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30 Sep 2016

One more Indian Plant received USFDA observations: Alkem’s Daman Plant

Alkem Laboratories has received 13 observations from the US drug regulator for its manufacturing facility at Daman. This obervation comes as response to The United States Food and Drug Administration (USFDA) had conducted an inspection at the company’s manufacturing facility located at Daman from September 20 to September 29, 2016

As a course of action Alkem has to respond it’s corrective and preventive actions to address the US FDA Observations and the same is proposed to be filed within the timeline stipulated by US FDA.

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