Zydus Lifesciences announced receiving the final approval from the USFDA for its Ammonium Lactate Cream, 12% (USRLD: Lac-Hydrin Cream®, 12%). This topical prescription medication is used to treat dry, scaly skin conditions. The product will be manufactured in Changodar, Ahmedabad, and distributed in the US, capitalizing on market sales that stood at USD 15 million as of December 2025. This marks another successful US filing for the group.
Zydus Secures USFDA Approval for Topical Medication
Zydus Lifesciences Limited confirmed on February 14, 2026, that it has received the final approval from the United States Food and Drug Administration (USFDA) for its Ammonium Lactate Cream, 12%. This product is marketed under the USRLD: Lac-Hydrin Cream®, 12%.
Therapeutic Use and Composition
The Ammonium Lactate Cream, 12%, is indicated as a topical prescription medication. Its primary uses include the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris. The cream functions by moisturizing the skin through increased hydration. Furthermore, as an alpha-hydroxy acid, it aids in relieving itching, softening the skin, and reducing scaling.
Manufacturing and Market Potential
The cream will be manufactured at the group’s topical manufacturing facility located in Changodar, Ahmedabad. Distribution within the United States will be managed by Viona Pharmaceuticals Inc. The announcement highlighted the market size, noting that the Ammonium Lactate Cream achieved annual sales of USD 15 million in the United States, based on IQVIA data up to December 2025.
Cumulative Regulatory Achievements
This approval adds to Zydus’s overall portfolio of US regulatory successes. As of December 31, 2025, the group has secured a total of 430 approvals. Since the commencement of the filing process in the FY 2003-04, Zydus has filed 505* ANDAs in total.
Source: BSE
