Esodel - DSR is a fixed-dose combination tablet formulated with Esomeprazole 40mg and Domperidone 30mg SR Cap, engineered for optimal therapeutic efficacy and stability. The formulation leverages advanced excipient compatibility to ensure uniform drug distribution and enhanced bioavailability. Esomeprazole, a proton pump inhibitor (PPI), is incorporated into a solid dosage form to ensure rapid gastric pH neutralization, while Domperidone, a prokinetic agent, is formulated as a sustained-release capsule to maintain prolonged gastrointestinal motility. The combination is designed to meet stringent pharmaceutical requirements, including dissolution profile optimization, chemical stability under varied storage conditions, and compatibility with excipients to prevent degradation. The SR capsule formulation ensures controlled release of Domperidone, enhancing therapeutic consistency and reducing peak-to-trough fluctuations. The product’s formulation adheres to international standards for pharmaceutical quality, ensuring reproducibility and scalability in large-scale manufacturing.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and designed to produce high-quality pharmaceutical products like Esodel - DSR. The facility includes advanced tablet compression lines, capsule filling systems, and robust quality control laboratories. Sterile processing capabilities are integrated for critical components, ensuring contamination-free production. The manufacturing process employs automated systems for precise dosing, blending, and coating, with real-time monitoring to maintain batch consistency. Production scalability is ensured through modular manufacturing lines capable of handling bulk supply demands without compromising quality. Quality systems are reinforced by ISO-certified processes, including HPLC, FTIR, and dissolution testing, to validate formulation integrity. The facility also adheres to strict environmental controls, maintaining optimal temperature and humidity levels to preserve product stability during manufacturing and storage.
Available Strengths and Packaging
Composition: Esomeprazole 40mg + Domperidone 30 mg SR Cap.
Packaging: 10x10 Alu Alu
Esodel - DSR is available in a single strength formulation, combining Esomeprazole 40mg and Domperidone 30mg SR Cap in a 10x10 Alu Alu blister pack. The packaging ensures product protection from moisture, light, and contamination, while facilitating efficient storage and distribution. The aluminum blister format provides tamper-evidence and extended shelf life, making it ideal for pharmaceutical supply chains requiring robust packaging solutions.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing, third-party production, and private label manufacturing services tailored to pharmaceutical buyers. Our capabilities include end-to-end formulation development, dosage form optimization, and scalable production of complex combinations like Esodel - DSR. We support global clients by providing flexible manufacturing solutions, including customized packaging, labeling, and regulatory compliance assistance. Our facility is equipped to handle private label manufacturing, enabling brands to launch products without upfront capital investment. For third-party manufacturing, we ensure full traceability, adherence to regulatory guidelines, and compliance with international quality standards. This makes us an ideal partner for pharmaceutical companies seeking to expand their product portfolios while maintaining cost-efficiency and market competitiveness.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and compliance with international pharmaceutical standards. Every batch of Esodel - DSR undergoes comprehensive testing, including dissolution profiling, HPLC analysis, and microbial contamination checks to ensure product purity and potency. Quality control systems are integrated with advanced analytical tools to monitor critical parameters such as disintegration time, content uniformity, and tablet hardness. Batch validation is conducted against USP, EP, and ICH guidelines to guarantee consistency and safety. Additionally, we maintain detailed documentation for traceability, supporting regulatory audits and supply chain transparency. Our commitment to quality is reinforced by regular calibration of testing equipment and adherence to ISO 9001 standards, ensuring that every product meets the highest benchmarks for pharmaceutical excellence.
Regulatory Compliance
Esodel - DSR is manufactured in full compliance with GMP, WHO guidelines, ISO 9001, and global regulatory frameworks, ensuring adherence to international quality and safety standards. Our facility is certified under GMP regulations, with continuous audits to maintain compliance with FDA, EMA, and PIC/S requirements. The product meets WHO prequalification standards for quality, safety, and efficacy, enabling seamless export to markets worldwide. ISO 14001 certification underscores our commitment to environmental responsibility, while ISO 22000 compliance ensures food safety standards are maintained in production processes. Regulatory documentation is prepared to align with regional requirements, including FDA 21 CFR Part 11 for electronic records and ICH guidelines for analytical method validation. This ensures that Esodel - DSR is positioned for global distribution without compliance barriers.
Global Supply Capability
We provide robust global supply capabilities, including bulk export, international distribution networks, and reliable supply chain logistics. Our export infrastructure is supported by partnerships with global logistics providers, ensuring timely and secure delivery to over 50 countries. Bulk supply capacity is optimized through scalable production lines, enabling large-volume orders without compromising quality or timelines. The supply chain is fortified with real-time tracking systems, inventory management, and contingency planning to mitigate disruptions. We also offer customized distribution solutions, including regional warehousing and direct-to-market shipping, to meet the diverse needs of pharmaceutical buyers. Our commitment to supply chain reliability is further enhanced by adherence to international trade regulations and documentation standards, ensuring smooth cross-border transactions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our expertise in high-quality, scalable production, regulatory compliance, and global supply chain reliability. Our facility’s adherence to GMP, ISO, and WHO standards ensures that Esodel - DSR meets the stringent requirements of international markets. As a manufacturer, we offer competitive pricing without compromising on quality, making us an ideal partner for bulk supply and private label manufacturing. Our ability to customize packaging, labeling, and regulatory documentation streamlines market entry and reduces time-to-market. Additionally, our commitment to innovation and continuous improvement positions us as a reliable long-term partner for pharmaceutical companies seeking sustainable growth.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is dedicated to providing tailored solutions for pharmaceutical buyers seeking reliable, high-quality products with global distribution capabilities.
FAQs
What manufacturing standards does Esodel - DSR adhere to?
Esodel - DSR is manufactured in compliance with cGMP, WHO guidelines, ISO 9001, and international regulatory frameworks, ensuring quality and safety for global markets.
Can Esodel - DSR be produced in different packaging formats?
Yes, we offer flexible packaging solutions, including 10x10 Alu Alu blister packs, to meet diverse distribution and storage requirements.
What is the shelf life of Esodel - DSR?
The product has a shelf life of 24 months when stored under recommended conditions (25°C ± 5°C, 60% RH ± 10%).
Does your facility support private label manufacturing?
Yes, we provide end-to-end private label manufacturing services, including formulation, packaging, and regulatory documentation.
What quality control tests are performed on Esodel - DSR?
Each batch undergoes dissolution testing, HPLC analysis, microbial testing, and content uniformity checks to ensure product integrity.
Can Esodel - DSR be exported to all global markets?
Yes, our compliance with FDA, EMA, PIC/S, and WHO standards enables seamless export to over 50 countries.
What is your minimum order quantity for bulk supply?
We accommodate bulk supply requests with flexible order quantities, tailored to meet the needs of pharmaceutical buyers.
How do you ensure supply chain reliability?
Our supply chain is supported by real-time tracking, regional warehousing, and partnerships with logistics providers to ensure timely delivery.
Can you assist with regulatory documentation for Esodel - DSR?
Yes, we provide comprehensive regulatory documentation, including FDA 21 CFR Part 11 compliance and ICH guideline adherence.
What is your lead time for production and delivery?
Lead times vary based on order volume, but we prioritize efficient production schedules to meet client deadlines while maintaining quality standards.
