Zydus Lifesciences Secures USFDA Approval for Ketoconazole Shampoo

10 Mar 2025 , 03:09 PM

Zydus Lifesciences Ltd has received final approval from the United States Food and Drug Administration (USFDA) to produce the antifungal drug Ketoconazole Shampoo, 2%. The approval is valid for all Zydus Lifesciences affiliates and subsidiaries, said the company in the stock exchange filing dated March 10, 2025.

Ketoconazole Shampoo, 2% is used to treat dandruff, fungal infections, and other skin conditions due to fungal overgrowth. This antifungal shampoo will be manufactured in Zydus Lifesciences’ topical manufacturing unit located at Changodar, Ahmedabad, Gujarat.

The Ketoconazole shampoo market generated annual sales of $68.89 million in the United States according to the IQVIA MAT data, January 2025, illustrating considerable demand. Zydus Lifesciences has received a total of 418 USFDA approvals and filed 483 Abbreviated New Drug Applications (ANDAs) since the commencement of ANDA filings in FY03-04 as of December 31, 2024.

For the quarter ended December 31, 2024, Zydus Lifesciences reported a total revenue of ₹5,269 crore, a 17% YoY growth. Its net profit rose 30% year-on-year (YoY) to ₹1,023 crore as against ₹789 crore in the corresponding quarter last year.

A major factor behind profit growth was a significant forex gain of ₹183 crore during the October-December 2024 period, as against ₹21 crore in the same quarter a year earlier. Consolidated Earnings Before Interest, Tax, Depreciation and Amortization (EBITDA) grew 25.86% YoY at ₹1,387 crore for the Q3FY25 period compared to ₹1,102 crore for Q3FY24 period. Further, EBITDA Margin In Q3FY25 increased By 200 bps to 26.3% on account of increased operational efficiency and profitability.