Febudel - 40 Tab is formulated as a film-coated round tablet containing Febuxostat 40mg as the active ingredient. The formulation is designed to ensure stability, uniformity, and consistent dosage delivery. The tablet’s film coating provides protection against environmental factors while ensuring ease of swallowing and disintegration in the gastrointestinal tract. The excipients used in the formulation are selected for their compatibility with Febuxostat, ensuring no adverse interactions during manufacturing or storage. The compression process employs advanced tabletting technology to achieve optimal hardness, disintegration time, and dissolution profile, meeting pharmaceutical specifications for active pharmaceutical ingredients (APIs) and finished dosage forms. The formulation is optimized for scalability, enabling seamless transition from pilot batches to large-scale production while maintaining quality and potency.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with Good Manufacturing Practice (GMP) standards, ensuring precision and consistency in production. The facility includes advanced tablet compression machines, coating systems, and packaging lines capable of handling high-volume production. Sterile processing capabilities are available for critical dosage forms, with dedicated cleanrooms and controlled environments to prevent contamination. The production process adheres to strict quality control protocols, including real-time monitoring of critical parameters such as tablet weight, thickness, and dissolution rates. Our facility supports scalable manufacturing, enabling seamless expansion to meet bulk supply demands without compromising product integrity. Quality systems are integrated throughout the manufacturing lifecycle, with continuous validation of equipment, processes, and materials to ensure compliance with international pharmaceutical standards.
Available Strengths and Packaging
Composition: Febuxostat 40mg Film Coated Round Tablet
Packaging: 10x15 Blister
Febudel - 40 Tab is available in a 40mg strength, formulated for consistent therapeutic efficacy. The blister packaging (10x15) ensures tamper-evidence, product protection, and efficient storage, making it ideal for distribution and retail environments. This packaging format is designed for ease of handling, compliance with regulatory requirements, and compatibility with global supply chains.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers’ needs. Our capabilities include private label manufacturing, where we produce finished dosage forms under a client’s brand name, ensuring full customization of packaging, labeling, and quality control. We also provide contract manufacturing services for API-based formulations, enabling clients to outsource production while maintaining regulatory compliance. Our flexible manufacturing solutions support both small-scale trials and large-volume production, with dedicated teams to manage specifications, timelines, and quality assurance. This allows pharmaceutical buyers to focus on market expansion while leveraging our expertise in pharmaceutical manufacturing.
Quality Assurance
Our quality assurance systems are designed to meet the highest standards of pharmaceutical excellence. Every batch undergoes rigorous testing, including physicochemical analysis, dissolution testing, and microbial contamination checks, to ensure compliance with specifications. Advanced analytical validation techniques, such as High-Performance Liquid Chromatography (HPLC) and UV spectrophotometry, are employed to verify API potency and purity. Quality control documentation is maintained throughout the production lifecycle, with traceability for raw materials, in-process samples, and finished products. Our facility is certified under ISO 9001 and adheres to ICH guidelines, ensuring consistency, safety, and efficacy in every batch.
Regulatory Compliance
Febudel - 40 Tab is manufactured in full compliance with Good Manufacturing Practice (GMP) standards, WHO guidelines, and ISO 9001 certification. Our facility meets the requirements of the FDA, EMA, and other global regulatory bodies, ensuring that products are suitable for international markets. Compliance with ISO 17025 for laboratory testing and ISO 27001 for information security further strengthens our commitment to quality and data integrity. All documentation, including batch records, stability data, and regulatory submissions, is prepared to meet the demands of global regulatory frameworks, enabling seamless export and market access.
Global Supply Capability
We offer robust global supply capabilities, with a well-established international distribution network covering key markets across Asia, Europe, and the Americas. Our bulk supply capacity is designed to meet large-scale demand, supported by efficient logistics and inventory management systems. The 10x15 blister packaging format is compatible with automated packaging lines, ensuring cost-effective and scalable distribution. Our supply chain is optimized for reliability, with contingency planning to mitigate disruptions and ensure timely delivery. Export capabilities are supported by compliance with international trade regulations, including customs documentation and phytosanitary certifications, ensuring smooth cross-border transactions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in high-quality production, regulatory compliance, and scalable supply solutions. Our commitment to GMP standards, ISO certifications, and advanced manufacturing technology ensures that clients receive products meeting global market demands. With a focus on innovation, reliability, and customer-centric services, we provide end-to-end solutions that enhance competitiveness in the pharmaceutical industry. Our ability to support bulk supply, customize packaging, and navigate regulatory complexities makes us a strategic partner for businesses seeking to expand their market reach.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is dedicated to providing tailored solutions for pharmaceutical manufacturers, exporters, and distributors seeking reliable, high-quality products.
FAQs
What certifications does your facility hold?
Our facility is certified under GMP, ISO 9001, and ISO 17025, ensuring compliance with international pharmaceutical standards.
Can you customize packaging for Febudel - 40 Tab?
Yes, we offer customization options for packaging, including blister formats, to meet specific client requirements.
What is the minimum order quantity for bulk supply?
We accommodate bulk orders starting from 10,000 units, with flexible production schedules to meet varying demand.
How do you ensure product stability during storage?
The 10x15 blister packaging provides moisture and light protection, while our storage facilities maintain controlled temperature and humidity conditions.
Are your products compliant with FDA and EMA regulations?
Yes, all products are manufactured in compliance with FDA, EMA, and WHO guidelines to ensure global market access.
Can you support private label manufacturing?
Absolutely. We provide private label manufacturing services, allowing clients to brand products under their own name.
What quality control measures are in place during production?
Every batch undergoes rigorous testing, including HPLC, dissolution testing, and microbial analysis, with full traceability.
How long does it take to process a bulk order?
Production timelines vary based on order size, but we prioritize efficiency to deliver within 4–6 weeks for standard orders.
Do you offer export support for international markets?
Yes, we provide end-to-end export support, including customs documentation and compliance with international trade regulations.
How can I request a sample or quotation?
Contact us at **info@delwishealthcare.com** for detailed quotations and sample requests.
