Amlodel -5 is a generic formulation of amlodipine, a calcium channel blocker, designed for consistent therapeutic performance. The tablet contains 5mg of amlodipine base, formulated with excipients such as microcrystalline cellulose, croscarmellose sodium, and magnesium stearate to ensure optimal tablet integrity, disintegration, and dissolution. The DPCO (Drug Price Control Order) designation underscores its role as an affordable, high-quality generic alternative, meeting stringent pharmaceutical specifications. The formulation is engineered to maintain stability under varied storage conditions, with a focus on preserving active pharmaceutical ingredient (API) potency and excipient compatibility. The tablet’s disintegration and dissolution profiles are optimized to ensure rapid bioavailability, aligning with pharmacokinetic requirements for effective blood pressure management. The manufacturing process prioritizes uniformity in tablet weight, hardness, and content uniformity, ensuring compliance with pharmacopeial standards.
Manufacturing Capability
Delwis Healthcare’s manufacturing infrastructure is equipped to produce Amlodel -5 with precision and scalability. The facility adheres to current Good Manufacturing Practices (cGMP) and is certified for pharmaceutical-grade production. Advanced tabletting machinery, including high-speed compression machines and robust quality control systems, ensures consistent tablet formation and batch homogeneity. Sterile processing capabilities are maintained through dedicated cleanrooms and validated aseptic techniques, ensuring compliance with critical quality attributes. The production line supports scalable manufacturing, enabling seamless transitions from small-scale trials to large-volume commercial batches. Quality systems are integrated throughout the manufacturing process, with real-time monitoring of parameters such as tablet weight, disintegration time, and content uniformity. The facility also complies with ISO 9001 standards, ensuring continuous improvement in operational efficiency and product consistency.
Available Strengths and Packaging
Amlodel -5 is available in a single strength of 5mg, formulated as a film-coated tablet. The product is packaged in 10x10 blister packs, designed for secure storage and easy dispensing. The blister packaging ensures protection from moisture, light, and contamination, maintaining the stability of the active ingredient. This packaging format is ideal for both retail and institutional distribution, offering convenience and tamper-evidence.
Contract Manufacturing / Third Party Manufacturing
Delwis Healthcare offers comprehensive contract manufacturing and third-party manufacturing services tailored to pharmaceutical buyers’ needs. Our facility supports private label manufacturing, enabling clients to produce branded formulations under their own trademarks. We provide end-to-end solutions, including API sourcing, formulation development, tablet compression, packaging, and regulatory documentation. Our team collaborates closely with clients to meet specific requirements, such as dosage form customization, packaging specifications, and compliance with regional regulatory frameworks. Whether you require small-batch trials or large-scale production, our scalable infrastructure ensures timely delivery without compromising quality.
Quality Assurance
Quality assurance is a cornerstone of Delwis Healthcare’s manufacturing process. Every batch of Amlodel -5 undergoes rigorous testing to ensure compliance with pharmacopeial standards and client specifications. Key quality control measures include HPLC (High-Performance Liquid Chromatography) for API content verification, dissolution testing to confirm bioavailability, and microbial limit testing for sterility. Analytical validation protocols are in place to ensure the accuracy and reproducibility of test results. Our quality control laboratory is equipped with advanced instrumentation, including UV spectrophotometers and dissolution apparatus, to meet international standards. All batches are documented with traceable records, ensuring full transparency and audit readiness.
Regulatory Compliance
Delwis Healthcare ensures full compliance with global regulatory frameworks, including GMP, WHO guidelines, and ISO standards. Our manufacturing processes adhere to ICH (International Council for Harmonisation) guidelines, ensuring alignment with international regulatory expectations. The facility is certified under ISO 9001 for quality management and ISO 17025 for testing and calibration capabilities. Compliance with WHO prequalification criteria further validates our commitment to producing high-quality, safe, and effective pharmaceutical products. All documentation, including batch records, stability data, and regulatory submissions, is maintained to meet the requirements of regulatory authorities in target markets.
Global Supply Capability
Delwis Healthcare is a trusted exporter with a robust international distribution network, capable of supplying Amlodel -5 to markets across the globe. Our logistics partners ensure reliable transportation, compliance with international shipping regulations, and timely delivery of bulk orders. The facility is equipped to handle large-scale bulk supply, with storage capacities designed to meet seasonal demand fluctuations. Our supply chain is optimized for consistency, with real-time tracking systems to monitor inventory levels and shipment status. Export capabilities are supported by complete documentation, including certificates of analysis (CoA), batch-specific regulatory filings, and compliance with destination-specific import requirements.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select Delwis Healthcare for its expertise in quality-driven manufacturing, regulatory compliance, and global supply reliability. Our commitment to GMP standards, coupled with scalable production capabilities, ensures seamless integration into your supply chain. The DPCO designation of Amlodel -5 positions it as a cost-effective solution for markets requiring affordable generics. With a focus on innovation, compliance, and customer-centric solutions, we deliver products that meet the highest industry standards while supporting your business objectives.
Bulk Supply Inquiry
Delwis Healthcare offers competitive bulk supply options for Amlodel -5. For inquiries regarding large-scale procurement, please contact our sales team at info@delwishealthcare.com.
FAQs
What is the DPCO status of Amlodel -5, and how does it impact its availability?
Amlodel -5 is designated as a DPCO (Drug Price Control Order) product, ensuring it is available at controlled prices in designated markets, enhancing accessibility for healthcare systems and patients.
Can Amlodel -5 be customized for different packaging formats?
Yes, Delwis Healthcare offers flexible packaging solutions, including blister packs, strip packs, and bulk containers, tailored to meet specific client requirements.
What quality control measures are in place for Amlodel -5?
Every batch undergoes rigorous testing, including HPLC, dissolution testing, and microbial limit analysis, ensuring compliance with pharmacopeial standards and client specifications.
Is Amlodel -5 suitable for export to international markets?
Yes, the product is manufactured to meet global regulatory standards, including WHO prequalification, ICH guidelines, and ISO certifications, ensuring compliance with international export requirements.
What is the minimum order quantity for bulk supply?
Bulk supply options are flexible, with minimum order quantities tailored to client needs. Please contact our sales team for customized solutions.
How does Delwis Healthcare ensure supply chain reliability?
Our logistics network includes real-time tracking, dedicated freight partners, and inventory management systems to ensure timely and consistent delivery of bulk orders.
Can Delwis Healthcare provide regulatory documentation for Amlodel -5?
Yes, we supply complete regulatory documentation, including batch certificates of analysis, stability data, and compliance certificates for global markets.
What is the shelf life of Amlodel -5 in its blister packaging?
The product has a shelf life of 24 months when stored under recommended conditions (cool, dry, and protected from light).
Is Amlodel -5 manufactured using sterile processing techniques?
While the product is not sterile, our manufacturing process adheres to strict GMP standards to ensure contamination-free production.
How does Delwis Healthcare support contract manufacturing for pharmaceutical buyers?
We offer end-to-end contract manufacturing services, including formulation development, tablet production, packaging, and regulatory documentation, tailored to meet client-specific requirements.
