Aleor had previously received tentative approval for this Abbreviated New Drug Application (ANDA). The approved ANDA is therapeutically equivalent to the reference listed drug product Metrogel Gel 1%, of Galderma Laboratories LP.

According to IQVIA, metronidazole gel USP has an estimated market size of $29 million for twelve months ending June 2021.

Alembic has a cumulative total of 149 ANDA approvals (132 final approvals and 17 tentative approvals) from USFDA.

Aleor is a 60:40 joint venture between Alembic and Orbicular Pharmaceutical Technologies formed in Apr 2016 focusing on commercialising dermatology products globally.

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's consolidated net profit dropped 45.42% to Rs 164.52 crore on a 1.13% fall in revenue from operations to Rs 1,326.03 crore in Q1 FY22 over Q1 FY21.