Montelukast Sodium

Montelukast Sodium Manufacturers in India - APIs 1

Product Description:

  • Therapeutic Category : Antiasthmatic
  • CAS Number : 151767-02-1
  • Molecular Formula : C35H35ClNNaO3S
  • Molecular Weight: 608.2 g/mol
  • Mesh Size : As per Customer Requirement
  • Form : Capsule, Granule, Powder, Suspension, Tablet
  • Metrochem Development Status : Commercial

Mechanism of Action:

Montelukast Sodium (empirical formula C35H35ClNNaO3S) is a highly selective leukotriene receptor antagonist that binds with high affinity to the  cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. These eicosanoids bind to cysteinyl leukotriene (CysLT) receptors. The CysLT type-1 (CysLT1) receptor is found in the human airway (including airway smooth muscle cells and airway macrophages) and on other pro-inflammatory cells (including eosinophils and certain myeloid stem cells). CysLTs have been correlated with the pathophysiology of asthma and allergic rhinitis. In asthma, leukotriene-mediated effects include airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process. In allergic rhinitis, CysLTs are released from the nasal mucosa after allergen exposure during both earlyand late-phase reactions and are associated with symptoms of allergic rhinitis. Montelukast is an orally active compound that binds with high affinity and selectivity to the CysLT1 receptor (in preference to other pharmacologically important airway receptors, such as the prostanoid, cholinergic, or b-adrenergic receptor). Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity.

Indication:

Montelukast Sodium  is a leukotriene receptor antagonist indicated for:

  • Prophylaxis and chronic treatment of asthma in patients 12 months of age and older.
  • Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.
  • Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6 months of age and older.

Metrochem API Expertise:

Metrochem API Pvt Ltd is a leading manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) through our manufacturing sites in Hyderabad and Vizag. Our API facilities have been inspected and approved by several global regulatory bodies including the US FDA, Japan PMDA, KFDA, and meet the cGMP compliance standards. Adapting quickly to the ever-evolving demands, we have emerged as one of the fastest growing organization in the pharmaceutical industry across the India. To cater our customer high volume requirements, we have dedicated each of our 6 manufacturing facilities to our 3 core product groups – APIs, Pelletization& Intermediates – reinforced by a well equipped, centralized Research & Development laboratory.

We have been successfully supplying APIs all over the globe for more than 15 years. Total reactor volume exceeds 1200 KL which includes pilot and multi-purpose units. We are capable of executing extensive API requirements for our customers. Metrochem API Pvt Ltd has an experienced team of highly skilled chemists, experienced regulatory professionals and supply chain experts, who are ready to handle your API manufacturing requirements with expert care. We also offer Contract Manufacturing, Contract Research, and Custom Synthesis services. We have a stand-alone R&D center located in Hyderabad with State-of-the-art analytical facilities and over 90 scientists.We have extensively worked on and delivered new products across a wide variety of therapeutic segments and as a company, we have built strong expertise in new product development.

Disclaimer : Metrochem API Pvt Ltd respects the intellectual property rights of others. Some of the Active Pharmaceuticals Ingredients (APIs) listed in the Metrochem’s product list or brochure or in the product list uploaded in Metrochem’s website may be protected by a valid patent in India or in any other countries concerned. However, mentioning of the name of such product(s) in the product brochure or the product list shall not be construed as infringement in any manner whatsoever. Without prejudice to the foregoing, Metrochem’s supply of API being protected by a valid product patent, if any, is intended solely for uses reasonably relating to the development and submission of information required under any law for the time being inforce, in India, or in a country other than India that regulates the manufacture, use, sale or import of the said product, strictly under the conditions as set forth in Section 107A of the Indian patents Act, 1970, as amended in 2005, or an equivalent provision (Bolar exemption) thereof in a country other than India. The disclaimer is applicable till the expiration of the corresponding product patent(s), if any, in the respective. countries concerned.  None of the products will be supplied to the countries wherein this could be in conflict with existing laws. However, the final responsibility lies exclusively with the buyer/ultimate customer.

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