Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for Phytonadione Injectable Emulsion USP, 10 mg/mL Single Dose Ampules. The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vitamin K1 Injectable Emulsion USP, 10 mg/mL, of Hospira, Inc.This Product is indicated in coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity.The Company expects to launch this Product through its marketing partners in the near future. According to IQVIA, the product had US sales of approximately USD 15 million for the twelve months ending September 2024. Powered by Capital Market - Live News

Net profit of Gland Pharma declined 15.74% to Rs 163.53 crore in the quarter ended September 2024 as against Rs 194.08 crore during the previous quarter ended September 2023. Sales rose 2.36% to Rs 1405.83 crore in the quarter ended September 2024 as against Rs 1373.42 crore during the previous quarter ended September 2023. ParticularsQuarter EndedSep. 2024Sep. 2023% Var. Sales1405.831373.42 2 OPM %21.1323.60 - PBDT350.60371.19 -6 PBT256.78289.89 -11 NP163.53194.08 -16 Powered by Capital Market - Live News

Gland Pharma will hold a meeting of the Board of Directors of the Company on 4 November 2024.Powered by Capital Market - Live News

Net profit of Gland Pharma declined 25.94% to Rs 143.76 crore in the quarter ended June 2024 as against Rs 194.10 crore during the previous quarter ended June 2023. Sales rose 15.97% to Rs 1401.71 crore in the quarter ended June 2024 as against Rs 1208.69 crore during the previous quarter ended June 2023. ParticularsQuarter EndedJun. 2024Jun. 2023% Var. Sales1401.711208.69 16 OPM %18.8624.32 - PBDT310.21326.58 -5 PBT218.25261.27 -16 NP143.76194.10 -26 Powered by Capital Market - Live News

Gland Pharma announced that the United States Food and Drug Administration (US FDA) has conducted surprise inspection of the Company`s Dundigal Facility at Hyderabad for Good Manufacturing Practices (GMP) between 22 July 2024 and 25 July 2024. The inspection was concluded with TWO (2) 483 Observations. These observations are procedural in nature. The corrective and preventive actions for these observations will be submitted to the US FDA within the stipulated period. The observations issued are neither repeated observations nor related to data integrity. Powered by Capital Market - Live News