Zydus receives final approval from USFDA for Dapsone Gel, 7.5%
2024-05-09 · Zydus Lifesciences Limited · original zyduslife.com ↗
Zydus receives final approval from USFDA for Dapsone Gel, 7.5% Ahmedabad, India, 09 May, 2024 Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) 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 USD 35.8 mn in the United States (IQVIA MAT March 24). The group now has 395 approvals and has so far filed over 4 60* ANDAs since the commencement of the filing process in FY 2003-04. (*as of 31st December 2023) ****
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