Alembic Pharma spurts after USFDA nod for glycemic control drug

Alembic Pharmaceuticals rose 4.13% to Rs 533.25 at 13:22 IST on the BSE after the company said it received US drug regulator's tentative approval for Dapagliflozin tablets of 5 mg and 10 mg.

The announcement was made during market hours today, 23 July 2019.

Meanwhile, the S&P BSE Sensex was up by 62.17 points or 0.16% to 38,093.75.

On the BSE, 3334 shares were traded in the counter so far compared with average daily volumes of 3658 shares in the past two weeks. The stock had hit a high of Rs 536.15 and a low of Rs 515. The stock hit a 52-week high of Rs 664 on 27 September 2018 and a 52-week low of Rs 435.1 on 21 June 2019.

Alembic Pharmaceuticals announced that it has received a tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Dapagliflozin tablets, 5 mg and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD) Farxiga tablets of 5 mg and 10 mg. Dapagliflozin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

According to IQVIA, Dapagliflozin tablets have an estimated market size of $1.7 billion for twelve months ending December 2018.

Alembic Pharmaceuticals' consolidated net profit rose 32.2% to Rs 124 crore on 8.6% rise in net sales to Rs 926.95 crore in Q4 March 2019 over Q4 March 2018.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company.

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