Pentadel-D is a dual-action medication formulated with Pantoprazole 40mg and Domperidone 10mg, designed for optimal stability and efficacy. Pantoprazole, a proton pump inhibitor, is combined with Domperidone, a prokinetic agent, to ensure uniform dispersion and dissolution. The tablet formulation incorporates excipients such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide to enhance flow properties, compressibility, and tablet integrity. The formulation is designed to maintain chemical stability under standard storage conditions, with a pH-neutral environment to prevent degradation of active ingredients. The tablet’s disintegration and dissolution profiles are optimized to ensure consistent bioavailability, meeting pharmaceutical standards for dosage uniformity and dissolution efficiency.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001 standards. The production process includes advanced tablet compression machinery, high-precision blending systems, and automated packaging lines to ensure consistency and scalability. Sterile processing capabilities are available for critical components, with dedicated cleanrooms maintaining ISO 7 and ISO 8 classifications. The facility supports large-scale production, with a capacity to manufacture millions of tablets per batch, ensuring efficient supply chain logistics. Quality systems are integrated throughout the manufacturing workflow, including real-time monitoring, batch traceability, and rigorous validation protocols to guarantee product integrity and compliance.
Available Strengths and Packaging
Composition: Pantoprazole 40mg + Domperidone 10mg Tab
Packaging: 10x10 Alu Alu
Pentadel-D is available in a single strength formulation, ensuring standardized dosing for pharmaceutical applications. The 10x10 Alu Alu blister pack provides secure, tamper-evident packaging, ideal for retail and institutional distribution. The aluminum blister format ensures protection from moisture, light, and contaminants, maintaining product stability during storage and transportation.
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 private label manufacturing capabilities allow clients to produce branded or generic formulations under their own trademarks, with full regulatory support. We specialize in scalable production solutions, accommodating both small-scale trials and large-volume orders. Our team collaborates closely with clients to ensure compliance with regional and international regulations, providing end-to-end support from formulation development to packaging.
Quality Assurance
Our quality control systems are designed to meet the highest pharmaceutical standards, with rigorous testing at every production stage. Each batch undergoes analytical validation using high-performance liquid chromatography (HPLC), dissolution testing, and physical property assessments to ensure potency, purity, and uniformity. In-process controls monitor critical parameters such as tablet hardness, disintegration time, and content uniformity. Final product testing includes microbial limit tests, heavy metal analysis, and dissolution profiling to guarantee safety and efficacy. All quality assurance protocols are documented and traceable, ensuring compliance with regulatory requirements.
Regulatory Compliance
We adhere to global regulatory frameworks, including cGMP, WHO guidelines, and ISO 9001 standards, to ensure product safety and quality. Our manufacturing processes comply with FDA, EMA, and PIC/S guidelines, enabling seamless market access in key regions. Documentation is maintained in accordance with ICH guidelines, supporting regulatory submissions and audits. Compliance with ISO 14001 environmental management standards further underscores our commitment to sustainable and responsible manufacturing practices.
Global Supply Capability
Our export capabilities span over 50 countries, supported by a robust international distribution network and logistics infrastructure. We provide bulk supply options to meet large-scale demand, with flexible order quantities and delivery timelines. Our supply chain is designed for reliability, featuring real-time tracking, inventory management systems, and compliance with international shipping regulations. We support both direct exports and partnerships with local distributors, ensuring timely and cost-effective delivery to global markets.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in high-quality production, regulatory compliance, and scalable supply solutions. Our commitment to cGMP standards, advanced manufacturing technology, and global distribution networks ensures reliable, consistent product availability. We offer competitive pricing, customized packaging solutions, and dedicated customer support to meet diverse market demands.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com to discuss your requirements and receive a tailored quotation.
FAQs
What manufacturing standards does Pentadel-D comply with?
Pentadel-D is manufactured in compliance with cGMP, ISO 9001, and WHO guidelines, ensuring adherence to global pharmaceutical standards.
Can Pentadel-D be produced in different packaging formats?
While the standard packaging is 10x10 Alu Alu, we offer customization options for alternative blister or strip packaging upon request.
What is the shelf life of Pentadel-D?
The product has a shelf life of 24 months when stored under recommended conditions (cool, dry, and protected from light).
Does your facility support sterile manufacturing?
Yes, our facility includes dedicated cleanrooms (ISO 7 and ISO 8) for sterile processing of critical components.
Can you provide documentation for regulatory submissions?
We supply comprehensive documentation, including batch certificates, stability data, and regulatory compliance reports.
What is your minimum order quantity for bulk supply?
Minimum order quantities are flexible and can be customized based on client requirements.
How do you ensure product consistency across batches?
We employ advanced quality control systems, including HPLC and dissolution testing, to ensure batch-to-batch consistency.
Can you support private label manufacturing?
Yes, we offer private label manufacturing services, allowing clients to brand the product under their own trademark.
What regions do you export to?
We export to over 50 countries, including Europe, Asia, Africa, and Latin America, with compliance for regional regulations.
How do you handle supply chain disruptions?
Our logistics team maintains contingency plans, including alternative shipping routes and inventory buffer stocks, to ensure supply chain reliability.
