Alembic Pharmaceuticals Limited announces USFDA Final Approval for Efinaconazole Topical Solution, 10%

Alembic Pharmaceuticals Limited (Alembic) today announced that it 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. Refer label for a detailed indication.

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 US$ 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.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 770.85 as compared to the previous close of Rs. 762.90. The total number of shares traded during the day was 338 in over 79 trades.

The stock hit an intraday high of Rs. 773.55 and intraday low of 762.50. The net turnover during the day was Rs. 259550.00.

Source : Equity Bulls

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AlembicPharmaceuticals INE901L01018 USFDA FinalApproval EfinaconazoleTopicalSolution