Ajanta Pharma gets approvals for 3 ANDAs

04 Aug 2015 Evaluate

Ajanta Pharma, a specialty focused pharmaceutical formulation company, has received final approval for its 3 ANDAs (Abbreviated New drug Application) by US FDA (United States Food and Drug Administration) such as Montelukast Tablets, 10mg, Montelukast sodium chewable tablets, 4mg & 5mg and Montelukast oral granules.

Montelukast sodium tablets, 10mg, the generic version of singular tablets by Merck, is indicated for treatment of prophylaxis and chronic treatment of asthma and to relive symptoms of seasonal and perennial rhinitis in patients 2 years of age and older. Montelukast 4mg chewable tablets ate suitable for 2 to 5years old patients while Montelukast 5mg chewable tablets are available for patients from 6 to 14 years of age. Montelukast oral granules are specially appropriate for patients of 12 months age and older.

For the 12 months ending June 2015, Montelukast tablets, Chewable tablets and Granules had sales of approximately $237 million, $31 million respectively. The company intends to launch these products shortly. The approval of the Montelukast product family is part of an ever growing portfolio that company has developed for the US market. Including these 3 ANDA approvals, company now has 5 approved ANDAs and another 20 ANDAs under approval with FDA.

Ajanta Pharma is engaged in manufacturing pharmaceutical products. The company runs three divisions -- prescription drugs, OTC and institutional sales.

Ajanta Pharma Share Price

2638.75 12.50 (0.48%)
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