Gland Pharma Limited updates on USFDA Pre-Market Inspection at Pashamylaram Facility

Gland Pharma Limited has announced that the Office of Medical Device and Radiological Health Operations (OMDRHO), United States Food and Drug Administration (US FDA) 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 from 23rd August, 2023 to 26th August, 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.

Shares of Gland Pharma Limited was last trading in BSE at Rs. 1546.35 as compared to the previous close of Rs. 1574.20. The total number of shares traded during the day was 14861 in over 2036 trades.

The stock hit an intraday high of Rs. 1581.95 and intraday low of 1539.75. The net turnover during the day was Rs. 23114533.00.

Source : Equity Bulls

Keywords

GlandPharma INE068V01023 USFDA Form483 2Observations PashamylaramFacility