New Delhi, April 9 Glenmark Pharmaceuticals announced on Thursday that it has received final approval from the US health regulator for its generic version of progesterone vaginal inserts used in fertility treatments.
The approval from the US Food and Drug Administration (USFDA) is for 100 mg strength progesterone vaginal inserts, Glenmark Pharmaceuticals Ltd said in a regulatory filing.
The USFDA has determined that the product is bioequivalent and therapeutically equivalent to the reference listed drug, Ferring Pharmaceuticals Inc's Endometrin vaginal inserts, 100 mg, it added.
Glenmark's 100 mg progesterone vaginal inserts will be distributed in the US by Glenmark Pharmaceuticals Inc, USA, the company said.
"This approval for 100 mg Progesterone Vaginal Inserts marks an important addition to our business and reinforces our focus on addressing patient needs in women's healthcare," said Marc Kikuchi, President & Business Head, North America, Glenmark.
Citing IQVIA sales data for the 12 months ended February 2026, the company said the market for Endometrin vaginal inserts, 100 mg, achieved annual sales of approximately USD 59.2 million.