Alembic Pharmaceuticals Limited has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Efinaconazole Topical Solution, 10%. The approval marks another key milestone in the company’s expanding US generics portfolio.
The approved product is therapeutically equivalent to the reference listed drug (RLD), Jublia Topical Solution, 10%, marketed by Bausch Health Americas, Inc.. Efinaconazole Topical Solution is indicated for the topical treatment of onychomycosis of the toenails caused by Trichophyton rubrum and Trichophyton mentagrophytes, two common fungal pathogens responsible for nail infections.
Alembic was among the first ANDA applicants to submit a substantially complete application with a Paragraph IV certification, positioning it strategically in the competitive US market. According to IQVIA data, Efinaconazole Topical Solution, 10%, recorded an estimated market size of approximately $500 million for the twelve months ending December 2025, highlighting the strong commercial potential of the product.
With this approval, Alembic continues to strengthen its US generics footprint. The company now has a cumulative total of 234 ANDA approvals from the USFDA, comprising 215 final approvals and 19 tentative approvals.