(RTTNews) - Glenmark Pharmaceuticals Limited (532296) has received final approval from the U.S. FDA for its Progesterone Vaginal Inserts, 100 mg, marking a new addition to the company's women's health portfolio in the United States.
The product has been deemed bioequivalent to Endometrin (100 mg), the reference listed drug marketed by Ferring Pharmaceuticals Inc. Glenmark will distribute the approved inserts in the U.S. through its subsidiary, Glenmark Pharmaceuticals Inc., USA.
According to IQVIA sales data for the 12-month period ending February 2026, the Endometrin Vaginal Inserts, 100 mg market generated approximately $59.2 million in annual sales across brand and therapeutic equivalents.
Marc Kikuchi, President & Business Head, North America, emphasized the strategic importance of the approval, noting that it reinforces Glenmark's commitment to expanding access to quality and affordable medicines. He added that the product strengthens the company's U.S. portfolio while supporting patient needs in women's healthcare.
Glenmark clarified that its Progesterone Vaginal Inserts are approved only for the indications listed in its FDA-approved label and are not marketed for all reference drug indications. The FDA-approved label for the reference drug Endometrin notes that Progesterone Vaginal Inserts are used to support embryo implantation and early pregnancy in women undergoing assisted reproductive technology (ART) procedures.
The approval further supports Glenmark's broader global footprint, which includes 11 manufacturing facilities, six R&D centers, and commercial operations across more than 80 countries. The company continues to focus on respiratory, dermatology, oncology, and women's health as part of its diversified portfolio.
Glenmark has traded between INR 1336.00 and INR 2297.90 over the past year. The stock is currently trading at INR 2160.90, down 0.38%.
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