is supported by advanced logistics partnerships, ensuring timely delivery of orders regardless of volume. The 10x1x10 Alu Alu packaging is optimized for secure transportation, minimizing risks of damage during transit. Supply chain reliability is ensured through real-time tracking systems, inventory management, and contingency planning to mitigate disruptions. We prioritize long-term partnerships with distributors and exporters, offering competitive pricing and flexible payment terms to meet diverse market demands.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our commitment to quality, compliance, and scalability. Our expertise in bulk supply ensures cost-effective solutions without compromising product integrity. As a manufacturer with global reach, we provide end-to-end support, from production to distribution, enabling clients to meet market demands efficiently. Our adherence to international standards and regulatory frameworks ensures seamless entry into global markets. Additionally, our responsive customer service and tailored solutions make us a reliable partner for businesses seeking to expand their product offerings.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our sales team at info@delwishealthcare.com. Our team is dedicated to providing tailored solutions for pharmaceutical buyers, exporters, and contract manufacturers seeking high-quality, compliant products.
FAQs
What is the manufacturing process for Cefox 250?
Cefox 250 is produced using automated tablet compression, blending, and coating technologies, ensuring uniformity and compliance with GMP standards.
Can Cefox 250 be customized for private label manufacturing?
Yes, we offer private label manufacturing services, allowing clients to brand the product under their own name.
What packaging options are available for Cefox 250?
The product is available in 10x1x10 Alu Alu blister packs, ideal for bulk supply and export.
Does your facility comply with ISO and GMP standards?
Yes, our facility is fully compliant with ISO 9001:2015, GMP, and WHO guidelines.
Can you handle large-scale bulk orders?
Absolutely. Our production lines are scalable to meet bulk supply demands for global markets.
What quality control measures are in place for Cefox 250?
Each batch undergoes HPLC, dissolution testing, and microbial limit checks to ensure quality and safety.
Are there export compliance certifications for Cefox 250?
Yes, the product is registered with global regulatory bodies and complies with FDA, EMA, and WHO requirements.
How do you ensure supply chain reliability?
We use real-time tracking, inventory management, and logistics partnerships to guarantee timely and secure deliveries.
Can you provide samples for quality assessment?
Yes, we offer samples for evaluation, subject to standard quality control protocols.
What is the lead time for bulk orders?
Lead times vary based on order size, but we prioritize expedited processing for urgent requirements.
