Aurobindo Pharma on Wednesday, December 20 said the USFDA has issued an establishment inspection report (EIR) for its wholly-owned subsidiary APL Healthcare's formulation manufacturing facility in Tirupati, Andhra Pradesh, classifying it as 'voluntary action indicated' (VAI).
The USFDA had conducted the inspection at the facility from September 13 to 19 this year.
VAI is the second-best classification that a plant can get from the USFDA. The classification, as defined by the regulator, is as follows: ‘Objectionable conditions or practices were found during the inspection but the agency is not prepared to take or recommend any administrative or regulatory action’.
A VAI is generally issued when a plant receives observations, and responds to them and the regulator believes the response by the company is satisfactory. It is then up to the regulator whether they would like to reinspect the facility to assess the remediation.
Aurobindo Pharma shares hit their record high of ₹1,081.95 apiece around 1pm today, December 20. The stock has gained 147.9% this year, so far.
First Published: Dec 20, 2023 1:12 PM IST
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