Alkem’s API Facility in Ankleshwar was inspected by the US Food and Drug Administration (USFDA) from December 5, 2016 to December 9, 2016. 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 USFDA Observations and the same is proposed to be filed within the timeline stipulated by USFDA.
Alkem Laboratories is a leading Indian pharmaceutical company with global operations, engaged in the development, manufacture and sale of pharmaceutical and nutraceutical products. The company produces branded generics, generic drugs, active pharmaceutical Ingredients (APIs) and nutraceuticals, which it markets in India and International markets.
