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Alembic Pharma on Thursday announced that its joint venture Aleor Dermaceuticals (Aleor) has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for efinaconazole topical solution.
Efinaconazole topical solution is used to treat fungal toenail infections (infections that may cause nail discoloration, splitting, or pain). Efinaconazole topical solution is in a class of medications called antifungals. The product has an estimated market size of $233 million for twelve months ending December 2020 according to IQVIA.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Jublia Topical Solution of Bausch Health Americas, Inc. Aleor has settled the case with Bausch Health and will launch its generic as per the terms of settlement.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. The drug maker reported 13.8% jump in consolidated net profit to Rs 259.20 crore on a 8.7% rise in net sales to Rs 1,314.33 crore in Q3 FY21 over Q3 FY20.
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