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The US Food and Drug Administration (USFDA) has cautioned Aurobindo Pharma Ltd that its oral solids formulation manufacturing facility may be subject to regulatory actions.
“With regard to the USFDA inspection of Unit VII, an oral solids formulation manufacturing facility of the company, we inform you that the company has received a letter from the USFDA classifying the inspection conducted at the aforesaid facility as official action indicated (OAI),” Aurobindo informed in a filing to BSE.
The company said that it believes that this OAI classification will not have any material impact on the existing revenues or the supplies to its US business at this juncture.
It will work closely with the US Food and Drug Administration (USFDA) “to comprehensively address the issues.”
Hyderabad-based Aurobindo Pharma’s scrip lost 5.32 per cent on the Bombay Stock Exchange on Thursday to end at ₹480.30.
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