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USFDA inspects Alkem Lab's manufacturing facility at St Louis, USA

There is no data integrity observation, the company said on Thursday.

September 16, 2022 9:44 IST | India Infoline News Service
Alkem Laboratories Limited has informed that USFDA had conducted a Pre-Approval inspection at the Company’s manufacturing facility located at St. Louis, USA.

The inspection was held from September 06, 2022 to September 14, 2022. At the end of the inspection, the Company has received Form 483 with two (2) observations. There is no data integrity observation, the company said on Thursday.

It further added, "This Pre-Approval Inspection is part of the routine business operations and the Company shall submit to US FDA within the stipulated timeline, a detailed response to close out the said observations."

On Friday, at around 9:43 AM, Alkem Laboratories Ltd is currently trading at Rs3,183.50 per share down by Rs2.75 or 0.09% from its previous closing of Rs3,186.25 per share on the BSE.

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