Alembic Pharma announces US FDA nod for topical corticosteroid

25 Apr 2022 , 11:32 AM

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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