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Alembic Pharma gains after getting USFDA tentative approval for MDD drug

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Alembic Pharmaceuticals rose 2% to Rs 622.15 at 11:17 on after the company said it received US drug regulator's tentative approval for vilazodone hydrochloride tablets.

The announcement was made during trading hours today, 19 April 2017.

Meanwhile, the S&P Sensex was up 31.41 points, or 0.11% to 29,350.51.

On the BSE, 8,115 shares were traded in the counter so far, compared with average daily volumes of 55,339 shares in the past one quarter. The stock had hit a high of Rs 629 and a low of Rs 616 so far during the day.

The stock hit a 52-week high of Rs 709.30 on 23 March 2017. The stock hit a 52-week low of Rs 517.90 on 24 June 2016.

Alembic Pharmaceuticals announced that it received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for vilazodone hydrochloride tablets, 10mg, 20mg and 40mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Viibryd Tablets, 10 mg, 20mg and 40mg, of Forest Labs LLC. Vilazodone Hydrochloride Tablets are indicated for the treatment of Major Depressive Disorder (MDD). Alembic is currently in litigation with Forest Labs LLC in District Court of Delaware and has stipulated to stay the case in view of the ongoing settlement discussions.

Vilazodone Hydrochloride Tablets have an estimated market size of $340 million for twelve months ending December 2016 according to IMS. Alembic now has a total of 54 ANDA approvals (47 final approvals and 7 tentative approvals) from the USFDA.

On a consolidated basis, net profit of Alembic Pharmaceuticals declined 67.81% to Rs 86.55 crore on 15.9% decline in net sales to Rs 769.86 crore in Q3 December 2016 over Q3 December 2015.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, manufactures and markets generic pharmaceutical products all over the world.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

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