Glenmark Pharmaceuticals Inc., USA (Glenmark) announces the launch of Epinephrine Injection USP, 30 mg/30 mL (1 mg/mL) Multiple-Dose Vial. Glenmark`s Epinephrine Injection USP, 30 mg/30 mL (1 mg/mL) Multiple-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug, Epinephrine Injection USP, 30 mg/30 mL (1 mg/mL) of BPI Labs, LLC, NDA 205029. Powered by Capital Market - Live News

Glenmark Pharmaceuticals Inc., USA (Glenmark) announced the upcoming launch of Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial. Glenmark`s Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug, Leucovorin Calcium for Injection, 350 mg/vial, of Hospira, Inc. [NDA 008107]. Glenmark will begin distribution in December 2025.Powered by Capital Market - Live News

Glenmark Pharmaceuticals announced that the U.S. Food and Drug Administration (U.S. FDA) completed Pre-Approval Inspection at the Company`s formulations manufacturing facility in Chhatrapati Sambhajinagar (Aurangabad). The inspection was carried out from 24 November to 28 November 2025, and concluded with zero 483 observations. Powered by Capital Market - Live News

Glenmark Pharmaceuticals has received Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the United States Food & Drug Administration (U.S. FDA) for its formulations manufacturing facility situated in Monroe, North Carolina, USA. This is following an inspection conducted by the Agency from 09 June to 17 June 2025. The commercial manufacturing at the Monroe site will now restart.Powered by Capital Market - Live News

Glenmark Pharmaceuticals announced the launch of Nebzmart� GFB Smartules� and Glenmark Airz� FB Smartules�, the world`s first nebulized, fixed-dose triple therapy for the treatment of Chronic Obstructive Pulmonary Disease (COPD). Both products combine three proven medicines - Glycopyrronium, Formoterol, and Budesonide - to reduce airway obstruction, inflammation, and improve lung function and symptom control. As a single, easy-to-use nebulized therapy, it minimizes the burden of multiple medications. This marks a breakthrough as a new standard of care for COPD patients, especially those who struggle with using Metered Dose Inhalers (MDI) or Dry Powder Inhalers (DPI). Powered by Capital Market - Live News