Glenmark Pharma gets Official Action Indicated observation from USFDA; Stock sheds 2.5%

29 Aug 2022 , 10:08 AM

Glenmark Pharmaceuticals Limited has informed to the exchanges regarding the US FDA inspection at Glenmark’s Goa (India) facility from May 12 to May 20, 2022 and issuance of Form-483 by US FDA with five observations.

In addition to this, the Company informed that it has received a communication from the USFDA indicating the inspection classification as “Official Action Indicated” (OAI). The OAI classification implies inter-alia that USFDA 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 USFDA agency and is committed to undertake all important steps required to address their observations at the earliest”, the company said.

it further added that “it is committed to maintaining the highest quality and compliant manufacturing standards at all of its facilities worldwide.”

At around 10:09 AM, Glenmark Pharmaceuticals Ltd is currently trading at Rs367.90 per share down by Rs9.3 or 2.47% from its previous closing of Rs377.20 per share on the BSE.

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