USFDA10 Mar 2025, 03:10 pm
Zydus receives final USFDA approval for Ketoconazole Shampoo, 2% with annual sales of USD 68.89 mn
AI Summary
Zydus Lifesciences Ltd has received final approval from the USFDA to manufacture Ketoconazole Shampoo, 2%. The antifungal medication is used to treat dandruff, fungal infections, and other skin conditions. The shampoo will be produced at the Group’s topical manufacturing site at Changodar, Ahmedabad. As of January 2025, the annual sales of Ketoconazole shampoo in the United States were USD 68.89 mn. Zydus now has 418 approvals and has filed 483 ANDAs since the commencement of the filing process in FY 2003-04.
Key Highlights
- Zydus receives final USFDA approval for Ketoconazole Shampoo, 2%
- Ketoconazole shampoo is an antifungal medication used to treat dandruff, fungal infections, and other skin conditions
- The shampoo will be produced at the Group’s topical manufacturing site at Changodar, Ahmedabad
- Ketoconazole shampoo had annual sales of USD 68.89 mn in the United States (IQVIA MAT January 2025)
- Zydus now has 418 approvals and has filed 483 ANDAs since the commencement of the filing process in FY 2003-04