Pentadel I.V. is a sterile, ready-to-use injectable solution containing Pantoprazole, a proton pump inhibitor (PPI), formulated for intravenous administration. The product’s composition includes Pantoprazole 40mg dissolved in Water for Injection (WFI), ensuring optimal solubility and stability. The formulation is designed to maintain chemical integrity during storage and administration, with minimal excipient content to reduce potential interactions. The pharmaceutical characteristics of Pantoprazole, including its hydrochloride salt form and solubility in aqueous solutions, are preserved through precise manufacturing processes. The formulation adheres to pharmaceutical standards for injectable solutions, ensuring compatibility with intravenous delivery systems and minimizing risk of precipitation or degradation. The use of DPCO (Drug Product Code of Origin) ensures traceability and compliance with regulatory requirements for active pharmaceutical ingredients (APIs).
Manufacturing Capability
Delwis Healthcare’s manufacturing infrastructure is equipped to produce Pentadel I.V. with rigorous adherence to GMP (Good Manufacturing Practice) standards. The facility features a dedicated sterile processing line for injectable products, including aseptic filling, sealing, and labeling systems to prevent contamination. Advanced filtration and purification technologies ensure the removal of particulates and microbial contaminants, meeting ISO 7 and ISO 8 cleanroom classifications. The production process employs validated methods for dissolving Pantoprazole in WFI, with real-time monitoring of pH, osmolarity, and particulate matter to ensure consistency. Scalability is achieved through modular production lines capable of handling bulk orders while maintaining quality control. The facility’s quality systems include automated documentation, traceability protocols, and regular internal audits to ensure compliance with regulatory frameworks.
Available Strengths and Packaging
Pentadel I.V. is available in a single strength: Pantoprazole 40mg Injection I.V. (DPCO). The product is packaged in 1 vial with Water for Injection (WFI), ensuring sterility and stability for immediate use. This packaging format is ideal for clinical applications requiring single-dose administration, with no additional diluent required.
Contract Manufacturing / Third Party Manufacturing
Delwis Healthcare offers comprehensive contract manufacturing and third-party manufacturing services tailored to pharmaceutical buyers’ needs. Our private label manufacturing capabilities allow clients to produce branded injectable products under their own regulatory frameworks, with full flexibility in formulation, packaging, and labeling. For third-party manufacturing, we provide turnkey solutions for API-based injectables, including formulation development, process validation, and final product packaging. Our services cater to both domestic and international clients, ensuring compliance with regional and global regulatory standards. Whether requiring small-scale prototyping or large-volume production, our scalable infrastructure supports diverse manufacturing demands while maintaining consistency and quality.
Quality Assurance
Quality assurance at Delwis Healthcare is built on a robust system of controls, testing, and validation to ensure product integrity. Each batch of Pentadel I.V. undergoes rigorous testing, including high-performance liquid chromatography (HPLC) for potency, microbial limit testing, and particulate matter analysis. Analytical validation ensures accuracy in determining Pantoprazole concentration and purity, with deviations flagged for corrective action. Batch testing protocols are aligned with ICH (International Council for Harmonisation) guidelines, ensuring compliance with pharmacopeial standards. Our quality control systems integrate real-time data monitoring, automated sampling, and statistical process control (SPC) to maintain consistency across production runs. All quality records are maintained in compliance with FDA and EMA regulations, providing full traceability for regulatory submissions.
Regulatory Compliance
Delwis Healthcare ensures full compliance with global regulatory frameworks, including GMP, WHO guidelines, and ISO 9001:2015 quality management standards. Our manufacturing processes adhere to FDA, EMA, and PIC/S guidelines, with regular audits and inspections to maintain certification. The facility is registered with regulatory authorities in key markets, enabling seamless export and distribution. Compliance with WHO prequalification standards ensures that Pentadel I.V. meets international benchmarks for quality, safety, and efficacy. Additionally, our documentation processes support regulatory submissions, including dossiers for market approval and GMP inspections.
Global Supply Capability
Delwis Healthcare provides reliable global supply capabilities, with an extensive international distribution network spanning key pharmaceutical markets. Our bulk supply capacity supports large-scale orders, with logistics partnerships ensuring timely delivery to destinations worldwide. The supply chain is designed for resilience, incorporating redundant systems to mitigate disruptions and maintain continuity. Export capabilities are supported by compliance with international trade regulations, including HS code classification and customs documentation. Bulk supply options are tailored to meet the needs of distributors, exporters, and contract manufacturers, with flexible order sizes and delivery schedules.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose Delwis Healthcare for our expertise in injectable formulation, regulatory compliance, and scalable production. Our commitment to GMP standards and quality assurance ensures consistent product performance, while our global supply network enables efficient distribution. As a trusted manufacturer, we offer end-to-end solutions, from API sourcing to final packaging, reducing time-to-market for clients. Our ability to accommodate private label and third-party manufacturing requests makes us a versatile partner for diverse industry needs.
Bulk Supply Inquiry
Delwis Healthcare offers bulk supply capabilities for Pentadel I.V. For inquiries regarding large-scale orders, please contact us at info@delwishealthcare.com.
FAQs
What manufacturing standards does Delwis Healthcare follow for Pentadel I.V.?
Delwis Healthcare adheres to GMP, WHO, and ISO 9001:2015 standards, ensuring compliance with global regulatory requirements.
Can Pentadel I.V. be customized for specific packaging formats?
Yes, we offer flexible packaging solutions, including single-dose vials with WFI, tailored to client specifications.
What certifications does Delwis Healthcare hold for pharmaceutical manufacturing?
Our facility is certified under FDA, EMA, and PIC/S guidelines, with regular audits to maintain compliance.
How does Delwis Healthcare ensure the sterility of Pentadel I.V.?
Sterility is maintained through aseptic processing, ISO-classified cleanrooms, and rigorous microbial testing.
Is bulk supply of Pentadel I.V. available for international markets?
Yes, we provide bulk supply capabilities with global distribution networks to support international clients.
What quality control measures are applied during production?
Each batch undergoes HPLC, microbial testing, and particulate analysis to ensure product integrity.
Can Delwis Healthcare support private label manufacturing for Pentadel I.V.?
Yes, we offer private label solutions, allowing clients to brand the product under their own regulatory framework.
What is the shelf life of Pentadel I.V. under recommended storage conditions?
The product has a shelf life of 24 months when stored at 2–8°C, as per stability studies.
How does Delwis Healthcare handle regulatory submissions for market approval?
We provide comprehensive documentation, including dossiers and GMP inspection reports, to support regulatory submissions.
What is the minimum order quantity for bulk supply of Pentadel I.V.?
Minimum order quantities are flexible and tailored to client needs, with options for small-scale trials or large-volume production.
