Alkem Laboratories Ltd receives Form 483 with 10 observations for Baddi facility

The USFDA had conducted an inspection at Alkem Laboratories Limited's manufacturing facility located at Baddi from 19th March, 2024 to 27th March, 2024. At the end of the inspection, the Company has received Form 483 with ten (10) observations. This was a GMP as well as a Pre-Approval Inspection. There is no data integrity observation.

This 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.

Shares of Alkem Laboratories Limited was last trading in BSE at Rs. 4999.00 as compared to the previous close of Rs. 5002.20. The total number of shares traded during the day was 1853 in over 570 trades.

The stock hit an intraday high of Rs. 5057.80 and intraday low of 4963.65. The net turnover during the day was Rs. 9290617.00.

Source : Equity Bulls

Keywords

AlkemLaboratories INE540L01014 USFDA Inspection Form483 10Observations Baddi