Zydus gets USFDA approval for Ketoconazole Shampoo production

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Zydus Lifesciences Limited received final approval from the US Food and Drug Administration (USFDA) to manufacture Ketoconazole Shampoo, 2 per cent, according to the announcement issued by the company today.

The shares of Zydus Lifesciences Limited were trading at 906.80 up by ₹6 or 0.67 per cent on the NSE today at 10.25 am.

The antifungal medication, used to treat dandruff and fungal skin infections, will be produced at the company’s topical manufacturing facility in Changodar, Ahmedabad. The product is the generic equivalent of Nizoral Shampoo, 2 per cent.

The approval adds to Zydus’s growing pharmaceutical portfolio in the US market, where Ketoconazole shampoo generated annual sales of $68.89 million according to IQVIA data from January 2025.

With this latest approval, Zydus now holds 418 approvals from the USFDA. The company has filed 483 Abbreviated New Drug Applications (ANDAs), since it began the filing process in fiscal year 2003-04, as reported in the company’s data through December 31, 2024.





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