Nojam Kids Nasal Drops is a sterile, isotonic nasal solution formulated with Xylometazoline HCL at 0.05% w/v, designed to meet the stringent requirements of pharmaceutical manufacturing. The formulation is based on a well-established pharmacopeial standard, ensuring stability, purity, and efficacy for pediatric use. The active ingredient, Xylometazoline HCL, is a selective alpha-2 adrenergic agonist, commonly used as a decongestant in nasal drops. The excipients include purified water, preservatives, and pH regulators to maintain optimal osmolarity and microbial stability. The formulation is prepared using advanced dissolution and homogenization techniques to ensure uniform dispersion of the active ingredient, critical for consistent therapeutic performance. The product’s clarity, pH neutrality, and absence of particulate matter are rigorously tested during manufacturing to meet pharmaceutical-grade specifications. The formulation is designed for short-term use in pediatric patients, with a focus on minimizing systemic absorption and ensuring safety in vulnerable populations.
Manufacturing Capability
Our manufacturing infrastructure is equipped to produce Nojam Kids Nasal Drops at scale, adhering to global Good Manufacturing Practice (GMP) standards. The facility features a dedicated sterile processing line for nasal solutions, including a Class 10,000 cleanroom environment to prevent contamination. Automated filling, capping, and sealing systems ensure precision in packaging, while real-time monitoring of temperature, humidity, and pressure maintains product integrity. The production process is validated to meet ISO 9001 and FDA 21 CFR Part 11 standards, with comprehensive documentation for traceability and compliance. Scalability is achieved through modular production lines capable of handling bulk orders without compromising quality. The facility is certified for pharmaceutical-grade manufacturing, with regular audits to ensure adherence to regulatory requirements. Advanced quality control systems, including HPLC and microbial testing, are integrated into the production workflow to guarantee consistency and safety.
Available Strengths and Packaging
Nojam Kids Nasal Drops is available in a single strength of 0.05% w/v Xylometazoline HCL, optimized for pediatric nasal congestion. The product is packaged in 10ml single-dose vials with an outer carton, designed to ensure product stability, child safety, and compliance with regulatory packaging standards. The 10ml volume is calibrated for ease of use in pediatric applications, while the outer packaging provides tamper-evidence and clear labeling for distribution. This packaging format is suitable for both domestic and international markets, with compatibility for secondary labeling as required by local regulations.
Contract Manufacturing / Third Party Manufacturing
As a trusted pharmaceutical manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to the needs of global buyers. Our capabilities include private label manufacturing, where we produce finished products under a client’s brand name, ensuring full customization of packaging, labeling, and regulatory documentation. For third-party manufacturing, we provide end-to-end solutions, from formulation development to packaging and distribution, with strict adherence to client specifications. Our facility is equipped to handle small-scale trials and large-volume production, making us an ideal partner for pharmaceutical companies seeking to enter new markets or expand their product portfolio. We support compliance with international standards, including FDA, EMA, and WHO guidelines, ensuring seamless integration into global supply chains.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to pharmaceutical quality standards. Every batch of Nojam Kids Nasal Drops undergoes comprehensive testing, including pH measurement, osmolarity checks, microbial limit testing, and HPLC analysis to confirm active ingredient concentration. The product is also tested for particulate matter, preservative efficacy, and sterility to ensure safety for pediatric use. All quality control processes are validated to meet ICH and USP guidelines, with documented results traceable to each batch. Our quality management system is ISO 9001-certified, ensuring continuous improvement and compliance with regulatory expectations. Additionally, we maintain a robust stability testing program to determine shelf life and storage conditions, providing clients with reliable data for regulatory submissions.
Regulatory Compliance
Nojam Kids Nasal Drops is manufactured in full compliance with GMP, WHO guidelines, and international pharmaceutical standards. Our facility holds certifications from regulatory authorities, including FDA, EMA, and the WHO Prequalification Programme, ensuring adherence to global quality benchmarks. The product is formulated to meet pharmacopeial standards, with documentation supporting compliance with USP, EP, and BP monographs. All manufacturing processes are validated to ensure consistency and reproducibility, with detailed records maintained for audit readiness. Our regulatory team assists clients in navigating local and international requirements, providing support for registration, labeling, and market authorization. This ensures seamless compliance for export to regions with stringent regulatory frameworks.
Global Supply Capability
We have a robust global supply chain infrastructure, enabling reliable export and distribution of Nojam Kids Nasal Drops to over 50 countries. Our logistics network includes partnerships with international freight forwarders and customs brokers, ensuring timely delivery and compliance with import regulations. The product is available in bulk supply formats, with capacity to meet large-scale demand without compromising quality. Our warehouse facilities are equipped for temperature-controlled storage and rapid dispatch, supporting both short-term and long-term supply needs. We prioritize supply chain reliability through real-time tracking systems and contingency planning, ensuring uninterrupted delivery even in challenging market conditions. This capability positions us as a preferred partner for pharmaceutical distributors and exporters seeking dependable, high-quality supply solutions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our expertise in pharmaceutical innovation, compliance, and scalability. Our facility’s advanced manufacturing capabilities, combined with rigorous quality assurance and regulatory compliance, ensure that Nojam Kids Nasal Drops meets the highest standards of safety and efficacy. We offer flexible production solutions tailored to client needs, with the ability to adapt to evolving market demands. Our global supply network and bulk supply capacity provide competitive advantages for businesses seeking to expand their reach. Additionally, our dedicated customer support team ensures seamless collaboration, from product development to post-market compliance. By choosing us, clients gain access to a trusted partner committed to excellence in pharmaceutical manufacturing.
Bulk Supply Inquiry
We offer competitive bulk supply options for Nojam Kids Nasal Drops. For inquiries regarding large-scale orders, pricing, or customization, please contact our sales team at info@delwishealthcare.com.
FAQs
What manufacturing standards are followed for Nojam Kids Nasal Drops?
Our production adheres to GMP, ISO 9001, and WHO guidelines, ensuring compliance with global pharmaceutical quality standards.
Can the product be customized for different packaging formats?
Yes, we offer flexible packaging solutions, including custom labeling and secondary packaging, to meet regional regulatory requirements.
What is the shelf life of Nojam Kids Nasal Drops?
The product has a shelf life of 24 months when stored under recommended conditions, with stability data provided for regulatory submissions.
Is the manufacturing process validated for scalability?
Yes, our facility is equipped to handle large-scale production while maintaining consistency and quality through validated processes.
What regulatory certifications does your facility hold?
Our facility is certified by FDA, EMA, and WHO, with compliance documentation available for global market entry.
Can you support private label manufacturing for this product?
Absolutely. We provide end-to-end private label manufacturing, including branding, packaging, and regulatory documentation.
What quality control measures are in place for batch testing?
Each batch undergoes HPLC, microbial testing, and sterility checks, with full traceability and documentation for quality assurance.
How do you ensure supply chain reliability for bulk orders?
Our logistics network includes temperature-controlled storage, real-time tracking, and contingency planning to guarantee timely delivery.
Are there options for export to specific regions?
Yes, we support exports to over 50 countries, with compliance documentation tailored to regional regulatory frameworks.
How can I request a bulk supply quotation?
Contact our sales team at **info@delwishealthcare.com** for detailed pricing and supply terms.
