Telwidet - AM is a dual-action antihypertensive formulation combining Telmisartan (40mg) and Amlodipine (5mg) in a single tablet. Telmisartan, an angiotensin II receptor blocker (ARB), inhibits the vasoconstrictor effects of angiotensin II, while Amlodipine, a dihydropyridine calcium channel blocker, promotes vasodilation by blocking calcium influx in vascular smooth muscle. The formulation employs a direct compression technique to ensure uniform drug distribution, with excipients selected for stability, disintegration, and bioavailability. The tablet’s physicochemical properties, including hardness, disintegration time, and dissolution profile, are optimized to meet pharmacopeial standards, ensuring consistent therapeutic performance. The combination leverages the complementary mechanisms of both active ingredients to enhance blood pressure control, reducing the need for multiple tablets and improving patient compliance. The formulation is designed for long-term stability under standard storage conditions, with minimal risk of degradation or interaction between components.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and designed for high-volume, high-quality production. The facility includes advanced tablet compression lines, coating systems, and packaging units capable of handling complex formulations like Telwidet - AM. Sterile processing capabilities are available for critical components, ensuring contamination-free production. The manufacturing process adheres to strict quality control protocols, including in-process testing for critical parameters such as tablet weight, content uniformity, and dissolution. Scalability is ensured through modular production lines that can accommodate bulk supply demands without compromising product integrity. Quality systems are integrated with digital traceability tools, enabling real-time monitoring of production parameters and batch-specific data. The facility is certified under ISO 9001 and maintains rigorous validation protocols for equipment, processes, and materials.
Available Strengths and Packaging
Composition: Telmisartan 40mg + Amlodipine 5mg Tab
Packaging: 10x10 Alu Alu
Telwidet - AM is available in a fixed-dose combination of 40mg Telmisartan and 5mg Amlodipine, ensuring precise dosing for therapeutic efficacy. The 10x10 Alu Alu blister pack offers a secure, moisture-resistant packaging solution ideal for retail and hospital distribution. The aluminum blister format provides protection against light, humidity, and contamination, extending shelf life while maintaining product integrity. This packaging design supports efficient inventory management and is compatible with automated dispensing systems, enhancing supply chain logistics.
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 capabilities extend to custom formulation development, dosage form optimization, and full-scale production of API-based combinations. We support global clients by providing flexible manufacturing solutions tailored to regulatory requirements and market demands. Our team collaborates closely with buyers to ensure alignment with specifications, from raw material sourcing to final packaging. Whether requiring bulk supply or niche formulations, we deliver scalable, cost-effective solutions that meet international quality and compliance standards.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch-specific testing, and adherence to pharmacopeial standards. Each batch undergoes in-process testing for critical parameters such as weight variation, disintegration time, and content uniformity. Finished products are subjected to dissolution testing, microbial limits, and heavy metal analysis to ensure safety and efficacy. Advanced analytical techniques, including HPLC and UV spectrophotometry, validate active ingredient potency and purity. Quality control systems are integrated with digital documentation tools, enabling traceability and audit readiness. Compliance with ICH guidelines and pharmacopeial monographs ensures consistency in product quality, supporting global market access.
Regulatory Compliance
We maintain full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and international standards such as ISO 9001 and ISO 14001. Our facilities are registered with regulatory authorities in key markets, including the FDA, EMA, and PMDA, ensuring seamless approval processes for global distribution. We adhere to ICH Q7 for API manufacturing and ICH Q8 for quality-by-design approaches. Documentation is maintained in accordance with 21 CFR Part 11 for electronic records, and all processes are validated to meet regulatory expectations. This compliance framework ensures that Telwidet - AM meets the highest standards of safety, efficacy, and quality for pharmaceutical buyers.
Global Supply Capability
Our global supply chain is designed to meet the demands of international markets with reliable bulk supply capacity and a robust distribution network. We export to over 50 countries, supported by strategic partnerships and logistics providers that ensure timely delivery. Bulk supply capabilities include flexible packaging options and volume discounts for large orders. Our supply chain is optimized for resilience, with redundant systems to mitigate disruptions and ensure uninterrupted service. We provide end-to-end logistics support, including customs documentation, quality certifications, and compliance-ready packaging, to facilitate smooth international trade.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our commitment to quality, compliance, and scalability. Our expertise in complex formulation development and GMP-compliant manufacturing ensures reliable bulk supply and market-ready products. We offer competitive pricing without compromising on quality, supported by a dedicated account management team to address client needs. Our global regulatory expertise and logistics network enable seamless market entry, while our flexible manufacturing capabilities allow customization to meet specific requirements. Partnering with us ensures access to a trusted supplier with a proven track record in delivering high-quality pharmaceutical solutions.
Bulk Supply Inquiry
We offer bulk supply capabilities for Telwidet - AM, tailored to meet the needs of pharmaceutical buyers. For inquiries regarding bulk orders, packaging customization, or regulatory documentation, please contact us at info@delwishealthcare.com.
FAQs
What is the manufacturing process for Telwidet - AM?
Telwidet - AM is manufactured using direct compression technology, ensuring uniform drug distribution and optimal tablet properties.
Can Telwidet - AM be produced in different packaging formats?
While the standard packaging is 10x10 Alu Alu, we can accommodate custom packaging requests for bulk supply.
What quality standards does Telwidet - AM comply with?
The product adheres to ICH, USP, and EP pharmacopeial standards, with full compliance to GMP and ISO certifications.
Is Telwidet - AM suitable for export to international markets?
Yes, our regulatory compliance and quality assurance systems ensure seamless approval and distribution in global markets.
What is the shelf life of Telwidet - AM?
The product has a shelf life of 24 months when stored under recommended conditions (cool, dry, and protected from light).
Can you provide third-party manufacturing services for Telwidet - AM?
Yes, we offer contract manufacturing and private label production for pharmaceutical buyers.
What documentation is provided for regulatory compliance?
We supply complete documentation, including batch certificates, analytical reports, and regulatory filings for global markets.
How does your supply chain ensure reliability?
Our logistics network and redundant systems ensure uninterrupted bulk supply, with real-time tracking and compliance-ready packaging.
Can Telwidet - AM be customized for specific dosage strengths?
While the product is available in a fixed-dose combination, we can explore custom formulation options upon request.
What is the minimum order quantity for bulk supply?
Minimum order quantities are flexible and can be discussed based on the buyer’s requirements and production scale.
