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USFDA observation lifts Aurobindo Pharma

Our Bureau Chennai | Updated on April 21, 2020 Published on April 21, 2020

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Shares of Aurobindo Pharmaceuicals jumped 12 per cent in early trade on Tuesday to ₹605.50 on US drug regulator observation.

"Further to our intimations dated 13th November 2019, 19th February and 21st February 2020 with regard to the inspection of Unit IV, an injectable manufacturing formulation facility of the Company, conducted between Nov 4-13, 2019, we would like to inform that US FDA has determined that the inspection classification of this facility is Voluntary Action Indicated," Aurobindo Pharma said in a release to the stock exchanges.

A VAI inspection classification indicates that, although investigators found and documented objectionable conditions during the inspection, FDA will not take or recommend regulatory or enforcement action because the objectionable conditions do not meet the threshold for action at this time.

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Published on April 21, 2020
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