Glenmark Pharmaceuticals has received final approval from the US Food and Drug Administration for Progesterone Vaginal Inserts, 100 mg, marking a significant addition to its women’s healthcare portfolio in the United States.

The product has been cleared as bioequivalent and therapeutically equivalent to Endometrin Vaginal Inserts, 100 mg, the reference drug from Ferring Pharmaceuticals. 

The approved product will be distributed in the US by Glenmark Pharmaceuticals Inc., USA, strengthening the company’s North America business at a time when fertility and reproductive health therapies continue to see steady demand.

According to IQVIA data cited by the company, the Endometrin market generated annual sales of nearly $59.2 million for the 12 months ended February 2026, highlighting the commercial opportunity from the launch. 

Marc Kikuchi, President and Business Head, North America at Glenmark Pharmaceuticals, said the approval reinforces the company’s focus on improving access to affordable medicines while deepening its presence in women’s healthcare in the US.

The approval is expected to further diversify Glenmark’s US generics basket and strengthen its position in specialised therapy segments beyond core oral solids, especially in reproductive medicine and fertility support treatments.