Pentadel - DSR is a dual-action pharmaceutical formulation combining Pantoprazole 40mg, a proton pump inhibitor (PPI), with Domperidone 30mg in a sustained-release (SR) capsule format. The formulation leverages advanced excipient compatibility and coating technologies to ensure optimal stability, bioavailability, and controlled release of Domperidone. Pantoprazole, a benzimidazole derivative, is formulated to provide rapid acid suppression by inhibiting parietal cell H+/K+-ATPase activity, while Domperidone, a prokinetic agent, is encapsulated in a modified-release matrix to prolong its gastrointestinal motility effects. The SR capsule design ensures a steady release of Domperidone over 12 hours, enhancing therapeutic consistency. The formulation is designed for robust stability under standard storage conditions (25°C/60% RH) and maintains chemical integrity through pH-controlled excipient selection and antioxidant incorporation.
Manufacturing Capability
Our manufacturing infrastructure is equipped to produce high-quality, consistent batches of Pentadel - DSR, adhering to stringent GMP standards. The facility includes state-of-the-art tablet compression, coating, and capsule filling lines capable of handling complex formulations like sustained-release capsules. Sterile processing capabilities are maintained through dedicated cleanrooms (ISO 7 and ISO 8 classifications) for critical steps, ensuring contamination-free production. The manufacturing process employs advanced granulation and dry-coating techniques to achieve uniform drug distribution and controlled release profiles. Production scalability is supported by modular manufacturing units, enabling seamless transitions from pilot batches to large-scale commercial production. Quality systems are integrated throughout the process, including real-time monitoring of critical parameters such as dissolution rates, hardness, and disintegration time.
Available Strengths and Packaging
Composition: Pantoprazole 40mg + Domperidone 30mg SR Cap.
Packaging: 10x10 Alu Alu
Pentadel - DSR is available in a single strength formulation, combining Pantoprazole 40mg and Domperidone 30mg SR Cap. The 10x10 Alu Alu packaging ensures tamper-evident protection, moisture resistance, and compliance with pharmaceutical packaging regulations. The aluminum blister packs are designed for efficient storage, transportation, and shelf-life stability, with UV-resistant materials to prevent degradation of active ingredients.
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’ needs. Our facility is equipped to handle complex formulations, including sustained-release capsules, and supports customization of packaging, labeling, and dosage forms. We provide end-to-end solutions for global markets, ensuring compliance with regional regulatory requirements. Our team collaborates closely with clients to optimize formulation parameters, scale production efficiently, and maintain cost-effectiveness without compromising quality. Whether you require a private-label product or a third-party manufacturing partnership, we deliver scalable, compliant, and high-quality solutions.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to international pharmaceutical standards. Each batch undergoes comprehensive testing, including HPLC for active ingredient quantification, dissolution testing for SR release profiles, and microbial contamination checks. In-process controls monitor critical parameters such as tablet hardness, disintegration time, and content uniformity. Finished products are validated against USP, EP, and BP monographs to ensure consistency and safety. Quality control systems are integrated with advanced data analytics tools for real-time process monitoring and root-cause analysis. We maintain a robust traceability system to ensure full compliance with GMP and regulatory audits.
Regulatory Compliance
Pentadel - DSR is manufactured in full compliance with GMP, WHO guidelines, ISO 9001:2015, and international regulatory frameworks. Our facility holds certifications for cGMP, ISO 14001 (environmental management), and ISO 45001 (occupational health and safety), ensuring adherence to global quality and safety standards. The product meets WHO prequalification criteria for active pharmaceutical ingredients (APIs) and excipients, enabling seamless export to markets in Africa, Asia, and Latin America. Regulatory submissions are supported by detailed documentation, including stability data, analytical reports, and clinical trial references where applicable. We ensure compliance with FDA, EMA, and PIC/S guidelines for export to developed markets.
Global Supply Capability
Our global supply chain is designed to meet the demands of international pharmaceutical buyers, with a focus on reliability, scalability, and compliance. We maintain a robust network of logistics partners for seamless distribution across continents, including temperature-controlled shipping for sensitive formulations. Bulk supply capacity is supported by automated packaging lines and inventory management systems, ensuring timely delivery of large orders. Our export capabilities are bolstered by compliance with IATA and IMDG regulations for hazardous material transport, as well as customs documentation for duty-free clearance. We prioritize supply chain resilience through dual-source raw material procurement and contingency planning, ensuring uninterrupted supply even in unforeseen circumstances.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our expertise in complex formulations, compliance-driven manufacturing, and global supply chain reliability. Our ability to produce high-quality, dual-action therapies like Pentadel - DSR positions us as a strategic partner for expanding market reach. We offer competitive pricing without compromising on quality, supported by a dedicated account management team to address client needs. Our commitment to innovation, coupled with adherence to international standards, ensures that our clients can confidently enter new markets and meet regulatory demands.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our sales team at info@delwishealthcare.com. We provide tailored solutions for large-scale procurement, ensuring timely delivery and compliance with your operational requirements.
FAQs
What manufacturing standards does Delwis Healthcare follow for Pentadel - DSR?
Our production adheres to cGMP, ISO 9001:2015, and WHO guidelines, ensuring compliance with global regulatory frameworks.
Can Pentadel - DSR be customized for different packaging formats?
Yes, we offer flexible packaging solutions, including 10x10 Alu Alu and other formats, to meet regional and client-specific requirements.
What is the shelf life of Pentadel - DSR under standard storage conditions?
The product has a shelf life of 24 months when stored at 25°C/60% RH, as validated through stability testing.
Does Delwis Healthcare provide third-party manufacturing services for pharmaceutical buyers?
Yes, we offer contract manufacturing, private labeling, and third-party production services for a wide range of dosage forms.
How does Delwis ensure the quality of sustained-release capsules like Pentadel - DSR?
We conduct rigorous dissolution testing, HPLC analysis, and microbial testing to ensure consistent release profiles and purity.
Can Pentadel - DSR be exported to international markets?
Yes, our compliance with WHO prequalification, FDA, and EMA guidelines enables seamless export to global markets.
What is the minimum order quantity for bulk supply of Pentadel - DSR?
We accommodate bulk orders starting from 10,000 units, with flexible scaling options for larger volumes.
How does Delwis handle supply chain disruptions or delays?
We implement contingency planning, including dual sourcing of raw materials and real-time logistics tracking, to ensure uninterrupted supply.
Is there a possibility of private-label manufacturing for Pentadel - DSR?
Yes, we support private-label manufacturing, allowing clients to brand the product under their own trademarks.
What documentation is provided for regulatory compliance?
We supply detailed certificates of analysis (CoA), stability data, and regulatory filings to support compliance with local and international authorities.
