Metadet Nasal Spray is a finely balanced formulation of Mometasone Furoate, a synthetic corticosteroid, dissolved in a sterile, isotonic aqueous solution. The 0.05%w/v concentration ensures optimal therapeutic efficacy while minimizing systemic absorption, a critical factor in nasal steroid formulations. The product’s formulation is designed for stability under a range of storage conditions, with excipients selected to maintain pH neutrality and prevent degradation. The nasal spray delivery system employs a metered-dose mechanism, ensuring consistent and accurate dosing. From a manufacturing perspective, the formulation is engineered for compatibility with high-speed filling lines, enabling efficient production while maintaining sterility and product integrity. The excipient profile includes a surfactant to enhance aerosol dispersion and a preservative to ensure microbial stability, aligning with pharmaceutical standards for nasal dosage forms.
Manufacturing Capability
Delwis Healthcare’s manufacturing infrastructure is equipped to produce Metadet Nasal Spray at scale, leveraging state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP). The facility includes ISO Class 7 and Class 8 cleanrooms for aseptic processing, ensuring sterility throughout the production cycle. Advanced filling lines with automated dosing systems enable precise metered-dose packaging, while dedicated drying and packaging zones maintain product stability. Our production capacity supports bulk supply for global markets, with scalability achieved through modular manufacturing units and flexible production schedules. Quality systems are integrated at every stage, including real-time monitoring of critical parameters such as pH, osmolarity, and particulate matter. The facility is also certified for ISO 9001:2015, ensuring adherence to international quality management standards.
Available Strengths and Packaging
Composition: Mometasone Furoate 0.05%w/v
Packaging: 10 ml (100 metered dose)
Metadet Nasal Spray is available in a single strength of 0.05%w/v, optimized for nasal application. The 10 ml packaging contains 100 metered doses, ensuring precise delivery and extended shelf life. The metered-dose system is designed for consistent aerosolization, with each dose calibrated to deliver the exact active ingredient concentration. Packaging is manufactured using high-density polyethylene (HDPE) containers with child-resistant closures, meeting global safety and regulatory standards.
Contract Manufacturing / Third Party Manufacturing
Delwis Healthcare offers comprehensive contract manufacturing and third-party manufacturing services tailored to pharmaceutical buyers. Our private-label capabilities allow clients to brand and market Metadet Nasal Spray under their own trademarks, with full customization of packaging and labeling. We support both small-scale pilot batches and large-volume production, ensuring flexibility to meet diverse market demands. Our team of formulation experts collaborates closely with clients to optimize product specifications, from excipient selection to delivery system design. Whether requiring a single formulation or a multi-product portfolio, Delwis Healthcare provides end-to-end solutions that align with global regulatory requirements.
Quality Assurance
Quality assurance for Metadet Nasal Spray is built on rigorous analytical validation and batch testing protocols. Each production batch undergoes comprehensive testing for active ingredient content, pH, osmolarity, and microbial limits, ensuring compliance with pharmacopeial standards. Advanced analytical techniques, including High-Performance Liquid Chromatography (HPLC) and UV spectrophotometry, are employed to validate potency and purity. Stability testing is conducted under accelerated conditions to predict shelf life and storage requirements. Our quality control systems are ISO 17025-accredited, with traceable documentation for all testing procedures. Batch records are maintained digitally, ensuring transparency and audit readiness for regulatory inspections.
Regulatory Compliance
Metadet Nasal Spray is manufactured in full compliance with Good Manufacturing Practices (GMP), WHO guidelines, and ISO 9001:2015 standards. The product adheres to international pharmacopeial requirements, including USP, EP, and BP specifications, ensuring global market access. Regulatory frameworks such as the FDA’s Current Good Manufacturing Practice (CGMP) and the EU’s GMP guidelines are strictly followed during production. Delwis Healthcare holds certifications for ISO 14001 (environmental management) and ISO 45001 (occupational health and safety), reflecting a commitment to sustainable and safe manufacturing. All documentation, including batch records and stability data, is prepared in accordance with ICH guidelines, facilitating regulatory submissions for markets worldwide.
Global Supply Capability
Delwis Healthcare delivers bulk supply capabilities to meet the demands of international pharmaceutical markets. Our global distribution network spans over 50 countries, supported by strategic partnerships with logistics providers for timely and secure shipping. The facility is equipped for large-scale bulk production, with storage capacity to handle seasonal demand fluctuations. Supply chain reliability is ensured through redundant inventory systems and real-time tracking technologies. Export capabilities are bolstered by compliance with international shipping regulations, including IATA and IMDG standards for hazardous material transport. Clients benefit from a seamless supply chain, with customized solutions for regional distribution and regulatory compliance.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select Delwis Healthcare for its expertise in nasal spray formulation, regulatory compliance, and scalable production. Our commitment to GMP standards, coupled with a proven track record in bulk supply, ensures reliable product quality and market readiness. The facility’s advanced manufacturing infrastructure and flexible production capabilities allow clients to meet diverse regional requirements without compromising on quality. With a focus on innovation and sustainability, Delwis Healthcare offers competitive pricing, rapid turnaround times, and dedicated support to streamline the supply chain.
Bulk Supply Inquiry
Delwis Healthcare provides bulk supply capabilities for Metadet Nasal Spray. For inquiries regarding large-scale procurement, please contact our team at info@delwishealthcare.com.
FAQs
What manufacturing standards does Delwis Healthcare follow for Metadet Nasal Spray?
Our production adheres to cGMP, ISO 9001:2015, and WHO guidelines, ensuring compliance with global regulatory requirements.
Can Metadet Nasal Spray be customized for private labeling?
Yes, we offer private-label manufacturing services, allowing clients to brand the product under their own trademarks.
What is the shelf life of Metadet Nasal Spray?
The product has a shelf life of 24 months when stored at 20–25°C, as confirmed by stability testing.
Does Delwis Healthcare support third-party manufacturing for nasal sprays?
Yes, we provide end-to-end third-party manufacturing solutions, including formulation development and packaging.
How does Delwis Healthcare ensure sterility during production?
Our facility uses ISO Class 7 and Class 8 cleanrooms, with aseptic processing techniques to maintain sterility.
Can Metadet Nasal Spray be exported to all regions?
Yes, we comply with IATA and IMDG regulations, enabling seamless export to over 50 countries.
What quality control measures are in place for batch testing?
Each batch undergoes HPLC, UV spectrophotometry, and microbial testing to ensure potency and purity.
What is the minimum order quantity for bulk supply?
We accommodate both small-scale and large-volume orders, with flexible MOQs tailored to client needs.
How does Delwis Healthcare handle regulatory submissions?
We provide complete documentation, including batch records and stability data, to support regulatory submissions.
Can Delwis Healthcare assist with packaging customization?
Yes, we offer customized packaging solutions, including child-resistant closures and tamper-evident seals.
