Telwidet - H is a bilayered tablet formulation combining Telmisartan 40mg and Hydrochlorothiazide 12.5mg, engineered for stability, uniformity, and controlled release. The bilayered design ensures distinct layers for each active ingredient, minimizing potential interactions while maintaining bioavailability. Telmisartan, an angiotensin II receptor blocker (ARB), is formulated in the first layer to ensure rapid dissolution and systemic absorption, while Hydrochlorothiazide, a thiazide diuretic, is encapsulated in the second layer for delayed release. The formulation employs high-quality excipients, including disintegrants, binders, and coatings, to ensure mechanical integrity, moisture resistance, and accurate dosing. Manufacturing processes prioritize precision in layering, compression, and coating to meet pharmaceutical standards for tablet hardness, disintegration time, and content uniformity. The product’s stability is validated through accelerated testing to ensure shelf-life compliance under varied storage conditions.
Manufacturing Capability
Our manufacturing infrastructure is designed to meet the stringent demands of pharmaceutical production, with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP). The facility includes automated tablet compression lines, high-speed coating equipment, and advanced quality control systems for real-time monitoring of critical parameters. Sterile processing capabilities are available for sensitive formulations, ensuring contamination-free production. Production scalability is achieved through modular manufacturing units that can accommodate bulk orders without compromising quality. The facility adheres to ISO 9001 quality management systems, with rigorous validation protocols for equipment, processes, and environmental controls. Dedicated quality assurance teams conduct in-process testing and final product inspections to ensure compliance with regulatory standards.
Available Strengths and Packaging
Composition: Telmisartan 40mg Tab + Hydrochlorothiazide 12.5mg Bilayered Tab
Packaging: 10x10 Alu Alu
Telwidet - H is available in a fixed-dose combination of Telmisartan 40mg and Hydrochlorothiazide 12.5mg, formulated as a bilayered tablet. The 10x10 Alu Alu packaging provides moisture-resistant, tamper-evident protection, ensuring product integrity during storage and transportation. This packaging format is ideal for bulk supply and distribution, offering convenience for pharmaceutical buyers requiring standardized packaging for global markets.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers’ needs. Our capabilities include private label manufacturing, where we produce branded formulations under a client’s proprietary name, and contract manufacturing for generic drug development. We support customization of dosage forms, packaging, and labeling to meet specific regulatory and market requirements. Our team collaborates closely with clients to ensure adherence to global quality standards, including GMP, WHO, and FDA guidelines. Whether you require small-scale trial batches or large-volume production, our flexible manufacturing infrastructure ensures timely delivery without compromising product quality.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and compliance with international pharmaceutical standards. Each production batch undergoes comprehensive testing for dissolution, content uniformity, and impurity analysis using HPLC and UV spectrophotometry. Raw materials are sourced from certified suppliers and tested for potency, purity, and heavy metal content. Finished products are subjected to stability testing under accelerated conditions to confirm shelf-life accuracy. Our quality control systems are validated to ensure reproducibility and traceability, with documented records for audit readiness. Compliance with ICH guidelines and pharmacopoeial standards ensures that Telwidet - H meets the highest benchmarks for safety and efficacy.
Regulatory Compliance
Telwidet - H is manufactured in full compliance with GMP, WHO guidelines, and ISO 9001:2015 standards. Our facility is routinely audited by regulatory authorities to ensure adherence to global quality frameworks, including FDA, EMA, and PIC/S requirements. We maintain detailed documentation for regulatory submissions, including batch records, stability data, and analytical reports. Our commitment to compliance extends to environmental sustainability practices, with waste management systems aligned with ISO 14001 standards. By adhering to these frameworks, we ensure that Telwidet - H is suitable for export to markets with stringent regulatory expectations.
Global Supply Capability
We provide robust global supply capabilities, including bulk supply options for pharmaceutical buyers seeking large-volume distribution. Our international distribution network spans key markets in Asia, Africa, Latin America, and Europe, supported by strategic partnerships with logistics providers. Bulk supply capacity is ensured through scalable production lines and efficient inventory management systems. Our supply chain reliability is reinforced by real-time tracking, compliance with Incoterms 2020, and adherence to customs regulations for seamless cross-border shipments. We prioritize on-time delivery and product integrity, making us a dependable partner for exporters and distributors requiring consistent supply chains.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in quality-driven production, regulatory compliance, and global supply chain management. Our commitment to GMP standards, advanced manufacturing technology, and customized solutions ensures that Telwidet - H meets the demands of diverse markets. With a focus on scalability, reliability, and cost-efficiency, we deliver competitive advantages for clients seeking to expand their product portfolios. Our transparent communication, responsive support, and adherence to international guidelines position us as a preferred partner for B2B buyers in the pharmaceutical industry.
Bulk Supply Inquiry
We offer bulk supply capabilities for Telwidet - H, tailored to meet the needs of pharmaceutical buyers. For inquiries regarding large-volume orders, packaging customization, or export logistics, please contact us at info@delwishealthcare.com.
FAQs
What manufacturing standards does Telwidet - H comply with?
Telwidet - H is manufactured in full compliance with cGMP, WHO guidelines, and ISO 9001:2015 standards, ensuring adherence to global pharmaceutical quality requirements.
Can Telwidet - H be produced in different packaging formats?
Yes, we offer customization options for packaging, including 10x10 Alu Alu and other formats, to meet specific market and regulatory needs.
What is the shelf life of Telwidet - H?
The shelf life of Telwidet - H is validated through stability testing and typically ranges from 24 to 36 months under recommended storage conditions.
Does your facility support contract manufacturing for third-party brands?
Yes, we provide private label manufacturing services, enabling clients to produce branded formulations under their own trademarks.
How do you ensure quality control during production?
Our quality control systems include in-process testing, batch validation, and analytical validation using HPLC and UV spectrophotometry to ensure product consistency.
Can Telwidet - H be exported to international markets?
Yes, our compliance with global regulatory frameworks, including FDA, EMA, and PIC/S, ensures seamless export to international markets.
What is the minimum order quantity for bulk supply?
We accommodate bulk supply requests with flexible order quantities, tailored to the needs of pharmaceutical buyers.
How do you handle supply chain disruptions?
Our supply chain resilience is supported by diversified production capabilities, real-time inventory tracking, and contingency planning to ensure uninterrupted delivery.
Are raw materials sourced from certified suppliers?
Yes, all raw materials are sourced from certified suppliers and undergo rigorous testing for potency, purity, and compliance with pharmacopoeial standards.
Can you provide documentation for regulatory submissions?
Yes, we supply comprehensive documentation, including batch records, stability data, and analytical reports, to support regulatory submissions and audits.
