Zydus Lifesciences gets USFDA’s final approval for Ketoconazole Shampoo

10 Mar 2025 Evaluate

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 $68.89 million 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.

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.

Zydus Lifesciences Share Price

922.45 -1.25 (-0.14%)
11-Dec-2025 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1806.90
Dr. Reddys Lab 1272.95
Cipla 1512.10
Zydus Lifesciences 922.45
Lupin 2080.35
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