Zydus Secures FDA Nod for Ketoconazole Shampoo Manufacturing

Zydus Lifesciences Limited has acquired final permission from the US Food and Drug Administration (USFDA) to manufacture 2% ketoconazole shampoo. According to the company's release today.

On the NSE, Zydus Lifesciences Limited's shares were up ?6 or 0.67 percent at 906.80 this morning at 10.25 a.m.

The company's topical manufacturing facility in Changodar, Ahmedabad, will create the antifungal drug, which is used to treat fungal skin diseases and dandruff. This product is the generic version of 2% Nizoral Shampoo.The approval expands Zydus's expanding pharmaceutical range in the US market, where, according to IQVIA statistics from January 2025, ketoconazole shampoo brought in $68.89 millionannually.

Zydus now has 418 USFDA approvals after this most recent one. According to the business's data through December 31, 2024, since the filing procedure started in fiscal year 2003–04, the company has submitted 483 Abbreviated New Drug Applications (ANDAs).

The primary activity of Zydus Lifesciences Limited, a multinational pharmaceutical firm based in India, is the production of generic medications. The USFDA approved a prostate cancer medication in October 2024. The USFDA has given Zydus Lifesciences permission to produce Enzalutamide pills, which are used to treat prostate cancer. Patients with castration-resistant and metastatic castration-sensitive prostate cancer are the target of this medication, which is an androgen receptor inhibitor. The product will be produced at Zydus' Ahmedabad factory. The company's larger plans to increase the range of cancer medicines it offers in the US market include this clearance.