Sugaraide M4 is a bilayered tablet formulation combining Glimepride 4mg and Metformin 500mg, designed to optimize therapeutic efficacy while ensuring stable drug release. The bilayered structure ensures controlled release of Glimepride, a sulfonylurea that stimulates insulin secretion, and Metformin, a biguanide that enhances insulin sensitivity. The formulation employs advanced excipient systems to maintain tablet integrity, ensure uniform drug distribution, and enhance bioavailability. The tablet’s layered design minimizes degradation risks during storage and ensures consistent dosing. The manufacturing process incorporates precision tablet compression techniques to achieve uniform thickness, hardness, and disintegration time, meeting stringent pharmaceutical standards. The formulation’s stability profile is validated through accelerated aging studies, ensuring shelf-life compliance under varied environmental conditions.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities designed to produce high-quality, multi-component tablets like Sugaraide M4. The facility adheres to current Good Manufacturing Practices (cGMP) and includes automated tablet compression lines, high-precision coating systems, and advanced quality control laboratories. Sterile processing capabilities are available for critical components, ensuring contamination-free production. The manufacturing process employs validated equipment for bilayered tablet formation, including multi-layer tabletting machines that ensure precise layer separation and uniform drug incorporation. Production scalability is achieved through modular manufacturing units capable of handling bulk orders without compromising quality. The facility’s quality systems include real-time monitoring, traceability protocols, and validated cleaning procedures to maintain compliance with regulatory standards.
Available Strengths and Packaging
Composition: Glimepride 4mg + Metformin 500mg PR Bilayered Tab
Packaging: 10x10 Blister
Sugaraide M4 is available in a single strength formulation, with each blister pack containing 10 tablets. The 10x10 blister packaging ensures tamper-evident storage, protects the product from moisture and light, and facilitates easy dispensing. The packaging design is optimized for pharmaceutical distribution, ensuring compliance with global packaging regulations.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive third-party manufacturing services, including private label production and contract manufacturing for pharmaceutical buyers. Our facility is capable of producing Sugaraide M4 under private label agreements, allowing clients to brand the product while leveraging our expertise in formulation development and quality assurance. Contract manufacturing services include full-scale production, packaging, and regulatory documentation support, tailored to meet the specific needs of global markets. We provide end-to-end solutions for pharmaceutical companies seeking to enter new markets or expand their product portfolios, ensuring compliance with international standards and regulatory requirements.
Quality Assurance
Our quality assurance systems are designed to ensure the highest standards of product consistency and safety. Every batch of Sugaraide M4 undergoes rigorous testing, including dissolution profiling, hardness testing, and disintegration time analysis to confirm compliance with pharmacopeial specifications. Analytical validation is performed using high-performance liquid chromatography (HPLC) and ultraviolet (UV) spectroscopy to verify active pharmaceutical ingredient (API) content and purity. Microbial testing, heavy metal analysis, and particle size distribution assessments are conducted to ensure product safety. All quality control processes are documented and traceable, adhering to ICH and WHO guidelines.
Regulatory Compliance
Sugaraide M4 is manufactured in full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and international quality standards such as ISO 9001 and ISO 14001. The production process adheres to regulatory frameworks in key markets, including the U.S. FDA, EU GMP, and ICH guidelines. All documentation, including batch records, stability data, and analytical reports, is prepared to meet the requirements of global regulatory authorities. Our facility is regularly audited by third-party agencies and regulatory bodies to ensure ongoing compliance with evolving standards.
Global Supply Capability
We provide robust global supply capabilities, including bulk supply options and a well-established international distribution network. Our facility is equipped to handle large-scale production, ensuring timely delivery of Sugaraide M4 to markets worldwide. Export capabilities are supported by partnerships with logistics providers specializing in pharmaceutical transportation, ensuring secure and temperature-controlled shipping. Bulk supply capacity is optimized through efficient inventory management and scalable production planning, enabling consistent supply chain reliability. Our supply chain infrastructure is designed to meet the demands of both regional and international pharmaceutical buyers.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our commitment to quality, regulatory compliance, and scalable production. Our expertise in multi-component tablet manufacturing ensures consistent product performance, while our global supply chain capabilities enable seamless market entry. We offer competitive pricing, timely delivery, and full regulatory support, making us a reliable partner for businesses seeking to expand their product portfolios. Our dedicated team provides end-to-end solutions, from formulation development to global distribution, ensuring long-term collaboration and customer satisfaction.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is ready to assist with order placement, customization, and regulatory documentation to meet your specific requirements.
FAQs
What manufacturing standards does Sugaraide M4 comply with?
Sugaraide M4 is manufactured in compliance with cGMP, WHO guidelines, and ISO 9001 standards, ensuring adherence to global regulatory requirements.
Can Sugaraide M4 be produced in different packaging formats?
While the standard packaging is 10x10 blister, we offer customization options for alternative packaging formats upon request.
What quality control measures are applied during production?
Each batch undergoes dissolution testing, HPLC analysis, microbial testing, and stability studies to ensure product consistency and safety.
Is Sugaraide M4 suitable for export to international markets?
Yes, our production process and documentation meet the regulatory requirements of major markets, including the EU, US, and Asia-Pacific regions.
What is the minimum order quantity for bulk supply?
Bulk supply options are flexible, with quantities tailored to meet the specific needs of pharmaceutical buyers.
Can private label manufacturing be done for Sugaraide M4?
Yes, we provide private label manufacturing services, allowing clients to brand the product while leveraging our production expertise.
How is the bilayered tablet formulation ensured to be stable?
The formulation undergoes accelerated stability testing to confirm shelf-life compliance, with excipients selected to prevent degradation under varied storage conditions.
What is the lead time for production and delivery?
Lead times are dependent on order volume and customization requirements. We provide detailed timelines upon request to ensure project alignment.
Are there options for customized packaging solutions?
Yes, we offer customized packaging solutions, including alternative blister sizes and labeling formats, to meet specific market demands.
How does your quality assurance system ensure product safety?
Our quality assurance system includes real-time monitoring, validated cleaning protocols, and third-party audits to ensure product safety and regulatory compliance.
