USFDA14 Feb 2026, 11:21 am
Zydus Lifesciences Receives Final USFDA Approval for Ammonium Lactate Cream, 12%
AI Summary
Zydus Lifesciences Ltd. has received final approval from the USFDA for Ammonium Lactate Cream, 12%. The cream is a topical prescription medication indicated for the treatment of dry, scaly skin (xerosis) and an inherited dry skin condition called ichthyosis vulgaris. It will be manufactured at the group’s topical manufacturing site at Changodar, Ahmedabad, and distributed by Viona Pharmaceuticals Inc. The group now has 430 approvals and has so far filed 505 ANDAs since the commencement of the filing process in FY 2003-04. The cream had annual sales of USD 15 mn in the United States (IQVIA MAT December 2025).
Key Highlights
- Zydus Lifesciences receives final approval from USFDA for Ammonium Lactate Cream, 12%
- Ammonium lactate cream is indicated for the treatment of dry, scaly skin (xerosis) and an inherited dry skin condition called ichthyosis vulgaris
- The cream will be manufactured at the group’s topical manufacturing site at Changodar, Ahmedabad, and distributed by Viona Pharmaceuticals Inc
- Zydus Lifesciences now has 430 approvals and has so far filed 505 ANDAs since the commencement of the filing process in FY 2003-04
- Ammonium lactate cream had annual sales of USD 15 mn in the United States (IQVIA MAT December 2025)