The approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product (RLD) Epiduo Forte Topical Gel of Galderma Laboratories, L.P (Galderma).

Adapalene and Benzoy,I Peroxide Topical Gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.

The topical gel for acne vulgaris has an estimated market size of US$211 million for twelve months ending Mar 2022 according to IQVIA.

Alembic has received a cumulative total of 170 ANDA approvals (146 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.

The drug maker reported consolidated net loss of Rs 65.88 crore in Q1 FY23 as against a net profit of Rs 164.52 crore posted in Q1 FY22. Net sales fell 4.8% year on year to Rs 1,262.14 crore in the quarter ended 30 June 2022.

The scrip shed 0.77% to currently trade at Rs 667.50 on the BSE.