Telwidet CT 80/12.5 is a fixed-dose combination tablet containing Telmisartan (80mg) and Chlorthalidone (12.5mg), designed for optimal therapeutic efficacy. The formulation employs a direct compression technique to ensure uniform drug distribution and consistent tablet hardness. Telmisartan, an angiotensin II receptor blocker (ARB), is combined with Chlorthalidone, a thiazide-like diuretic, to enhance antihypertensive activity through dual mechanisms. The excipients include microcrystalline cellulose as a filler, magnesium stearate as a lubricant, and a film-coating agent to ensure stability and disintegration properties. The tablet’s disintegration time is optimized to ensure rapid dissolution in gastric fluid, while its physical properties (e.g., tablet weight, thickness, and friability) meet pharmacopeial standards. The formulation is designed for long-term stability, with rigorous testing for compatibility between active pharmaceutical ingredients (APIs) and excipients to prevent degradation or interaction.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities to produce Telwidet CT 80/12.5 with precision and efficiency. The production process adheres to Good Manufacturing Practice (GMP) standards, ensuring compliance with international regulatory requirements. High-speed tablet presses and advanced coating equipment enable consistent tablet formation and uniform film-coating. The facility supports sterile processing for critical components, with dedicated cleanrooms classified at ISO Class 7 and Class 8 for non-sterile operations. Quality control systems are integrated throughout the manufacturing workflow, including real-time monitoring of critical parameters such as compression force, tablet hardness, and dissolution rates. The facility’s scalability allows for seamless transitions from small-scale trials to large-volume production, accommodating bulk supply demands without compromising product quality. Additionally, our quality systems include validated analytical methods for in-process testing and final product release, ensuring adherence to pharmacopeial standards.
Available Strengths and Packaging
Composition: Telmisartan 80mg + Chlorthalidone 12.5mg Tablets
Packaging: 10x10 Alu Alu (10 blister packs, each containing 10 tablets in aluminum blister packaging)
Contract Manufacturing / Third Party Manufacturing
As a leading pharmaceutical manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to meet the needs of global buyers. Our private label manufacturing capabilities allow clients to produce branded products under their own trademarks, with full customization of packaging, labeling, and formulation parameters. We support contract manufacturing for Telwidet CT 80/12.5 and similar combination therapies, ensuring compliance with regulatory standards while maintaining cost-efficiency. Our team collaborates closely with clients to optimize production timelines, manage supply chain logistics, and ensure adherence to specifications. Whether you require small-batch trials or large-scale commercialization, our flexible manufacturing framework accommodates diverse requirements, making us a reliable partner for pharmaceutical buyers seeking scalable and compliant solutions.
Quality Assurance
Our quality assurance systems are designed to ensure the consistency, safety, and efficacy of Telwidet CT 80/12.5. Every batch undergoes rigorous testing, including dissolution testing, hardness measurement, and content uniformity analysis, to meet pharmacopeial standards. Analytical validation methods such as High-Performance Liquid Chromatography (HPLC) and Ultraviolet (UV) spectrophotometry are employed to confirm API potency and purity. We conduct routine stability studies to assess shelf life and storage conditions, ensuring product integrity over time. Additionally, our quality control protocols include microbial testing, heavy metal analysis, and dissolution profiling to guarantee compliance with international quality benchmarks. All production processes are validated to minimize variability, and our facilities maintain documented quality records for traceability and audit readiness.
Regulatory Compliance
Telwidet CT 80/12.5 is manufactured in full compliance with Good Manufacturing Practice (GMP) standards, WHO guidelines, and ISO 9001:2015 quality management systems. Our facility is certified by regulatory authorities in multiple jurisdictions, including the FDA, EMA, and PIC/S, ensuring adherence to global pharmaceutical regulations. The product meets specifications outlined in the United States Pharmacopeia (USP) and European Pharmacopeia (EP), with documentation supporting compliance with ICH guidelines for quality, safety, and efficacy. We maintain detailed records of raw material sourcing, production processes, and finished product testing, enabling seamless regulatory submissions for market approval. Our commitment to compliance extends to environmental sustainability practices, with waste management and energy efficiency protocols aligned with international standards.
Global Supply Capability
We provide reliable global supply capabilities for Telwidet CT 80/12.5, supported by an extensive international distribution network and bulk supply infrastructure. Our export logistics team ensures timely delivery to over 50 countries, with partnerships in key markets to facilitate regulatory clearances and customs compliance. The 10x10 Alu Alu packaging is optimized for secure transportation, minimizing damage during transit. Our bulk supply capacity allows for large-volume orders, with flexible shipping options to meet urgent or long-term demand. We prioritize supply chain reliability through redundant inventory management, real-time tracking systems, and contingency planning to mitigate disruptions. Whether you require small or large-scale exports, our team ensures seamless coordination with logistics providers to guarantee on-time delivery and compliance with international trade regulations.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our expertise in scalable, compliant production and global supply solutions. Our GMP-certified facilities and ISO 9001 accreditation ensure consistent quality, while our flexible manufacturing capabilities enable customization to meet diverse market needs. As a trusted supplier, we offer competitive pricing without compromising on regulatory standards, making us an ideal partner for bulk supply and export operations. Our dedicated customer support team provides end-to-end assistance, from product development to post-market compliance, ensuring long-term collaboration. With a proven track record in delivering high-quality pharmaceutical products, we empower buyers to meet market demands efficiently and reliably.
Bulk Supply Inquiry
For bulk supply inquiries, contact us at info@delwishealthcare.com to discuss pricing, order requirements, and logistics for Telwidet CT 80/12.5.
FAQs
What manufacturing standards does Telwidet CT 80/12.5 comply with?
The product adheres to GMP, WHO guidelines, ISO 9001:2015, and pharmacopeial standards (USP/EP), ensuring global regulatory compliance.
Can Telwidet CT 80/12.5 be produced in bulk quantities?
Yes, our facility supports large-scale production, with scalable manufacturing capabilities to meet bulk supply demands.
What is the shelf life of Telwidet CT 80/12.5?
The product has a shelf life of 24 months when stored under recommended conditions (cool, dry, and protected from light).
Does the packaging meet international export requirements?
The 10x10 Alu Alu packaging is designed for secure transportation and complies with global export regulations.
Can you customize packaging for Telwidet CT 80/12.5?
Yes, we offer private label manufacturing and customized packaging solutions to meet client specifications.
What quality control measures are in place for Telwidet CT 80/12.5?
Every batch undergoes dissolution testing, content uniformity analysis, and microbial testing to ensure compliance with pharmacopeial standards.
How does your supply chain ensure timely delivery?
Our global distribution network and logistics partnerships ensure reliable, on-time delivery with real-time tracking for export orders.
Can you provide documentation for regulatory submissions?
Yes, we supply complete regulatory documentation, including batch certificates, stability reports, and compliance certificates for global market access.
What is the minimum order quantity for bulk supply?
Minimum order quantities are flexible and tailored to client requirements, with options for small-scale trials or large-volume orders.
How do you ensure sustainability in manufacturing?
Our facility employs energy-efficient processes, waste management systems, and eco-friendly packaging to minimize environmental impact.
