Zydus triumphs with USFDA approval for Ketoconazole Shampoo.

Zydus Lifesciences Limited has received final approval from the US Food and Drug Administration (USFDA) for the production of Ketoconazole Shampoo, 2 percent, as announced by the company today. The antifungal medication is used to treat dandruff and fungal skin infections, and will be manufactured at the company’s topical manufacturing facility in Changodar, Ahmedabad. This product is the generic equivalent of Nizoral Shampoo, 2 percent, and is expected to bolster Zydus’s pharmaceutical portfolio in the US market. The approval follows data indicating that Ketoconazole shampoo generated annual sales of $68.89 million in January 2025, according to IQVIA. With this latest approval, Zydus now holds a total of 418 approvals from the USFDA and has filed 483 Abbreviated New Drug Applications (ANDAs) since initiating the process in fiscal year 2003-04, as of December 31, 2024. On the stock market, shares of Zydus Lifesciences Limited were trading at 906.80, up by ₹6 or 0.67 percent on the NSE at 10.25 am.