Alkem Labs dips 11% as USFDA issues 13 observations for Daman facility

The stock dipped 11% to Rs 1,858 on the BSE in intra-day trade on back of heavy volumes.

Shares of Alkem Laboratories have dipped 11% to Rs 1,858 per share on the BSE in intra-day trade after the company said it has received a Form 483 with 13 observations from the US Food & Drug Administration (FDA) for its manufacturing facility at Amaliya, Daman.

“The US FDA had conducted an inspection at the Company's manufacturing facility located at Amaliya, Daman, India from 19th March, 2018 to 27th March, 2018. Post the inspection, the Company has received a Form 483 with thirteen observations,” Alkem Labs said in a regulatory filing.

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 US FDA, it added.

Alkem Labs also said that US FDA had conducted an inspection at the Company's manufacturing facility located at St. Louis, USA from 12th March, 2018 to 16th 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, it added.

At 01:35 pm; the stock was trading 9% lower at Rs 1,897 as compared to 0.49% decline in the S&P BSE Sensex. The trading volumes on the counter more than doubled with a combined 331,734 shares changed hands on the BSE and NSE so far.