Alkem Laboratories receives 14 USFDA observations

Pharma major Alkem Laboratories nosedived by 11 per cent on Wednesday as the US Food and Drug Administration issued 13 observations to the company’s Daman facility and one observation to its US based manufacturing unit.
 
The US health regulator issued a Form 483 with 13 observations for the company’s Daman facility at Amaliya, after conducting an inspection between March 19 to 27, 2018. The USFDA had conducted the inspection at the company ’s US facility between March 12 to 16, 2018.
 
According to reports, the company has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the set out period.
 
Following the development, Alkem Laboratories hit an intraday low of Rs. 1,856.60 per share and an intraday high of Rs. 2,095 per share on BSE. The stock had touched its 52-week high of Rs. 2,468 per share on January 10, 2018 and its 52-week low of Rs. 1,578 per share on August 11, 2017 on BSE, respectively.
 
At 15:02 hours IST, the stock was trading at Rs. 1,940 per share, lower by 7.28 per cent on BSE on Wednesday. Meanwhile, S&P BSE Sensex was trading at 33,019.68 level, lower by 0.51 per cent and NSE Nifty50 was trading at 10,139 level, 0.44 per cent.