Zydus Secures Final USFDA Approval for Ammonium Lactate Cream, Expands Generics Basket
New Delhi: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for Ammonium Lactate Cream, 12%, further strengthening its dermatology portfolio in the United States market.
The company, in a regulatory filing, said that it has secured final approval for Ammonium Lactate Cream, 12% (USRLD: Lac-Hydrin Cream®, 12%).
Ammonium Lactate Cream, 12% is a topical prescription medication indicated for the treatment of dry, scaly skin (xerosis) and an inherited dry skin condition known as ichthyosis vulgaris. The cream works by increasing skin hydration and, as an alpha-hydroxy acid, helps relieve itching, soften the skin, and reduce scaling.
The product will be manufactured at the group’s topical manufacturing facility located at Changodar, Ahmedabad. Distribution in the United States will be handled by Viona Pharmaceuticals Inc..
As per IQVIA MAT December 2025 data, Ammonium Lactate Cream recorded annual sales of USD 15 million in the United States, indicating a steady market opportunity for the product.
With this latest approval, the group now has a total of 430 approvals. Since the commencement of its filing process in FY 2003-04, Zydus has filed 505 ANDAs, as of December 31, 2025.
Zydus Lifesciences Limited, along with its subsidiaries and affiliates, continues to expand its presence in the US generics market through a steady pipeline of filings and approvals.
