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Alembic Pharma gains after USFDA nod for ophthalmic drug

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Alembic Pharmaceuticals was up 1.14% to Rs 536 at 12:10 IST on the BSE after the company said it received US drug regulator's tentative approval for Bimatoprost Ophthalmic Solution.

The announcement was made during the market hours today, 9 August 2019.

Meanwhile, the S&P BSE Sensex was up by 421.49 points or 1.13% at 37,748.85.

On the BSE, 1870 shares were traded in the counter so far compared with average daily volumes of 3728 shares in the past two weeks. The stock had hit an intraday high of Rs 543.25 and an intraday low of Rs 531.05. The stock hit a 52-week high of Rs 664 on 27 September 2018. The stock hit a 52-week low of Rs 435.1 on 21 June 2019.

Alembic Pharmaceuticals announced that it received tentative approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Bimatoprost Ophthalmic Solution, 0.01%. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), LUMIGAN ophthalmic solution 0.01%, of Allergan Inc.

Bimatoprost Ophthalmic Solution, 0.01 % is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. It had an estimated market size of $704 million for twelve months ending December 2018 according to IQVIA.

Alembic now has a total of 100 ANDA approvals (88 final approvals and 12 tentative approvals) from USFDA.

On consolidated basis, company's net profit rose 64% to Rs 148.35 crore on 10% rise in net sales to Rs 948.91 crore in Q1 June 2019 over Q1 June 2018.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. The company manufactures and markets generic pharmaceutical products all over the world.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Fri, August 09 2019. 12:23 IST