Alembic Pharma's Aleor Dermaceuticals gets USFDA nod for generic product

Drug firm Alembic Pharmaceuticals on Wednesday said its joint venture firm Aleor Dermaceuticals has received approval from the US health regulator to market a generic product, which is used to treat various skin conditions, in the American market.

The company said its joint venture firm Aleor has received final approval from the US Food and Drug Administration (USFDA) to market its abbreviated new drug application (ANDA) Clobetasol Propionate Cream in the US market.

The approved product is generic version of Fougera Pharmaceuticals' Temovate Cream which is indicated for relief of inflammatory and pruritic manifestations.

According to IQVIA, the Clobetasol Propionate Cream USP (0.05 per cent) had an estimated market size of USD 57 million (about Rs 405 crore) for the 12-months ending September 2019.

Alembic now has a cumulative total of 118 ANDA approvals from the USFDA.

The company's shares on Wednesday ended 0.41 per cent higher at Rs 634.30 on the BSE.

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