USFDA concludes GMP and Pre-Approval inspection of Alkem's Indore unit

Alkem Laboratories announced that US FDA had conducted a GMP and Pre-Approval inspection at the Company's 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.

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