USFDA issues 13 observations to Alkem Laboratories’ Daman facility

28 Mar 2018 Evaluate

Alkem Laboratories has received a Form 483 with thirteen observations from US Food and Drug Administration (USFDA) for the company’s manufacturing facility located at Amaliya, Daman, India. 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 the USFDA. The regulator had conducted an inspection at the company’s manufacturing facility from March 19, 2018 to March 27, 2018.

Furthermore, the USFDA had conducted an inspection at the company's manufacturing facility located at St. Louis, USA from March 12, 2018 to March 16, 2018. In response to the one Form 483 observation issued by the USFDA, the company has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines.

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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