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Montelukast Sodium Structure

product_type

API

grade

BP / USP

chemical_formula

C35H35ClNNaO3S

iupac_name

[R-(E)]-1-[[[1-[3-[2-(7-Chloroquinolin-2-yl)vinyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt

cas_no

151767-02-1

molecular_weight

608.18 g/mol

chemical_class

Quinoline Derivative

therapeutic_class

Antiasthmatic

Synonyms

PHYSIOCHEMICAL PROPERTIES

appearance White to off-white amorphous powder
solubility Freely soluble in water and methanol; Practically insoluble in acetonitrile and ethanol
melting_point 141–144°C
ph 4.5 – 6.5 (1% aqueous solution)

Product Description

Montelukast Sodium is a selective leukotriene receptor antagonist used in the management of asthma, allergic rhinitis, and exercise-induced bronchoconstriction. It blocks leukotriene-mediated airway inflammation and bronchoconstriction, improving airflow and reducing symptoms. With its high oral bioavailability, strong safety profile, and once-daily dosing, it is among the most widely used antiasthmatic APIs globally.

How Montelukast Sodium Works

Montelukast selectively blocks cysteinyl leukotriene type 1 (CysLT1) receptors in the lungs and airways. By preventing leukotriene binding, it reduces airway edema, smooth muscle contraction, and mucus production, leading to improved respiratory function and reduced allergic inflammation.

Use(s)

Adverse Effects

Why choose Salius for Montelukast Sodium?

  1. WHO-GMP Certified Manufacturing
    Salius Pharma manufactures Montelukast Sodium in WHO-GMP and ISO 9001:2015 certified facilities, ensuring superior purity, safety, and compliance with international pharmacopoeial standards.
  2. Consistent Quality and Reliability
    Strict quality control and validation ensure each batch meets global specifications for assay, impurities, and stability—minimizing batch-to-batch variation.
  3. Global Export Experience & Documentation Support
    Salius Pharma provides full regulatory documentation including DMF, impurity profiles, stability data, and CTD/ACTD dossiers to support international filings in both regulated and semi-regulated markets.
  4. Documents We Provide
  5. Focus on Chronic Therapy APIs
    With deep expertise in chronic therapy APIs, Salius Pharma ensures reliable supply and technical support for long-term disease management drugs like Montelukast.
Attribute Why Salius Pharma Is a Good Choice
Quality Certification WHO GMP, ISO 9001:2015, FDA audited facilities
Affordability & Generic Access Cost competitive generics for global supply
Export Experience Proven track record of supplying globally

What You Receive in Our Package

When you order from Salius Pharma, you receive more than just a product — you receive a complete, professionally prepared package that meets international regulatory and quality expectations.

Each Shipment Includes:

Product

Expected Delivery Time

We ensure prompt and reliable shipping worldwide. Delivery times vary depending on destination, order volume, and regulatory requirements.

Overall Delivery Time:

7 to 21 business days from dispatch, depending on your location.

FAQs

It is used for the prevention and long-term treatment of asthma, and for relieving symptoms of seasonal and perennial allergic rhinitis.

It blocks cysteinyl leukotriene receptors (CysLT1) in the lungs and airways, reducing inflammation and preventing bronchoconstriction.

Headache, abdominal pain, and mild fatigue are common; mood changes and sleep disturbances are rare but possible.

Yes. Salius Pharma exports Montelukast Sodium worldwide with DMF and complete regulatory documentation support.

Yes. Full DMF, impurity profiles, COA, MSDS, stability data, and CTD-format dossiers are provided for registration in international markets.

Place an Order or Request a Quote from Salius Pharma

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