US FDA Inspection at Alkem's manufacturing facility located at Indore

US FDA had conducted a GMP and Pre-Approval inspection at Alkem Laboratories Limited's manufacturing facility located at Indore from 01st July, 2022 to 07th 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.

This GMP and 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 observation.

Shares of Alkem Laboratories Limited was last trading in BSE at Rs. 3104.00 as compared to the previous close of Rs. 3081.75. The total number of shares traded during the day was 901 in over 311 trades.

The stock hit an intraday high of Rs. 3115.90 and intraday low of 3093.40. The net turnover during the day was Rs. 2796584.00.

Source : Equity Bulls

Keywords

AlkemLaboratories INE540L01014 USFDA GMP PreApproval Inspection Indore ManufacturingFacility Form483