Gasodel Susp is a stabilized suspension formulation designed for pharmaceutical manufacturers requiring high-quality, consistent active pharmaceutical ingredients (APIs) in a ready-to-use format. The product combines Megaldrate, a magnesium hydroxide compound known for its alkalizing properties, with Simethicone, a silicone-based anti-foaming agent. The suspension formulation ensures uniform dispersion of APIs, enhancing stability and ease of administration. From a manufacturing perspective, the product is engineered to maintain physicochemical integrity during storage and transport, with controlled particle size distribution and viscosity to prevent sedimentation. The formulation process involves precise blending, homogenization, and sterilization (if required) to meet pharmaceutical standards. Megaldrate’s solubility profile and Simethicone’s surfactant properties are optimized to ensure compatibility, with minimal risk of chemical interactions. The suspension’s rheological properties are tailored for ease of dosing and patient compliance, making it suitable for bulk supply in pharmaceutical manufacturing pipelines.
Manufacturing Capability
Our manufacturing infrastructure is designed to meet the stringent demands of pharmaceutical production, with state-of-the-art facilities equipped for sterile and non-sterile suspension manufacturing. The production line includes advanced homogenization systems, high-precision blending equipment, and temperature-controlled storage units to maintain API stability. Sterile processing capabilities are available for critical applications, adhering to ISO 7 and ISO 8 cleanroom standards. All manufacturing processes comply with current Good Manufacturing Practices (cGMP), ensuring consistency, traceability, and quality assurance. The facility is scalable to accommodate bulk supply requirements, with modular production units capable of handling large-scale orders without compromising product integrity. Quality systems include real-time monitoring, automated data collection, and rigorous validation protocols to ensure compliance with regulatory frameworks.
Available Strengths and Packaging
Composition: Megaldrate 400mg + Simethicone 20mg Susp.
Packaging: 170ml
Gasodel Susp is available in a single strength formulation, with 400mg of Megaldrate and 20mg of Simethicone per 170ml suspension. The packaging is designed for stability, with airtight seals and tamper-evident closures to ensure product integrity during transportation and storage. The 170ml volume is optimized for bulk supply, catering to pharmaceutical manufacturers requiring efficient distribution and dosing accuracy.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers’ needs. Our capabilities include private label manufacturing, where we produce finished products under a client’s brand, ensuring compliance with regulatory requirements. We also provide flexible contract manufacturing options, allowing clients to leverage our expertise in formulation development, quality control, and scalable production. Our team supports customization of packaging, labeling, and dosage forms, ensuring alignment with global market demands. For pharmaceutical exporters and distributors, we offer end-to-end solutions, from raw material sourcing to finished product delivery, with full traceability and documentation.
Quality Assurance
Our quality assurance systems are built on rigorous analytical validation, batch testing, and compliance with international pharmaceutical standards. Every batch of Gasodel Susp undergoes comprehensive testing, including pH measurement, particle size analysis, and stability testing to ensure consistency. Advanced techniques such as high-performance liquid chromatography (HPLC) and infrared spectroscopy are employed for API quantification and impurity detection. Microbial testing, endotoxin analysis, and sterility checks (where applicable) are conducted to meet cGMP and ISO standards. All quality control processes are documented and traceable, with continuous monitoring to ensure adherence to specifications. Our commitment to quality extends to raw material sourcing, with suppliers vetted for compliance with Good Supplier Practices (GSP).
Regulatory Compliance
Gasodel Susp is manufactured in full compliance with global regulatory frameworks, including cGMP, WHO guidelines, and ISO 9001:2015 quality management standards. Our facility is certified for pharmaceutical production, with documentation prepared for submission to regulatory authorities such as the FDA, EMA, and PIC/S. Compliance with WHO prequalification standards ensures the product meets international quality benchmarks for export. We maintain detailed batch records, stability data, and deviation reports to support regulatory submissions. Our team is proficient in navigating regional regulatory requirements, providing support for market entry in diverse geographies.
Global Supply Capability
We specialize in bulk supply solutions, with a robust international distribution network and export-ready logistics infrastructure. Our facility is equipped to handle large-scale orders, ensuring timely delivery to global markets. We maintain strategic partnerships with freight forwarders and customs brokers to streamline cross-border shipments, adhering to import regulations and documentation requirements. Bulk supply capacity is supported by automated inventory management systems, enabling efficient order fulfillment and supply chain reliability. Our export capabilities extend to regions with stringent regulatory environments, with products compliant for use in Asia, Europe, Africa, and Latin America.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in scalable production, regulatory compliance, and supply chain reliability. Our commitment to quality ensures that Gasodel Susp meets the highest standards for bulk supply, with consistent performance and traceability. As a manufacturer, we offer competitive pricing, flexible production timelines, and tailored solutions to meet diverse market needs. Our global presence and adherence to international standards position us as a trusted partner for pharmaceutical buyers seeking reliable, high-quality products.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com.
FAQs
What manufacturing standards does Gasodel Susp comply with?
Gasodel Susp is manufactured in accordance with cGMP, WHO guidelines, and ISO 9001:2015 standards, ensuring compliance with global regulatory requirements.
Can Gasodel Susp be produced in sterile conditions?
Yes, our facility is equipped with sterile processing capabilities, including ISO 7 and ISO 8 cleanroom environments, to meet requirements for sterile suspension production.
What is the shelf life of Gasodel Susp?
The product has a shelf life of 24 months when stored under recommended conditions (temperature 20–25°C, humidity <60%).
Is bulk supply available for Gasodel Susp?
Yes, we offer bulk supply capabilities with flexible order quantities to meet the demands of pharmaceutical manufacturers and exporters.
What quality control measures are in place for Gasodel Susp?
Each batch undergoes rigorous testing, including HPLC, particle size analysis, microbial testing, and stability studies, to ensure compliance with quality standards.
Can Gasodel Susp be customized for specific markets?
Yes, we support customization of packaging, labeling, and dosage forms to meet regional regulatory and market-specific requirements.
What documentation is provided for regulatory submissions?
We provide complete documentation, including batch records, stability data, analytical reports, and compliance certificates for regulatory submissions.
How does your export process ensure compliance with international regulations?
Our export process includes compliance with WHO prequalification, FDA, EMA, and PIC/S standards, with support for local regulatory submissions in target markets.
What is the minimum order quantity for Gasodel Susp?
Minimum order quantities are flexible and can be customized based on the buyer’s requirements and production scale.
How can I request a sample or bulk supply?
Contact our team at info@delwishealthcare.com for sample requests, bulk supply inquiries, or to discuss customization options.
