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20 April, 2024 12:24 IST
Ajanta Pharma gets USFDA approval for three ANDAs
Source: IRIS | 04 Aug, 2015, 11.32AM
Rating: NAN / 5 stars.
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Ajanta Pharma, a company engaged in manufacturing & marketing of pharmaceutical products, announced that it has received final approval for its 3 ANDAs (Abbreviated New Drug Application) by US FDA (US Food & Drug Administration).

Montelukast Tablets, 10mg; Montelukast Sodium Chewable Tablets, 4mg & 5mg and Montelukast oral granules.

Montelukast Sodium Tablets, 10 mg, the generic version of Singular 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.

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 FDA.

Shares of the company gained Rs 89.95, or 5.8%, to trade at Rs 1,641.50. The total volume of shares traded was 54,766 at the BSE (11.28 a.m., Tuesday).

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