Glenmark Pharmaceuticals Limited has received final approval from the United States Food & Drug Administration (U.S. FDA) for its Progesterone Vaginal Inserts, 100 mg. The FDA has determined these inserts to be bioequivalent and therapeutically equivalent to the reference listed drug, Endometrin® Vaginal Inserts, 100 mg, previously marketed by Ferring Pharmaceuticals Inc. Glenmark's Progesterone Vaginal Inserts will be distributed in the U.S. by its subsidiary, Glenmark Pharmaceuticals Inc., USA. According to IQVIA® sales data for the 12-month period ending February 2026, the market for Endometrin® Vaginal Inserts, 100 mg achieved annual sales of approximately $59.2 million (approximately ₹493 crore). Marc Kikuchi, President & Business Head, North America at Glenmark, stated that this approval is an important addition to the company's business, reinforcing its focus on women's healthcare and expanding access to quality, affordable medicines in the U.S. The company noted that its Progesterone Vaginal Inserts, 100 mg is approved only for the indications listed in Glenmark’s approved label. Glenmark Pharmaceuticals is a global, research-led pharmaceutical company with a diversified portfolio across respiratory, dermatology, and oncology.
