Drug Approval

Zydus receives final approval from USFDA for Tretinoin Cream

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

  • By IPP Bureau | April 28, 2024

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.

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