Glenmark Pharma gets USFDA nod for Progesterone Vaginal Inserts

Glenmark Pharmaceuticals said it has received final USFDA approval for its Progesterone Vaginal Inserts, 100 mg, deemed bioequivalent and therapeutically equivalent to Endometrin Vaginal Inserts, 100 mg of Ferring Pharmaceuticals.

The product will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

Marc Kikuchi, President & Business Head, North America said, At Glenmark, we remain focused on expanding access to quality and affordable medicines while continuing to strengthen our portfolio in the U.S. This approval for Progesterone Vaginal Inserts, 100 mg marks an important addition to our business and reinforces our focus on addressing patient needs in womens healthcare.

 

Glenmark Pharmaceuticals is engaged in the business of development, manufacturing, and marketing of pharmaceutical products, both formulations and active pharmaceutical ingredients, to regulated and semi-regulated markets.

Glenmark Pharmaceuticals reported a 15.9% jump in consolidated net profit to Rs 403.21 crore on a 17.8% increase in revenue from operations to Rs 3,888 crore in Q3 FY26 over Q3 FY25.

Shares of Glenmark Pharmaceuticals declined 1.39% to Rs 2,144.05 on the BSE.