Aurobindo Pharma gains 2% as USFDA grants VAI to Hyderabad Unit IV; ends flat

The classification suggested that the matter has not escalated to the extent of slapping warnings letter or import alert.

Aurobindo Pharma gains 2% as USFDA grants VAI to Hyderabad Unit IV; ends flat
NEW DELHI: Shares of Aurobindo Pharma gained on Wednesday's trade amid reports that the US drug regulator USFDA has classified Unit IV of Hyderabad plant as VAI (voluntary action indicated).

The classification suggested that the matter has not escalated to the extent of slapping warnings letter or import alert.

Following the report, the stock rose 1.60 per cent to hit a high of Rs 770.40 on BSE. It eventually ended the day flat at Rs 759.35, up 0.15 per cent.

In May, the drug regulator issued a Form 483 to the company's Unit-IV citing seven observations relating to violation of current good manufacturing practices (cGMP) following an inspection that was held during April 20-28 this year, TOI reported.

According to USFDA, FDA Form 483 is issued to a firm at the conclusion of an inspection when investigators have observed any conditions, that in their judgement, may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The FDA Form 483 notifies the company's management of objectionable conditions.
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