Glenmark's Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug
Glenmark will begin distribution in November 2025
This approval marks a significant milestone in women’s health, introducing Bayer’s first hormone-free treatment for menopause-related symptoms
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 $60.7 million
The acquired ANDAs represent a market opportunity of about US$ 38 million in the USA
The GMP-compliant facility with automated environmental monitoring accommodates both white room and class 7 and 8 cleanroom space
The portfolio consists of liquids and immediate release solid orals which are in the therapeutic segment to treat infections associated with UTIs
According to IQVIATM sales data for the 12-month period ending February 2025, the Adderall Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg market3 achieved annual sales of approximately $421.7 million.
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