Alkem Laboratories: Announcement under Regulation 30 (LODR)-Press Release / Media Release | Value Research

Alkem Laboratories: Announcement under Regulation 30 (LODR)-Press Release / Media Release

This is to inform you that US FDA had conducted a Pre-Approval inspection at the Companys manufacturing facility located at St. Louis USA from 06th September 2022 to 14th September 2022. At the end of the inspection the Company has received Form 483 with two (2) observations. There is no data integrity observation.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.

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