Ashru -5 is a precision-formulated eye drop solution engineered for stability, efficacy, and compliance with pharmaceutical standards. The formulation combines Carboxy MethylCellulose Sodium I.P. Stabilized at 0.5% w/v, a viscoelastic agent that enhances tear film integrity and provides prolonged ocular surface hydration, with Oxychloro Complex at 0.0075% w/v, a broad-spectrum antiseptic that inhibits microbial growth. The stabilized composition ensures consistent performance and shelf-life extension, critical for pharmaceutical manufacturers prioritizing product reliability. The 10ml packaging is designed for ease of use, sterility maintenance, and compatibility with automated dispensing systems. From a formulation perspective, the product’s pH is optimized for ocular compatibility, and its isotonicity ensures minimal irritation during application. The manufacturing process integrates advanced emulsification and homogenization techniques to achieve a uniform, clear solution free from particulate matter, ensuring compliance with stringent pharmaceutical quality benchmarks.
Manufacturing Capability
Our manufacturing infrastructure is equipped to produce Ashru -5 at scale, adhering to ISO 9001 and GMP-certified facilities. The sterile processing capability includes aseptic filling lines with HEPA-filtered environments, ensuring contamination-free production. The facility supports batch sizes ranging from small-scale trials to large-volume commercial production, with scalable equipment for consistent quality and efficiency. Advanced quality systems, including real-time monitoring and automated data collection, ensure adherence to Good Manufacturing Practice (GMP) standards. The production process incorporates validated sterilization techniques, such as terminal steam sterilization for vials and filtration for liquid components, to guarantee product safety. Additionally, the facility is designed for compliance with current Good Manufacturing Practice (cGMP) regulations, with documented procedures for raw material testing, in-process controls, and final product validation.
Available Strengths and Packaging
The composition of Ashru -5 is standardized at Carboxy MethylCellulose Sodium I.P. Stabilized 0.5% w/v and Oxychloro Complex 0.0075% w/v, ensuring consistent therapeutic performance. The product is available in a 10ml single-dose packaging, optimized for sterility, convenience, and compliance with regulatory requirements for over-the-counter and prescription eye drops.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer contract manufacturing, private label production, and third-party manufacturing services tailored to pharmaceutical buyers’ needs. Our capabilities include end-to-end development, from formulation optimization to large-scale production, ensuring compliance with global regulatory standards. We support customization for varying strengths, packaging formats, and labeling requirements, enabling clients to meet regional market demands. Our flexible manufacturing model accommodates both short-run trials and long-term bulk supply, with dedicated project management teams to ensure timely delivery and quality assurance.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and compliance with international pharmaceutical standards. Every batch of Ashru -5 undergoes comprehensive testing for pH, osmolality, sterility, and microbial limits, ensuring product safety and efficacy. Advanced analytical techniques, including high-performance liquid chromatography (HPLC) and UV spectrophotometry, validate the purity and concentration of active ingredients. Quality control systems are integrated with digital traceability tools, enabling real-time monitoring of production parameters. Additionally, we adhere to ICH and USP guidelines, ensuring consistency in product quality and regulatory compliance for global markets.
Regulatory Compliance
Ashru -5 is manufactured in full compliance with GMP, WHO guidelines, and ISO 9001 standards, ensuring adherence to international regulatory frameworks. Our facility holds certifications for Good Manufacturing Practice (GMP) under both FDA and EU guidelines, enabling seamless export to global markets. The product’s formulation and manufacturing process meet WHO prequalification criteria, supporting access in low- and middle-income countries. Compliance with ISO 14001 environmental management standards further demonstrates our commitment to sustainable pharmaceutical practices. All documentation, including batch records, stability data, and regulatory filings, is prepared to meet the requirements of regulatory authorities worldwide.
Global Supply Capability
We provide robust global supply capabilities, including export-ready packaging, international distribution networks, and bulk supply options for pharmaceutical buyers. Our logistics partners ensure timely delivery to over 50 countries, with cold chain support for temperature-sensitive products. The 10ml packaging is designed for efficient storage and transportation, reducing waste and enhancing supply chain reliability. Bulk supply capacity is supported by scalable production lines, enabling clients to meet large-volume demand without compromising quality. Our supply chain infrastructure includes contingency planning for disruptions, ensuring uninterrupted delivery to customers worldwide.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our proven expertise in high-quality formulation, regulatory compliance, and global supply chain reliability. Our GMP-certified facilities, combined with advanced manufacturing technology, ensure consistent product quality and scalability. As a trusted supplier, we offer competitive pricing, customized solutions, and end-to-end support, from development to market entry. Our commitment to sustainability, innovation, and compliance positions us as a strategic partner for businesses seeking to expand their presence in the global pharmaceutical market.
Bulk Supply Inquiry
For bulk supply inquiries, please contact us at info@delwishealthcare.com. Our team is dedicated to providing tailored solutions for pharmaceutical manufacturers, exporters, and contract partners seeking reliable, high-quality products.
FAQs
What manufacturing standards does Ashru -5 comply with?
Ashru -5 is manufactured in accordance with GMP, WHO guidelines, and ISO 9001 standards, ensuring compliance with global regulatory requirements.
Can Ashru -5 be produced in different packaging formats?
Yes, we offer flexible packaging options, including the standard 10ml single-dose vial, to meet diverse market demands.
What quality control measures are in place for Ashru -5?
Every batch undergoes rigorous testing for pH, osmolality, sterility, and microbial limits, with analytical validation per ICH and USP guidelines.
Is Ashru -5 suitable for export to international markets?
Yes, our compliance with FDA, EU, and WHO standards ensures seamless export to global markets.
What is the shelf life of Ashru -5?
The stabilized formulation ensures a shelf life of up to 24 months when stored under recommended conditions.
Can Ashru -5 be customized for private label manufacturing?
Yes, we support private label production with customization options for branding, labeling, and packaging.
How does your supply chain ensure reliability?
Our logistics network includes cold chain support, regional distribution hubs, and contingency planning for uninterrupted delivery.
What certifications does your facility hold?
Our facility is certified under GMP, ISO 9001, and ISO 14001, ensuring adherence to global quality and sustainability standards.
Can you handle large-scale bulk production?
Yes, our scalable manufacturing infrastructure supports both small-scale trials and large-volume bulk supply.
How do you ensure compliance with regulatory frameworks?
We maintain documentation aligned with FDA, EU, and WHO regulations, with regular audits to ensure ongoing compliance.
