Sugaraide MP 2/15 is a ternary antidiabetic formulation engineered for pharmaceutical manufacturers requiring a stable, scalable, and bioavailable combination therapy. The product integrates Glimipiride (a sulfonylurea) at 2mg, Metformin sustained-release (SR) at 500mg, and Pioglitazone at 15mg, each selected for its pharmacological profile and compatibility within a combined dosage form. The sustained-release formulation of Metformin ensures prolonged gastric residence time, enhancing absorption and reducing peak fluctuations. The combination leverages synergistic metabolic pathways—Glimipiride stimulates insulin secretion, Metformin improves insulin sensitivity, and Pioglitazone enhances hepatic glucose uptake—while maintaining physicochemical stability through controlled pH buffering and excipient compatibility. The formulation employs a layered compression technique to ensure uniform drug distribution and dissolution profile, with excipients selected for their role in tablet integrity, moisture resistance, and tablet disintegration. The product’s design supports high potency, minimal excipient interference, and compliance with ICH and USP monograph standards.
Manufacturing Capability
Our manufacturing infrastructure is tailored to produce Sugaraide MP 2/15 with precision and scalability, meeting the demands of global pharmaceutical buyers. The facility is equipped with state-of-the-art tablet compression machines, high-speed coating systems, and advanced blending units to ensure homogeneity of the ternary combination. Sterile processing capabilities are available for critical components, with dedicated cleanrooms classified at ISO 7 and ISO 5 standards to prevent cross-contamination. The production line adheres to current Good Manufacturing Practices (cGMP) and includes real-time monitoring systems for critical parameters such as tablet hardness, disintegration time, and active pharmaceutical ingredient (API) content. Scalability is achieved through modular production units, enabling seamless transitions from small-scale trials to bulk manufacturing. Quality systems are reinforced by automated data integrity (DI) protocols, traceability matrices, and validated process analytical technology (PAT) tools. The facility also supports API sourcing, excipient compatibility testing, and formulation optimization to meet specific regulatory and market requirements.
Available Strengths and Packaging
Composition: Glimipiride 2mg + Metformin 500mg SR + Pioglitazone 15mg Tab
Packaging: 10x10 Blister
Sugaraide MP 2/15 is available in a fixed-dose combination of 2mg Glimipiride, 500mg Metformin SR, and 15mg Pioglitazone. The 10x10 blister packaging ensures tamper-evident storage, moisture resistance, and efficient distribution for pharmaceutical buyers requiring secure, ready-to-market packaging.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer end-to-end contract manufacturing and third-party production services for pharmaceutical buyers seeking to launch or scale antidiabetic therapies. Our private label manufacturing capabilities enable clients to produce Sugaraide MP 2/15 under their brand, with full customization of packaging, labeling, and dosage forms. We support both small-batch prototyping and large-scale commercial production, adhering to client specifications for API sourcing, excipient selection, and formulation optimization. Our team collaborates with buyers to navigate regulatory requirements, ensuring compliance with local and international standards. For exporters and distributors, we provide turnkey solutions, including regulatory documentation, labeling compliance, and logistics coordination.
Quality Assurance
Quality assurance for Sugaraide MP 2/15 is anchored in rigorous analytical validation, batch testing, and adherence to pharmaceutical quality standards. Each production batch undergoes in-process testing for dissolution profile, content uniformity, and hardness, with final testing confirming compliance with ICH Q1A and USP <711> specifications. Advanced analytical techniques, including HPLC and UV spectrophotometry, are employed to validate API potency and impurity levels. Batch records are audited for traceability, with data integrity protocols ensuring transparency and regulatory readiness. Our quality systems include validated cleaning procedures, environmental monitoring, and stability testing to guarantee shelf-life compliance. All processes are documented to meet ISO 9001 and FDA 21 CFR Part 11 standards, ensuring consistency and reliability for pharmaceutical buyers.
Regulatory Compliance
Sugaraide MP 2/15 is manufactured in full compliance with Good Manufacturing Practices (GMP), WHO guidelines, and ISO 9001:2015 standards. The product adheres to ICH guidelines for quality, safety, and efficacy, with documentation prepared for submission to regulatory authorities worldwide. Our facility is certified under ISO 17025 for testing and calibration, ensuring analytical accuracy. Compliance with FDA, EMA, and WHO regulations is prioritized, with documentation supporting market access in both developed and emerging markets. The manufacturing process is validated to meet ICH Q7 and Q8 requirements, ensuring consistency across batches. Regulatory support includes dossiers for pre-market approval, labeling compliance, and export documentation, tailored to regional requirements.
Global Supply Capability
Our global supply chain ensures reliable bulk supply, international distribution, and export capability for Sugaraide MP 2/15. With a network spanning Asia, Africa, Latin America, and Europe, we facilitate seamless logistics, including temperature-controlled shipping and customs compliance. Bulk supply capacity is scalable, with storage facilities capable of handling large inventories to meet seasonal or market-driven demand. Supply chain reliability is reinforced by redundant inventory systems, real-time tracking, and partnerships with global logistics providers. Exporters benefit from our expertise in navigating import regulations, duty classifications, and documentation requirements, ensuring timely delivery to international markets.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturers select us for our expertise in multi-component formulation, regulatory compliance, and scalable production. Our commitment to cGMP, ISO certification, and WHO guidelines ensures product quality and market readiness. As a manufacturer, we offer competitive pricing, rapid turnaround, and tailored solutions to meet specific business needs. Our global supply network and bulk supply capabilities provide exporters with reliable access to diverse markets, while our quality assurance systems guarantee compliance and consistency. For partners seeking to enter the antidiabetic therapeutics segment, we deliver a seamless blend of technical excellence, regulatory support, and operational efficiency.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is dedicated to supporting pharmaceutical buyers with customized solutions, from formulation development to global distribution.
FAQs
What are the available strengths for Sugaraide MP 2/15?
The product is available in a fixed-dose combination of 2mg Glimipiride, 500mg Metformin SR, and 15mg Pioglitazone.
What packaging options are available for Sugaraide MP 2/15?
The product is supplied in 10x10 blister packaging for secure, ready-to-market distribution.
Can Sugaraide MP 2/15 be manufactured under private label?
Yes, we offer private label manufacturing services to produce the product under your brand.
What regulatory certifications does your facility hold?
Our facility is certified under GMP, ISO 9001:2015, and WHO guidelines, ensuring global compliance.
Can you support bulk supply for international markets?
Yes, we provide scalable bulk supply with a global distribution network and export-ready documentation.
What quality assurance measures are in place for Sugaraide MP 2/15?
The product undergoes rigorous batch testing, HPLC validation, and compliance with ICH and USP standards.
Do you offer contract manufacturing for third-party buyers?
Yes, we provide end-to-end contract manufacturing services, including formulation, production, and regulatory support.
What is the shelf life of Sugaraide MP 2/15?
The product has a shelf life of 24 months when stored under recommended conditions.
Can you assist with export documentation and customs compliance?
Yes, we provide tailored export documentation and support for customs clearance in target markets.
How can I inquire about bulk supply?
Contact us at **info@delwishealthcare.com** for detailed inquiries and supply arrangements.
