U.S Food and Drug Administration (USFDA) has concluded pre-approval inspection at Alkem Laboratories’ manufacturing facility located at St. Louis, USA, conducted during September 06, 2022 to September 14, 2022. At the end of the inspection, the company has received Form 483 with two observations. There is no data integrity observation.
This Pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline, a detailed response to close out the said observations.
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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