Freshiza is a sterile, isotonic aqueous solution of chlorhexidine gluconate at 0.20% w/v, formulated for use in pharmaceutical settings requiring broad-spectrum antimicrobial activity. The active ingredient, chlorhexidine gluconate, is a cationic bisbiguanide compound known for its substantivity and prolonged antimicrobial effect. The formulation utilizes purified water as the solvent, ensuring compatibility with pharmaceutical-grade materials and minimizing the risk of chemical interactions. The solution is pH-adjusted to maintain stability and prevent degradation during storage. The 0.20% concentration is optimized for efficacy while minimizing potential irritation, making it suitable for industrial applications such as surface disinfection, equipment sterilization, and pharmaceutical process validation. The formulation is designed to meet stringent pharmaceutical standards, with a focus on solubility, shelf-life, and consistency across batches.
Manufacturing Capability
Freshiza is manufactured using state-of-the-art pharmaceutical infrastructure compliant with current Good Manufacturing Practices (cGMP). Our facility is equipped with aseptic filling lines, high-efficiency particulate air (HEPA) filtration systems, and temperature-controlled storage areas to ensure sterility and product integrity. The manufacturing process adheres to ISO 9001 quality management standards, with dedicated cleanrooms (ISO Class 7 and Class 5) for critical steps such as formulation and packaging. The 100ml pump bottle packaging is produced using automated filling and capping systems to ensure precision and contamination control. Our production capacity is scalable to meet bulk supply demands, with the ability to produce thousands of units per day while maintaining consistency in quality and compliance. The facility is also equipped with real-time monitoring systems for critical parameters such as pH, conductivity, and microbial load, ensuring adherence to pharmaceutical specifications.
Available Strengths and Packaging
Composition: Chlorhexidine Gluconate Soln. 0.20% w/v
Packaging: 100ml With Pump Bottle
Freshiza is available exclusively in a 0.20% w/v strength, optimized for industrial applications requiring precise antimicrobial potency. The 100ml pump bottle design ensures convenient handling and accurate dispensing, with a durable, tamper-evident closure to maintain sterility. The packaging is designed for compliance with pharmaceutical regulations, including requirements for labeling, storage conditions, and batch traceability.
Contract Manufacturing / Third Party Manufacturing
As a trusted pharmaceutical manufacturer, we offer comprehensive contract manufacturing, private label, and third-party production services tailored to meet the needs of global buyers. Our facility is equipped to handle custom formulations, including variations in concentration, solvent type, and packaging specifications. We support private label manufacturing, enabling clients to brand products under their own trademarks while maintaining compliance with regulatory standards. Our contract manufacturing capabilities include full-process validation, from raw material sourcing to final packaging, ensuring consistency and quality across all production runs. We also provide documentation for regulatory submissions, including batch records, stability data, and analytical reports, to facilitate market entry in diverse regions.
Quality Assurance
Our quality assurance systems are designed to ensure the consistency, purity, and safety of Freshiza at every stage of production. Each batch undergoes rigorous testing, including microbial limit testing, sterility checks, and pH measurement to confirm compliance with pharmaceutical specifications. Analytical validation is performed using high-performance liquid chromatography (HPLC) to quantify chlorhexidine gluconate content and detect impurities. The product is also tested for physical properties such as clarity, color, and particulate matter to ensure visual and functional integrity. All quality control measures are documented and traceable, with continuous monitoring of critical process parameters to prevent deviations. Our facility maintains a robust quality management system (QMS) aligned with ISO 9001 and ICH guidelines, ensuring adherence to global pharmaceutical standards.
Regulatory Compliance
Freshiza is manufactured in full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and international regulatory frameworks. Our facility holds certifications for ISO 9001, ISO 14001 (environmental management), and ISO 45001 (occupational health and safety), demonstrating a commitment to quality, sustainability, and worker safety. The product meets the requirements of the FDA, EMA, and WHO for pharmaceutical-grade disinfectants, with documentation prepared for regulatory submissions in target markets. All manufacturing processes are validated to ensure reproducibility and compliance with pharmacopeial standards, including USP, EP, and BP. Our quality assurance team maintains detailed records for audits and inspections, ensuring transparency and regulatory readiness for global distribution.
Global Supply Capability
As a leading exporter of pharmaceutical products, we offer reliable bulk supply capabilities with a well-established international distribution network. Our logistics partners enable seamless export to over 150 countries, with customized solutions for regional regulatory requirements and shipping conditions. The 100ml pump bottle packaging is designed for efficient bulk storage and transportation, with options for temperature-controlled shipping to preserve product integrity. Our supply chain is optimized for scalability, allowing us to meet large-volume orders while maintaining strict adherence to delivery timelines. We also provide inventory management support and long-term supply agreements to ensure uninterrupted availability for pharmaceutical buyers.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in producing high-quality, compliant disinfectant solutions. Our facility’s adherence to GMP, ISO standards, and global regulatory frameworks ensures that Freshiza meets the demands of diverse markets. The ability to scale production and customize packaging options provides flexibility for clients with unique requirements. Our commitment to quality assurance and regulatory compliance reduces the risk of delays in market entry, while our global supply network ensures timely delivery. As a trusted manufacturer and supplier, we offer competitive pricing, transparent documentation, and dedicated support to build long-term partnerships with B2B clients.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our team at info@delwishealthcare.com. We are committed to providing reliable, high-quality pharmaceutical products to meet the needs of global buyers.
FAQs
What manufacturing standards does Freshiza comply with?
Freshiza is manufactured in compliance with cGMP, ISO 9001, and WHO guidelines, ensuring adherence to global pharmaceutical quality standards.
Can Freshiza be customized for specific packaging requirements?
Yes, we offer flexible packaging options, including the 100ml pump bottle, and can accommodate custom design specifications for bulk supply.
What is the shelf life of Freshiza?
Freshiza has a shelf life of 24 months when stored under recommended conditions (2–8°C), as confirmed by stability testing.
Is Freshiza suitable for export to international markets?
Yes, Freshiza meets the regulatory requirements of the FDA, EMA, and WHO, making it suitable for export to over 150 countries.
What quality control measures are in place for Freshiza?
Each batch undergoes microbial testing, pH analysis, and HPLC validation to ensure purity, sterility, and potency.
Can Freshiza be produced in different concentrations?
While Freshiza is currently available at 0.20% w/v, we can produce customized concentrations based on client specifications.
What is the minimum order quantity for bulk supply?
We offer flexible bulk supply options, with minimum order quantities tailored to the scale of your operation.
How does your supply chain ensure reliability?
Our logistics network includes temperature-controlled shipping and inventory management systems to ensure timely, consistent delivery.
Do you provide documentation for regulatory submissions?
Yes, we supply complete documentation, including batch records, stability data, and analytical reports, to support regulatory approvals.
Can I request a sample of Freshiza before placing an order?
Yes, we welcome sample requests to demonstrate product quality and compliance. Contact our team for details.
