Zydus Lifesciences gets final approval from USFDA for Adapalene and Benzoyl Peroxide Topical Gel

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market 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 decrease the number and severity of acne pimples.

Zydus Lifesciences
Zydus Lifesciences

Adapalene works by affecting the growth of cells and decreasing swelling and inflammation and Benzoyl Peroxide works by reducing the amount of acne-causing bacteria and by causing the skin to dry and peel off. The drug will be manufactured at group’s topical facility at Ahmedabad. Adapalene and Benzoyl Peroxide Topical Gel had a market size of USD 195 million (as per IQVIA MAT April 22). The group now has 315 approvals and has so far filed over 420 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company. The company’s subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.

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