Zydus Lifesciences Limited, along with its subsidiaries and affiliates, commonly referred to as "Zydus," has secured the final nod from the United States Food and Drug Administration (USFDA) for the commercialization of Dapsone Gel, 7.5%, with the USRLD name Aczone® Gel 7.5%.

Dapsone Gel is a medication primarily utilized for the treatment of acne and will be produced at the group's dedicated topical manufacturing facility located in Changodar, Ahmedabad, India.

In the United States, Dapsone Gel, 7.5%, recorded annual sales of USD 35.8 million as of March 24, according to data from IQVIA MAT.

This approval marks a significant milestone for Zydus, adding to its extensive portfolio of 395 approvals. Since the initiation of the filing process in FY 2003-04, Zydus has submitted over 460 Abbreviated New Drug Applications (ANDAs), further solidifying its position in the pharmaceutical industry.