Hynox -10 is a hydroxyzine 10mg tablet formulated using advanced pharmaceutical techniques to ensure stability, uniformity, and consistent performance. The active ingredient, hydroxyzine, is combined with excipients such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide to optimize tablet integrity and disintegration. The formulation is designed for high potency, with precise dosing to meet therapeutic requirements. Manufacturing processes focus on maintaining chemical stability, ensuring uniform active ingredient distribution, and achieving optimal tablet hardness and disintegration time. The product is suitable for both domestic and international markets, with a formulation tailored for long-term storage and efficient distribution.
Manufacturing Capability
Our manufacturing infrastructure is equipped with state-of-the-art facilities to produce Hynox -10 at scale while maintaining strict quality control. The facility adheres to current Good Manufacturing Practices (cGMP) and includes advanced tablet compression lines, coating systems, and packaging units. Sterile processing capabilities are available for critical stages, ensuring contamination-free production. The facility is designed for scalability, allowing seamless transitions from small batches to large-scale production without compromising quality. Quality systems include real-time monitoring, automated data collection, and rigorous validation protocols to ensure compliance with pharmaceutical standards.
Available Strengths and Packaging
Composition: Hydroxyzine 10mg Tab
Packaging: 10x10 Alu Alu
Hynox -10 is available in a 10mg strength, formulated for consistent dosing. The packaging consists of 10x10 aluminum blister packs, providing secure, moisture-resistant storage and protection against environmental factors. This packaging format is ideal for retail and wholesale distribution, ensuring product integrity during transportation and storage.
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. Our capabilities include custom formulation development, packaging customization, and compliance with regional regulatory requirements. We support clients in bringing products to market by leveraging our expertise in scalable production, regulatory documentation, and quality assurance. Whether you require a private label solution or a turnkey manufacturing partnership, we provide flexible, cost-effective options to meet diverse market demands.
Quality Assurance
Our quality assurance systems are designed to ensure consistency, safety, and compliance throughout the production lifecycle. Each batch undergoes rigorous testing, including high-performance liquid chromatography (HPLC) for active ingredient quantification, dissolution testing, and physical property analysis. Analytical validation processes confirm the stability, potency, and purity of Hynox -10. We maintain detailed documentation and traceability systems to support regulatory audits and ensure adherence to international quality standards.
Regulatory Compliance
Hynox -10 is manufactured in full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and ISO 9001 standards. Our facility is certified to meet global regulatory requirements, including FDA, EMA, and PIC/S guidelines. We ensure all documentation, including batch records, stability data, and compliance reports, meets the expectations of international pharmaceutical regulators. This compliance framework enables seamless export and market entry in diverse regions.
Global Supply Capability
We provide robust global supply capabilities, including export-ready products, international distribution networks, and bulk supply options. Our logistics partners ensure timely delivery to over 50 countries, with reliable supply chain management to meet urgent and long-term demand. Bulk supply capacity is supported by scalable production lines and efficient inventory management systems. We prioritize supply chain reliability, offering customized solutions to address market-specific requirements and ensure uninterrupted availability.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners choose us for our expertise in high-quality production, regulatory compliance, and global supply capabilities. Our commitment to cGMP standards, advanced manufacturing technology, and rigorous quality control ensures consistent product performance. We offer competitive pricing, flexible manufacturing options, and dedicated support to help clients succeed in competitive markets. With a proven track record of meeting international regulatory demands, we are a reliable partner for bulk supply and strategic sourcing.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com.
FAQs
What certifications does your facility hold for manufacturing Hynox -10?
Our facility is certified under cGMP, ISO 9001, and WHO guidelines, ensuring compliance with global pharmaceutical standards.
Can Hynox -10 be produced in different packaging formats?
While Hynox -10 is currently available in 10x10 Alu Alu packaging, we offer customization options for alternative packaging formats upon request.
What is the shelf life of Hynox -10?
Hynox -10 has a shelf life of 24 months when stored under recommended conditions, as confirmed by stability testing.
Do you provide contract manufacturing services for Hynox -10?
Yes, we offer contract manufacturing services, including private label and third-party production, tailored to your specifications.
What quality control tests are performed on Hynox -10?
Each batch undergoes HPLC analysis, dissolution testing, and physical property checks to ensure potency, purity, and consistency.
Can Hynox -10 be exported to international markets?
Yes, our compliance with FDA, EMA, and PIC/S guidelines enables seamless export to over 50 countries.
What is the minimum order quantity for bulk supply?
We accommodate bulk orders starting from 10,000 units, with flexible options for larger quantities.
How do you ensure supply chain reliability for Hynox -10?
Our logistics network and inventory management systems ensure timely delivery, with contingency plans for urgent orders.
Can you provide documentation for regulatory submissions?
Yes, we supply complete documentation, including batch records, stability data, and compliance reports for regulatory submissions.
What is the production capacity for Hynox -10?
Our facility is capable of producing up to 5 million tablets per day, with scalability to meet large-scale demand.
