What is Ammonium Lactate Cream, 12% used for?

Ammonium Lactate Cream, 12% is used for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris, helping to moisturize, relieve itching, soften skin, and decrease scaling.

Who manufactures and distributes the approved Ammonium Lactate Cream?

The Ammonium Lactate Cream will be manufactured at Zydus's topical manufacturing site in Ahmedabad and distributed by Viona Pharmaceuticals Inc.

What is the market size for Ammonium Lactate Cream in the U.S.?

The Ammonium Lactate Cream had annual sales of $15 million in the U.S. as of December 2025.

Home / Health / Zydus Gets FDA Nod for Skin Cream

Zydus Gets FDA Nod for Skin Cream

14 Feb

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Summary

Zydus Lifesciences received final FDA approval for Ammonium Lactate Cream.
The cream is indicated for dry, scaly skin conditions like ichthyosis.
Annual U.S. sales for this cream reached $15 million.

Generic drugmaker Zydus Lifesciences announced it has received final approval from the U.S. Food and Drug Administration (FDA) for its Ammonium Lactate Cream, 12%.

This topical prescription medication is specifically indicated for the treatment of dry, scaly skin conditions, including xerosis and ichthyosis vulgaris. The cream works by increasing skin hydration.

As an alpha-hydroxy acid, the formulation helps to relieve itching, soften the skin, and decrease scaling. Zydus stated the product will be manufactured at their topical manufacturing site located in Ahmedabad.

Distribution of the approved cream will be handled by Viona Pharmaceuticals Inc. The U.S. market for Ammonium Lactate Cream, 12% represented annual sales of $15 million, according to IQVIA data from December 2025.

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