Alkem Laboratories fell 2.5% to Rs 1,922 on BSE in otherwise strong market after the company said the US health regulator has inspected its Baddi plant and issued three observations on account of violation of good manufacturing norms.
“The US Food and Drug Administration (USFDA) had conducted an inspection at the company's manufacturing facility located at Baddi, India from 2nd March, 2017 to 10th March, 2017. In this regard, the company has received the inspection report which contains three 483 observations,” Alkem Laboratories said in exchange filing on March 10, 2017.
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 US FDA, it added.
Alkem Laboratories own and operate 14 manufacturing facilities across five locations in India and two manufacturing facilities in the United States.
At 11:09 am; the stock was down 2.3% at Rs 1,927 as compared to 1.72% rise in the S&P BSE Sensex. A combined 88,287 shares changed hands on the counter on BSE and NSE so far.
“The US Food and Drug Administration (USFDA) had conducted an inspection at the company's manufacturing facility located at Baddi, India from 2nd March, 2017 to 10th March, 2017. In this regard, the company has received the inspection report which contains three 483 observations,” Alkem Laboratories said in exchange filing on March 10, 2017.
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 US FDA, it added.
Alkem Laboratories own and operate 14 manufacturing facilities across five locations in India and two manufacturing facilities in the United States.
At 11:09 am; the stock was down 2.3% at Rs 1,927 as compared to 1.72% rise in the S&P BSE Sensex. A combined 88,287 shares changed hands on the counter on BSE and NSE so far.
