Montelukast Sodium API Manufacturer & Supplier India
GMP-Certified · API Exporter India · Surat, Gujarat
Leukotriene receptor antagonist API used in the prophylaxis and chronic treatment of asthma and allergic rhinitis. Request a quotation for bulk Montelukast Sodium supply to regulated global markets.
Montelukast Sodium Product Overview
Vubrix Pharma is a leading global manufacturer and exporter of Montelukast Sodium API. We supply high-purity, pharmacopeial-grade Montelukast to pharmaceutical formulation companies worldwide, specializing in API suitable for standard tablets, pediatric chewables, and oral granules.
Montelukast (supplied as Montelukast Sodium, CAS No: 151767-02-1) is a leukotriene receptor antagonist (LTRA) used primarily in the maintenance treatment of asthma and to relieve symptoms of seasonal allergies.
Appearance: White to pale yellow hygroscopic powder. Solubility: Freely soluble in water and methylene chloride, freely to very soluble in alcohol.
Applications
- Asthma Management: Prophylaxis and chronic treatment of asthma in adults and pediatric patients.
- Exercise-Induced Bronchoconstriction: Prevention of bronchoconstriction induced by exercise.
- Allergic Rhinitis: Relief of symptoms of seasonal and perennial allergic rhinitis.
Technical Specifications
- Purity: NLT 98.0% - 102.0% (anhydrous basis).
- Physical Properties: Controlled particle size distribution (PSD) tailored for different formulation types, especially chewable tablets.
- Documentation: CoA, MOA, MSDS, and Open Part DMF available for regulatory support.
Manufacturing Process
Mechanism of Action: Montelukast binds with high affinity and selectivity to the cysteinyl leukotriene (CysLT1) receptor, blocking the action of leukotrienes (LTC4, LTD4, LTE4), which are potent inflammatory mediators.
Vubrix Pharma manufactures Montelukast Sodium under strict WHO-GMP compliance. We take special care during synthesis to control hygroscopicity and ensure a flawless impurity profile.
Learn more about our manufacturing capabilities and quality assurance systems.
Packaging Information
Standard Packaging: 10 Kg or 25 Kg double polyethylene bags packed in fiber drums. The product is hygroscopic and sensitive to light, so it is often packed under an inert atmosphere (Nitrogen).
Storage Information
Storage Conditions: Store in airtight containers, protected from light and moisture, at room temperature.
Quality Standards
Our Montelukast Sodium is carefully monitored for residual solvents and related substances. We ensure perfect PSD consistency for flawless formulation into chewables and granules.
Export Markets
We reliably export Montelukast Sodium to regulatory and semi-regulatory markets across North America, Europe, the Middle East, and Latin America.
Why Choose Vubrix Pharma
Respiratory Formulation Manufacturers and Pediatric Medication Specialists choose Vubrix Pharma for our superior PSD control, eliminating bitter aftertaste and stability issues in chewable formats.
- Therapeutic class: Antiasthmatic
- End application: Asthma and allergy formulations
Frequently Asked Questions about Montelukast Sodium
What is Montelukast Sodium API used for?
It is used to formulate medications for the management of asthma, exercise-induced bronchoconstriction, and allergic rhinitis.
Is your Montelukast API suitable for chewable tablets?
Yes, we offer specific particle size distributions (PSD) ideal for manufacturing pediatric chewable tablets.
What pharmacopeial standards does your Montelukast meet?
It meets USP, EP, and BP pharmacopeial standards.
Is Vubrix Pharma WHO-GMP certified?
Yes, our manufacturing facilities are WHO-GMP certified.
What is the CAS number for Montelukast Sodium?
The CAS number is 151767-02-1.
Do you provide a Drug Master File (DMF) for Montelukast?
Yes, an open part DMF is available to support your product registrations.
Is Montelukast sensitive to light and moisture?
Yes, it is hygroscopic and light-sensitive, requiring specialized packaging and careful handling.
How is the API packaged for bulk shipping?
It is packed in double PE bags, often flushed with Nitrogen, inside robust fiber drums.
What is the minimum order quantity (MOQ)?
Our standard MOQ is 10 kg, depending on the specific grade required.
How does Montelukast work?
It is a leukotriene receptor antagonist that blocks inflammatory mediators (leukotrienes) in the airways.
Do you supply Montelukast for combination formulations?
Yes, our API is frequently used in combination with antihistamines like Levocetirizine.
Can Vubrix Pharma contract manufacture finished Montelukast tablets?
Yes, we offer contract manufacturing for standard and chewable tablets.
What is the shelf life of your Montelukast API?
The typical shelf life is 24 to 36 months when stored properly.
Are residual solvents strictly controlled?
Yes, all residual solvents are maintained well below ICH limits.
Is Montelukast soluble in water?
Yes, Montelukast Sodium is freely soluble in water.
Can I receive a commercial sample?
Yes, samples and Certificates of Analysis (CoA) are available for qualified B2B buyers.
Do you export to Latin America and the Middle East?
Yes, we have strong export channels to both regions and assist with local regulatory compliance.
How do you ensure batch-to-batch consistency?
Through validated manufacturing processes, strict environmental controls, and rigorous quality control testing.
What are the payment terms?
We offer standard international terms, such as TT and LC, based on buyer assessment.
How can I request pricing?
Use the inquiry form on this page or contact us directly via email or WhatsApp.
Request a Quote for Montelukast Sodium
Get pricing, MOQ, lead time, and documentation for Montelukast Sodium. Our team responds within 24 hours.