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Alembic Pharma gains after USFDA approval for itraconazole capsules

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Capital Market
Last Updated : Dec 17 2016 | 12:01 AM IST

Alembic Pharmaceuticals rose 0.83% to Rs 622.80 at 11:22 IST on BSE after the company said it received US drug regulator's approval for itraconazole capsules.

The announcement was made during trading hours today, 16 December 2016.

Meanwhile, the BSE Sensex was down 25.45 points, or 0.10%, to 26,493.62.

On the BSE, so far 1,314 shares were traded in the counter, compared with average daily volumes of 9,873 shares in the past one quarter. The stock had hit a high of Rs 636.75 and a low of Rs 621.55 so far during the day.

The stock hit a 52-week high of Rs 727.25 on 30 December 2015. The stock hit a 52-week low of Rs 514.35 on 5 February 2016. The stock had outperformed the market over the past 30 days till 15 December 2016, rising 1.37% compared with the 0.84% rise in the Sensex. The scrip had also outperformed the market in past one quarter, falling 5.98% as against Sensex's 7.27% decline.

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

Alembic Pharmaceuticals announced that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for itraconazole capsules, 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Sporanox Capsules, 100 mg of Janssen Pharmaceuticals, Inc.

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Itraconazole capsules are indicated for the treatment of blastomycosis, histoplasmosis and aspergillosis in immunocompromised and non-immunocompromised patients and onychomycosis in non-immunocompromised patients.

Itraconazole capsules had an estimated market size of $42 million for twelve months ending December 2015 according to MS. Alembic now has a total of 52 ANDA approvals (46 final approvals and 6 tentative approvals) from USFDA.

On a consolidated basis, net profit of Alembic Pharmaceuticals declined 58.47% to Rs 119.83 crore on 13.13% decline in net sales to Rs 871.56 crore in Q2 September 2016 over Q2 September 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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First Published: Dec 16 2016 | 11:15 AM IST

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