USFDA inspects Gland Pharma's Dundigal Facility in Hyderabad

The Company has received 1 (ONE) observation on Form 483 with respect to ANDA.

August 26, 2022 9:19 IST | India Infoline News Service
Gland Pharma Limited has informed to the exchanges regarding USFDA Inspection at Dundigal Facility, Hyderabad.
It is informed 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 Dundigal Facility at Hyderabad from August 22, 2022 to August 25, 2022.
Now, the Company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility. There is no data integrity observation as for now, the company said.
It further added, the Company is committed to address the observation and will submit its response to US FDA within the stipulated time.

At around 9:19 AM, Gland Pharma was trading at Rs2396.05 per share lower by 0.29% on the BSE.

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