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Glenmark Pharma’s, Baddi manufacturing unit has received 7 observations, from the US health regulator after an audit. Its Baddi unit contributes approx 10% of the revenue of the US sales.
In a BSE filing Glenmark Pharmaceuticals stated, “The Baddi unit of Glenmark Pharmaceuticals underwent an US FDA (US Food and Drug Administration) audit from November 6 -11, 2017. The USFDA issued seven observations through the form 483.”
Further, it stated that it will be responding to the USFDA on the observations shortly, but it did not give any details about the nature of the observations.
