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Respiratory

Montelukast

Singulair®

Montelukast is a leukotriene receptor antagonist for prophylaxis and chronic treatment of asthma and relief of allergic rhinitis.

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Product Details

Dosage FormOral Tablet / Chewable Tablet / Granules
Strength4 mg, 5 mg, 10 mg
StorageStore at 25°C. Protect from moisture and light.
CategoryRespiratory
AvailabilityAvailable for Transfer

Indication

Prophylaxis and chronic treatment of asthma (≥12 months); seasonal and perennial allergic rhinitis; exercise-induced bronchoconstriction prevention.

Mechanism of Action

Selectively blocks leukotriene D4 (LTD4) at the CysLT1 receptor, reducing bronchoconstriction, mucus secretion, vascular permeability, and eosinophilic inflammation.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Montelukast includes comprehensive documentation and support:

Master Formula

Complete formulation with manufacturing parameters, excipient specifications, and process controls.

Analytical Methods

Validated methods for assay, impurities, dissolution, and stability-indicating analysis.

CTD/eCTD Templates

Market-ready regulatory dossier templates — available through Burrard Intelligence subscription.

Stability Data

ICH-compliant stability studies (accelerated and long-term) with detailed protocols.

Manufacturing Protocols

Scale-up procedures, batch records, equipment specifications, and in-process controls.

Expert Support

Direct advisory access to formulation scientists and regulatory specialists throughout transfer.

Ready for Montelukast Technology Transfer?

Our team can deliver the complete know-how package within 2–21 business days. Book a consultation to discuss your specific requirements.

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