Alkem Laboratories cracks 8 per cent on US FDA observations

Mumbai based pharma major, Alkem Laboratories in an exchange filing informed the exchanges that the company has received the inspection report which contains thirteen 483 observations.

The observations received are concerning the Daman facility which was inspected by the US FDA from September 20 to September 29, 2016. This assumes importance as Daman facility contributed around 30 percent to company's US revenue in FY16 and 6 percent to total revenue during the year. Also, almost half of company's ANDAs have been filed from this facility.

The company shall put together a detailed response with adequate corrective and preventive measures to address the US FDA’s observations and the same is proposed to be filed within the timeline stipulated by the regulator, said the company in a statement.

Alkem Laboratories became yet another Indian company to receive damning observations from the US watchdog on good manufacturing practices.

Reacting to the developments, Alkem’s stock plunged more than 8 per cent in early trade to touch an intra-day low of Rs1653 on NSE.