Alkem Laboratories Ltd. slumped after the company said its Daman plant received 13 observations from the U.S. Food and Drug Administration.
The U.S. regulator conducted an inspection at the Daman manufacturing facility over a ten-day period from September 20 to September 29, 2016, Alkem said in a filing to the exchanges. The company said it will submit its response to the regulator’s observations in the Form 483 inspection report shortly.
lkem Laboratories has received the inspection report which contains thirteen 483 observations, it said.
Here are some more highlights from the report:
- The approval for the cholesterol-treatment drug Crestor which is due from the Daman facility in early November should come through if observations are not critical in nature.
- Alkem has no other pending 483s across its other facilities.
- India business expected to remain the cash cow.
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., Alkem share price was down 4 per cent at Rs. 1,725 as compared to a flat Nifty index.