Glenmark Pharma North Carolina facility gets USFDA OAI status
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Mumbai: Glenmark Pharmaceuticals Limited has recently announced that the company has received Official Action Indicated (OAI) status from the US Food and Drug Administration (USFDA) for the company's Monroe, North Carolina (USA) facility.
The OAI classification implies inter‐alia that the USFDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved.
Monroe facility was inspected from April 04 to May 19, 2022, and received Form‐483 with 17 observations.
The Company had done a voluntary recall of all its products from this site in August 2021 and since then has not been commercializing any product from this site.
Glenmark continues to cooperate with the USFDA and is committed to undertake all necessary steps required to address their observations at the earliest," the company stated in a BSE filing.
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