Alkem Labs receives 4 Form 483 observations from USFDA

Alkem Laboratories (Alkem Labs) has received four observations from USFDA at its manufacturing facility located at St. Louis, Fen ton Park, USA. Inspite of this development, the stock of Alkem Labs is trading higher by a per cent on the BSE.

The USFDA had inspected the company's manufacturing facilities located at St. Louis, Fen ton Park, USA from 16th August 2019 to 22nd August, 2019 and at Baddi, India from 19th August, 2019 to 23rd August, 2019. Post the inspection, the company has received a Form 483 with four observations for the facility located at St. Louis, Fenton Park, USA and, at the same time, no Form 483 is received for the facility located in India.

The pharma company is suggested to give a detailed response with adequate corrective and preventive measures to address the USFDA Observations for the US facility and the same is proposed to be filed within the timeline stipulated by USFDA.

On Thursday, SBI Mutual Fund and Aditya Birla Sun Life Mutual Fund had bought shares of Alkem Labs worth around Rs. 538 crore through open market transactions. According to NSE data, SBI Mutual Fund bought 24 lakh shares and Aditya Birla Sun Life MF purchased 7.5 lakh shares of the pharma company for Rs. 1,708.45 apiece. While SBI MF acquired shares for Rs. 410.02 crore, Aditya Birla bought the scrips for Rs. 128.13 crore.

On Monday, the stock of Alkem Labs is trading up by Rs. 17.95 or 1.01 per cent at Rs. 1789.25 on the BSE. On Friday, the stock of the company had closed at Rs. 1750.05, an increase by 1.21 per cent or Rs. 21.25. The 52-week high is Rs. 2265.00 and 52-week low is Rs. 1660.35 on BSE.