Logo
Logo

About Montelukast Sodium API

Product
  • Therapeutic Category呼吸器

  • 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

Mechanism of Action

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.

Indication

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

Dr. Reddy’sの専門知識・技術

ハイデラバード(インド)に本社を構えるDr. Reddy’s Laboratoriesは、世界的に有名な原薬(API)供給業者です。Dr. Reddy’sのAPIビジネスは米国、ヨーロッパ、ブラジル、南米、日本、中国、韓国、その他の新興市場において製薬会社の推奨パートナーとなっています。

Dr. Reddy’sのAPIビジネスは、ステロイド、ペプチド、複合長鎖分子、高薬理活性API(HPAPI /腫瘍学薬)など、複合APIの開発・製造において、30年以上にわたり高度な技術的実績を築き上げ、成長しています。この専門知識・技術は弊社の知的財産および規制関連業務の実績と共に、一貫して規制基準を満たし、それを超える優れた価値を生み出しています。Dr. Reddyの(-) API, R&D (研究開発)、IP、規制の高度な専門知識・技能の結果です。

顧客が真っ先に市場に参入するのに重要な要素は、機敏な供給網です。弊社は全施設を効率的に、そしてコストを最適化して稼働させ、品質と安全性、また、生産性の最新基準に従うことで、そうした供給網を実現させます。オフィスと工場の結びつきを強化し、ダイナミックな市場の変化に迅速に対応しています。そうした理由から、弊社は不足を解消して突発的な供給を満たすことができるのです。

RFQ Form

Phone

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.