Alembic Pharmaceuticals’ joint venture gets USFDA’s tentative approval for Metronidazole Gel

Alembic Pharmaceuticals’ (Alembic) joint venture Aleor Dermaceuticals (Aleor) has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Metronidazole Gel USP, 1%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Metrogel Gel, 1 %, of Galderma Laboratories LP (Galderma).

Metronidazole Gel USP, 1% has an estimated market size of $32 million for twelve months ending December 2020 according to IQVIA.

Alembic has a cumulative total of 142 ANDA approvals (124 final approvals and 18 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.