Vomidel - MD is a pharmaceutical formulation containing 4mg of ondansetron, a selective 5-HT3 receptor antagonist. The product is developed using advanced excipient combinations and controlled-release technology to ensure uniformity, stability, and bioavailability. The formulation is designed to meet stringent pharmaceutical requirements, including disintegration time, dissolution profile, and chemical stability under varied storage conditions. The active pharmaceutical ingredient (API) is combined with excipients such as microcrystalline cellulose, magnesium stearate, and hypromellose to achieve optimal flow properties, tablet hardness, and tablet disintegration. The manufacturing process prioritizes consistency in particle size distribution, compression force, and coating uniformity to ensure reproducible quality. The product’s formulation is validated through physicochemical testing, including pH compatibility, moisture content analysis, and thermal stability studies, ensuring compliance with pharmacopeial standards.
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 facility includes a dedicated sterile processing area for tablet compression and coating, supported by aseptic processing equipment such as high-speed tablet presses, fluid bed coating systems, and automated blister packaging lines. The production process adheres to strict quality control protocols, including real-time monitoring of critical parameters like tablet weight variation, hardness, and disintegration time. The facility is designed for scalability, enabling seamless transition from small-scale trial batches to large-volume commercial production. Advanced quality systems, including validated analytical instruments (HPLC, UV-Vis spectrophotometry, and dissolution testing), ensure consistent product quality. Additionally, the facility maintains a robust documentation system for traceability, change control, and deviation management, ensuring compliance with regulatory audits.
Available Strengths and Packaging
Composition: Ondansetron 4mg
Packaging: 20x10 Blister
Vomidel - MD is available in a 4mg strength formulation, packaged in 20x10 blister packs. The blister packaging ensures product stability, tamper-evidence, and ease of distribution. Each blister pack contains 10 individual tablets, with 20 packs per box, designed for efficient storage, transportation, and retail display. The packaging material is selected for its barrier properties against moisture and light, ensuring the product remains chemically stable under standard storage conditions.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing, private label, and third-party manufacturing services tailored to pharmaceutical buyers. Our capabilities include full-service formulation development, API sourcing, and finished dosage form production, enabling clients to bring products to market efficiently. We support private label manufacturing by adhering to client specifications for dosage form design, packaging, and labeling. Our contract manufacturing division is equipped to handle both small-scale pilot batches and large-volume commercial production, ensuring flexibility to meet diverse market demands. Clients benefit from our expertise in regulatory compliance, supply chain management, and cost-effective production strategies, making us an ideal partner for global pharmaceutical brands.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to international pharmacopoeial standards. Every production batch undergoes comprehensive testing, including identification, assay, dissolution testing, and impurity profiling using HPLC and mass spectrometry. Quality control measures are integrated at every stage of manufacturing, from raw material inspection to final product release. The facility maintains a validated quality management system (QMS) that ensures traceability, documentation, and continuous improvement. All testing procedures are validated per ICH guidelines, and results are archived for regulatory audits. Additionally, we conduct stability studies to determine shelf life and storage conditions, ensuring product integrity throughout the supply chain.
Regulatory Compliance
We comply with global regulatory frameworks, including cGMP, WHO guidelines, and ISO 9001:2015 standards. Our manufacturing processes are aligned with FDA, EMA, and PIC/S requirements, ensuring products meet the specifications for international markets. The facility is regularly audited by regulatory authorities and third-party inspectors to maintain compliance with Good Distribution Practices (GDP) and Good Clinical Practice (GCP). We also adhere to the ICH Q7 guidelines for API manufacturing and ICH Q8 for pharmaceutical development. Our commitment to regulatory compliance ensures seamless approval processes for clients seeking market entry in Europe, Asia, and the Americas.
Global Supply Capability
Our global supply capability is supported by an extensive international distribution network and robust logistics infrastructure. We provide bulk supply options tailored to meet the demands of pharmaceutical distributors, exporters, and contract manufacturers. The facility is equipped for large-scale production, enabling consistent supply to meet regional and global market needs. Our supply chain is designed for reliability, with contingency planning to mitigate disruptions. We offer customized export solutions, including compliance with international shipping regulations, temperature-controlled logistics, and documentation for customs clearance. Our bulk supply capacity ensures timely delivery, supporting clients in achieving market penetration and operational efficiency.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in high-quality, compliant manufacturing. Our facility’s adherence to cGMP, ISO, and WHO standards ensures product reliability and regulatory compliance. We offer scalable production solutions, flexible packaging options, and cost-effective manufacturing strategies to meet diverse market demands. Our commitment to innovation, quality assurance, and global supply chain reliability positions us as a preferred partner for pharmaceutical brands seeking trusted manufacturing and distribution services.
Bulk Supply Inquiry
We provide bulk supply capabilities for Vomidel - MD. For inquiries regarding large-scale procurement, please contact our sales team at info@delwishealthcare.com.
FAQs
What manufacturing standards does Vomidel - MD comply with?
Vomidel - MD is manufactured in compliance with cGMP, ISO 9001:2015, and WHO guidelines, ensuring adherence to international regulatory standards.
Can Vomidel - MD be produced in different packaging formats?
While the standard packaging is 20x10 blister, we offer customization for alternative packaging formats upon client request.
What excipients are used in Vomidel - MD formulation?
The formulation includes microcrystalline cellulose, magnesium stearate, and hypromellose as excipients to ensure stability and disintegration.
Is Vomidel - MD suitable for export to international markets?
Yes, our compliance with global regulatory frameworks ensures seamless export to markets in Europe, Asia, and the Americas.
What quality control measures are in place for Vomidel - MD?
Every batch undergoes rigorous testing, including HPLC, dissolution testing, and impurity profiling, ensuring product consistency and safety.
Can Vomidel - MD be produced in bulk quantities?
Yes, our facility is equipped for large-scale production, enabling bulk supply to meet global demand.
What is the shelf life of Vomidel - MD?
The product has a shelf life of 24 months when stored under recommended conditions (cool, dry, and protected from light).
How does your company ensure supply chain reliability?
We maintain a robust logistics network and contingency planning to ensure timely delivery and supply chain continuity.
Can Vomidel - MD be customized for private label manufacturing?
Yes, we support private label manufacturing with customization options for dosage form design, packaging, and labeling.
How can I inquire about bulk supply of Vomidel - MD?
For bulk supply inquiries, please contact our sales team at **info@delwishealthcare.com**.
