Gland Pharma Ltd. has announced that the Office of Medical Device and Radiological Health Operations (OMDRHO), United States Food and Drug Administration (USFDA) conducted 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 Pashamylaram Facility at Hyderabad.

The Pre-Market Inspection was conducted from August 23-26, 2023. The Company has received 2 (two) observations on Form 483 with respect to ANDA filed for the product to be manufactured in a PEN device at the said Facility. There is no data integrity observation.

The Company is committed to address the observations and will submit its response to US FDA within the stipulated time.

Gland Pharma Ltd. recently received Establishment Inspection Report (EIR) from the USFDA indicating closure of the inspection for Dundigal Facility.