Alkem Laboratories receives EIR from USFDA for Daman formulation facility

23 Dec 2016 Evaluate

Alkem Laboratories has been issued an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its Daman formulation facility which was inspected in September 2016. The inspection has now been closed by the USFDA.

The USFDA had inspected the Daman formulation facility from September 20-29, 2016 and had issued Form 483 with thirteen observations. Post this, the company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines. The USFDA has reviewed the CAPA and has found them acceptable.

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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