The US Food and Drug Administration (USFDA) has concluded that the inspection classification of Aurobindo Pharma's API manufacturing facility is Voluntary Action Indicated (VAI).
The drug maker announced the receipt of an Establishment Inspection Report (EIR) from the USFDA for its API non-antibiotic manufacturing facility in Pydibhimavaram, Srikakulam District, Andhra Pradesh.The US drug regulator had inspected the facility in February 2019 and issued a warning letter in June 2019 and this unit was further inspected by USFDA from 25 July to 2 August 2022 and issued a form 483 with 3 observations.
The USFDA has indicated that the inspection is closed.
Aurobindo Pharma develops, manufactures and distributes generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients.
The pharmaceutical company reported 41.3% fall in consolidated net profit to Rs 409.45 crore on a 3.7% decline in net sales to Rs 5,673.65 in Q2 FY23 over Q2 FY22.
The scrip rose 0.21% to currently trade at Rs 479.10 on the BSE.
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