Alkem Laboratories has informed that US FDA had conducted an inspection at the Company’s API (Active Pharmaceutical Ingredient) manufacturing facility located at Ankleshwar, India from 5th December to 9th December, 2016. In this regard, the Company has received the inspection report which contains three 483 observations. 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.
The above information is a part of company’s filings submitted to BSE.
