Zydus Lifesciences gets USFDA’s final approval for Tretinoin Cream

26 Apr 2024 Evaluate

Zydus Lifesciences 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 $54.8 million in the United States (IQVIA MAT February 2024). 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 (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.


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