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Exchange Received Time  28/11/2017 10:14:28 Exchange Disseminated Time 28/11/2017 10:14:33 Time Taken 00:00:05 | Sub: USFDA Audit -Baddi Unit We have to inform you that the Baddi unit of Glenmark Pharmaceuticals Limited underwent an US FDA audit from November 6, 2017 to November 11, 2017. The USFDA issued seven observations through the form 483. We are in the midst of providing a comprehensive response to the observations and would be replying to the FDA shortly on the observations. At this point in time, we would like to inform you that the Baddi unit contributes approximately 10 percent of the revenue of US sales. |
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