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Alembic Pharma's JV gets USFDA nod for clobetasol propionate shampoo

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Alembic Pharmaceuticals on Tuesday (19 May) said its joint venture, Aleor Dermaceuticals received US drug regulator's approval for clobetasol propionate shampoo.

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

Clobetasol propionate shampoo, 0.05% is indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. Clobetasol propionate shampoo, 0.05%, has an estimated market size of $28 million for twelve months ending December 2019 according to IQVIA.

Alembic has a cumulative total of 122 ANDA approvals (109 final approvals and 13 tentative approvals) from USFDA.

On a consolidated basis, the pharmaceutical company's net profit rose 88.10% to Rs 233.25 crore on a 30.19% increase in the net sales to Rs 1,206.83 crore in Q4 March 2020 over Q4 March 2019. The result was announced on 23 April 2020.

Alembic Pharmaceuticals is engaged developing formulations and active pharmaceutical ingredients (API).

Shares of the drug maker fell 0.05% to Rs 880 on BSE. The scrip hovered in the range of Rs 865.05 to Rs 889.85 so far.

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

First Published: Tue, May 19 2020. 12:12 IST
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