USFDA issues Form 483 to Alkem's manufacturing facility in Indore; Stock under pressure

Form 483 is issued when an adverse observation is made by USFDA

July 08, 2022 9:20 IST | India Infoline News Service
USFDA had conducted a GMP and Pre-Approval inspection at Alkem Laboratories Limited's manufacturing facility located at Indore from July 01, 2022 to July 07, 2022.

At the end of the inspection, the Company has received Form 483 with one observation with respect to ANDA filed for the products to be manufactured at the said plant. There is no data integrity observation, the company informed.

Further as per the filing, this GMP and Pre-Approval Inspection is part of the routine business operations and the Company shall submit to USFDA within the stipulated timeline, a detailed response to close out the said observation.

At around 9:19 AM, Alkem Laboratories was trading at Rs3,101.85 per share down by Rs2.15 or 0.07% from its previous closing of Rs3,104 per share on the BSE.

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