Ajanta Pharma receives final approval for Monelukast

Ajanta Pharma has received final approval for its three ANDAs (Abbreviated New Drug Application) by USFDA for Montelukast tablets in the strength of 10 mg, 4mg and 5mg and Montelukast oral granules. Montelukast sodium tablets, 10 mg, the generic version of Singulair tablets by Merck, is indicated for treatment of prophylaxis and chronic treatment of asthma and to relieve symptoms of seasonal and perennial allergic rhinitis in patients two years of age and older. It may be noted, Montelukast tablets, chewable tablets and granules have an estimated market sales of 5237 million, 587 million and 531 million in a year. So far, Ajanta Pharma has 5 approved ANDAs .

Company Profile : Ajanta Pharma Ltd

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