Alembic Pharma gets USFDA nod for antifungal ANDA
Alembic Pharmaceuticals announced that it has received final approval from US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Efinaconazole Topical Solution, 10%.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Jublia Topical Solution, 10%, of Bausch Health Americas, Inc. (Bausch). The said drug is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.According to IQVIA, Efinaconazole Topical Solution, 10%, has an estimated market size of $500 million for twelve months ending December 2025.
The company has a cumulative total of 234 ANDA approvals (215 final approvals and 19 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development company, is engaged in the manufacture and marketing of generic pharmaceutical products across global markets. The companys consolidated net profit fell 3.9% to Rs 132.97 crore despite a 10.8% jump in net sales to Rs 1,876.31 crore in Q3 FY26 over Q3 FY25.
The counter fell 1.31% to Rs 757 on the BSE.
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