Glenmark Pharmaceuticals Limited has secured 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, produced by Ferring Pharmaceuticals Inc. Glenmark’s product will be distributed in the United States by Glenmark Pharmaceuticals Inc., USA.
The approval marks a significant addition to Glenmark’s portfolio, particularly in the area of women’s healthcare. Marc Kikuchi, President & Business Head, North America, commented on the approval, stating that the company remains focused on expanding access to quality and affordable medicines while strengthening its portfolio in the U.S.
According to IQVIA® sales data for the 12-month period ending February 2026, the market for Endometrin® Vaginal Inserts, 100 mg, reached annual sales of approximately $59.2 million. This data includes brand and all available therapeutic equivalents, although Glenmark’s product is approved only for the indications listed in its approved label.
Glenmark Pharmaceuticals Ltd. is a global, research-led pharmaceutical company with a focus on innovation and accessibility. The company operates 11 manufacturing facilities across four continents, supported by six R&D centres, and has a commercial presence in over 80 countries. Glenmark is recognised among the Top 100 biopharmaceutical companies globally by pharmaceutical sales for 2024.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).