By: IPP Bureau
Last updated : May 24, 2025 12:14 pm
Isotretinoin capsules are indicated to treat severe, disfiguring nodular acne
Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) Isotretinoin capsules USP, 10 mg 20 mg, 25 mg, 30 mg, 35 mg and 40 mg (USRLD: Absorica Capsules, 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg).
Isotretinoin capsules are indicated to treat severe, disfiguring nodular acne. Isotretinoin capsules will be produced at the Group's manufacturing site at Moraiya, Ahmedabad.
Isotretinoin capsules had annual sales of USD 115.4 mn in the United States (IQVIA MAT March 2025).
The group now has 427 approvals and has so far filed 492* ANDAs since the commencement of the filing process in FY 2003-04.