Aurobindo Pharma falls over 20% on receiving USFDA observations

K. S. Badri Narayanan Updated - October 07, 2019 at 08:13 PM.

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Shares of Aurobindo Pharma crashed over 20 per cent on Monday, following the US drug regulator's adverse observation.

After hitting a year low of ₹450.35, the stock ended the day at ₹451.70, down 20.41 per cent, on the NSE.

The USFDA has issued a note (after inspecting Aurobindo’s Unit-7 between September 19-27, 2019) indicating procedural lapses along with lack of Quality control.

The USFDA observations are as follows: Failure to review any unexplained discrepancy; failure to consider failure of batch or components; Control procedures not established; No written procedures for production and process controls; Equipment and utensils not cleaned at appropriate levels; Procedures applicable to Quality control not thoroughly followed; and written production and process controls not developed in execution of production, process controls.

Published on October 7, 2019 05:43