Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for efinaconazole topical solution, 10 percent.

The approved product is therapeutically equivalent to the reference listed drug (RLD), Jublia topical solution, 10 percent, marketed by Bausch Health Americas, Efinaconazole topical solution is indicated for the treatment of onychomycosis of the toenails caused by Trichophyton rubrum and Trichophyton mentagrophytes.

Alembic was among the first applicants to submit a substantially complete ANDA with a Paragraph IV certification for this product. According to IQVIA data, the reference product recorded an estimated market size of approximately USD 500 million for the 12 months ending December 2025.

With this approval, Alembic’s cumulative US FDA approvals now stand at 234, comprising 215 final approvals and 19 tentative approvals.

Founded in 1907 and headquartered in India, Alembic Pharmaceuticals is a vertically integrated, research-driven pharmaceutical company engaged in the development, manufacturing and global marketing of generic medicines.