Hynox Syrup is a meticulously formulated pharmaceutical product containing Hydroxyzine Hydrochloride at a concentration of 10mg per 100ml. The formulation is designed to ensure optimal solubility, stability, and uniformity, meeting stringent pharmaceutical standards for industrial use. Hydroxyzine Hydrochloride, a substituted piperidine derivative, is synthesized through a controlled chemical process to achieve high purity and consistent potency. The syrup’s formulation incorporates excipients such as purified water, preservatives, and emulsifying agents to enhance shelf life and ensure compatibility with manufacturing processes. The product’s pH is carefully balanced to prevent degradation of the API and maintain stability under varying storage conditions. The formulation is designed for compatibility with large-scale production, ensuring homogeneity and batch consistency. The syrup’s viscous texture and clear appearance are achieved through advanced mixing and homogenization techniques, ensuring ease of handling and accurate dosing during manufacturing.
Manufacturing Capability
Our manufacturing infrastructure is equipped to produce Hynox Syrup at scale while maintaining compliance with global pharmaceutical standards. The facility features state-of-the-art equipment for API synthesis, formulation, and packaging, including high-precision blending systems, autoclaved storage tanks, and automated filling lines. Sterile processing capabilities are ensured through ISO Class 7 cleanroom environments, with dedicated lines for aseptic filling and sealing. The production process adheres to Good Manufacturing Practice (GMP) guidelines, with rigorous controls over temperature, humidity, and contamination risks. Scalability is a core strength, enabling seamless transitions from pilot batches to commercial volumes without compromising quality. The facility’s quality systems include real-time monitoring, validated process controls, and comprehensive documentation to support regulatory audits. Additionally, the infrastructure supports customization for private-label manufacturing and contract production, allowing flexibility for diverse B2B客户需求.
Available Strengths and Packaging
Composition: Hydroxyzine Hydrochloride 10mg
Packaging: 100ml
Hynox Syrup is available in a single strength of 10mg per 100ml, ensuring consistency for bulk supply and industrial applications. The 100ml packaging is designed for efficient storage, transportation, and dispensing, with a focus on minimizing product degradation and maximizing usability in pharmaceutical manufacturing workflows.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to pharmaceutical buyers. Our capabilities include private-label manufacturing, where we produce Hynox Syrup under a client’s brand name, ensuring full customization of packaging, labeling, and documentation. For contract manufacturing, we provide end-to-end solutions, from API sourcing to final packaging, with strict adherence to client specifications and regulatory requirements. Our team collaborates closely with buyers to optimize production timelines, reduce costs, and ensure compliance with international standards. Whether you require a single batch or large-scale production, our flexible manufacturing framework supports diverse B2B needs, positioning us as a reliable partner for global pharmaceutical suppliers.
Quality Assurance
Quality assurance is central to our production process, with a multi-tiered system ensuring the highest standards of purity, potency, and consistency. Every batch of Hynox Syrup undergoes rigorous testing, including physicochemical analysis, microbial testing, and stability studies to confirm compliance with ICH, USP, and EP guidelines. Analytical validation methods such as HPLC and UV spectrophotometry are employed to verify API content and detect impurities. Batch testing is conducted at multiple stages, from raw material inspection to finished product release, with detailed records maintained for traceability. Our quality control systems are integrated with advanced data management tools, enabling real-time monitoring and continuous improvement. Compliance with ISO 9001 and GMP standards ensures that all products meet the stringent requirements of global pharmaceutical markets.
Regulatory Compliance
Our production of Hynox Syrup is fully aligned with international regulatory frameworks, including GMP, WHO guidelines, and ISO standards. The facility is certified under GMP guidelines for both API and finished dosage forms, ensuring adherence to quality, safety, and efficacy protocols. Compliance with WHO Prequalification criteria enables seamless export to developing markets, while ISO 17025 accreditation validates our analytical testing capabilities. Additionally, our processes meet the requirements of the FDA, EMA, and other regulatory bodies, facilitating global market access. All documentation, including batch records, stability data, and certificates of analysis, is prepared in compliance with regulatory expectations, supporting audits and registrations for pharmaceutical buyers.
Global Supply Capability
We provide robust global supply capabilities, with a well-established international distribution network and bulk supply capacity to meet large-scale demands. Our export infrastructure supports seamless delivery to over 50 countries, leveraging reliable logistics partners and compliance with international shipping regulations. Bulk supply is optimized through scalable production and efficient packaging solutions, ensuring cost-effective delivery for pharmaceutical manufacturers and exporters. The supply chain is designed for reliability, with contingency planning to mitigate disruptions and ensure timely delivery. Our commitment to quality and compliance ensures that Hynox Syrup meets the demands of diverse markets, from developed regions to emerging economies.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in producing high-quality, compliant APIs and finished products. Our competitive advantages include ISO-certified manufacturing, full regulatory compliance, and a proven track record in bulk supply. We offer tailored solutions to meet specific client requirements, from formulation customization to packaging specifications. Our commitment to innovation, combined with rigorous quality control, ensures that Hynox Syrup remains a trusted choice for global buyers. By partnering with us, you gain access to a reliable, scalable, and compliant supply chain that supports your business growth and market expansion.
Bulk Supply Inquiry
For bulk supply inquiries, please contact our sales team at info@delwishealthcare.com. Our team is dedicated to providing tailored solutions for pharmaceutical manufacturers, exporters, and contract partners seeking high-quality, compliant products for global markets.
FAQs
What certifications does your facility hold for manufacturing Hynox Syrup?
Our facility is certified under GMP, ISO 9001, and ISO 17025, ensuring compliance with international pharmaceutical standards.
Can you customize packaging for Hynox Syrup for private-label manufacturing?
Yes, we offer private-label manufacturing services, allowing customization of packaging, labeling, and documentation to meet client specifications.
What is the minimum order quantity for bulk supply of Hynox Syrup?
We accommodate bulk supply requests starting from 1,000 liters, with flexible production schedules to meet large-scale demands.
Does your manufacturing process ensure sterility for Hynox Syrup?
Yes, our aseptic filling lines and ISO Class 7 cleanroom environments ensure sterility and contamination-free production.
What regulatory standards does Hynox Syrup comply with?
Hynox Syrup complies with GMP, WHO guidelines, ISO standards, and regulatory requirements of the FDA, EMA, and other global authorities.
Can you provide documentation for export compliance?
Yes, we supply complete documentation, including certificates of analysis, batch records, and regulatory compliance reports for seamless export.
How do you ensure the stability of Hynox Syrup during storage?
The formulation is designed with preservatives and pH stabilization to ensure long-term stability under standard storage conditions.
What is your lead time for contract manufacturing orders?
Lead times vary based on order size, but we offer expedited production timelines for urgent bulk supply requests.
Can you produce Hynox Syrup in different strengths?
Currently, Hynox Syrup is available in a single strength of 10mg per 100ml, though we can explore customization based on client needs.
How do you handle quality control during the manufacturing process?
We implement real-time monitoring, batch testing, and analytical validation to ensure consistent quality throughout production.
