Alkem Laboratories has received thirteen observations from the US Food and Drug Administration (US FDA) after the regulator inspected its manufacturing facility at Daman. US FDA had conducted an inspection at the Company’s manufacturing facility from September 20 to September 29, 2016. 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.
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.
