Montzine Plus is a fixed-dose combination tablet formulated to deliver synergistic therapeutic effects through its three active ingredients. Levocetrizine Hydrochloride (5mg) is a second-generation antihistamine with high selectivity for H1-receptors, offering antiallergic activity with minimal sedation. Montelukast (10mg) is a leukotriene receptor antagonist that modulates inflammatory responses in respiratory conditions. Ambroxol HCL (75mg) functions as an expectorant and mucolytic agent, enhancing bronchial clearance. The formulation employs a direct compression technique to ensure uniform drug distribution, with excipients selected for compatibility, stability, and disintegration properties. The tablet’s design balances physicochemical stability, dissolution rates, and bioavailability, making it suitable for long-term storage and consistent therapeutic performance. The combination addresses multifactorial respiratory and allergic conditions, aligning with the demand for integrated therapeutic solutions in pharmaceutical manufacturing.
Manufacturing Capability
Our manufacturing infrastructure is equipped to produce Montzine Plus with precision and scalability, adhering to stringent GMP standards. The facility features state-of-the-art tablet compression lines, including high-speed rotary tablet presses capable of handling complex multi-layered formulations. Sterile processing capabilities are maintained through ISO Class 7 cleanrooms, ensuring contamination-free production. Quality systems are integrated throughout the manufacturing process, from raw material handling to packaging, with real-time monitoring of critical parameters such as tablet hardness, disintegration time, and content uniformity. The production line supports batch sizes ranging from small-scale trials to large-volume commercial runs, enabling rapid scaling for global supply. Advanced analytical tools, including HPLC and dissolution testing equipment, ensure consistent product quality. Our facility also complies with cGMP guidelines for active pharmaceutical ingredients (APIs) and excipients, ensuring adherence to international regulatory frameworks.
Available Strengths and Packaging
Montzine Plus is available in a single strength: Levocetrizine Hydrochloride 5mg + Montelukast 10mg + Ambroxol HCL 75mg. The product is packaged in 10x10 Alu Alu blister packs, designed for optimal protection against moisture, light, and physical damage. The aluminum blister format ensures extended shelf life and facilitates efficient storage and distribution, making it ideal for both domestic and international markets.
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 private label manufacturing capabilities allow clients to brand Montzine Plus under their own trademarks, with full customization of packaging, labeling, and dosage forms. We support both OEM and ODM solutions, enabling partners to meet specific regulatory and market requirements. Our team collaborates closely with clients to ensure compliance with local and international standards, including FDA, EMA, and WHO guidelines. Whether you require bulk production, small-scale trials, or specialized formulation adjustments, our flexible manufacturing framework ensures timely delivery without compromising quality.
Quality Assurance
Quality assurance for Montzine Plus is built on rigorous control systems, analytical validation, and compliance with pharmacopeial standards. Each batch undergoes extensive testing, including HPLC for active ingredient quantification, dissolution testing to confirm bioavailability, and microbial limit checks to ensure sterility. In-process controls monitor critical parameters such as tablet weight, thickness, and hardness, while final product testing verifies potency, purity, and stability. Our quality systems are aligned with ICH guidelines and include traceability mechanisms for raw materials and finished products. All documentation adheres to GMP requirements, ensuring transparency and audit readiness for global markets.
Regulatory Compliance
Montzine Plus is manufactured in full compliance with GMP, WHO guidelines, and ISO 9001:2015 quality management standards. Our facility holds certifications for cGMP for APIs and finished dosage forms, with regular audits by regulatory authorities to maintain compliance. The product meets the requirements of the FDA, EMA, and PIC/S for international export, ensuring acceptance in over 150 markets. Documentation includes batch records, stability data, and analytical reports, supporting regulatory submissions and market access. We also adhere to the ICH Q7 guidelines for API manufacturing and the ICH Q8 framework for quality by design (QbD) principles.
Global Supply Capability
Our global supply chain is designed to meet the demands of pharmaceutical distributors, exporters, and bulk buyers. With a robust international distribution network, we facilitate seamless exports to Asia, Africa, Latin America, and Europe, supported by partnerships with logistics providers specializing in pharmaceutical freight. Bulk supply capacity is scalable, with the ability to produce and ship large quantities while maintaining consistent quality. Our supply chain incorporates real-time tracking systems and contingency planning to ensure reliability, even during disruptions. We also offer customized logistics solutions, including temperature-controlled shipping for sensitive formulations, to meet the specific needs of global clients.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners select us for our expertise in multi-ingredient formulation, compliance-driven manufacturing, and global supply reliability. Our commitment to GMP standards, coupled with advanced quality systems, ensures that Montzine Plus meets the highest regulatory benchmarks. As a manufacturer and supplier, we provide end-to-end solutions, from production to distribution, with a focus on scalability and cost-efficiency. Our ability to deliver bulk supply without compromising quality positions us as a strategic partner for businesses seeking to expand their market reach.
Bulk Supply Inquiry
We offer competitive bulk supply options for Montzine Plus. For inquiries regarding large-scale procurement, please contact our team at info@delwishealthcare.com.
FAQs
What manufacturing standards does Montzine Plus adhere to?
Montzine Plus is produced under cGMP guidelines, with compliance to WHO, FDA, and EMA regulations, ensuring global market acceptance.
Can Montzine Plus be customized for private label manufacturing?
Yes, we offer private label manufacturing services, allowing clients to brand the product under their own trademarks.
What is the shelf life of Montzine Plus in 10x10 Alu Alu packaging?
The product has a shelf life of 24 months when stored under recommended conditions, as confirmed by stability testing.
Does your facility support sterile processing for Montzine Plus?
Yes, our ISO Class 7 cleanroom facilities ensure sterile processing for all production batches.
Can Montzine Plus be produced in different dosage strengths?
While the product is currently available in a single strength, we can customize formulations based on client specifications.
What quality control measures are in place for Montzine Plus?
Each batch undergoes HPLC, dissolution testing, and microbial limit checks, with full documentation for regulatory compliance.
Is Montzine Plus suitable for export to international markets?
Yes, the product meets the regulatory requirements of over 150 countries, including the FDA, EMA, and PIC/S.
How does your supply chain ensure reliability for bulk orders?
Our logistics partners and real-time tracking systems ensure timely delivery, with contingency plans for supply chain disruptions.
Can you provide samples for quality assessment before bulk procurement?
Yes, we offer sample batches for testing, with full documentation to support quality assurance processes.
What is the minimum order quantity for Montzine Plus?
We accommodate both small-scale trials and large-volume orders, with flexible MOQs based on client requirements.
