Alembic Pharma Receives USFDA Approval for Generic Efinaconazole Topical Solution

Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Efinaconazole Topical Solution, 10%, a generic antifungal treatment for toenail onychomycosis caused by Trichophyton rubrum and Trichophyton mentagrophytes. The drug is therapeutically equivalent to Bausch Health Americas' Jublia Topical Solution. The market for this medication is estimated at USD 500 million for the year ending December 2025. Alembic has a total of 234 ANDA approvals from the USFDA. Following the announcement, Alembic's shares declined by around 2.7% on the BSE.