Glenmark gets nod from US Food & Drug Administration for generic drug

Glenmark Pharmaceuticals on Friday said its US-based unit has received approval from the US health regulator to market Metronidazole Vaginal gel, in the American market.

The drug firm has received final approval by the United States Food & Drug Administration (USFDA) for its product which is a generic version of Bausch Health US LLC's MetroGel-Vaginal, the drug firm said in a statement.

According to IQVIA sales data for the 12-month period ending November 2021, the MetroGel-Vaginal Gel achieved annual sales of approximately around USD 60.4 million.

Glenmark's current portfolio consists of 173 products authorised for distribution in the US marketplace and 46 ANDA's pending approval with the USFDA.

In addition to these internal filings, the drug firm continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio, Glenmark noted.