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Glenmark Pharmaceuticals on Thursday said it has received final approval from the US health regulator for its generic version of progesterone vaginal inserts used in fertility treatments. The approval by the US Food and Drug Administration (USFDA) is for progesterone vaginal inserts of strength 100 mg, Glenmark Pharmaceuticals Ltd said in a regulatory filing. It has been determined by the USFDA to be bioequivalent and therapeutically equivalent to the reference listed drug, Endometrin vaginal inserts, 100 mg of Ferring Pharmaceuticals Inc, it added. Glenmark's progesterone vaginal inserts 100 mg will be distributed in the US by Glenmark Pharmaceuticals Inc, USA, the company said. "This approval for Progesterone Vaginal Inserts, 100 mg marks an important addition to our business and reinforces our focus on addressing patient needs in women's healthcare," Glenmark President & Business Head, North America, Marc Kikuchi said. Citing IQVIA sales data for the 12 months ended February ..

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Glenmark Pharmaceuticals on Friday said its US-based unit is gearing up to introduce a generic sodium phosphates injection in the American market. The Mumbai-based drug firm said its product is therapeutically equivalent to Hosira Inc's reference listed drug. Glenmark will begin distribution of the injection in the US market in April 2026, it said in a regulatory filing. According to IQVIA, sales data for the 12-month period ending December 2025, the Sodium Phosphates Injection USP single-dose vials saw annual sales of around USD 66.8 million. Shares of the company were trading 0.82 per cent up at Rs 2,144.50 apiece on BSE.

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Choice International

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