Montzine Syrup is a carefully formulated combination of Levocetirzine Hydrochloride (2.5mg) and Montelukast (4mg) in a liquid dosage form, optimized for stability, solubility, and compatibility. The active ingredients are dissolved in a pH-balanced aqueous base, ensuring uniform dispersion and consistent potency. Levocetirzine Hydrochloride, a selective histamine H1-receptor antagonist, is formulated to provide antihistaminic activity, while Montelukast, a leukotriene receptor antagonist, targets inflammatory pathways in respiratory conditions. The formulation incorporates excipients such as purified water, glycerin, and citric acid to enhance viscosity, prevent microbial contamination, and maintain pH stability. The syrup’s low viscosity ensures ease of administration, while its clear, homogeneous appearance reflects rigorous quality control during manufacturing. The combination of these two active ingredients in a single syrup formulation simplifies dosing and improves patient compliance, making it a versatile option for pharmaceutical manufacturers seeking to meet market demands for combined therapies.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is designed to meet the highest standards of quality and efficiency. The production of Montzine Syrup is carried out in a state-of-the-art facility equipped with advanced mixing, homogenization, and filling systems to ensure consistent product quality. The facility adheres to current Good Manufacturing Practices (cGMP) and maintains a controlled environment to prevent contamination during sterile processing. High-speed, automated filling lines ensure precise dosing and packaging, while real-time monitoring systems track critical parameters such as temperature, pH, and viscosity. The production process is scalable to accommodate bulk supply demands, with the capability to produce large quantities without compromising quality. Our quality systems include rigorous validation protocols, traceability mechanisms, and continuous process monitoring to ensure compliance with global regulatory standards.
Available Strengths and Packaging
Composition: Levocetirzine Hydrochloride 2.5mg + Montelukast 4mg Syrup
Packaging: 60ml With Outer
Montzine Syrup is available in a single strength formulation, combining 2.5mg of Levocetirzine Hydrochloride and 4mg of Montelukast per 60ml syrup. The packaging includes a 60ml container with an outer carton, ensuring secure storage and transport. This packaging design is optimized for stability during distribution and compliance with pharmaceutical safety standards.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive contract manufacturing and third-party production services tailored to the needs of pharmaceutical buyers. Our facility supports private label manufacturing, enabling clients to produce branded products under their own trademarks. We provide end-to-end solutions, from raw material sourcing to finished product packaging, ensuring full customization and compliance with international standards. Our team of experts collaborates closely with clients to optimize formulations, streamline production timelines, and meet specific regulatory requirements. Whether you require small-scale trial batches or large-volume production, our scalable infrastructure and flexible services position us as a reliable partner for global pharmaceutical markets.
Quality Assurance
Our quality assurance systems are built on a foundation of rigorous testing, analytical validation, and adherence to pharmaceutical standards. Every batch of Montzine Syrup undergoes comprehensive quality control checks, including potency testing, impurity analysis, and stability studies to ensure consistency and safety. Advanced analytical techniques such as High-Performance Liquid Chromatography (HPLC) and Ultraviolet-Visible (UV-Vis) spectroscopy are employed to validate the concentration of active ingredients and detect any deviations. We maintain detailed batch records and implement corrective and preventive action (CAPA) protocols to address any non-conformities. Our commitment to quality is further reinforced by regular audits, internal inspections, and third-party certifications, ensuring that all products meet the stringent requirements of regulatory authorities and end-users.
Regulatory Compliance
Montzine Syrup is manufactured in full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and international ISO standards such as ISO 9001 and ISO 14001. Our facility is certified under these frameworks, ensuring adherence to global quality and environmental management benchmarks. The product is also aligned with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, which facilitate regulatory approval across multiple markets. We maintain detailed documentation for regulatory submissions, including stability data, analytical reports, and manufacturing records, to support compliance with regional and national authorities. This commitment to regulatory excellence enables seamless export and distribution, meeting the demands of pharmaceutical buyers seeking reliable, compliant products.
Global Supply Capability
Our global supply capability is designed to meet the demands of international markets, with a robust distribution network and scalable bulk supply options. We specialize in exporting pharmaceutical products to over 50 countries, leveraging a well-established logistics infrastructure to ensure timely and secure delivery. Our facility is equipped to handle large-volume orders, with the capacity to produce and ship bulk quantities while maintaining product integrity. We prioritize supply chain reliability through strategic partnerships with logistics providers, real-time tracking systems, and contingency planning to mitigate disruptions. Whether you require small or large-scale exports, our team ensures compliance with import regulations, customs documentation, and quality assurance protocols to support seamless global distribution.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in producing high-quality, compliant products like Montzine Syrup. Our facility’s adherence to GMP, WHO, and ISO standards ensures that every batch meets the highest quality benchmarks, reducing the risk of regulatory non-compliance. The scalability of our manufacturing process allows us to accommodate varying production volumes, making us an ideal partner for bulk supply needs. Additionally, our commitment to innovation, customer-centric solutions, and transparent communication strengthens long-term partnerships. By choosing us, you gain access to a reliable supplier with the technical know-how, regulatory expertise, and logistical capabilities to support your global pharmaceutical ambitions.
Bulk Supply Inquiry
For bulk supply inquiries, contact our dedicated team at info@delwishealthcare.com. Our experts are ready to assist with customized solutions, regulatory documentation, and seamless supply chain coordination.
FAQs
What manufacturing standards does Montzine Syrup comply with?
Montzine Syrup is manufactured in compliance with cGMP, WHO guidelines, and ISO 9001/14001 standards, ensuring adherence to global quality and safety benchmarks.
Can Montzine Syrup be produced in different packaging formats?
While the standard packaging is 60ml with an outer carton, we offer customization options for alternative packaging formats upon request.
What is the shelf life of Montzine Syrup?
Montzine Syrup has a shelf life of 24 months when stored under recommended conditions, as validated through stability testing.
Does your facility support contract manufacturing for third-party brands?
Yes, we provide private label manufacturing services, enabling clients to produce branded products under their own trademarks.
How do you ensure the purity of active ingredients in Montzine Syrup?
We source high-purity raw materials and conduct rigorous analytical testing, including HPLC and UV-Vis spectroscopy, to ensure potency and purity.
Can you supply Montzine Syrup in bulk for international markets?
Yes, our facility is equipped for large-volume production, and we support global exports with a reliable supply chain and logistics network.
What quality control measures are in place for batch testing?
Every batch undergoes potency, impurity, and stability testing, with detailed records maintained for traceability and regulatory compliance.
Are your products compliant with regional regulatory frameworks?
Yes, our products are designed to meet the requirements of regulatory authorities in multiple regions, including the FDA, EMA, and PMDA.
How do you handle supply chain disruptions?
We implement contingency planning, real-time tracking, and strategic partnerships to ensure uninterrupted supply and delivery.
Can I request a sample of Montzine Syrup for evaluation?
Yes, we offer sample requests for evaluation purposes. Please contact us at info@delwishealthcare.com for details.
