Zydus Lifesciences gets USFDA’s approval for Dapsone Gel

09 May 2024 Evaluate

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Dapsone Gel, 7.5%, (USRLD: Aczone Gel 7.5%). 

Dapsone Gel is used to treat acne and will be manufactured at the group’s topical manufacturing facility at Changodar, Ahmedabad (India). Dapsone Gel, 7.5% had annual sales of $35.8 million in the United States (IQVIA MAT March 24).

The group now has 395 approvals and has so far filed over 460 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.


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