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Hot Pursuit News

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(10 Mar 2025, 10:34)

Zydus Life gets USFDA approval for Ketoconazole Shampoo, 2%

Zydus Lifesciences announced that it has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Ketoconazole shampoo, 2%.


Ketoconazole shampoo, a generic version of Nizoral Shampoo (2%), is an antifungal medication used to treat dandruff, fungal infections, and other skin conditions. It will be produced at the group’s topical manufacturing site at Changodar, Ahmedabad.

According to IQVIA MAT data for January 2025, Ketoconazole shampoo had annual sales of $68.89 million in the United States.

With this approval, Zydus Lifesciences now holds 418 USFDA approvals, having filed 483 ANDAs since FY 2003-04.

Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company reported a 29.62% jump in consolidated net profit of Rs 1,023.5 crore in Q3 FY25 compared with Rs 789.6 crore in Q3 FY24. Revenue from operations increased 16.96% YoY to Rs 5,269.1 crore during the quarter.

Shares of Zydus Lifesciences rose 0.67% to Rs 907.20 on the BSE.

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