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Alembic Pharma hits the roof after USFDA nod for anti-depression drug

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Capital Market
Last Updated : Jun 11 2018 | 2:31 PM IST

Alembic Pharmaceuticals hit an upper circuit limit of 20% at Rs 521.80 at 14:14 IST on BSE after the company said it received US drug regulator's approval for Bupropion Hydrochloride tablets in strength of 75 and 100 milligrams.

The announcement was made during trading hours today, 11 June 2018.

Meanwhile, the S&P BSE Sensex was up 228.76 points, or 0.65% to 35,672.43.

On the BSE, 51,000 shares were traded in the counter so far compared with average daily volumes of 3,526 shares in the past two weeks. The stock had hit a low of Rs 440 in intraday trade. The stock hit a 52-week high of Rs 588 on 15 February 2018. The stock hit a 52-week low of Rs 412.40 on 24 May 2018.

Alembic Pharmaceuticals announced that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bupropion Hydrochloride tablets USP, 75 mg and 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Wellbutrin tablets, 75 mg and 100 mg, of GlaxoSmithKline LLC. Bupropion Hydrochloride tablets USP, 75 mg and 100 mg is indicated for the treatment of major depressive disorder. Bupropion Hydrochloride tablets USP, 75 mg and 100 mg, have an estimated market size of $37 million for twelve months ending December 2017 according to IMS.

Alembic now has a total of 72 ANDA approvals (64 final approvals and 8 tentative approvals) from USFDA.

On a consolidated basis, net profit of Alembic Pharmaceuticals rose 0.81% to Rs 93.79 crore on 15.10% rise in net sales to Rs 853.31 crore in Q4 March 2018 over Q4 March 2017.

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

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First Published: Jun 11 2018 | 2:15 PM IST

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