Alkem Laboratories has received two observations from the US health regulator after inspection of its Baddi facility in Himachal Pradesh. The United States Food and Drug Administration (USFDA) had conducted an inspection at the company's manufacturing facility at Baddi from February 17 to 21, 2020. The company has received a Form 483 with two observations.
The company shall put together a detailed response with adequate corrective and preventive measures to address the observations and the same is proposed to be filed within the timeline stipulated by the US health regulator.
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.
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