Sensodel is a meticulously formulated pharmaceutical product engineered for stability, efficacy, and compatibility in industrial production. The formulation combines Potassium Nitrate at 5% weight by volume (w/v) with Sodium Fluride at 0.70% w/v, creating a balanced composition that ensures optimal solubility and active ingredient retention. Potassium Nitrate serves as a mild abrasive and buffering agent, while Sodium Fluride acts as a fluoride-releasing agent, enhancing enamel remineralization. The formulation’s homogeneity is achieved through advanced dispersion techniques, ensuring uniform distribution of active components. Manufacturing considerations include pH stabilization, preservative integration, and compatibility testing to prevent degradation during storage. The product’s physicochemical properties, such as viscosity and surface tension, are optimized for application in dental care settings, while its shelf life is extended through controlled moisture and temperature management.
Manufacturing Capability
Delwis Healthcare’s manufacturing infrastructure is designed to meet the stringent demands of pharmaceutical production. Our state-of-the-art facility adheres to current Good Manufacturing Practices (cGMP) and is equipped with advanced machinery for precise mixing, homogenization, and packaging. Sterile processing capabilities are available for sensitive formulations, ensuring contamination-free production. The facility complies with ISO 9001:2015 quality management systems and maintains rigorous validation protocols for equipment, processes, and environmental controls. Scalability is a core strength, with production lines capable of handling bulk orders while maintaining consistency in product quality. Our quality systems include real-time monitoring, automated data collection, and traceability mechanisms to ensure compliance with regulatory standards.
Available Strengths and Packaging
Sensodel is available in a single strength formulation, with Potassium Nitrate at 5% w/v and Sodium Fluride at 0.70% w/v, encapsulated in a 50gm packaging unit. This standardized composition ensures uniformity in product performance, while the 50gm size is optimized for industrial distribution and end-user application. The packaging is designed for stability during transportation and storage, with tamper-evident features to maintain product integrity.
Contract Manufacturing / Third Party Manufacturing
Delwis Healthcare offers comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers’ needs. Our private label manufacturing capabilities allow clients to produce branded products under their own specifications, with full transparency in formulation, packaging, and quality control. We support contract manufacturing for both small and large-scale production runs, ensuring adherence to regulatory standards and client-specific requirements. Our team provides end-to-end solutions, from raw material sourcing to final packaging, with flexibility in formulation adjustments and packaging formats. This service is ideal for pharmaceutical distributors, exporters, and manufacturers seeking to expand their product portfolios without in-house production constraints.
Quality Assurance
Our quality assurance framework is built on rigorous testing, validation, and compliance with international standards. Every batch of Sensodel undergoes stringent quality control checks, including pH testing, microbial limit testing, and heavy metal analysis to ensure safety and purity. Analytical validation is performed using high-performance liquid chromatography (HPLC) and spectrophotometric methods to confirm active ingredient concentration and stability. Batch testing protocols are designed to meet WHO and FDA guidelines, with documented results available for audit purposes. Our quality systems also include in-process controls, environmental monitoring, and deviation management to prevent contamination and ensure consistency.
Regulatory Compliance
Sensodel complies with global regulatory frameworks, including cGMP, WHO guidelines, and ISO 9001:2015 standards. Our manufacturing processes are validated to meet the requirements of regulatory bodies such as the FDA, EMA, and PIC/S. The product is formulated and packaged in accordance with ICH guidelines, ensuring compatibility with international markets. Documentation, including batch records, stability data, and analytical reports, is maintained to support regulatory submissions and audits. Our facility is regularly inspected by third-party auditors to ensure ongoing compliance with evolving standards.
Global Supply Capability
Delwis Healthcare boasts a robust global supply chain, enabling seamless export and distribution to over 50 countries. Our international distribution network includes partnerships with logistics providers specializing in pharmaceutical transportation, ensuring timely and secure delivery. Bulk supply capacity is optimized for large-scale orders, with flexible packaging options to meet regional requirements. Supply chain reliability is maintained through redundant inventory systems, real-time tracking, and contingency planning. We prioritize adherence to import regulations, including documentation for customs clearance and compliance with destination-specific quality standards.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from Delwis Healthcare’s expertise in precision manufacturing, regulatory compliance, and global supply chain management. Our commitment to quality ensures consistent product performance, while our scalable production capabilities support growth without compromising standards. As a trusted supplier, we offer competitive pricing, rapid turnaround times, and dedicated support to meet client needs. With a focus on innovation and reliability, Delwis Healthcare empowers partners to deliver high-quality products to global markets.
Bulk Supply Inquiry
Delwis Healthcare provides bulk supply capabilities for Sensodel, tailored to meet the demands of pharmaceutical buyers. For inquiries regarding large-scale procurement, please contact us at info@delwishealthcare.com.
FAQs
What is the shelf life of Sensodel?
Sensodel has a shelf life of 24 months when stored in controlled conditions (15–25°C, 45–60% RH).
Can Sensodel be customized for different packaging formats?
Yes, we offer flexible packaging options, including 50gm units, to meet regional and client-specific requirements.
Does Delwis Healthcare provide third-party manufacturing services?
Yes, we offer contract manufacturing and private label production under cGMP standards.
What quality control measures are in place for Sensodel?
Every batch undergoes pH testing, microbial limit testing, and HPLC analysis to ensure purity and potency.
Is Sensodel compliant with FDA and WHO regulations?
Yes, our formulation and manufacturing processes adhere to FDA, WHO, and ICH guidelines.
Can Delwis Healthcare support export to specific regions?
Yes, we have a global distribution network and compliance expertise for exporting to over 50 countries.
What is the minimum order quantity for bulk supply?
Bulk orders are flexible, with minimum quantities tailored to client needs and production capacity.
How does Delwis Healthcare ensure supply chain reliability?
We use real-time tracking, redundant inventory systems, and logistics partners to ensure timely and secure delivery.
Can I request a sample of Sensodel before placing an order?
Yes, samples are available upon request for quality evaluation and formulation testing.
What is the lead time for production and delivery?
Lead times vary based on order size and regional destination, with expedited options available for urgent requirements.
