Manufacturing Process of Montelukast Levocetirizine Tablets
We are a WHO-GMP approved Pharmaceutical Contract Manufacturing Company located in India. We, Den Mark Pharmaceuticals Pvt. Ltd. strictly follows guidelines outlined by the World Health Organization's Good Manufacturing Practices (WHO GMP) to ensure the production of top-quality Montelukast Levocetirizine tablets.
Here's a comprehensive overview of the manufacturing process.
- Raw Material Procurement and Testing: Den Mark Pharmaceuticals sources pharmaceutical-grade Montelukast and Levocetirizine from approved suppliers. Upon arrival, each batch undergoes rigorous testing to verify its purity, potency, and compliance with pharmacopeial standards.
- Granulation: The first step involves granulation, where Montelukast and Levocetirizine are blended with excipients like microcrystalline cellulose, lactose, and croscarmellose sodium. The mixture is then granulated using a suitable binder solution to form uniform granules.
- Drying: The wet granules are dried to remove moisture using fluidized bed dryers or tray dryers. Proper drying ensures the granules' stability and flow properties.
- Milling and Sieving: The dried granules are milled to achieve the desired particle size distribution. Subsequently, the milled granules are sieved to remove oversized or undersized particles, ensuring uniformity.
- Lubrication: To prevent adhesion and enhance flow properties, lubricants such as magnesium stearate or sodium stearyl fumarate are added to the granules and mixed thoroughly using suitable equipment.
- Compression: The lubricated granules are then compressed into tablets of the specified size and shape using high-quality tablet compression machines. The compression process is carefully monitored to maintain uniformity and tablet hardness.
- Film Coating: Optionally, the Montelukast Levocetirizine Tablets may undergo film coating to improve their appearance, taste masking, and stability. Coating solutions containing polymers, plasticizers, and pigments are applied using coating pans or fluidized bed coaters.
- Quality Control Checks: Quality control checks are performed at various stages throughout the manufacturing process to ensure compliance with WHO GMP standards. These checks include in-process testing, weight variation, hardness, disintegration, and friability tests.
- Packaging: Once the tablets pass all quality control tests, they are packed into blister packs or bottles using automated packaging equipment in a controlled environment to prevent contamination and maintain product integrity.
- Labelling and Batch Release: Each batch of Montelukast Levocetirizine tablets is labeled with essential information, including product name, strength, batch number, manufacturing date, and expiry date. After final inspection and approval, the batch is released for distribution.
- Storage and Distribution: The finished Montelukast Levocetirizine tablets are stored under recommended storage conditions to maintain stability and efficacy. Den Mark Pharmaceuticals ensures proper distribution channels to safely deliver products to pharmacies, hospitals, and other healthcare providers.
- Post-Market Surveillance: Den Mark Pharmaceuticals conducts post-market surveillance to monitor the safety and efficacy of Montelukast Levocetirizine tablets. Any adverse events or product complaints are promptly investigated and addressed to uphold the company's commitment to quality and patient safety.
By following the stringent quality control designed manufacturing processes under WHO-GMP guidelines, Den Mark Pharmaceuticals Pvt. Ltd. ensures the production of top-quality Montelukast Levocetirizine tablets that meet the highest standards of pharmaceutical excellence.