Gland Pharma has received the Establishment Inspection Report (EIR) from the Office of Product Evaluation and Quality Center for Devices and Radiological Health, US FDA indicating closure of the inspection at Dundigal Facility in Hyderabad. Earlier, the Pre-Market Inspection covering US FDA’s Quality System/Current Good Manufacturing Practice regulations for Medical Devices (21 CFR Part 820) at the company’s Dundigal Facility at Hyderabad was conducted from August 22, 2022 to August 25, 2022. The company had received 1 observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.
