Alembic Pharma gains USFDA approval for Clobetasol spray

Alembic Pharmaceuticals rose 1.80% to Rs 535 after the company said its joint venture received US drug regulator's approval for Clobetasol Propionate spray.

Alembic Pharmaceuticals (Alembic) announced that its joint venture Aleor Dermaceuticals (Aleor) has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Clobetasol Propionate spray, 0.05%.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Clobex spray, 0.05% of Galderma Laboratories L.P. (Galderma).

Clobetasol Propionate spray, 0.05% is indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older.

Clobetasol has an estimated market size of $22 million for twelve months ending December 2018 according to IQVIA. Alembic has a cumulative total of 103 ANDA approvals (91 final approvals and 12 tentative approvals) from USFDA. The announcement was made during market hours today, 4 October 2019.

Meanwhile, the S&P BSE Sensex was up 228 points or 0.60% to 38334.78.

On the BSE, 645 shares were traded in the counter so far compared with average daily volumes of 3709 shares in the past one quarter. The stock hit a high of Rs 541 and a low of Rs 526 so far during the day.

The stock hit a 52-week high of Rs 649.9 on 03 Oct 2018. The stock hit a 52-week low of Rs 435.1 on 21 Jun 2019.

On a consolidated basis, the drug maker's net profit rose 64% to Rs 148.35 crore on a 10% rise in the 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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