Alkem Labs receives 4 observations from USFDA

On Thursday, shares of Alkem Laboratories marked a positive start in the morning session on Thursday following the news that the pharma company received Establishment Inspection Report (EIR) for its manufacturing facility located at St. Louis, Fenton Logistics Park, USA.

The stock was expected to see some good trade throughout the day as an EIR is a positive development for the facility that gets reinstate into a state of Good Manufacturing Practices.

The US FDA has issued an EIR for the facility which was inspected from 16th August, 2019 to 22nd August, 2019. In the statement to the exchange, the company mentioned that it had received a Form 483 issued by the US FDA containing four observations. The inspection has now been closed by the US FDA.

Last week, Alkem Laboratories had received a Form 483 with two (2) observations after the US FDA had conducted an inspection from 26th August, 2019 to 30th August, 2019 at the company's manufacturing facility located at Daman, India.

According to the FDA, Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Observations are made when in the investigator’s judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.

Shares of ALkem Laboratories Ltd had opened at Rs. 1850.00 as compared to the previous close of Rs. 1848.50. The stock hit an intraday high of Rs. 1868.50 and intraday low of Rs. 1830.95. AT closing hours, the stock was trading at Rs. 1821.00, down 1.49 per cent from its previous close.