Alembic Pharma sweetens after getting USFDA nod

Alembic Pharmaceuticals rose 0.85% to Rs 625.05 at 13:54 IST on BSE after the company recieved US health regulator approved approval for Fluoxetine Hydrochloride tablets.

The announcement was made during market hours today, 7 April 2017.

Meanwhile, the S&P BSE Sensex was down 66.42 points, or 0.22%, to 29,860.92.

On the BSE, so far 13,000 shares were traded in the counter, compared with average daily volumes of 52,734 shares in the past one quarter. The stock had hit a high of Rs 635 and a low of Rs 610 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 515.55 on 18 April 2016. The stock had underperformed the market over the past one month till 6 April 2017, rising 2.72% compared with the Sensex's 3.55% rise. The scrip also underperformed the market over the past one quarter, rising 2.2% as against the Sensex's 11.84% advance.

The large-cap company has equity capital of Rs 37.70 crore. Face value per share is Rs 2.

Alembic Pharmaceuticals said that the company has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Fluoxetine Hydrochloride tablets, 10 mg and 20 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product Prozac Tablets, 10 mg and 20 mg, of Eli Lilly and Company.

Fluoxetine Hydrochloride Tablets are indicated for the treatment of Major Depressive Disorder and Obsessive Compulsive Disorder in adult and pediatric patients. Fluoxetine Tablets are also indicated for the treatment of binge eating and vomiting behaviour in moderate to severe Bulimia Nersova and acute treatment of Panic Disorder, in adult patients.

Fluoxetine Hydrochloride Tablets have an estimated market size of $120 million for 12 months ended December 2015, according to IMS. Alembic Pharma now has a total of 53 ANDA 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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