Domox is a sterile, isotonic eye drop solution formulated with moxifloxacine hydrochloride, equivalent to 0.5% w/v moxifloxacine, dissolved in a pH-balanced aqueous medium. The formulation is designed to ensure stability, sterility, and compatibility with ocular tissues, making it suitable for pharmaceutical manufacturing. The active ingredient, moxifloxacine hydrochloride, is a fluoroquinolone antibiotic with broad-spectrum antimicrobial activity, selected for its efficacy against common ocular pathogens. The formulation process involves precise dissolution of the active pharmaceutical ingredient (API) in purified water, followed by filtration and filling into sterile vials. The solution is buffered to maintain pH compatibility with the ocular surface, ensuring patient comfort and minimizing irritation. The formulation’s physicochemical properties, including osmolarity and viscosity, are optimized to enhance ocular retention and therapeutic effectiveness. Manufacturing adheres to pharmaceutical-grade standards, ensuring uniformity in active ingredient concentration, clarity, and absence of particulate matter.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities designed to produce high-quality pharmaceutical products like Domox. The facility includes a dedicated sterile processing area with Class 100,000 cleanroom environments, ensuring contamination-free production of eye drops. Advanced aseptic filling lines, equipped with automated sensors and real-time monitoring systems, guarantee precise dosing and sterility. All manufacturing processes comply with current Good Manufacturing Practices (cGMP) and adhere to international standards for pharmaceutical production. The facility is certified under ISO 9001:2015 and ISO 14001:2015 for quality management and environmental responsibility. Production scalability is achieved through modular manufacturing units, enabling seamless transitions from small-scale trials to large-volume commercial batches. Rigorous quality control systems, including in-process testing and final product validation, ensure consistency and compliance with specifications.
Available Strengths and Packaging
Composition: Moxifloxacine Hydrochloride I.P. Eq. to Moxifloxacine 0.5% w/v Eye drops.
Packaging: 5ml
Domox is available in a single strength of 0.5% w/v moxifloxacine, formulated to meet therapeutic requirements for ocular infections. The 5ml packaging is designed for ease of use, ensuring optimal storage and handling during distribution.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive third-party manufacturing services, including private label production and contract manufacturing for pharmaceutical buyers. Our capabilities extend to full-scale production of eye drops, from API sourcing to final packaging, ensuring end-to-end quality control. We support customization of packaging, labeling, and dosage forms to meet specific client requirements. Our contract manufacturing division adheres to cGMP standards and is equipped to handle both small and large-volume orders, providing flexibility for global pharmaceutical buyers. Partners benefit from our expertise in regulatory compliance, supply chain management, and cost-effective production solutions.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and adherence to pharmaceutical quality standards. Each batch of Domox undergoes comprehensive testing for pH, osmolarity, microbial contamination, and active ingredient content using validated methods such as HPLC and microbial limit tests. Analytical validation ensures the accuracy, precision, and reproducibility of test results, meeting USP, EP, and BP standards. Quality control systems are integrated throughout the manufacturing process, with in-process checks at critical stages to prevent deviations. Final product testing includes sterility testing, particulate matter analysis, and visual inspection to ensure compliance with regulatory requirements.
Regulatory Compliance
Domox is manufactured in full compliance with GMP guidelines, WHO prequalification criteria, and ISO 9001:2015 standards. Our facility is registered with regulatory authorities in multiple jurisdictions, including the FDA, EMA, and PIC/S, ensuring global market access. The product meets specifications outlined in pharmacopoeias such as USP, EP, and BP, and is compliant with ICH guidelines for quality, safety, and efficacy. All documentation, including batch records, stability data, and regulatory submissions, is maintained to meet international regulatory expectations.
Global Supply Capability
We have a robust global supply chain infrastructure, enabling reliable export and distribution of Domox to markets worldwide. Our international distribution network includes partnerships with logistics providers specializing in pharmaceuticals, ensuring timely and secure delivery. Bulk supply capacity is supported by scalable production capabilities, with the ability to meet large-volume orders without compromising quality. Supply chain reliability is ensured through redundant systems, real-time tracking, and adherence to cold chain requirements for temperature-sensitive products.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our commitment to quality, compliance, and scalability. Our expertise in sterile pharmaceutical manufacturing, combined with global regulatory compliance, ensures seamless market entry. We offer competitive pricing, flexible production solutions, and dedicated support for clients navigating complex regulatory landscapes. Our ability to deliver bulk supply with consistent quality and on-time delivery makes us a preferred partner for businesses seeking reliable, high-standard pharmaceutical products.
Bulk Supply Inquiry
We offer bulk supply capabilities for Domox, tailored to meet the needs of pharmaceutical buyers. For inquiries regarding large-volume orders, please contact:
info@delwishealthcare.com
FAQs
What manufacturing standards does Domox comply with?
Domox is manufactured in compliance with cGMP, ISO 9001:2015, and WHO prequalification standards, ensuring adherence to global regulatory requirements.
Can Domox be produced in different packaging formats?
Yes, we offer customization options for packaging, including 5ml single-dose vials, to meet specific client requirements.
What quality control measures are in place for Domox?
Each batch undergoes rigorous testing for pH, osmolarity, microbial contamination, and active ingredient content using validated analytical methods.
Is Domox suitable for export to international markets?
Yes, Domox is manufactured to meet the regulatory standards of the FDA, EMA, and PIC/S, enabling seamless export to global markets.
What is the shelf life of Domox?
Domox has a shelf life of 24 months when stored under recommended conditions, as confirmed by stability studies.
Can you provide private label manufacturing services?
Yes, we offer private label manufacturing, allowing clients to brand the product under their own label while maintaining quality and compliance.
What is the minimum order quantity for bulk supply?
We accommodate both small and large orders, with minimum quantities tailored to client specifications and production capacity.
How do you ensure supply chain reliability?
Our supply chain is supported by real-time tracking, redundant logistics systems, and partnerships with certified logistics providers to ensure timely delivery.
Are there certifications for your manufacturing facility?
Our facility is certified under ISO 9001:2015 and ISO 14001:2015, with ongoing compliance audits to maintain standards.
Can you assist with regulatory documentation for Domox?
Yes, we provide complete regulatory documentation, including batch records, stability data, and compliance certificates, to support global market entry.
