Glenmark gets USFDA approval for generic Endometrin vaginal inserts
Final approval for progesterone vaginal inserts expands Glenmark’s women’s healthcare portfolio in the US, targeting a market of over $59 million
Final approval for progesterone vaginal inserts expands Glenmark’s women’s healthcare portfolio in the US, targeting a market of over $59 million
This marks a meaningful step in the company's continued expansion in the region
Glenmark's Milnacipran Hydrochloride Tablets, 12.5 mg, 25 mg, 50 mg, and 100 mg is the authorized generic to Savella Tablets, 12.5 mg, 25 mg, 50 mg, and 100 mg
The product is bioequivalent and therapeutically equivalent to Fresenius Kabi’s reference drug (NDA 212832)
The product addresses a market with approximately $66.8 million in annual sales as of December 2025.
According to IQVIA sales data for the 12-month period ending October 2025, the Epinephrine Injection USP, 30 mg/30 mL (1 mg/mL) market2 achieved annual sales of approximately $67.6 million
Glenmark's Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug
Glenmark’s Ropivacaine Hydrochloride Injection USP is bioequivalent and therapeutically equivalent to the reference listed drug Naropin Injection of Fresenius Kabi USA
According to IQVIA sales data for the 12-month period ending June 2025, the Mycamine for Injection, 50 mg/vial and 100 mg/vial market achieved annual sales of approximately $60.7 million
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