Zydus Lifesciences receives USFDA approval for Ketoconazole Shampoo, 2%

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Ketoconazole Shampoo, 2% (USRLD: Nizoral Shampoo, 2%).

Ketoconazole shampoo is an antifungal medication used to treat dandruff, fungal infections, and other skin conditions. Ketoconazole shampoo will be produced at the Group's topical manufacturing site at Changodar, Ahmedabad.

Ketoconazole shampoo had annual sales of USD 68.89 mn in the United States (IQVIA MAT January 2025).

The group now has 418 approvals and has so far filed 483* ANDAs since the commencement of the filing process in FY 2003-04.

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