Zydus Lifesciences gets final USFDA approval to manufacture antifungal shampoo

Zydus Lifesciences Ltd announced on Monday that it has received a final approval from the United States Food and Drug Administration (USFDA) for Ketoconazole Shampoo, an antifungal medication.The pharmaceutical company has been awarded the final approval by the US drug regulator for manufacturing Ketoconazole Shampoo, 2%. The USFDA approval for the production of the shampoo has also been received for all its subsidiaries and affiliates, Zydus Lifesciences informed the stock exchanges in a filing dated March 10.
The aforementioned shampoo is indicated for the treatment of dandruff, fungal infections and other skin conditions. It is an antifungal medication.
According to Zydus Lifesciences, Ketoconazole shampoo will be produced at the Group’s topical manufacturing facility located at Changodar in Ahmedabad, Gujarat.
As per IQVIA MAT data for January 2025, the Ketoconazole shampoo garnered an annual sale of $68.89 million in the United States.As on December 31, 2024, Zydus Lifesciences has received a total of 418 approvals and has filed 483 Abbreviated New Drug Applications (ANDAs) since the process of filing started in FY03-04.

Following the announcement, shares of Zydus Lifesciences gained over 1% on Monday to hit an intraday high of ₹911 per piece on the BSE. However, the stock pared some of its early gains to trade flat at ₹900.45 apiece, down 0.08%, on the BSE at 12:22 pm.

In the quarter ended December 31, 2024, Zydus Lifesciences reported a 17% year-on-year (YoY) growth in total revenue at ₹5,269 crore, while its net profit rose sharply by 30% to ₹1,023 crore compared to ₹789 crore in the same period last year.

Its profit grew due to a surge in the company’s forex gain, which stood at ₹183 crore during the October to December 2024 period, compared to a gain of ₹21 crore in the year-ago quarter.

Zydus Lifesciences’ Earnings Before Interest, Tax, Depreciation and Amortisation (EBITDA) jumped 25.86% YoY to ₹1,387 crore in Q3FY25 from ₹1,102 crore in the corresponding period of the preceding financial year, while its EBITDA margin expanded by 200 basis points to 26.3% in the quarter.