Sugaraide 2M is a bilayered tablet formulation combining Glimepride (2mg) and Metformin sustained-release (500mg) in a dual-layered structure, ensuring controlled release and enhanced bioavailability. The formulation integrates a rapid-acting layer for Glimepride and a prolonged-release layer for Metformin SR, optimizing therapeutic efficacy. The bilayered design ensures precise dosing, minimizes gastrointestinal irritation, and improves patient compliance. From a manufacturing perspective, the tablet is produced using advanced compression techniques to maintain layer integrity, with excipients selected for stability, compatibility, and disintegration properties. The sustained-release Metformin component employs a polymer-based matrix to ensure gradual drug release over 12–14 hours, while Glimepride is formulated for immediate dissolution. The combination leverages synergistic pharmacological properties to enhance glucose regulation, with formulation parameters validated for uniformity, dissolution, and content uniformity.
Manufacturing Capability
Delwis Healthcare’s manufacturing infrastructure is equipped to produce Sugaraide 2M with precision and scalability. Our state-of-the-art facility adheres to current Good Manufacturing Practices (cGMP) and maintains a Class 10,000 cleanroom environment for sterile processing. The production line includes high-speed tablet compression machines, advanced coating systems for sustained-release layers, and automated blister packaging units. The facility supports batch sizes ranging from small trials to large-scale commercial production, ensuring flexibility for pharmaceutical buyers. Quality systems are integrated throughout the manufacturing process, including real-time monitoring of critical parameters such as tablet hardness, disintegration time, and layer separation. Our dedicated R&D team ensures continuous improvement in formulation stability and process validation, meeting global standards for pharmaceutical quality.
Available Strengths and Packaging
Composition: Glimepride 2mg + Metformin 500mg SR Bilayered Tab
Packaging: 10x10 Blister
Sugaraide 2M is available in a fixed-dose combination of 2mg Glimepride and 500mg Metformin SR, formulated as a bilayered tablet. The 10x10 blister packaging ensures tamper-evidence, product stability, and efficient distribution. Each blister pack contains 10 tablets, with 10 packs per box, ideal for retail and bulk supply. The packaging design complies with international pharmaceutical standards, offering protection against moisture, light, and contamination.
Contract Manufacturing / Third Party Manufacturing
Delwis Healthcare offers comprehensive contract manufacturing and private label services for pharmaceutical buyers seeking to launch branded products. Our facility is equipped to produce complex formulations like Sugaraide 2M, with expertise in bilayered tablet development, sustained-release technologies, and multi-layered dosage forms. We support third-party manufacturers by providing end-to-end solutions, including formulation development, GMP-compliant production, and packaging. Our scalable infrastructure enables customization of strengths, packaging formats, and labeling, catering to diverse market demands. Pharmaceutical buyers benefit from our ability to meet stringent regulatory requirements while maintaining cost-efficiency and production flexibility.
Quality Assurance
Delwis Healthcare’s quality assurance systems are designed to ensure consistency, safety, and efficacy of Sugaraide 2M. Every batch undergoes rigorous testing, including high-performance liquid chromatography (HPLC) for active ingredient quantification, dissolution testing to validate sustained-release properties, and microbial limit testing for contamination. Analytical validation ensures accuracy in potency, disintegration time, and layer separation. Quality control measures are integrated at every stage, from raw material sourcing to final packaging, with documented records for traceability. Our facility holds ISO 9001 certification and complies with ICH and USP guidelines, ensuring adherence to global pharmaceutical quality standards.
Regulatory Compliance
Delwis Healthcare ensures full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and international regulatory frameworks. Our production processes meet the requirements of the FDA, EMA, and PIC/S, enabling seamless export to global markets. The facility is certified under ISO 9001:2015 and ISO 14001:2015 for quality and environmental management. Regulatory documentation, including batch records, stability data, and deviation reports, is maintained to support audits and market approvals. Compliance with pharmacopeial standards (USP, EP, BP) ensures product acceptance across regions, while adherence to data integrity protocols guarantees transparency in manufacturing.
Global Supply Capability
Delwis Healthcare provides reliable global supply capabilities, with a well-established international distribution network spanning over 50 countries. Our bulk supply capacity supports large-volume orders, with logistics optimized for timely delivery. The company maintains strategic partnerships with freight forwarders and customs brokers to ensure compliance with import regulations and duty requirements. Supply chain reliability is ensured through real-time tracking, inventory management systems, and contingency planning for disruptions. Export capabilities include compliance with FDA, EMA, and WHO regulations, enabling seamless entry into regulated markets. Bulk supply options are tailored to meet the needs of pharmaceutical distributors, exporters, and contract manufacturers.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose Delwis Healthcare for its expertise in complex formulation development, compliance-driven manufacturing, and scalable production. Our commitment to quality, coupled with a robust regulatory framework and global supply network, ensures competitive advantage in the pharmaceutical market. The facility’s advanced technology and dedicated team provide end-to-end solutions, from R&D to commercialization. Partners benefit from cost-effective production, rapid time-to-market, and support for regulatory submissions. Delwis Healthcare’s focus on innovation and reliability makes it a trusted partner for bulk supply and contract manufacturing needs.
Bulk Supply Inquiry
Delwis Healthcare offers bulk supply capabilities for Sugaraide 2M. For inquiries regarding large-volume orders, please contact us at info@delwishealthcare.com.
FAQs
What is the manufacturing process for Sugaraide 2M?
Sugaraide 2M is manufactured using advanced tablet compression and coating technologies to ensure bilayered integrity, with quality control at every stage.
Can Delwis Healthcare produce private label versions of Sugaraide 2M?
Yes, we offer private label manufacturing services, enabling pharmaceutical buyers to brand and distribute the product globally.
What certifications does Delwis Healthcare hold for regulatory compliance?
Our facility is certified under ISO 9001:2015, ISO 14001:2015, and complies with FDA, EMA, and WHO guidelines.
Is Sugaraide 2M suitable for export to regulated markets?
Yes, the product meets international regulatory standards, ensuring compliance with FDA, EMA, and PIC/S requirements.
What is the shelf life of Sugaraide 2M in blister packaging?
The product has a shelf life of 24 months when stored under recommended conditions, with stability data validated per ICH guidelines.
Can Delwis Healthcare accommodate custom packaging formats?
Yes, we support customized packaging solutions, including alternative blister designs and labeling, to meet market-specific requirements.
What quality tests are performed on Sugaraide 2M batches?
Each batch undergoes HPLC, dissolution testing, microbial limit testing, and physical property analysis to ensure compliance.
How does Delwis Healthcare ensure supply chain reliability?
Our global distribution network, real-time tracking systems, and contingency planning ensure timely and consistent bulk supply.
What is the minimum order quantity for bulk supply?
Minimum order quantities are flexible and tailored to the buyer’s requirements, with options for small-scale trials and large-volume production.
How can I request a sample or quotation for Sugaraide 2M?
Contact us at **info@delwishealthcare.com** for sample requests, pricing details, and bulk supply inquiries.
