Zydus Lifesciences Gains USFDA Approval for Ketoconazole Shampoo

Zydus Lifesciences has secured USFDA approval to market its generic Ketoconazole Shampoo for treating dandruff and fungal infections. This antifungal product will be produced at Zydus's Ahmedabad site. In 2025, Ketoconazole shampoo generated sales of $68.89 million in the US market.

Zydus Lifesciences has announced a significant milestone with the green light from the United States Food and Drug Administration (USFDA) to market a generic version of Ketoconazole Shampoo. The product is designed to address dandruff, fungal infections, and various other skin conditions.

The shampoo will be manufactured at the Zydus Group's specialized topical production facility located in Changodar, Ahmedabad, marking a strategic expansion in their product line. Notably, Ketoconazole shampoo saw annual US sales of $68.89 million as per IQVIA MAT January 2025 data.

Following the announcement, shares of Zydus Lifesciences experienced a modest rise, trading 0.22% higher on the Bombay Stock Exchange, reflecting market confidence in the company's growth trajectory.

(With inputs from agencies.)