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USFDA concludes GMP and Pre-Approval inspection of Alkems Indore unit

USFDA concludes GMP and Pre-Approval inspection of Alkems Indore unit

July 07, 2022 5:49 IST | capital market
Alkem Laboratories announced that US FDA had conducted a GMP and Pre-Approval inspection at the Companys manufacturing facility located at Indore from 01 July 2022 to 07 July 2022. At the end of the inspection, the Company has received Form 483 with one (1) observation with respect to ANDA filed for the products to be manufactured at the said plant. There is no data integrity observation.Powered by Capital Market - Live News

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