Shares of Alkem Laboratories slumped as much as 8.7 per cent today after the pharma company said it has received 13 observations about Daman plant from US FDA.
Alkem Laboratories said that the US regulator had conducted an inspection at the company's manufacturing facility located at Daman from September 20 to September 29, 2016.
Alkem Laboratories has received the inspection report which contains thirteen 483 observations, it said.
A Form 483 is issued by the FDA when its investigators observe any conditions that in their judgement may constitute violations of the US Food Drug and Cosmetic Act.
Alkem Laboratories "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 US FDA," it said.
At 10:20 a.m., shares of Alkem Laboratories were down 4 per cent at Rs 1,725 as compared to a flat Nifty index.
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