Hynox-25 is a robust, high-purity formulation of Hydroxyzine hydrochloride, designed for pharmaceutical manufacturers prioritizing consistency and stability. The active ingredient, Hydroxyzine (25mg), is combined with excipients such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide to ensure optimal tablet integrity, disintegration, and dissolution properties. The formulation undergoes rigorous process validation to meet stringent pharmaceutical specifications, including controlled release characteristics and compatibility with excipients. The tablet’s compression process employs advanced die design and lubrication techniques to achieve uniformity in weight, thickness, and hardness. Stability studies confirm the product’s shelf life under accelerated conditions, ensuring compliance with international pharmacopeial standards. This formulation is ideal for applications requiring antihistaminic activity, sedative effects, or anxiolytic properties, with a focus on industrial scalability and regulatory compliance.
Manufacturing Capability
Our manufacturing infrastructure is engineered to deliver high-quality pharmaceutical products at scale, with a dedicated facility equipped for sterile and non-sterile tablet production. The facility features state-of-the-art equipment, including high-speed tablet presses, fluid bed dryers, and automated packaging lines, ensuring precision in dosage form manufacturing. Sterile processing capabilities are maintained through ISO Class 7 cleanrooms, with validated HVAC systems and HEPA filtration to minimize contamination risks. All production processes adhere to current Good Manufacturing Practices (cGMP), with continuous monitoring of critical parameters such as temperature, humidity, and particle count. The facility supports scalable production, enabling seamless transitions from small batch trials to large-scale commercialization. Quality systems are integrated throughout the manufacturing lifecycle, with real-time data acquisition and traceability protocols to ensure compliance with global regulatory standards.
Available Strengths and Packaging
Composition: Hydroxyzine 25mg Tab
Packaging: 10x10 Alu Alu
Hynox-25 is available in a single strength of 25mg, designed for consistent therapeutic dosing. The packaging consists of 10x10 aluminum blister packs, providing a tamper-evident, moisture-resistant solution for retail and institutional distribution. This packaging format ensures product integrity during transportation and storage, while its compact design optimizes shelf space and supply chain efficiency.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers’ needs. Our capabilities include private label manufacturing, where we produce branded dosage forms under a client’s proprietary name, as well as contract manufacturing for generic drug products. We support full-service solutions, from formulation development to packaging and labeling, ensuring alignment with global regulatory requirements. Our team collaborates closely with clients to optimize production timelines, reduce costs, and maintain compliance with quality standards. Whether sourcing from a single supplier or integrating multiple partners, we provide end-to-end support to meet the demands of diverse markets.
Quality Assurance
Our quality assurance framework is built on rigorous testing, analytical validation, and adherence to pharmaceutical quality standards. Every batch undergoes comprehensive quality control checks, including physical testing (e.g., hardness, disintegration time), chemical analysis (e.g., HPLC for active ingredient quantification), and microbiological testing for contamination. Analytical validation ensures method reliability, with documented validation reports for each testing procedure. We maintain detailed batch records and traceability systems to support regulatory audits. All products are tested for stability under accelerated conditions, ensuring shelf-life compliance with ICH and USP guidelines. Our commitment to quality is reinforced by continuous improvement programs and third-party audits to maintain industry-leading standards.
Regulatory Compliance
We ensure full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and ISO 9001:2015 quality management standards. Our manufacturing processes adhere to international regulatory frameworks, including FDA, EMA, and PIC/S guidelines, enabling seamless market access in over 150 countries. All documentation, from raw material specifications to batch records, is prepared in accordance with regulatory requirements, facilitating approval processes for global markets. Our facility holds certifications for GMP compliance, ISO 14001 environmental management, and ISO 45001 occupational health and safety standards, reflecting our dedication to sustainable and safe operations.
Global Supply Capability
With a robust international distribution network, we provide reliable bulk supply to pharmaceutical buyers worldwide. Our export capabilities are supported by strategic partnerships with logistics providers, ensuring timely delivery to destinations across Asia, Europe, Africa, and the Americas. Bulk supply capacity is optimized through automated packaging and warehousing systems, enabling efficient handling of large orders without compromising quality. Our supply chain is designed for resilience, with redundant inventory management and real-time tracking to mitigate disruptions. We prioritize compliance with import regulations and customs documentation, streamlining the export process for distributors and exporters.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in scalable, compliant production. Our focus on quality, regulatory adherence, and global supply chain efficiency ensures reliable delivery of high-standard products. With a proven track record in manufacturing antihistamines and other therapeutic agents, we offer competitive pricing without compromising on compliance or performance. Our ability to adapt to market-specific requirements, coupled with transparent communication and technical support, positions us as a preferred partner for buyers seeking dependable, high-quality pharmaceutical solutions.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com to discuss customization, pricing, and logistics.
FAQs
What manufacturing standards does Hynox-25 comply with?
Hynox-25 is manufactured under cGMP, WHO, and ISO 9001:2015 standards, ensuring compliance with global regulatory frameworks.
Can Hynox-25 be produced in different packaging formats?
While Hynox-25 is currently available in 10x10 Alu Alu blister packs, we offer customization for alternative packaging formats upon request.
What quality control measures are applied during production?
Each batch undergoes rigorous testing, including HPLC analysis, dissolution testing, and microbiological screening, to ensure consistency and safety.
Is Hynox-25 suitable for export to international markets?
Yes, Hynox-25 meets export requirements for over 150 countries, with documentation compliant with FDA, EMA, and PIC/S guidelines.
How does your facility handle scalability for bulk orders?
Our facility is designed for scalable production, with automated systems enabling seamless transitions from small to large batches without compromising quality.
What certifications does your manufacturing facility hold?
Our facility is certified for GMP, ISO 9001:2015, ISO 14001, and ISO 45001, reflecting our commitment to quality, sustainability, and safety.
Can you provide private label manufacturing services for Hynox-25?
Yes, we offer private label manufacturing, allowing clients to brand the product under their own name while maintaining compliance and quality standards.
What is the typical lead time for bulk supply?
Lead times vary based on order size and customization requirements. For specific timelines, contact our sales team for a tailored quotation.
How do you ensure supply chain reliability?
We maintain redundant inventory systems, real-time tracking, and partnerships with logistics providers to ensure uninterrupted supply chain operations.
Are there options for customized formulation adjustments?
Yes, our R&D team collaborates with clients to adjust formulations, excipients, or packaging specifications to meet specific market needs.
