Zydus Lifesciences Gains USFDA Approval for Ammonium Lactate Cream
Filing Summary
Zydus Lifesciences Ltd has received final approval from the United States Food and Drug Administration for its Ammonium Lactate Cream, 12%. This topical prescription medication is used for treating dry, scaly skin conditions. The cream will be manufactured at Zydus’s facility in Changodar, Ahmedabad, and distributed by Viona Pharmaceuticals Inc. The product had annual sales of USD 15 million in the United States as of December 2025. Zydus has now secured 430 approvals and filed 505 ANDAs since FY 2003-04.
Zydus Lifesciences Ltd has received final approval from the United States Food and Drug Administration (USFDA) for its Ammonium Lactate Cream, 12%. This approval was announced on February 14, 2026. The cream is a topical prescription medication indicated for the treatment of dry, scaly skin conditions such as xerosis and ichthyosis vulgaris.
The cream will be manufactured at Zydus’s topical manufacturing site located in Changodar, Ahmedabad. Distribution will be handled by Viona Pharmaceuticals Inc. According to IQVIA MAT data from December 2025, the product had annual sales of USD 15 million in the United States.
Zydus has now achieved a total of 430 approvals and has filed 505 Abbreviated New Drug Applications (ANDAs) since the commencement of its filing process in the fiscal year 2003-04.
Zydus Lifesciences Ltd focuses on the development and manufacturing of pharmaceutical products. The company is committed to expanding its product portfolio through strategic regulatory approvals and enhancing its presence in key markets.