Alembic Pharmaceuticals Limited (Alembic) has announced that its wholly owned subsidiary, Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Epiduo Forte Topical Gel, 0.3%/2.5%, of Galderma Laboratories, L.P; (Galderma). Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.
Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 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 USFDA.
Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 663.80 as compared to the previous close of Rs. 672.65. The total number of shares traded during the day was 12417 in over 1484 trades.
The stock hit an intraday high of Rs. 685.00 and intraday low of 662.10. The net turnover during the day was Rs. 8295234.00.