Hot Pursuit     25-Apr-22
Alembic Pharma announces US FDA nod for topical corticosteroid
Alembic Pharmaceuticals said that Aleor Dermaceuticals has received final approval from the US Food & Drug Administration (US FDA) for its ANDA for Clobetasol Propionate Foam.

The approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product (RLD) Olux Foam of Mylan Pharmaceuticals Inc.

Clobetasol Propionate Foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older.

Clobetasol Propionate Foam has an estimated market size of US$10 million for twelve months ending Dec 2021 according to IQVIA.

Aleor Dermaceuticals is a wholly owned subsidiary of Alembic Pharmaceuticals. Aleor was a 60:40 joint venture between Alembic and Orbicular Pharmaceutical Technologies formed in April 2016 focusing on commercialising dermatology products globally.

Alembic had acquired the balance 40% stake in Aleor from its JV partner Orbicular Pharmaceutical Technologies in March 2022.

Alembic has received a cumulative total of 165 ANDA approvals (141 final approvals and 24 tentative approvals) from US FDA.

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

On a consolidated basis, the company reported a 39.7% fall in net profit to Rs 176.42 crore on a 3.2% fall in net sales to Rs 1,271.7 crore in Q3 FY22 over Q3 FY21.

The scrip fell 1.08% to currently trade at Rs 757.50 on the BSE.

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