Glenmark slips after US FDA classifies Goa facility inspection as OAI

29 Aug 2022 , 10:44 AM

The United States Food and Drug Administration (US FDA) had inspected Glenmarks Goa (India) facility from May 12 to May 20, 2022. Post the inspection, the American drug regulator issued Form-483 with five observations. Announcing updates on the same, Glenmark said that it has received a communication from the US FDA indicating the inspection classification as ?Official Action Indicated? (OAI). The OAI classification implies inter-alia that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved. Glenmark continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest, the company said in a statement. Glenmark Pharmaceuticals is a global pharmaceutical company with a presence across specialty, generics, and OTC businesses. The companys consolidated net profit declined 37.20% to Rs 192.53 crore on a 7.67% fall in sales to Rs 2,720.10 crore in Q1 FY23 over Q1 FY22. Powered by Capital Market – Live News