Amlodel TH is a triple-combination antihypertensive formulation engineered for stability, bioavailability, and uniformity in pharmaceutical manufacturing. The active ingredients—Amlodipine Besylate (a dihydropyridine calcium channel blocker), Telmisartan (an angiotensin II receptor blocker), and Hydrochlorothiazide (a thiazide diuretic)—are combined in a fixed-dose ratio to optimize therapeutic efficacy. The formulation employs a direct compression technique, ensuring consistent tablet weight, hardness, and disintegration time. Excipients such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide are incorporated to enhance flow properties, tablet integrity, and compatibility with active pharmaceutical ingredients (APIs). The coating layer provides moisture resistance and improves patient compliance. The formulation’s physicochemical stability is validated through accelerated stability testing, ensuring shelf-life compliance under varied storage conditions.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities to produce Amlodel TH with precision and scalability. The production line includes high-speed tablet presses, automated blending systems, and advanced coating equipment to ensure uniformity in tablet composition. Sterile processing capabilities are maintained through ISO Class 7 cleanrooms, ensuring contamination-free environments for critical steps. All manufacturing processes adhere to current Good Manufacturing Practices (cGMP) and are validated for reproducibility and consistency. The facility supports large-scale production, with the capacity to scale up or down based on demand while maintaining quality standards. Robust quality systems, including real-time monitoring and data integrity protocols, ensure traceability and compliance with regulatory requirements.
Available Strengths and Packaging
Composition: Amlodipine Besylate 5mg + Telmisartan 40mg + Hydrochlorothiazide 12.5mg Tab
Packaging: 10x10 Alu Alu
Amlodel TH is available in a single fixed-dose strength, ensuring standardized dosing for therapeutic consistency. The 10x10 Alu Alu blister packaging provides tamper-evident protection, moisture resistance, and ease of distribution. This packaging format is ideal for retail and wholesale markets, offering secure storage and extended shelf life.
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. Our capabilities include formulation development, API sourcing, and full-scale production of finished dosage forms, ensuring compliance with global regulatory standards. We support customization of packaging, labeling, and dosage forms to meet specific market requirements. Our team provides end-to-end solutions, from raw material procurement to regulatory documentation, enabling clients to streamline their supply chain and accelerate time-to-market.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to international quality standards. Each batch undergoes comprehensive testing, including high-performance liquid chromatography (HPLC) for API quantification, dissolution testing for bioavailability, and microbial limit checks for sterility. In-process controls and final product inspections ensure dimensional accuracy, content uniformity, and physical integrity. Documentation compliance with ICH, USP, and EP guidelines is maintained to support regulatory submissions. Continuous improvement initiatives and root-cause analysis protocols ensure defect-free production and traceability throughout the supply chain.
Regulatory Compliance
Amlodel TH is manufactured in full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and ISO 9001:2015 quality management standards. Our facility is certified by regulatory authorities in multiple jurisdictions, ensuring alignment with regional and international frameworks. Compliance with the International Council for Harmonisation (ICH) guidelines ensures consistency in quality, safety, and efficacy documentation. We support regulatory submissions for markets including the EU, US, and Asia-Pacific, ensuring seamless approval processes for global distribution.
Global Supply Capability
We provide reliable bulk supply capabilities with a robust international distribution network spanning over 50 countries. Our logistics partners ensure timely delivery of finished products to regional warehouses and end-users, minimizing supply chain disruptions. The facility’s capacity to produce large-volume batches supports bulk supply demands, while inventory management systems ensure stock availability. Our export capabilities are fortified by compliance with customs regulations, phytosanitary requirements, and documentation standards, enabling seamless cross-border trade.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in scalable production, regulatory compliance, and quality-driven manufacturing. Our commitment to innovation, combined with a proven track record of meeting global market demands, positions us as a reliable partner for bulk supply and customized solutions. We offer competitive pricing, transparent documentation, and dedicated customer support to ensure long-term collaboration and operational efficiency.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is ready to assist with quotation, documentation, and logistics planning for your pharmaceutical needs.
FAQs
Is Amlodel TH manufactured under cGMP standards?
Yes, our production processes adhere to current Good Manufacturing Practices (cGMP) and ISO 9001:2015 standards.
What is the shelf life of Amlodel TH in 10x10 Alu Alu packaging?
The product has a shelf life of 24 months when stored under recommended conditions.
Can Amlodel TH be produced in different packaging formats?
While the standard packaging is 10x10 Alu Alu, we offer customization for alternative formats upon request.
What quality control measures are in place for Amlodel TH?
Each batch undergoes HPLC, dissolution testing, and microbial limit checks to ensure compliance with regulatory standards.
Does your facility support export to international markets?
Yes, we have a global distribution network and compliance with international export regulations.
Can you provide documentation for regulatory submissions?
We supply complete regulatory documentation, including stability data, batch certificates, and compliance reports.
What is the minimum order quantity for bulk supply?
Minimum order quantities are flexible and can be tailored to meet specific client requirements.
How do you ensure supply chain reliability?
Our inventory management systems and logistics partnerships ensure consistent supply and on-time delivery.
Can Amlodel TH be produced in different strengths?
While the standard strength is fixed, we can accommodate custom formulations upon consultation.
What certifications does your facility hold?
Our facility is certified under GMP, WHO, ISO 9001:2015, and regional regulatory frameworks.
