Alembic Pharmaceuticals has received final approval from the 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). Efinaconazole Topical Solution is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes. 

Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification. Efinaconazole Topical Solution, 10%, has an estimated market size of $500 million for twelve months ending December 2025 according to IQVIA. 

Alembic has a cumulative total of 234 ANDA approvals (215 final approvals and 19 tentative approvals) from USFDA.

Alembic Pharmaceuticals (Alembic Pharma) is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.