Gland Pharma announced that following the Inspection for Good Manufacturing Practices (GMP) by US FDA at the Company's Pashamylaram Facility at Hyderabad between 25 July, 2024 and 02 August, 2024; the Company has received Establishment Inspection Report (EIR) from the US FDA indicating closure of the inspection.Powered by Capital Market - Live

The Pashamylaram facility received an EIR, which indicates closure of the inspection, Gland Pharma said in a filing. The USFDA inspected the facility between 25 July 2024 and 2 August 2024 for good manufacturing practices (GMP) and issued three Form 483 observations. These observations were procedural in nature. Gland Pharma is one of the largest and fastest-growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. The company also pioneered Heparin technology in India. On a consolidated basis, the firm's net profit declined 15.74% to Rs 163.53 crore despite a 2.36% increase in revenue from operations to Rs 1,405.83 crore in Q2 FY25 over Q2 FY24. The scrip rose 0.10% to settle at Rs 1,678.95 on Friday, 18 January 2025. Powered by Capital Market - Live

Gland Pharma Ltd is up for a third straight session today. The stock is quoting at Rs 1699.55, up 1.41% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is down around 0.43% on the day, quoting at 23211.05. The Sensex is at 76656.14, down 0.5%. Gland Pharma Ltd has slipped around 3.65% in last one month. Meanwhile, Nifty Pharma index of which Gland Pharma Ltd is a constituent, has slipped around 1.43% in last one month and is currently quoting at 21909.75, up 0.39% on the day. The volume in the stock stood at 62727 shares today, compared to the daily average of 2.35 lakh shares in last one month.The PE of the stock is 25.06 based on TTM earnings ending September 24.Powered by Capital Market - Live

Gland Pharma will hold a meeting of the Board of Directors of the Company on 3 February 2025.Powered by Capital Market - Live

The United States Food and Drug Administration (USFDA) conducted a surprise inspection of the company's Dundigal Facility for good manufacturing practices (GMP) between 22 July 2024 and 25 July 2024. Earlier, on 25 July, the durg maker stated that the inspection was concluded with 2 483 observations. These observations were procedural in nature and also were neither repeated observations nor related to data integrity. Now, the company has received an EIR from the USFDA stating closure of the inspection. Gland Pharma is one of the largest and fastest-growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. The company also pioneered Heparin technology in India. On a consolidated basis, the firm's net profit declined 15.74% to Rs 163.53 crore despite a 2.36% increase in revenue from operations to Rs 1,405.83 crore in Q2 FY25 over Q2 FY24. The scrip rose 0.24% to currently trade at Rs 1,676.75 on the BSE.Powered by Capital Market - Live

Gland Pharma Ltd dropped for a fifth straight session today. The stock is quoting at Rs 1785, down 2.46% on the day as on 13:19 IST on the NSE. The benchmark NIFTY is down around 0.02% on the day, quoting at 23521.8. The Sensex is at 77676.23, up 0.07%.Gland Pharma Ltd has gained around 0.55% in last one month.Meanwhile, Nifty Pharma index of which Gland Pharma Ltd is a constituent, has increased around 0.59% in last one month and is currently quoting at 22868.1, down 1.9% on the day. The volume in the stock stood at 3.11 lakh shares today, compared to the daily average of 2.26 lakh shares in last one month.The PE of the stock is 27.3 based on TTM earnings ending September 24.Powered by Capital Market - Live

Gland Pharma Ltd rose for a third straight session today. The stock is quoting at Rs 1900.05, up 3.15% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is down around 0.45% on the day, quoting at 24079.19921875. The Sensex is at 79453, down 0.61%. Gland Pharma Ltd has added around 5.51% in last one month. Meanwhile, Nifty Pharma index of which Gland Pharma Ltd is a constituent, has added around 3.86% in last one month and is currently quoting at 23553.4, down 1.12% on the day. The volume in the stock stood at 3.67 lakh shares today, compared to the daily average of 1.73 lakh shares in last one month.The PE of the stock is 27.52 based on TTM earnings ending September 24.Powered by Capital Market - Live

In a regulatory filing made yesterday, the company stated that the Agence nationale de s'curit' du m'dicament et des produits de sant' (ANSM), France, conducted a good manufacturing practices (GMP) inspection of Cenexi's Fontenay manufacturing facility (material subsidiary of Gland Pharma) between 9 to 19 of December 2024. The said inspection was concluded, and the facility received an official notification on 24 December 2024, citing ten observations. Cenexi is committed to working closely with the ANSM to address the observations,' Gland Pharma stated. Gland Pharma is one of the largest and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. The company also pioneered Heparin technology in India. On a consolidated basis, the firm's net profit declined 15.74% to Rs 163.53 crore despite a 2.36% increase in revenue from operations to Rs 1,405.83 crore in Q2 FY25 over Q2 FY24. The scrip was up 0.62% to currently trade at Rs 1791 on the BSE. Powered by Capital Market - Live

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vitamin K1 Injectable Emulsion USP, 10 mg/mL, of Hospira, Inc. The approved drug is indicated in coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity. The pharma company expects to launch this Product through its marketing partners in the near future. According to IQVIA, the product had US sales of approximately $15 million for the twelve months ending September 2024. Gland Pharma is one of the largest and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. The company also pioneered Heparin technology in India. On a consolidated basis, the firm's net profit declined 15.74% to Rs 163.53 crore despite a 2.36% increase in revenue from operations to Rs 1,405.83 crore in Q2 FY25 over Q2 FY24. Powered by Capital Market - Live

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