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

Cosmo Pharmaceuticals N.V. and Glenmark Pharmaceuticals announced that the European Commission (EC) has granted Marketing Authorization (MA) for Winlevi� (clascoterone 10 mg/g cream), following the positive opinion issued by the European Medicines Agency`s Committee for Medicinal Products for Human Use (CHMP) on 25 August 2025. Winlevi� is authorized in EU for the treatment of acne vulgaris in both adults and adolescents aged 12 to <18 years, with usage in adolescents limited to facial application. With receipt of this approval, Glenmark will initiate commercializing Winlevi� across 15 countries in EU namely Bulgaria, the Czech Republic, Denmark, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain and Sweden. Powered by Capital Market - Live News

Net profit of Glenmark Pharmaceuticals rose 72.31% to Rs 610.35 crore in the quarter ended September 2025 as against Rs 354.21 crore during the previous quarter ended September 2024. Sales rose 76.56% to Rs 6003.79 crore in the quarter ended September 2025 as against Rs 3400.50 crore during the previous quarter ended September 2024. ParticularsQuarter EndedSep. 2025Sep. 2024% Var. Sales6003.793400.50 77 OPM %39.3017.70 - PBDT2493.72592.85 321 PBT2352.52472.57 398 NP610.35354.21 72 Powered by Capital Market - Live News