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Aurobindo Pharma shares tumble 5% on USFDA observations

PTI New Delhi | Updated on November 06, 2019

US health regulator has issued four observations each for Aurobindo Pharma’s two units in Hyderabad. File Photo   -  BusinessLine

Shares of Aurobindo Pharma tumbled 5 per cent on Wednesday after the company said the US health regulator has issued four observations each for its two units in Hyderabad after inspecting the sites last month.

On the BSE, the scrip declined 4.80 per cent to close at ₹450.75. During the trade, the shares dropped 6.56 per cent to ₹442.40. At the NSE, it fell 5 per cent to close at ₹450.

The USFDA inspected active pharmaceutical ingredients (API) manufacturing facility (Unit V) at Pashamylaram and API manufacturing facility (Unit VIII) at Gaddapotharam in Hyderabad between October 21 and October 28, the company said in a BSE filing.

“At the end of the inspections, we have been issued a Form 483 with four observations for each facility.We believe that these observations are related to procedural improvements and none of the observations are related to data integrity,” it added.

The company will be responding to the US Food and Drug Administration (USFDA) as per the prescribed time lines, the drug firm said.

Published on November 06, 2019

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