United States Food and Drug Administration (USFDA) has conducted an inspection at Alkem Laboratories’ manufacturing facility located at Baddi, from May 13 to 17, 2019.
At the end of the inspection, the company has received a Form 483 with four 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.
