Aurobindo Pharma shares hit a 52-week high of Rs 1,081.95 on 20 December after the company informed that its wholly owned subsidiary, APL Healthcare Limited, had received voluntary action indicated (VAI) status from the USFDA.
The USFDA (US Food and Drug Administration) conducted an inspection at APL Healthcare Limited’s formulation manufacturing facility in Tirupati, Andhra Pradesh, between 13 and 19 September.
VAI is the second-best classification a manufacturing facility can get from the USFDA. The classification as per the US regulator is defined as, ‘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 unit receives observations and responds to them, and the regulator believes the responses are satisfactory.
It is now up to the regulator to reinspect the facility to assess the remediation.
At 3:30 pm, the shares of Aurobindo Pharma closed 0.20% higher at Rs 1,034.95 on NSE.