The US Food and Drug Administration (USFDA) has conducted an inspection at Alkem Laboratories’ manufacturing facility located at Baddi, India from September 11, 2017 to September 15, 2017. The company has received the inspection report which contains two 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.
Company Name | CMP |
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