Tenidel - M is a bilayered tablet formulation combining Teneligliptin (20mg) and Metformin (500mg) in a dual-layered structure, ensuring optimal drug release and bioavailability. The formulation employs advanced coating technologies to achieve controlled release of Teneligliptin, while Metformin is designed for immediate dissolution to enhance therapeutic efficacy. The bilayered design minimizes excipient interactions, ensuring stability during storage and uniform drug delivery. The tablet’s composition includes hydrophilic and hydrophobic excipients to maintain structural integrity and improve disintegration properties. Manufacturing focuses on precise blending, compression, and coating processes to meet stringent quality parameters, including dissolution rate consistency and tablet hardness. The formulation is optimized for compatibility with existing pharmaceutical infrastructure, enabling seamless integration into production lines.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001 standards. The production line supports high-speed tablet compression, advanced coating technologies, and automated packaging systems to ensure precision and scalability. Sterile processing capabilities are available for critical components, with dedicated cleanrooms maintaining ISO 7 and ISO 8 classifications. The facility is designed for large-scale production, with modular systems enabling flexible adjustments to meet varying order volumes. Quality systems include real-time monitoring, process validation, and continuous improvement protocols to ensure consistency and compliance. Our expertise in complex dosage forms, such as bilayered tablets, ensures reliable output while adhering to global regulatory requirements.
Available Strengths and Packaging
Composition: Teneligliptin 20mg Tab + Metformin 500mg Bilayered Tab
Packaging: 10x10 Alu Alu
The bilayered design allows for tailored release profiles, with Teneligliptin’s delayed release complementing Metformin’s immediate action. The 10x10 Alu Alu packaging provides moisture resistance, tamper-evidence, and enhanced shelf life, ensuring product integrity during transportation and storage. This packaging format is ideal for bulk distribution, offering convenience for pharmaceutical buyers requiring standardized packaging solutions.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer contract manufacturing, private label production, and third-party manufacturing services to pharmaceutical buyers worldwide. Our capabilities include formulation development, dosage form customization, and packaging solutions tailored to client specifications. We support complex formulations such as bilayered tablets, ensuring compliance with global standards while meeting specific regulatory and market requirements. Our flexible production model accommodates small-scale trials and large-volume commercialization, with dedicated teams to manage quality control, documentation, and regulatory submissions. This service is ideal for buyers seeking to outsource manufacturing while maintaining brand control and market competitiveness.
Quality Assurance
Our quality assurance systems prioritize rigorous testing and validation to ensure product consistency and safety. Each batch undergoes comprehensive analytical validation, including high-performance liquid chromatography (HPLC), dissolution testing, and physical property assessments. Quality control measures include in-process monitoring, stability testing, and documentation of critical process parameters. We adhere to international standards such as USP, EP, and BP, with traceability systems ensuring full transparency throughout the supply chain. Regular internal audits and third-party inspections validate compliance with cGMP and ISO standards, providing pharmaceutical buyers with confidence in product quality and regulatory readiness.
Regulatory Compliance
We comply with global regulatory frameworks, including cGMP, WHO guidelines, and ISO 9001/14001 standards. Our manufacturing processes meet the requirements of the FDA, EMA, and other regional authorities, with documentation prepared for regulatory submissions and audits. We ensure adherence to Good Distribution Practices (GDP) and maintain certifications for pharmaceutical quality systems. Our commitment to regulatory compliance enables seamless market entry in diverse regions, supporting buyers in navigating complex approval processes and maintaining product integrity across international markets.
Global Supply Capability
Our global supply chain ensures reliable bulk supply, with a robust network for international distribution and export capabilities. We support large-volume orders through efficient logistics partnerships, ensuring timely delivery to key markets. Our facilities are equipped for storage under controlled conditions, with packaging solutions designed for long-term stability. We prioritize supply chain reliability through risk management strategies, including redundant production lines and inventory management systems. This capability positions us as a preferred partner for pharmaceutical exporters and distributors seeking consistent, high-quality supply chains.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in advanced formulation technologies, compliance-driven manufacturing, and scalable production. Our commitment to quality, combined with global regulatory adherence, ensures seamless market access and product reliability. With a focus on innovation and efficiency, we deliver cost-effective solutions tailored to meet the demands of the pharmaceutical industry. Our partnerships with leading global clients underscore our ability to deliver excellence in manufacturing, supply, and compliance.
Bulk Supply Inquiry
For bulk supply inquiries, contact our dedicated team at info@delwishealthcare.com to discuss customization, pricing, and logistics for large-volume orders.
FAQs
What manufacturing standards does Tenidel - M comply with?
Tenidel - M is manufactured in facilities compliant with cGMP, ISO 9001, and WHO guidelines, ensuring adherence to global pharmaceutical standards.
Can Tenidel - M be produced in different packaging formats?
Yes, we offer flexible packaging solutions, including 10x10 Alu Alu, to meet diverse market requirements.
What quality control measures are applied during production?
Each batch undergoes HPLC, dissolution testing, and physical property checks to ensure consistency and safety.
Is Tenidel - M suitable for export to international markets?
Yes, our compliance with FDA, EMA, and WHO standards enables seamless export to global markets.
How does the bilayered design enhance drug efficacy?
The bilayered structure ensures controlled release of Teneligliptin while Metformin dissolves immediately, optimizing therapeutic outcomes.
What is the shelf life of Tenidel - M?
The product has a shelf life of 24 months when stored under recommended conditions, as validated through stability testing.
Can Tenidel - M be customized for private label manufacturing?
Yes, we support private label production, allowing clients to brand the product while maintaining quality and compliance.
What is the minimum order quantity for bulk supply?
We accommodate bulk orders starting from 10,000 units, with scalable production capabilities for larger volumes.
How do you ensure regulatory compliance for international markets?
Our documentation and production processes align with regional regulatory requirements, ensuring smooth market entry.
What support is available for supply chain logistics?
We provide end-to-end logistics support, including shipping, customs documentation, and inventory management for global distribution.
