Montzine is a fixed-dose combination tablet designed for pharmaceutical manufacturers, featuring Levocetrizine Hydrochloride 5mg and Montelukast 10mg as active ingredients. The formulation leverages advanced excipient compatibility studies to ensure stability, uniformity, and disintegration properties during manufacturing. Levocetrizine Hydrochloride, a second-generation antihistamine, is combined with Montelukast, a leukotriene receptor antagonist, in a matrix that ensures controlled release and optimal bioavailability. The tablet’s formulation is optimized for tabletting processes, with excipients selected for their compatibility with both active pharmaceutical ingredients (APIs) and their ability to enhance mechanical strength, dissolution rate, and shelf-life. The manufacturing process prioritizes homogeneity, ensuring consistent API content across batches, while maintaining physicochemical stability under varying storage conditions.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is designed to meet the demands of high-volume, high-quality production of combination therapies like Montzine. The facility is equipped with state-of-the-art tabletting machines, high-speed compression systems, and advanced coating technologies to ensure precision in dosage form manufacturing. Sterile processing capabilities are available for critical APIs, with dedicated cleanrooms classified at ISO 7 and ISO 8 standards. All production lines adhere to Good Manufacturing Practices (GMP) and are validated to ensure compliance with regulatory requirements. The facility supports scalable production, enabling seamless transitions from small-scale trials to bulk supply for global markets. Quality systems are integrated throughout the manufacturing process, including real-time monitoring of critical parameters such as tablet hardness, disintegration time, and weight variation.
Available Strengths and Packaging
Montzine is available in a single strength: Levocetrizine Hydrochloride 5mg + Montelukast 10mg. The product is packaged in 10x10 Alu Alu blister packs, ensuring tamper-evidence, moisture resistance, and compliance with pharmaceutical packaging standards. The aluminum blister format provides optimal protection against environmental factors, ensuring product integrity during storage and transportation.
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 capabilities include private label manufacturing, where we produce branded formulations under a client’s proprietary name, as well as contract manufacturing for generic and branded products. We support full end-to-end manufacturing, from API sourcing and formulation development to packaging and labeling. Our team collaborates closely with clients to ensure compliance with regulatory requirements and to deliver cost-effective, high-quality solutions. Whether you require a single product or a multi-product portfolio, our flexible manufacturing infrastructure enables efficient production cycles and rapid time-to-market.
Quality Assurance
Our quality assurance systems are designed to ensure consistency, safety, and compliance in every batch of Montzine. Rigorous quality control measures include in-process testing, final product testing, and stability studies to validate shelf-life and storage conditions. Each batch undergoes analytical validation through high-performance liquid chromatography (HPLC), dissolution testing, and microbial limit testing to confirm API integrity and purity. We maintain detailed batch records and employ advanced data integrity systems to ensure traceability and transparency. Our quality control protocols align with international standards such as ICH, USP, and EP, ensuring products meet the highest regulatory benchmarks.
Regulatory Compliance
Montzine is manufactured in full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and international ISO standards (ISO 9001 and ISO 14001). Our facility is certified by regulatory authorities in multiple jurisdictions, including the FDA, EMA, and MHRA, ensuring adherence to global quality and safety requirements. We maintain documentation for regulatory submissions, including dossiers for marketing authorization and pre-approval inspections. Our compliance framework extends to environmental management, with systems in place to minimize waste and ensure sustainable manufacturing practices.
Global Supply Capability
We provide reliable global supply capabilities, supporting bulk supply for pharmaceutical distributors, exporters, and contract manufacturers. Our international distribution network spans key markets in Asia, Europe, the Americas, and Africa, with logistics partnerships ensuring timely delivery. The 10x10 Alu Alu packaging format is compatible with global distribution channels, offering flexibility for both regional and international buyers. Our bulk supply capacity is scalable, enabling large-volume orders without compromising quality or consistency. We prioritize supply chain reliability through real-time inventory tracking, predictive analytics, and contingency planning to mitigate disruptions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in producing high-quality combination therapies like Montzine. Our commitment to GMP compliance, regulatory adherence, and sustainable manufacturing ensures products meet global market demands. With a proven track record in bulk supply and private label manufacturing, we offer competitive pricing, rapid turnaround times, and customized solutions tailored to your business needs. Our transparent quality systems and dedicated customer support further enhance the value proposition for partners seeking reliable, scalable production.
Bulk Supply Inquiry
For bulk supply inquiries, contact our team at info@delwishealthcare.com to discuss your requirements and explore partnership opportunities.
FAQs
What is the composition of Montzine?
Montzine contains Levocetrizine Hydrochloride 5mg and Montelukast 10mg in a single tablet formulation, designed for combination therapy.
Can Montzine be manufactured in different strengths?
Currently, Montzine is available in a single strength: Levocetrizine Hydrochloride 5mg + Montelukast 10mg. Custom strengths can be developed based on regulatory and market requirements.
What packaging options are available for Montzine?
Montzine is packaged in 10x10 Alu Alu blister packs, ensuring protection against moisture and tamper-evidence.
Does your facility support sterile manufacturing processes?
Yes, our facility is equipped with ISO 7 and ISO 8 cleanrooms for sterile processing, ensuring compliance with GMP standards.
Can you provide private label manufacturing services for Montzine?
Yes, we offer private label manufacturing, enabling clients to produce branded formulations under their own brand name.
What quality control measures are in place for Montzine?
Montzine undergoes rigorous testing, including HPLC, dissolution testing, and microbial limit testing, to ensure compliance with ICH, USP, and EP standards.
Are you compliant with global regulatory frameworks?
Yes, our manufacturing processes adhere to GMP, WHO guidelines, and ISO standards, ensuring global marketability.
What is your bulk supply capacity for Montzine?
We offer scalable bulk supply capabilities, with production volumes tailored to meet the needs of distributors and exporters.
How do you ensure supply chain reliability?
Our supply chain is supported by real-time inventory tracking, logistics partnerships, and contingency planning to ensure timely delivery.
Can you assist with regulatory submissions for Montzine?
Yes, we provide documentation and support for regulatory submissions, including dossiers for marketing authorization and pre-approval inspections.
