Montelukast

Montelukast (CAS 158966-92-8) is a leukotriene receptor antagonist active pharmaceutical ingredient used in the treatment of asthma and allergic rhinitis. It is sourced by pharmaceutical manufacturers and contract formulators as a finished API for solid oral dosage development.

The primary application is in the manufacture of prescription and OTC oral tablets and chewable formulations targeting respiratory indications. Generic drug manufacturers source this API to produce bioequivalent products following patent expiry.

This material is an active procurement target across regulated and semi-regulated markets. Pediatric chewable tablet formats represent a distinct formulation segment, requiring specific particle size and excipient compatibility considerations.

These factors are highly relevant to QA and formulation teams during the development process. It also appears as a key intermediate reference in analytical method development and pharmacokinetic research programs.

The product is supplied as a white to off-white crystalline powder, typically as the sodium salt form. Standard grades available include USP, BP, and Ph. Eur. compliant material for global distribution.

Documentation packages are provided to support regulatory submissions in major markets. Bulk quantities are offered for commercial manufacturing, with smaller research-grade quantities available for formulation development.