Telwidet Trio 12.5 is a fixed-dose combination tablet formulated to deliver synergistic antihypertensive effects through three distinct mechanisms of action. The formulation integrates Cilnidipine, a dihydropyridine calcium channel blocker, which inhibits vascular smooth muscle contraction; Telmisartan, an angiotensin II receptor blocker (ARB), which reduces aldosterone secretion and vascular resistance; and Chlorthalidone, a thiazide-like diuretic, which promotes sodium and water excretion. The tablet is manufactured using advanced direct compression techniques, ensuring uniform drug distribution and optimal disintegration properties. The excipient profile includes hydrophilic colloids, disintegrants, and film-coating agents to enhance stability, bioavailability, and patient compliance. The formulation is designed to maintain chemical stability under standard storage conditions, with a shelf life of 24 months when stored in controlled environments.
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 includes high-speed tablet compression machines, multi-layer coating systems, and automated packaging units capable of handling complex combination formulations. Sterile processing capabilities are available for critical components, supported by Class 100,000 cleanroom environments and aseptic filling systems. The facility adheres to rigorous quality control protocols, including real-time monitoring of critical process parameters such as tablet hardness, disintegration time, and active pharmaceutical ingredient (API) content. Scalability is ensured through modular production lines that can accommodate large-scale bulk manufacturing while maintaining consistency in product quality. Advanced quality systems, including Hazard Analysis and Critical Control Points (HACCP) and traceability frameworks, guarantee compliance with global pharmaceutical standards.
Available Strengths and Packaging
Composition: Cilnidipine 10mg + Telmisartan 40mg + Chlorthalidone 12.5mg Tablets
Packaging: 10x10 Alu Alu
Telwidet Trio 12.5 is available in a single dosage strength, optimized for therapeutic efficacy. The 10x10 Alu Alu packaging provides robust protection against moisture, light, and physical damage, ensuring product integrity during storage and transportation. The aluminum blister packaging is designed for high-volume distribution, with tamper-evident seals and batch-specific labeling to meet regulatory requirements.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing, private label, and third-party production services tailored to pharmaceutical buyers’ needs. Our facility is equipped to produce custom combination therapies, including API sourcing, formulation development, and scale-up manufacturing. We support global clients by providing end-to-end solutions, from raw material procurement to finished product packaging. Our team specializes in producing complex multitherapeutic formulations, ensuring compliance with regulatory frameworks while maintaining cost-efficiency. Private label manufacturing capabilities allow clients to brand products under their own trademarks, with full documentation and traceability.
Quality Assurance
Our quality assurance systems are built on rigorous analytical validation and continuous process monitoring. Each batch undergoes extensive testing, including high-performance liquid chromatography (HPLC) for API quantification, dissolution testing to ensure bioavailability, and microbial limit checks for sterility. In-process controls are implemented at critical stages, such as granulation, compression, and coating, to maintain product homogeneity. Final product testing includes physicochemical analysis, tablet disintegration, and tablet hardness assessments. Compliance with International Council for Harmonization (ICH) guidelines and United States Pharmacopeia (USP) standards ensures consistency and safety. All quality records are maintained in accordance with cGMP requirements, supporting audit readiness and regulatory submissions.
Regulatory Compliance
We adhere to stringent regulatory standards, including cGMP, World Health Organization (WHO) guidelines, and ISO 9001 quality management systems. Our manufacturing processes comply with FDA, EMA, and PIC/S regulations, ensuring global market access. Documentation for regulatory submissions, including stability data, analytical reports, and batch records, is prepared to meet the requirements of international pharmacopeias. Our facility is certified for ISO 14001 environmental management and ISO 22000 food safety standards, reflecting our commitment to sustainable and safe pharmaceutical practices.
Global Supply Capability
Our export capabilities span over 150 countries, supported by a well-established international distribution network and partnerships with logistics providers. We offer bulk supply capacity to meet large-volume orders, with flexible shipping options for both regional and global markets. Supply chain reliability is ensured through redundant inventory management, real-time tracking systems, and compliance with Incoterms 2020. Our facility is equipped to handle urgent orders, with a minimum lead time of 4–6 weeks for standard production runs. We prioritize supply chain resilience, mitigating risks through diversified sourcing and localized production hubs.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in producing complex combination therapies. Our competitive advantages include compliance with global regulatory standards, scalable manufacturing solutions, and a proven track record in supplying high-quality APIs and finished products. We offer customized packaging, regulatory documentation, and technical support to streamline market entry. Our commitment to innovation, sustainability, and cost-efficiency positions us as a reliable partner for B2B clients seeking reliable, high-quality pharmaceutical solutions.
Bulk Supply Inquiry
For bulk supply inquiries, contact our sales team at info@delwishealthcare.com to discuss pricing, lead times, and customization options.
FAQs
What manufacturing standards does Telwidet Trio 12.5 comply with?
Telwidet Trio 12.5 is manufactured in accordance with cGMP, ISO 9001, and WHO guidelines, ensuring compliance with global regulatory requirements.
Can the product be produced in different packaging formats?
While the standard packaging is 10x10 Alu Alu, we can customize packaging options based on client specifications, including blister, strip, or carton formats.
What is the shelf life of Telwidet Trio 12.5?
The product has a shelf life of 24 months when stored in controlled environments (15–30°C, 60% relative humidity).
Does the manufacturer offer contract manufacturing services?
Yes, we provide end-to-end contract manufacturing, including API sourcing, formulation development, and packaging, tailored to client needs.
What quality control measures are in place for batch testing?
Each batch undergoes HPLC analysis, dissolution testing, microbial limit checks, and physical property assessments to ensure product consistency.
Can the product be exported to international markets?
Yes, our global supply network supports exports to over 150 countries, with compliance to FDA, EMA, and PIC/S regulations.
What is the minimum order quantity for bulk supply?
Minimum order quantities are flexible and depend on production schedules. For specific details, contact our sales team.
How does the manufacturer ensure supply chain reliability?
We maintain redundant inventory systems, real-time tracking, and localized production hubs to ensure timely and reliable delivery.
Are there options for private label manufacturing?
Yes, we offer private label manufacturing services, allowing clients to brand products under their own trademarks.
What certifications does the facility hold?
Our facility is certified for cGMP, ISO 9001, ISO 14001, and ISO 22000, reflecting our commitment to quality and sustainability.
