Tenidel-20 is a pharmaceutical formulation containing teneligliptin as the active ingredient, delivered in a 20mg tablet dosage form. The formulation is designed to ensure stability, uniformity, and consistent bioavailability, critical for pharmaceutical manufacturing. The tablet composition includes teneligliptin, along with excipients such as microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and colloidal silicon dioxide, which are selected for their compatibility with the active pharmaceutical ingredient (API) and their ability to enhance tablet integrity, disintegration, and dissolution properties. The manufacturing process involves blending, compression, and coating steps to achieve a uniform, robust tablet with controlled release characteristics. The formulation is optimized for long-term stability under standard storage conditions, ensuring compliance with pharmaceutical quality standards. The excipients are chosen to minimize degradation risks and maintain the therapeutic efficacy of teneligliptin, while the tablet’s physical properties, such as hardness and disintegration time, are tailored to meet regulatory requirements for solid dosage forms.
Manufacturing Capability
Delwis Healthcare’s pharmaceutical manufacturing infrastructure is equipped to produce high-quality tablets like Tenidel-20 with advanced capabilities in sterile processing, GMP compliance, and scalable production. The facility features state-of-the-art equipment, including high-speed tablet presses, fluid bed dryers, and automated packaging lines, enabling precise control over critical quality attributes. Sterile processing is supported by a dedicated aseptic manufacturing zone, compliant with ISO 7 and ISO 8 cleanroom standards, ensuring contamination-free production for sensitive dosage forms. All manufacturing processes adhere to current Good Manufacturing Practices (cGMP), with rigorous validation protocols for equipment, processes, and materials. The facility is designed for scalability, allowing seamless transitions from small-scale development to large-volume commercial production. Quality systems include real-time monitoring, batch-specific traceability, and integrated process analytical technology (PAT) to ensure consistency and compliance. Additionally, the facility maintains robust documentation and audit trails to meet regulatory inspections and quality assurance requirements.
Available Strengths and Packaging
Composition: Teneligliptin 20mg Tab
Packaging: 10x10 Alu Alu
Tenidel-20 is available in a 20mg strength, formulated to meet the therapeutic requirements of diabetes management. The packaging consists of a 10x10 aluminum blister pack, designed for secure, moisture-resistant storage and easy dispensing. This packaging format ensures product integrity during transportation and shelf life, while also complying with global pharmaceutical packaging standards. The aluminum blister packaging provides protection against light, humidity, and physical damage, making it ideal for both domestic and international distribution.
Contract Manufacturing / Third Party Manufacturing
Delwis Healthcare offers comprehensive contract manufacturing and third-party manufacturing services tailored to meet the needs of pharmaceutical buyers. Our facility is equipped to handle private label manufacturing, enabling clients to produce branded or generic formulations under their own trademarks. We provide end-to-end solutions, from API sourcing and formulation development to packaging and labeling, ensuring full compliance with regulatory requirements. Our team of experienced professionals supports clients in navigating complex manufacturing processes, including stability testing, process validation, and regulatory submissions. Whether you require small-scale prototyping or large-volume production, our flexible manufacturing capabilities allow for customization to suit specific product requirements. This service is ideal for pharmaceutical distributors, exporters, and manufacturers seeking to expand their product portfolios while maintaining quality and compliance standards.
Quality Assurance
Delwis Healthcare’s quality assurance systems are designed to ensure the highest standards of pharmaceutical excellence. Every batch of Tenidel-20 undergoes rigorous quality control (QC) testing, including in-process checks, finished product analysis, and stability testing. Analytical validation methods such as high-performance liquid chromatography (HPLC), dissolution testing, and microbial limit testing are employed to confirm the identity, potency, and purity of the final product. Batch testing is conducted in accordance with International Council for Harmonisation (ICH) guidelines and United States Pharmacopeia (USP) standards, ensuring consistency and compliance. Our quality control protocols include real-time monitoring of critical parameters, such as tablet hardness, disintegration time, and content uniformity, to guarantee product performance. Additionally, all raw materials and packaging components are tested for compliance with Good Manufacturing Practices (GMP) and regulatory specifications. This comprehensive approach ensures that Tenidel-20 meets the stringent quality requirements of global pharmaceutical markets.
Regulatory Compliance
Delwis Healthcare is fully compliant with global regulatory frameworks, including Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and ISO standards. Our facility is certified under ISO 9001 for quality management and ISO 14001 for environmental management, reflecting our commitment to sustainable and compliant manufacturing. All production processes adhere to FDA, EMA, and other regional regulatory requirements, ensuring that Tenidel-20 meets the standards for safety, efficacy, and quality. Our quality assurance systems are aligned with ICH guidelines, ensuring consistency in analytical methods and documentation. Additionally, we maintain compliance with WHO prequalification criteria, enabling seamless export to international markets. Regulatory submissions, including technical documentation and batch records, are prepared to meet the requirements of global regulatory authorities, ensuring smooth approval processes for pharmaceutical buyers.
Global Supply Capability
Delwis Healthcare has a robust global supply chain infrastructure, enabling reliable export and distribution of Tenidel-20 to markets worldwide. Our international distribution network includes partnerships with logistics providers and customs brokers, ensuring timely and cost-effective delivery to destinations across continents. The facility is capable of producing bulk quantities of Tenidel-20, with a production capacity designed to meet the demands of large-scale pharmaceutical buyers. Our supply chain reliability is supported by advanced inventory management systems, real-time tracking, and contingency planning to mitigate disruptions. We offer flexible supply options, including scheduled shipments and just-in-time delivery, to accommodate the needs of distributors and exporters. The combination of compliance with global regulatory standards and a well-established logistics network ensures that Tenidel-20 can be supplied consistently and efficiently to meet market demands.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose Delwis Healthcare for our expertise in high-quality manufacturing, regulatory compliance, and global supply capabilities. Our facility’s adherence to GMP, ISO, and WHO standards ensures that Tenidel-20 meets the stringent requirements of international markets. The ability to scale production and offer customized solutions makes us a reliable partner for businesses seeking to expand their product offerings. Our commitment to quality assurance, combined with a proven track record of regulatory compliance, positions us as a trusted supplier in the pharmaceutical industry. Additionally, our dedicated support team provides end-to-end assistance, from manufacturing to export logistics, ensuring seamless collaboration with clients. By choosing Delwis Healthcare, buyers gain access to a reliable, compliant, and scalable partner dedicated to excellence in pharmaceutical manufacturing.
Bulk Supply Inquiry
Delwis Healthcare offers bulk supply capabilities for Tenidel-20, tailored to meet the needs of pharmaceutical buyers. For inquiries regarding large-scale procurement, please contact our sales team at info@delwishealthcare.com.
FAQs
What manufacturing standards does Delwis Healthcare follow for Tenidel-20?
Delwis Healthcare adheres to current Good Manufacturing Practices (cGMP), ISO 9001, and WHO guidelines to ensure compliance with global pharmaceutical standards.
Can Tenidel-20 be produced in different packaging formats?
While Tenidel-20 is currently available in 10x10 Alu Alu packaging, we offer customization options for alternative packaging formats upon request.
What regulatory approvals are required for exporting Tenidel-20?
Export compliance includes adherence to FDA, EMA, and WHO guidelines, with all documentation prepared to meet international regulatory requirements.
How does Delwis Healthcare ensure quality control for Tenidel-20?
Quality control involves HPLC, dissolution testing, microbial testing, and compliance with ICH and USP standards to guarantee product consistency.
What is the minimum order quantity for bulk supply of Tenidel-20?
Bulk supply options are flexible, with quantities tailored to meet the specific needs of pharmaceutical buyers.
Can Delwis Healthcare provide private label manufacturing for Tenidel-20?
Yes, we offer private label manufacturing services, enabling clients to produce branded formulations under their own trademarks.
What is the production scalability for Tenidel-20?
Our facility is designed for scalable production, supporting both small-scale development and large-volume commercial manufacturing.
How does Delwis Healthcare ensure supply chain reliability?
We maintain a robust logistics network, real-time tracking, and contingency planning to ensure consistent and timely delivery of Tenidel-20.
What certifications does Delwis Healthcare hold?
Our facility is certified under ISO 9001, ISO 14001, and complies with GMP and WHO standards, ensuring quality and environmental responsibility.
Can Tenidel-20 be customized for specific market requirements?
Yes, we provide customization options for packaging, labeling, and formulation to meet the specific needs of global markets.
