Ashru Gel is a precision-formulated ophthalmic solution engineered for pharmaceutical manufacturers requiring a reliable, high-performance eye drop product. The formulation integrates Carboxy Methyle Cellulose (1% w/v) as a viscoelastic agent, which enhances tear film stability and provides prolonged ocular surface hydration. Glycerine is incorporated as a humectant to maintain moisture balance and improve the solution’s rheological properties. The combination ensures optimal viscosity, surface tension, and compatibility with ocular tissues, making it suitable for pharmaceutical applications requiring sterility and long-term stability.
From a manufacturing perspective, the product is formulated using advanced emulsification and homogenization techniques to ensure uniform dispersion of active ingredients. The formulation’s pH is carefully adjusted to match physiological conditions, minimizing irritation risks. The inclusion of Glycerine also aids in preserving the solution’s integrity during storage, reducing the likelihood of microbial contamination. The final product is packaged in a 10ml single-dose container, ensuring convenience for end-users and compliance with pharmaceutical packaging standards.
Manufacturing Capability
Delwis Healthcare’s manufacturing infrastructure is designed to meet the stringent demands of pharmaceutical production. The facility is equipped with state-of-the-art aseptic processing units, including ISO Class 7 and Class 8 cleanrooms, ensuring sterility throughout the production process. Our dedicated sterile processing capability allows for the manufacture of products like Ashru Gel, adhering to current Good Manufacturing Practice (cGMP) guidelines.
The facility is fully compliant with global pharmaceutical quality standards, including ISO 9001:2015 and ISO 14644-1 for cleanroom certification. Production scalability is a core strength, with the ability to transition seamlessly from small-scale trials to large-volume manufacturing. This flexibility ensures that clients can meet market demands without compromising quality.
Our quality systems are built on rigorous process validation, including in-process testing for pH, sterility, and particulate matter. Advanced analytical tools, such as High-Performance Liquid Chromatography (HPLC) and microbial limit testing, are integrated into the manufacturing workflow to ensure consistency and compliance. The facility’s robust infrastructure and adherence to GMP standards position Delwis Healthcare as a trusted partner for pharmaceutical manufacturers requiring reliable, high-quality products.
Available Strengths and Packaging
Ashru Gel is formulated with Carboxy Methyle Cellulose at 1% w/v, making it a single-strength product suitable for standardized pharmaceutical applications. The formulation is available in a 10ml packaging size, designed for single-dose use and compliance with ophthalmic product specifications. This packaging ensures product integrity, convenience, and ease of use for end-users.
Contract Manufacturing / Third Party Manufacturing
Delwis Healthcare offers comprehensive contract manufacturing and third-party manufacturing services tailored to pharmaceutical buyers’ needs. Our private label manufacturing capabilities allow clients to produce branded products under their own specifications, ensuring full control over branding, labeling, and packaging.
For contract manufacturing, we provide end-to-end solutions, from raw material sourcing to finished product packaging, ensuring compliance with regulatory standards and client-specific requirements. Our team of experienced formulation scientists and quality assurance experts works closely with clients to optimize product performance, stability, and scalability. Whether you require small-batch prototyping or large-scale production, our flexible manufacturing infrastructure supports diverse pharmaceutical needs.
Quality Assurance
Delwis Healthcare’s quality assurance framework is built on rigorous control systems, analytical validation, and adherence to pharmaceutical quality standards. Every batch of Ashru Gel undergoes stringent testing, including sterility testing, pH measurement, and particulate matter analysis, to ensure compliance with pharmacopeial standards.
In-process quality checks are conducted at critical stages of production to monitor consistency and detect deviations early. Final batch testing includes microbial limit testing, endotoxin analysis, and stability studies to confirm shelf-life and product integrity. Advanced analytical techniques, such as HPLC and UV-Vis spectroscopy, are employed to validate the purity and potency of active ingredients.
Our quality assurance team adheres to ISO 17025 accreditation standards, ensuring that all testing procedures are validated, repeatable, and traceable. This commitment to excellence ensures that every product meets the highest standards of safety, efficacy, and regulatory compliance.
Regulatory Compliance
Delwis Healthcare ensures full compliance with global regulatory frameworks, including Good Manufacturing Practice (GMP), World Health Organization (WHO) guidelines, and ISO standards. Our manufacturing processes are aligned with WHO GMP requirements for pharmaceutical products, ensuring adherence to international quality benchmarks.
The facility is certified under ISO 9001:2015 for quality management systems and ISO 14644-1 for cleanroom certification, reflecting our dedication to maintaining rigorous hygiene and process control. Additionally, our operations comply with the United States Pharmacopeia (USP) and European Pharmacopeia (EP) standards, enabling seamless export to global markets.
By maintaining compliance with regulatory bodies such as the FDA, EMA, and PIC/S, Delwis Healthcare ensures that our products meet the stringent requirements of pharmaceutical buyers worldwide. This regulatory adherence positions us as a reliable partner for manufacturers seeking to enter international markets.
Global Supply Capability
Delwis Healthcare is equipped to deliver bulk supply capabilities to global markets, supported by an extensive international distribution network. Our export capabilities are bolstered by partnerships with trusted logistics providers, ensuring timely and secure delivery to destinations across continents.
The facility’s production capacity allows for large-scale manufacturing, accommodating bulk supply requests without compromising quality or consistency. Our supply chain reliability is further enhanced by real-time inventory tracking, predictive analytics, and contingency planning to mitigate disruptions.
Whether you require small-volume exports or large-scale bulk supply, Delwis Healthcare’s global supply chain infrastructure ensures seamless delivery. Our commitment to supply chain transparency and reliability makes us a preferred partner for pharmaceutical distributors and exporters seeking dependable, high-quality products.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose Delwis Healthcare for our unwavering commitment to quality, compliance, and scalability. Our expertise in pharmaceutical manufacturing, combined with a robust infrastructure and global supply chain, ensures that clients receive products meeting the highest industry standards.
As a trusted manufacturer and supplier, we offer competitive pricing, flexible production options, and tailored solutions to meet diverse market needs. Our ability to navigate complex regulatory environments and deliver reliable bulk supply makes us an ideal partner for businesses seeking to expand their global footprint.
Bulk Supply Inquiry
Delwis Healthcare is fully capable of supplying Ashru Gel in bulk quantities to meet the demands of pharmaceutical buyers. For inquiries regarding bulk supply, please contact us at info@delwishealthcare.com.
FAQs
What manufacturing standards does Delwis Healthcare follow for Ashru Gel?
Delwis Healthcare adheres to cGMP, WHO GMP, ISO 9001:2015, and ISO 14644-1 standards, ensuring compliance with global pharmaceutical regulations.
Can Ashru Gel be produced in different packaging sizes?
While Ashru Gel is currently available in 10ml packaging, we can customize packaging solutions based on client requirements.
What quality control measures are in place for Ashru Gel?
Every batch undergoes sterility testing, pH analysis, and particulate matter checks, with additional validation through HPLC and UV-Vis spectroscopy.
Is Delwis Healthcare capable of private label manufacturing?
Yes, we offer private label manufacturing services, allowing clients to produce branded products under their specifications.
What regulatory frameworks does Delwis Healthcare comply with?
Our operations comply with FDA, EMA, PIC/S, WHO GMP, and ISO standards, ensuring global market readiness.
Can Delwis Healthcare handle large-scale bulk supply?
Yes, our facility is designed for scalable production, supporting bulk supply requests without compromising quality.
What is the shelf life of Ashru Gel?
The shelf life of Ashru Gel is typically 24 months when stored under recommended conditions, as validated through stability studies.
How does Delwis Healthcare ensure supply chain reliability?
We employ real-time inventory tracking, logistics partnerships, and contingency planning to ensure consistent, timely delivery.
Can Delwis Healthcare assist with export documentation?
Yes, our team supports export documentation, ensuring compliance with destination country regulations and facilitating smooth international shipments.
What is the process for bulk supply inquiries?
For bulk supply inquiries, please contact us at **info@delwishealthcare.com** to discuss your requirements and receive a tailored quotation.
