Alkem Laboratories lost 8.23% to Rs 1,920 at 14:41 IST on BSE after the US drug regulator issued Form 483 with 13 observations for its Daman plant.
The announcement was made during market hours today, 28 March 2018.Meanwhile, the S&P BSE Sensex was down 214.82 points or 0.65% at 32,959.57
On the BSE, 93,000 shares were traded on the counter so far as against the average daily volumes of 25,000 shares in the past two weeks. The stock had hit a high of Rs 2,095 and a low of Rs 1,856.60 so far during the day. The stock had hit a record high of Rs 2,468 on 10 January 2018 and a 52-week low of Rs 1,578 on 11 August 2017.
The large-cap company has equity capital of Rs 23.91 crore. Face value per share is Rs 2.
Alkem Laboratories said that the USFDA had conducted an inspection at the company's manufacturing facility located at Amaliya, Daman from 19 March 2018 to 27 March 2018. Post the inspection, the company has received a Form 483 with thirteen observations. The company shall put together a detailed response with adequate corrective and preventive measures to address the USFDA observations and the same is proposed to be filed within the timeline stipulated by the USFDA, Alkem Laboratories said.
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Further to this, the USFDA had conducted an inspection at the company's manufacturing facility located at St. Louis, USA from 12 March 2018 to 16 March 2018. In response to the one Form 483 observation issued by the US FDA, the company has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines.
Alkem Laboratories' consolidated net profit fell 23.44% to Rs 180.87 crore on 17.45% rise in net sales to Rs 1740.47 crore in Q3 December 2017 over Q3 December 2016.
Alkem Laboratories is a pharmaceutical company with global operations, engaged in the development, manufacture and sale of pharmaceutical and nutraceutical products.
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