Ajanta Pharma Limited, through its subsidiary Ajanta Pharma USA Inc, has launched montelukast sodium oral granules (4 mg), a bioequivalent generic version of Merck Sharp & Dohme’s Singulair granules, in the US market. Ajanta Pharma offers montelukast granules in cartons containing 30 individual sachets.
Montelukast is indicated to prevent the wheezing and shortness of breath caused by asthma and decrease the number of asthma attacks.
The approval and launch of the montelukast granules is part of an ever-growing portfolio that Ajanta Pharma has developed for the US market. To date, the US Food & Drug Administration (FDA) has granted five ANDA final approvals and two ANDA tentative approvals. An additional 19 ANDAs are pending approval from the US FDA.
