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Aurobindo Pharma tumbles after USFDA scrutiny

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Aurobindo Pharma declined 5.39% to Rs 448 after the US drug regulator issued four observations to the company's Hyderabad units.

The United States Food and Drug Administration (USFDA) inspected Unit V, API manufacturing facility at Pashamylaram, Hyderabad and Unit VIII, API manufacturing facility at Gaddapotharam, Hyderabad of the company from 21st to 28th October 2019 and from 21st to 25th October 2019, respectively. At the end of the inspections, USFDA issued a 'Form 483' with 4 observations for each facility.

The company believes that these observations are related to procedural improvements and none of the observations are related to data integrity. The company said it will be responding to USFDA as per the prescribed time lines.

With respect to Unit IV, formulation manufacturing facility at Pashamylaram, Hyderabad, the inspection is in progress, the firm added. The announcement was made during trading hours today, 6 November 2019.

Shares of Aurobindo Pharma slipped 6.75% in three trading sessions to its current market price of Rs 448 from a recent closing low of Rs 480.45 on 1 November 2019.

Aurobindo Pharma's consolidated net profit jumped 41.6% to Rs 480.45 crore on 28.1% surge in net sales to Rs 5,356.84 crore in Q2 September 2019 over Q2 September 2018.

Aurobindo Pharma is engaged in producing oral and injectable generic formulations and active pharmaceutical ingredients (APIs).

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Wed, November 06 2019. 12:22 IST