Clazit 80M is a dual-action antidiabetic formulation combining Gliclazide and Metformin, two widely prescribed agents for managing hyperglycemia. The tablet is formulated using advanced pharmaceutical techniques to ensure stability, uniformity, and bioavailability of both active ingredients. Gliclazide, a sulfonylurea, is combined with Metformin, a biguanide, in a ratio optimized for synergistic therapeutic effects. The formulation employs a direct compression method, utilizing excipients such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide to ensure tablet integrity, disintegration, and flow properties. The physicochemical compatibility of the components is validated through stability studies, ensuring no degradation or interaction under standard storage conditions. The final product meets specifications for disintegration time, dissolution rate, and content uniformity, ensuring consistent therapeutic performance.
Manufacturing Capability
Our manufacturing infrastructure is designed to produce high-quality pharmaceutical products like Clazit 80M with precision and scalability. The facility is equipped with state-of-the-art machinery, including high-speed tablet presses, fluid bed dryers, and automated packaging systems, ensuring adherence to Good Manufacturing Practices (GMP). Sterile processing capabilities are available for critical components, supported by aseptic filling lines and controlled environmental chambers. The production process is validated to maintain sterility, contamination control, and product integrity. Our quality systems include real-time monitoring, in-process testing, and rigorous validation protocols to ensure compliance with regulatory standards. The facility supports large-scale production, with the ability to scale up or down based on demand, while maintaining consistent quality. Advanced quality assurance systems, including traceability and batch-specific documentation, ensure full transparency and regulatory compliance.
Available Strengths and Packaging
Clazit 80M is available in a single strength: Gliclazide 80mg + Metformin 500mg. The product is packaged in 10x10 blister packs, ensuring secure, tamper-evident storage and convenient dispensing. The blister packaging is designed for stability during transportation and shelf life, meeting international pharmaceutical packaging standards.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to the needs of pharmaceutical buyers. Our private label manufacturing capabilities allow clients to produce branded products under their own trademarks, with full customization of packaging, labeling, and formulation. We support contract manufacturing for both generic and branded products, adhering to global regulatory requirements. Our team provides end-to-end solutions, from formulation development to finished product packaging, ensuring compliance with GMP, ISO, and WHO standards. We also offer flexible production schedules and batch size options to accommodate diverse market demands.
Quality Assurance
Our quality assurance framework is built on rigorous testing, analytical validation, and compliance with international pharmaceutical standards. Each batch of Clazit 80M undergoes comprehensive quality control checks, including physical testing (e.g., hardness, disintegration, and weight variation), chemical analysis (e.g., HPLC for active ingredient quantification), and microbiological testing. Analytical validation ensures method accuracy, precision, and reproducibility, aligning with ICH and USP guidelines. Batch testing is conducted at multiple stages of production to detect deviations and ensure product consistency. Our quality systems are integrated with digital traceability tools, enabling full documentation and audit readiness.
Regulatory Compliance
We ensure full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and ISO 9001:2015 quality management standards. Our manufacturing processes adhere to regulatory frameworks in the US, EU, and Asia-Pacific regions, including FDA, EMA, and PIC/S requirements. All products are manufactured under validated processes, with documentation compliant with ICH Q7 and Q10 guidelines. We maintain certifications for ISO 14001 (environmental management) and ISO 45001 (occupational health and safety), reflecting our commitment to sustainable and safe operations.
Global Supply Capability
Our global supply chain is designed to meet the demands of international markets, with robust export capabilities and a well-established distribution network. We provide bulk supply options for both domestic and international clients, supported by a reliable logistics infrastructure that ensures timely delivery. Our facilities are equipped to handle large-scale orders, with storage capabilities for raw materials and finished products. We maintain strategic partnerships with logistics providers to ensure compliance with customs regulations and import documentation. Our supply chain is optimized for resilience, with contingency planning to mitigate disruptions and ensure uninterrupted supply.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our expertise in high-quality production, regulatory compliance, and global supply capabilities. Our commitment to GMP standards, combined with flexible manufacturing solutions, ensures that clients can meet market demands efficiently. We offer competitive pricing, rapid turnaround times, and dedicated customer support to enhance partnership value. Our ability to scale production, coupled with stringent quality control, makes us a reliable partner for bulk supply and international distribution.
Bulk Supply Inquiry
We offer bulk supply capabilities for Clazit 80M and other pharmaceutical products. For inquiries regarding bulk orders, please contact us at info@delwishealthcare.com.
FAQs
What manufacturing processes are used for Clazit 80M?
Clazit 80M is manufactured using direct compression techniques, ensuring uniformity and stability of the active ingredients.
Does the blister packaging meet international standards?
Yes, the 10x10 blister packaging complies with global pharmaceutical packaging regulations for safety and shelf-life preservation.
Can Clazit 80M be produced in different strengths?
Currently, Clazit 80M is available in a single strength (Gliclazide 80mg + Metformin 500mg). Custom formulations can be developed upon request.
What quality control measures are in place during production?
Each batch undergoes rigorous testing, including HPLC analysis, dissolution testing, and microbiological checks, to ensure compliance with GMP standards.
Are there certifications for regulatory compliance?
Yes, our facility is certified under ISO 9001, ISO 14001, and ISO 45001, with adherence to WHO and FDA guidelines.
Can you support export to specific regions?
We have a global distribution network and can support exports to all major pharmaceutical markets, including the EU, US, and Asia-Pacific.
What is the minimum order quantity for bulk supply?
Minimum order quantities are flexible and can be tailored to meet the specific needs of our clients.
How long does it take to process a bulk order?
Production timelines vary based on order size, but we prioritize efficiency to ensure timely delivery without compromising quality.
Do you offer private label manufacturing?
Yes, we provide private label manufacturing services, allowing clients to brand products under their own trademarks.
How can I contact your team for bulk inquiries?
For bulk supply inquiries, please email **info@delwishealthcare.com** for personalized assistance.
