Vomidel Injection is formulated with Ondansetron as the active pharmaceutical ingredient (API), delivered in a sterile, isotonic aqueous solution suitable for intravenous or intramuscular administration. The formulation is designed to ensure stability, compatibility, and consistent therapeutic performance. Ondansetron, a selective 5-HT3 receptor antagonist, is dissolved in a pH-adjusted buffer system to maintain optimal solubility and bioavailability. The excipients include sodium chloride, water for injection, and preservative-free components to ensure sterility and long-term stability. The formulation is manufactured under strict quality control protocols to meet international pharmacopeial standards, ensuring uniformity in potency, purity, and shelf life. The product’s physicochemical properties are optimized for compatibility with various infusion systems and therapeutic regimens, making it suitable for diverse pharmaceutical applications.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001:2015 standards. The production line specializes in sterile injectable formulations, featuring aseptic filling, sealing, and packaging systems to ensure contamination-free manufacturing. The facility is designed for scalability, enabling seamless transition from small-scale development to large-volume commercial production. Advanced quality control systems, including real-time monitoring and automated data collection, ensure consistent product quality. Our sterile processing capability adheres to ISO 7 and ISO 8 cleanroom standards, with rigorous validation protocols for equipment, processes, and environmental controls. The facility is also certified for pharmaceutical-grade raw material handling, ensuring traceability and compliance with regulatory requirements.
Available Strengths and Packaging
Composition: Ondansetron 2mg Inj. (DPCO)
Packaging: 10 x 2ml amp.
Vomidel Injection is available in a single strength of 2mg per 2ml ampule, packaged in a 10 x 2ml blister strip. The packaging is designed for stability during storage and transportation, with tamper-evident features to ensure product integrity. The ampules are manufactured to meet international standards for pharmaceutical packaging, ensuring safe handling and compliance with regulatory guidelines for injectable products.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing, private label, and third-party production services tailored to the needs of pharmaceutical buyers. Our capabilities include formulation development, API integration, and full-scale production of injectable solutions, with flexibility to accommodate custom specifications. We support private label manufacturing for brand owners seeking to launch proprietary products, ensuring compliance with global regulatory frameworks. Our team of experts provides end-to-end solutions, from raw material sourcing to final product packaging, ensuring seamless integration into clients’ supply chains. Whether you require a single batch or large-scale production, our scalable infrastructure ensures timely delivery without compromising quality.
Quality Assurance
Our quality assurance system is built on rigorous analytical validation, batch testing, and adherence to international pharmacopeial standards. Each production batch undergoes comprehensive testing, including HPLC for API quantification, microbial limit tests, endotoxin analysis, and pH/viscosity checks. The facility is equipped with advanced analytical tools, such as UV-Vis spectrophotometers and particle size analyzers, to ensure precision in quality control. All processes are validated to meet ICH and USP guidelines, with documented protocols for stability testing, sterility assurance, and shelf life determination. Our quality management system (QMS) ensures traceability, compliance, and continuous improvement, supporting clients in meeting regulatory and market demands.
Regulatory Compliance
Vomidel Injection is manufactured in full compliance with GMP, WHO guidelines, and ISO 11135:2014 standards for sterilization. The product meets the requirements of the USP, EP, and BP pharmacopeias, ensuring global acceptance for export and distribution. Our facility is registered with regulatory authorities in major markets, including the FDA, EMA, and PIC/S, enabling seamless compliance with international export protocols. We maintain detailed documentation for audit readiness, including batch records, deviation reports, and validation data. Our commitment to regulatory excellence ensures that clients can confidently navigate global markets with minimal compliance hurdles.
Global Supply Capability
We offer robust export capabilities, supported by an extensive international distribution network spanning Asia, Europe, Africa, and the Americas. Our bulk supply capacity is designed to meet the demands of large-scale pharmaceutical buyers, with logistics partnerships ensuring timely delivery to remote regions. The facility is equipped for high-volume production, enabling consistent supply chain reliability even during peak demand. Our supply chain management system prioritizes transparency, with real-time tracking and inventory optimization to minimize delays. Whether you require small or large orders, our infrastructure ensures seamless global distribution without compromising product integrity.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our combination of regulatory compliance, scalable production, and global reach. Our expertise in injectable formulation ensures high-quality products that meet international standards, reducing time-to-market for clients. With a focus on reliability and innovation, we provide end-to-end solutions that align with your business objectives. Our commitment to quality assurance and regulatory excellence ensures that your products are ready for global distribution, supported by a dedicated team of professionals. Partnering with us means accessing a trusted manufacturer with the capacity to meet your bulk supply needs while maintaining compliance and consistency.
Bulk Supply Inquiry
For bulk supply inquiries, contact our sales team at info@delwishealthcare.com to discuss customization, pricing, and delivery schedules.
FAQs
What is the shelf life of Vomidel Injection?
Vomidel Injection has a shelf life of 24 months when stored under recommended conditions (2–8°C).
Can Vomidel Injection be customized for different packaging formats?
Yes, we offer flexible packaging solutions, including vials, pre-filled syringes, and custom blister strips.
What certifications does your facility hold?
Our facility is certified under ISO 9001:2015, GMP, and WHO GMP guidelines, ensuring compliance with global standards.
Do you provide contract manufacturing services for injectable products?
Yes, we specialize in contract manufacturing for injectable formulations, including private label and third-party production.
What is the minimum order quantity for Vomidel Injection?
Minimum order quantities are customizable based on production requirements and client specifications.
Can you support export to specific regions?
Yes, we have a global distribution network and support exports to all major pharmaceutical markets.
How do you ensure product sterility during manufacturing?
Our aseptic filling process operates in ISO 7 cleanrooms, with rigorous sterility testing for each batch.
What quality control measures are in place for batch testing?
Each batch undergoes HPLC, microbial testing, endotoxin analysis, and pH/viscosity checks to ensure compliance.
Can you accommodate urgent bulk orders?
Yes, our scalable production capacity allows for expedited orders without compromising quality.
What is your policy for regulatory documentation?
We provide complete regulatory documentation, including batch records, validation reports, and compliance certificates.
