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
The positive outcome clears the way for Glenmark to resume commercial manufacturing at the site
Glenmark will begin distribution in November 2025
Glenmark’s Ropivacaine Hydrochloride Injection USP is bioequivalent and therapeutically equivalent to the reference listed drug Naropin Injection of Fresenius Kabi USA
Glenmark’s Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials is bioequivalent and therapeutically equivalent to the reference listed drug, Halaven Injection, 1 mg/2 mL (0.5 mg/mL),of Eisai
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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