Alkem Laboratories, a Rs. 5,850 crore plus pharma giant, has received a Form 483 with thirteen observations from US FDA. The inspection had conducted at the company's manufacturing facility located at Amaliya, Daman, India from March 19 to March 27, 2018. Further it also received one Form 483 observation for its facility located at St. Louis, USA.
Alkem scrip declined sharply by over Rs. 58 to Rs. 2,034 on BSE in the morning session today from its previous day's close of Rs. 2,092.30.
The company shall put together a detailed response with adequate corrective and preventive measures to address the US FDA observations and the same is proposed to be filed within the timeline stipulated by the agency.