This action follows the recent inspection of the unit by the US Food and Drug Administration (USFDA) in August 2021.
In November 2021, Aurobindo Pharma received a communication from the USFDA classifying the inspection conducted at its Unit I (API) manufacturing facility in Hyderabad, India between August 2 to August 12, 2021 as Official Action Indicated (OAI), keeping the status unchanged.
Aurobindo Pharma said it believes that the USFDA warning letter will not impact the existing business from this facility. The company will be engaging with the regulator and is fully committed in resolving this issue at the earliest.
On a consolidated basis, Aurobindo Pharmas net profit fell 13.7% to Rs 696.71 crore on 7.7% decline in net sales to Rs 5,889.93 crore in Q2 FY22 over Q2 FY21.
Hyderabad-based Aurobindo Pharma develops, manufactures and distributes generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients.
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