Ajanta Pharma Limited, a Rs. 1,450 crore plus Mumbai-based fully-integrated pharmaceutical company, announced that its subsidiary Ajanta Pharma USA Inc has introduced montelukast sodium oral granules (4mg), a bioequivalent generic version of Merck's Singulair granules, in the US market.
Ajanta Pharma offers montelukast granules in cartons containing 30 individual sachets.
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 United States 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.