Esodel 40 IV is a high-purity, sterile injectable solution formulated with Esomeprazole Sodium as the active pharmaceutical ingredient (API), dissolved in Water for Injection (WFI) to ensure compatibility with intravenous administration. The formulation is pH-adjusted to maintain stability and minimize degradation during storage. Esomeprazole Sodium, a proton pump inhibitor (PPI), is known for its potent acid-suppressing properties, making it a critical component in pharmaceutical formulations for managing gastrointestinal disorders. The product’s formulation is designed to meet stringent pharmaceutical standards, ensuring consistent potency, sterility, and shelf-life stability. The use of WFI as the solvent ensures compatibility with IV administration protocols, while the absence of preservatives or excipients beyond the API maintains a clean formulation suitable for sensitive patient populations.
Manufacturing Capability
Our manufacturing infrastructure is equipped to produce Esodel 40 IV with precision and compliance, leveraging advanced pharmaceutical technologies. The facility adheres to current Good Manufacturing Practices (cGMP) and maintains ISO 14644-1 Class 7 cleanroom environments for sterile processing. The production process includes automated filling, sealing, and labeling systems to ensure accuracy and traceability. Our capabilities extend to large-scale production, with flexible batch sizes to accommodate both small and bulk orders. The facility is certified under ISO 9001:2015 quality management systems, ensuring consistent quality and process control. Additionally, we employ state-of-the-art analytical instrumentation for real-time monitoring of critical parameters such as pH, osmolarity, and particulate matter, ensuring compliance with pharmacopeial standards.
Available Strengths and Packaging
Composition: Esomeprazole Sodium 40mg Injection
Packaging: 1 vial with WFI
Esodel 40 IV is available in a single strength of 40mg, formulated as a 1 vial with WFI for immediate use. The packaging ensures sterility and stability during transportation and storage, meeting global pharmaceutical requirements for IV administration.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive third-party manufacturing services, including private label and contract manufacturing for pharmaceutical buyers. Our capabilities extend to producing Esodel 40 IV under a customer’s brand name, with full flexibility in packaging, labeling, and regulatory documentation. We support global clients by adhering to international standards such as ICH, FDA, and EMA guidelines, ensuring compliance with local regulatory requirements. Our contract manufacturing services are ideal for pharmaceutical companies seeking to expand their product portfolios without investing in in-house production infrastructure.
Quality Assurance
Our quality assurance systems are designed to ensure the highest standards of product integrity and safety. Every batch of Esodel 40 IV undergoes rigorous testing, including high-performance liquid chromatography (HPLC) for potency confirmation, microbial limit testing, and endotoxin analysis. We employ advanced analytical validation techniques to ensure accuracy and reproducibility of test results. All quality control processes are documented and traceable, with full compliance to pharmacopeial monographs (USP, EP, BP). Additionally, our facility maintains a robust quality management system (QMS) to monitor deviations, investigate non-conformances, and implement corrective actions promptly.
Regulatory Compliance
Esodel 40 IV is manufactured in full compliance with global regulatory frameworks, including cGMP, WHO guidelines, and ISO 14644-1 standards for cleanroom environments. Our facility is registered with major regulatory authorities, including the FDA, EMA, and PIC/S, ensuring adherence to international quality and safety requirements. We maintain detailed documentation for regulatory inspections, including batch records, deviation reports, and stability data. Our compliance with ISO 9001:2015 and ISO 17025:2017 standards further demonstrates our commitment to quality and traceability in pharmaceutical manufacturing.
Global Supply Capability
As a leading exporter, we provide reliable bulk supply capabilities for Esodel 40 IV, supported by an extensive international distribution network. Our logistics partners ensure timely delivery to over 50 countries, with compliance to customs regulations and import documentation requirements. We offer flexible supply options, including small-scale shipments for regional markets and bulk orders for large-scale distributors. Our supply chain is designed for resilience, with redundant inventory management and real-time tracking systems to ensure uninterrupted delivery. We also support long-term supply agreements, ensuring consistent availability for pharmaceutical buyers worldwide.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in producing high-quality, compliant products like Esodel 40 IV. Our combination of advanced manufacturing capabilities, regulatory compliance, and global supply chain infrastructure ensures reliable, cost-effective solutions. We prioritize transparency, offering full traceability from raw material sourcing to final product delivery. Our commitment to innovation and quality makes us a preferred partner for companies seeking to meet the demands of the global pharmaceutical market.
Bulk Supply Inquiry
We offer bulk supply capabilities for Esodel 40 IV. For inquiries regarding large-scale orders, please contact:
info@delwishealthcare.com
FAQs
What regulatory standards does Esodel 40 IV comply with?
Esodel 40 IV is manufactured in compliance with cGMP, WHO guidelines, ISO 14644-1, and international pharmacopeial standards (USP, EP, BP).
Can Esodel 40 IV be customized for private label manufacturing?
Yes, we offer private label manufacturing services, allowing clients to brand Esodel 40 IV under their own trademarks.
What is the shelf life of Esodel 40 IV?
The product has a shelf life of 24 months when stored under recommended conditions (2–8°C).
Is Esodel 40 IV suitable for export to international markets?
Yes, our compliance with global regulatory frameworks ensures seamless export to over 50 countries.
What quality control measures are in place for Esodel 40 IV?
Each batch undergoes HPLC testing, microbial limit testing, and endotoxin analysis to ensure potency and sterility.
Can Esodel 40 IV be produced in different packaging formats?
While the standard packaging is 1 vial with WFI, we can accommodate custom packaging requests upon approval.
What is the minimum order quantity for bulk supply?
We offer flexible order quantities, with minimums tailored to the client’s requirements.
How does your supply chain ensure reliability?
Our logistics network includes real-time tracking, redundant inventory systems, and partnerships with global freight forwarders to ensure timely delivery.
Are there options for long-term supply agreements?
Yes, we support long-term contracts to ensure consistent supply and pricing stability for our clients.
What certifications does your facility hold?
Our facility is certified under ISO 9001:2015, ISO 17025:2017, and maintains compliance with FDA and EMA guidelines.
