Montzine Kid is a fixed-dose combination tablet designed for pharmaceutical manufacturing, combining Levocetrizine Hydrochloride (2.5mg) and Montelukast (4mg) in a stable, uniform formulation. The active ingredients are carefully selected for their pharmacological synergy, with Levocetrizine acting as an antihistamine and Montelukast as a leukotriene receptor antagonist, both contributing to respiratory management. The formulation employs excipients such as microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide to ensure optimal tablet integrity, disintegration, and dissolution. The manufacturing process prioritizes compatibility between active pharmaceutical ingredients (APIs) and excipients, ensuring uniformity in content, hardness, and weight variation. The tablet’s physicochemical properties, including pH neutrality and moisture resistance, are optimized for stability during storage and transportation. The formulation adheres to stringent pharmaceutical standards, ensuring consistency for bulk supply and scalability in large-scale production.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is equipped with state-of-the-art facilities compliant with current Good Manufacturing Practices (cGMP) and ISO 9001:2015 standards. The facility includes advanced tablet compression lines, high-speed coating systems, and automated packaging units to ensure precision in production. Sterile processing capabilities are available for critical components, supported by Class 10,000 cleanroom environments and validated aseptic techniques. The manufacturing process employs validated analytical methods for in-process testing, including dissolution profiling, particle size analysis, and content uniformity checks. Production scalability is achieved through modular design, enabling seamless transitions from small-scale trials to bulk supply. Quality systems are integrated throughout the manufacturing lifecycle, with real-time monitoring and data integrity protocols to ensure compliance with regulatory requirements.
Available Strengths and Packaging
Montzine Kid is available in a single strength: Levocetrizine Hydrochloride 2.5mg + Montelukast 4mg. The product is packaged in 10x10 Alu Alu blister packs, ensuring tamper-evident sealing, moisture protection, and secure storage. The packaging design meets international pharmaceutical standards for durability and compliance with transportation regulations.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer comprehensive third-party manufacturing services, including private label production and contract manufacturing for pharmaceutical buyers. Our capabilities extend to custom formulation development, API sourcing, and full-scale production of finished dosage forms. We support clients in meeting regional and global regulatory requirements, with flexibility to adapt to specific packaging preferences, labeling specifications, and dosage form requirements. Our team of pharmacists, chemists, and quality assurance specialists ensures seamless collaboration, from pre-formulation studies to commercial-scale manufacturing.
Quality Assurance
Our quality assurance framework is built on rigorous control systems, including in-process testing, batch-specific validation, and analytical verification of critical quality attributes. Each batch undergoes comprehensive testing for dissolution, disintegration, weight variation, and content uniformity using validated high-performance liquid chromatography (HPLC) and UV spectrophotometry methods. Microbial testing, including sterility checks and endotoxin analysis, ensures product safety. Quality control is further supported by traceability systems, electronic batch records, and third-party audits to maintain compliance with pharmaceutical standards such as USP, EP, and BP.
Regulatory Compliance
Montzine Kid is manufactured in full compliance with Good Manufacturing Practices (GMP), World Health Organization (WHO) guidelines, and international ISO standards (ISO 9001, ISO 14001). The product adheres to regulatory frameworks in key markets, including the FDA, EMA, and PIC/S, ensuring eligibility for global supply. Documentation includes validated process validation protocols, stability data, and regulatory dossiers for market authorization. Our facility maintains certifications for cGMP, ISO 17025 for testing laboratories, and compliance with the ICH Q7 guidelines for API manufacturing.
Global Supply Capability
We provide robust global supply capabilities, including export-ready packaging, international distribution networks, and bulk supply options for pharmaceutical buyers. Our logistics partnerships enable efficient delivery to over 150 countries, with compliance to international shipping regulations and temperature-controlled transportation for sensitive products. Bulk supply capacity is supported by scalable production lines, ensuring timely fulfillment of large orders without compromising quality. Supply chain reliability is guaranteed through redundant inventory management, real-time tracking systems, and contingency planning for disruptions.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in scalable production, regulatory compliance, and end-to-end supply chain solutions. Our commitment to quality, combined with flexible manufacturing options and global distribution capabilities, positions us as a reliable partner for bulk supply and market entry. We prioritize transparency, innovation, and adherence to international standards, ensuring seamless integration into clients’ business operations.
Bulk Supply Inquiry
We offer competitive bulk supply options for Montzine Kid. For inquiries, please contact our team at info@delwishealthcare.com to discuss volume discounts, packaging specifications, and supply timelines.
FAQs
What certifications does your facility hold for manufacturing Montzine Kid?
Our facility is certified under cGMP, ISO 9001:2015, and ISO 14001, ensuring compliance with global pharmaceutical standards.
Can you customize packaging for Montzine Kid?
Yes, we offer flexible packaging solutions, including 10x10 Alu Alu blister packs, to meet regional and client-specific requirements.
What regulatory approvals are required for exporting Montzine Kid?
We ensure compliance with FDA, EMA, PIC/S, and WHO guidelines, providing all necessary documentation for international markets.
How do you ensure the stability of Montzine Kid during storage?
The formulation is designed with pH-neutral excipients and moisture-resistant packaging to maintain stability under standard storage conditions.
What is the minimum order quantity for bulk supply?
We accommodate bulk orders starting from 10,000 units, with flexible scaling options for large-scale distribution.
Can you provide analytical data for quality validation?
Yes, we supply validated HPLC, dissolution, and microbial testing reports to support quality assurance and regulatory submissions.
What is your lead time for manufacturing orders?
Lead times vary based on order size, but we typically deliver within 4–6 weeks for standard bulk supply requests.
Do you offer contract manufacturing for similar products?
Yes, we provide end-to-end contract manufacturing services, including formulation development and commercial production.
How do you ensure supply chain reliability?
Our logistics network includes temperature-controlled shipping, real-time tracking, and contingency planning to guarantee on-time delivery.
Can you assist with market registration for Montzine Kid?
We support clients with regulatory documentation and compliance strategies for market authorization in target regions.
