Alkem Laboratories share price plunged as much as 11 percent in afternoon Wednesday after the US health regulator issued 13 observations to Daman facility and 1 to US plant.
The Mumbai-based pharma company informed exchanges that it has received a Form 483 with thirteen observations from US Food and Drug Administration (USFDA) for Daman facility.
The regulator had conducted an inspection at manufacturing facility located at Amaliya, Daman during March 19-27, 2018.
"The company will 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 USFDA," Alkem said.
Furthermore, the US FDA had also conducted an inspection at manufacturing facility in USA during March 12-16, 2018 and issued one Form 483 observation.
The company said it has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines.
At 13:38 hours IST, the stock price was quoting at Rs 1,896.50, down Rs 195.80, or 9.36 percent on the BSE.
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