Alkem Laboratories Ltd receives 3 observations from USFDA for API manufacturing facility located at Mandva

The US FDA had conducted an inspection at Alkem Laboratories Limited's API manufacturing facility located at Mandva from 27th November, 2023 to 01st December, 2023. At the end of the inspection, the Company has received Form 483 with three (3) observations. 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. 4641.40 as compared to the previous close of Rs. 4725.70. The total number of shares traded during the day was 10591 in over 3020 trades.

The stock hit an intraday high of Rs. 4740.00 and intraday low of 4622.70. The net turnover during the day was Rs. 49350200.00.

Source : Equity Bulls

Keywords

AlkemLaboratories INE540L01014 USFDA Inspection 3Observations