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About Montelukast Sodium API

Product
  • Therapeutic CategoryRespiratorio

  • API Technology

    Synthetic

  • Dose Form

    Granular, Tablet or Chewable

  • Dr Reddy's Development Status

    Available (Commercial)

  • Available Regulatory Filing

    USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, China DMF, Japan DMF

Mecanismo de acción

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 early-and 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 β-adrenergic receptor). Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity.

Indicación

SINGULAIR 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

Experiencia de Dr. Reddy

Con sede en Hyderabad, India, Dr. Reddy's Laboratories es uno de los principales proveedores de ingredientes farmacéuticos activos (API) a nivel mundial. El negocio API de Dr. Reddy es considerado como un socio preferido de las compañías farmacéuticas en los Estados Unidos, Europa, Brasil, América Latina, Japón, China, Corea y los mercados emergentes.

El negocio de API de Dr. Reddy se nutre de las fortalezas técnicas profundas establecidas en los últimos 30 años en el desarrollo y fabricación de API complejas como esteroides, péptidos, moléculas complejas de cadena larga y API altamente potentes (HPAPI / medicamentos oncológicos). Esta experiencia se complementa con nuestra destreza en propiedad intelectual y asuntos regulatorios que nos ayudan a cumplir y superar los estándares regulatorios de manera consistente. Los APIs de Dr. Reddy´s Montelukast Sodium es el resultado de la amplia experiencia en R&D, IP y Normatividad Aplicable.

Un componente clave para ayudar a nuestros clientes a ser los primeros en comercializar es una cadena de suministro receptiva. Logramos esto al asegurarnos de que todas nuestras instalaciones funcionen de manera eficiente y con los últimos estándares de calidad, seguridad y productividad. Una fuerte interconexión entre las empresas y las fábricas permite una reacción rápida a los cambios dinámicos del mercado, de modo que podamos evitar la escasez y satisfacer los repentinos aumentos de la demanda.

RFQ Form

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FAQs

What are the dosage strengths available for MONTELUKAST API?
  • Granule - 4MG BASE; Tablet - 10MG BASE; Tablet Chewable - 4 & 5MG

What should be monitored while taking MONTELUKAST API?
  • Monitored for mood or behavior changes, including suicidal thinking or behavior

What is MONTELUKAST API used to treat?
  • It is a respiratory agent used to treat the Prophylaxis and chronic treatment of asthma, exercise-induced bronchoconstriction

What are offerings of Dr. Reddy's for MONTELUKAST API?
  • We offer an Amorphous form

What is the process available for ordering MONTELUKAST API?
Disclaimer: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act (Bolar Exemption) and not for commercial sale.