Zydus Lifesciences bags USFDA approval for Adapalene and Benzoyl Peroxide Topical Gel

7 Jun 2022 , 10:12 AM

Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), has received final approval from the United States Food and Drug Administration (USFDA) to commercialize Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% (USRLD: Epiduo Forte).

A combination of Adapalene (a retinoid) and Benzoyl Peroxide (an antibiotic and skin-peeling agent), the gel is used to reduce the number and severity of acne pimples.

Adapalene affects the growth of cells and decreases swelling and inflammation and Benzoyl reduces the amount of acne-causing bacteria by causing the skin to dry and peel off.

The drug will be manufactured at the group’s topical facility in Ahmedabad. As per IQVIA MAT April 22 data, Adapalene and Benzoyl Peroxide Topical Gel had a market size of USD 195 million.

The Zydus group now holds 315 approvals and has so far filed over 420 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences is currently trading at Rs359.05 down by Rs5.6 or 1.54% from its previous closing of Rs364.65 on the BSE. The scrip opened at Rs364.30 and has touched intraday high and low of Rs365.15 and Rs357.50 respectively.