Zydus receives final approval from USFDA for Tretinoin Cream

Zydus receives final approval from USFDA for Tretinoin Cream

By: IPP Bureau

Last updated : April 28, 2024 8:45 pm



The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad (India)


Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market Tretinoin Cream USP, 0.1%, (USRLD: Retin-A Cream, 0.1%).

Tretinoin cream is used to treat acne. The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad (India).

Tretinoin Cream USP, 0.1% had annual sales of USD 54.8 mn in the United States (IQVIA MAT Feb-24).

The group now has 394 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences Limited USFDA

First Published : April 28, 2024 12:00 am