Ajanta Pharma USA Inc., a subsidiary of Ajanta Pharma Limited, has launched montelukast sodium IR tablets (10mg) and montelukast sodium chewable tablets (4mg & 5mg), generic versions of Singulair tablets and Singulair chewable tablets, respectively.
The United States Food & Drug Administration (FDA) approval extends the breadth of the montelukast offerings from Ajanta Pharma into three dosage forms (immediate-release tablets, chewable tablets, and oral granules).
Montelukast IR tablets and chewable tablets are part of an ever-growing portfolio that Ajanta Pharma has developed for the US market. To date, the US FDA has granted Ajanta Pharma five ANDA final approvals and two ANDA tentative approvals. An additional 19 ANDAs are pending approval from the US FDA.