Zydus Lifesciences Ltd.

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for 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 $115.4 million 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.

Zydus Lifesciences (formerly known as Cadila Healthcare), a company limited by shares, incorporated and domiciled in India, operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.