Gland Pharma Ltd 25 Jul 2024 12:00 AM
USFDA conducts surprise inspection of Gland Pharma`s Dundigal facility,
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
Gland Pharma Ltd 24 Jul 2024 12:00 AM
Gland Pharma receives USFDA tentative approval for Latanoprostene Bunod Ophthalmic Solution,
Gland Pharma has received tentative approval from the United States Food and Drug Administration (USFDA) for Latanoprostene Bunod Ophthalmic Solution, 0.024%. The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vyzulta� Ophthalmic Solution, 0.024%, registered by Bausch & Lomb Inc. (Bausch & Lomb). Based on the available updates, the Company believes that it is the first applicant to have filed its ANDA with Paragraph IV certification. Upon final approval, the Company may be eligible for 180 days of generic drug exclusivity. Latanoprostene Bunod Ophthalmic Solution, 0.024%, is indicated for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. According to IQVIA, the product had US sales of approximately USD 153 million for the twelve months ended December 2023. Powered by Capital Market - Live News
Gland Pharma Ltd 20 Jul 2024 12:00 AM
Gland Pharma schedules board meeting,
Gland Pharma will hold a meeting of the Board of Directors of the Company on 6 August 2024.Powered by Capital Market - Live News
Gland Pharma Ltd 08 Jun 2024 12:00 AM
Gland Pharma appoints Srinivas Sadu as Executive Chairman and CEO,
Gland Pharma announced that Srinivas Sadu, the incumbent Managing Director (MD) and CEO, has been appointed as Executive Chairman and CEO of the company, effective 10 June  2024. Srinivas Sadu, a seasoned professional with over two decades of rich experience, has been a key part of Gland`s journey. He assumed the role of MD and CEO on April 25, 2019, and has been instrumental in the company`s growth and success. His career with the company began in 2000, and he steadily rose through the ranks to become chief operating officer in 2011Powered by Capital Market - Live News
Gland Pharma Ltd 23 May 2024 12:00 AM
Gland Pharma to hold AGM,
Gland Pharma announced that the 46th Annual General Meeting(AGM) of the company will be held on 30 August 2024.Powered by Capital Market - Live News
Subscribe for our
newsletter
Open Account Now