Glenmark Receives U.S. FDA Approval for Progesterone Vaginal Inserts, 100 mg
Glenmark Pharmaceuticals Limited has secured final approval from the United States Food & Drug Administration (U.S. FDA) for Progesterone Vaginal Inserts, 100 mg. The FDA determined that the product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Endometrin® Vaginal Inserts, 100 mg, manufactured by Ferring Pharmaceuticals Inc. (NDA 022057). Glenmark's Progesterone Vaginal Inserts, 100 mg will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.Marc Kikuchi, President & Business Head, North America, commented on the launch, stating that the approval for Progesterone Vaginal Inserts, 100 mg, marks an important addition to the company's business and reinforces its focus on addressing patient needs in women's healthcare, while remaining dedicated to expanding access to quality and affordable medicines.
IQVIA® sales data for the 12-month period ending February 2026 showed that the Endometrin® Vaginal Inserts, 100 mg market achieved annual sales of approximately $59.2 million*.
The company's global pharmaceutical operations are supported by 11 worldclass manufacturing facilities across four continents and six cutting-edge R&D centers. Glenmark Pharmaceuticals Ltd. focuses on providing a diversified portfolio across branded, innovative, generics, and consumer health products, with key areas of focus including respiratory, dermatology, and oncology.
The following table summarizes the key approval details:
| Product | Strength | Status | Reference Drug (RLD) |
|---|---|---|---|
| Progesterone Vaginal Inserts | 100 mg | U.S. FDA Approved | Endometrin® Vaginal Inserts, 100 mg |
*Data source: IQVIA® National Sales Perspectives: Retail & Non-Retail, February 2026.
GLENMARK Stock Price Movement
On Wednesday, Glenmark Pharmaceuticals Limited shares rallied, closing at ₹2173.5 after gaining 2.86%. The stock concluded its trading on a total volume of 544,557 shares.Source:
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