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Ajanta Pharma receives US FDA final approval for generic Singulair tablets

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Ajanta Pharma Limited, a Rs.1,450 crore plus Mumbai based specialty focused pharmaceutical formulation company, has received final approval from the United States Food and Drug Administration (FDA)  for its 3 Abbreviated New Drug Applications (ANDAs), montelukast tablets, 10mg,  montelukast sodium chewable tablets, 4mg & 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.

Montelukast 4mg chewable tablets are suitable for 2 to 5 year 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 of age and older.

The approval of the montelukast product family is part of an ever-growing portfolio that Ajanta Pharma has developed for the US market. Including these 3 ANDA approvals, Ajanta now has 5 approved ANDAs and another 20 ANDAs under approval with US FDA.

Ajanta Pharma is an established pharmaceutical formulation company with clear focus on fast growing therapeutic segments of cardiology, ophthalmology, dermatology, & pain management in the Indian market and is among the fastest growing in the country. In the emerging markets company has presence in more than 35 countries across Africa, Philippines, Rest of Asia, Middle East, CIS and Latin America.

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