Alembic Pharma in pink of health after receiving USFDA nod for drug

Alembic Pharmaceuticals rose 1.58% to Rs 526 at 11:04 IST on BSE after the company said that it has received US drug regulator's approval for Darifenacin Extended-Release Tablets, 7.5 mg and 15 mg.

The announcement was made during market hours today, 12 December 2017.

Meanwhile, the S&P BSE Sensex was down 144.22 points, or 0.43% to 33,311.57. The S&P BSE Mid-Cap index was down 69.95 points, or 0.41% to 17,036.34, underperforming the Sensex.

On the BSE, 5,904 shares were traded in the counter so far, compared with average daily volumes of 4,642 shares in the past one quarter. The stock had hit a high of Rs 533 and a low of Rs 513 so far during the day. The stock had hit a 52-week high of Rs 709.30 on 23 March 2017. The stock had hit a 52-week low of Rs 469.75 on 20 September 2017.

The stock had outperformed the market over the past one month till 11 December 2017, advancing 1.31% compared with the Sensex's 0.42% rise. The scrip had, however, underperformed the market over the past one quarter gaining 3.46% as against the Sensex's 4.94% rise. The scrip had also underperformed the market over the past one year dropping 18.92% as against the Sensex's 25.08% rise.

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

Alembic Pharmaceuticals has received US Food & Drug Administration (USFDA) approval for its abbreviated new drug application (ANDA) Darifenacin Extended-Release Tablets, 7.5 mg and 15 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Enablex Extended-Release Tablets 7.5 mg and 15 mg, of Allergan Pharmaceuticals.

Darifenacin Extended-Release Tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. The drug has an estimated market size in US of $64 million for twelve months ended December 2016, according to IMS.

Alembic Pharmaceuticals' consolidated net profit rose 1.4% to Rs 121.56 crore on 10.2% decline in net sales to Rs 789.29 crore in Q2 September 2017 over Q2 September 2016.

Alembic Pharmaceuticals manufactures and markets generic pharmaceutical products.

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