Zydus Lifesciences gets USFDA’s final approval for Ammonium Lactate Cream

14 Feb 2026 Evaluate

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) 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 called ichthyosis vulgaris. It is used to moisturise the skin by increasing hydration and, as an alpha-hydroxy acid, helps relieve itching, soften skin, and decrease skin scaling.

Ammonium lactate cream will be manufactured at the group’s topical manufacturing site at Changodar, Ahmedabad, and distributed by Viona Pharmaceuticals Inc. Ammonium lactate cream had annual sales of $15 million in the United States (IQVIA MAT December 2025). The group now has 430 approvals and has so far filed 505 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as Cadila Healthcare), a company limited by shares, incorporated and domiciled in India, operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.


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904.85 -15.95 (-1.73%)
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