Alembic Pharmaceuticals (Alembic), a vertically integrated research and development pharmaceutical company on April 8 announced that its joint venture Aleor Dermaceuticals (Aleor) has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for 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, 10% is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

Efinaconazole Topical Solution, 10% has an estimated market size of USD 233 million for twelve months ending December 2020 according to IQVIA.

Aleor has settled the case with Bausch Health and will launch its generic as per the terms of settlement.

Alembic has a cumulative total of 140 ANDA approvals (123 final approvals and 17 tentative approvals) from USFDA.

 Shares of the company declined Rs 2.1, or 0.22%, to settle  at  Rs 971.15.  The total volume of shares traded  was  22,799 at  the BSE (Thursday).