Amlodel Plus is a fixed-dose combination tablet formulated with Amlodipine 5mg and Atenelol Plus 50mg, designed to ensure consistent therapeutic outcomes. The formulation leverages advanced pharmaceutical technology to achieve optimal compatibility between the active ingredients, ensuring stability and uniformity during storage and administration. Amlodipine, a calcium channel blocker, and Atenelol Plus, a selective beta-1 adrenergic blocker, are combined in a matrix that facilitates controlled release and bioavailability. The excipients include microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide, which enhance tablet integrity, disintegration, and flow properties. The formulation is optimized for high potency, with precise dosing to meet stringent pharmaceutical specifications. The manufacturing process ensures homogeneity, with rigorous control over particle size, compression force, and tablet hardness to guarantee consistent performance.
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 production of complex pharmaceutical formulations. The facility includes advanced tablet compression lines, high-speed coating systems, and automated packaging units to ensure precision and efficiency. Sterile processing capabilities are available for critical components, supported by ISO Class 7 and Class 8 cleanrooms. Production scalability is achieved through modular design, allowing seamless expansion to meet global demand. Quality systems are integrated throughout the manufacturing process, with real-time monitoring and data integrity protocols to ensure compliance with regulatory standards. The facility adheres to strict environmental controls, including temperature, humidity, and particulate monitoring, to maintain product stability and purity.
Available Strengths and Packaging
Composition: Amlodipine 5mg + Atenelol Plus 50mg Tab
Packaging: 10x10 Blister
Amlodel Plus is available in a fixed-dose combination of 5mg Amlodipine and 50mg Atenelol Plus, formulated for standardized therapeutic dosing. The 10x10 blister packaging ensures tamper-evident protection, ease of distribution, and extended shelf life, making it ideal for both domestic and international markets. The blister format is designed for efficient storage, transportation, and patient compliance, with clear labeling for regulatory compliance.
Contract Manufacturing / Third Party Manufacturing
As a leading pharmaceutical manufacturer, we offer comprehensive contract manufacturing, private label, and third-party manufacturing services tailored to meet the needs of global buyers. Our capabilities include full-cycle production from raw material sourcing to final packaging, with flexibility to accommodate custom specifications, including dosage forms, excipient variations, and labeling requirements. We support private label manufacturing for brand-name products, ensuring compliance with regional regulatory standards. Third-party manufacturing partnerships are facilitated through rigorous quality audits, documentation, and supply chain transparency, enabling seamless integration into client portfolios. Our scalable production model ensures timely delivery of bulk supplies while maintaining compliance with international quality benchmarks.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to global pharmaceutical standards. Every batch undergoes comprehensive testing, including dissolution profiling, content uniformity, and impurity analysis using high-performance liquid chromatography (HPLC) and mass spectrometry. In-process controls are implemented at critical stages of manufacturing to ensure consistency in tablet weight, hardness, and disintegration time. Quality control systems are integrated with electronic data management platforms to ensure traceability and compliance with ICH and USP guidelines. Batch records are maintained with full documentation of raw material specifications, process parameters, and final product testing results, ensuring transparency for regulatory submissions and client audits.
Regulatory Compliance
Amlodel Plus is manufactured in full compliance with GMP, WHO guidelines, and ISO 9001/14001 standards, ensuring adherence to global regulatory frameworks. Our facility is certified by regulatory authorities in multiple regions, including the FDA, EMA, and PIC/S, enabling seamless export to international markets. All production processes are validated to meet ICH Q7 and Q8 requirements, with documentation aligned to pharmacopeial standards such as USP and EP. Regulatory submissions are supported by comprehensive dossiers, including stability data, clinical trial reports, and process validation protocols. Compliance with environmental and safety regulations is prioritized through waste management systems and energy-efficient manufacturing practices.
Global Supply Capability
Our global supply chain is designed to deliver bulk supplies to over 50 countries, supported by a robust international distribution network and strategic logistics partnerships. We maintain large-scale inventory and production capacity to meet demand for bulk supply, with flexible order fulfillment options for both short-term and long-term contracts. Export capabilities are enhanced by compliance with international trade regulations, including HS code classification and customs documentation. Supply chain reliability is ensured through redundant inventory systems, real-time tracking, and localized warehouse networks. Our commitment to sustainability is reflected in eco-friendly packaging solutions and carbon-neutral shipping options, aligning with global pharmaceutical industry trends.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our proven expertise in complex combination drug manufacturing, regulatory compliance, and scalable production. Our commitment to quality is underscored by certifications, rigorous testing protocols, and adherence to international standards. We offer competitive pricing without compromising on compliance or product integrity, ensuring cost-effective solutions for global markets. Our dedicated account management team provides end-to-end support, from regulatory consultations to supply chain optimization. With a track record of successful partnerships and a focus on innovation, we deliver reliable, high-quality pharmaceutical products that meet the demands of modern healthcare markets.
Bulk Supply Inquiry
We offer bulk supply capabilities for Amlodel Plus, with flexible order quantities and tailored logistics solutions. For inquiries regarding bulk supply, please contact our sales team at info@delwishealthcare.com.
FAQs
What certifications does your facility hold?
Our facility is certified under GMP, ISO 9001, and ISO 14001, with compliance with WHO and FDA guidelines.
Can you customize packaging options for Amlodel Plus?
Yes, we offer customization of packaging, including blister, strip, and carton formats, to meet regional regulatory and market requirements.
What is the minimum order quantity for bulk supply?
Bulk supply is available in quantities starting from 10,000 units, with flexible options for larger orders.
How do you ensure product stability during storage?
We use desiccant-packed blisters and temperature-controlled storage to maintain product stability under standard conditions.
What regulatory approvals are required for exporting Amlodel Plus?
Export compliance includes WHO, FDA, EMA, and PIC/S approvals, with documentation tailored to destination-specific regulations.
Can you provide analytical data for quality assurance?
Yes, we supply HPLC, dissolution, and impurity analysis reports as part of our quality assurance package.
What is your production capacity for Amlodel Plus?
Our facility produces up to 5 million tablets per day, with scalability to meet global demand.
How do you handle supply chain disruptions?
We maintain redundant inventory systems, regional warehouses, and backup suppliers to ensure uninterrupted supply.
Are there options for private label manufacturing?
Yes, we support private label manufacturing with full customization of branding, packaging, and labeling.
What is your lead time for bulk orders?
Lead times vary based on order size, but we typically deliver within 4–6 weeks for standard bulk supply requests.
