Aurobindo Pharma Ltd sharesclimbed nearly 19% in intra-day trade on Wednesday after one of the units of the pharma company received an establishment inspection report (EIR) from the US drug regulator with no major negatives.
“The company has received the Establishment Inspection Report (EIR) with Voluntary Action Initiated (VAl) status from the US Food and Drug Administration (USFDA) for Unit IV,” Aurobindo Pharma said in an exchange filing on Wednesday.
EIR is basically a factual report on all the activities conducted by FDA investigators during the time spent at the manufacturing establishment. VAI means objectionable conditions or practices were found but the FDA is not taking or recommending any administrative or regulatory action.
The USFDA had inspected Aurobindo Pharma’s Unit IV, a general injectable formulation manufacturing facility at Pashamylaram in Hyderabad, from 4 November to 13November.At the end of the inspection, the USFDA had issued ‘Form 483’ with 14 observations.
On 13 November, Aurobindo Pharma had informed stock exchanges that it believed that none of these observations were related to data integrity issues.
At 11:01 am, Aurobindo Pharma shares were trading at Rs 589.50 apiece, up 17.8%, after hitting the day’s high of Rs 594. The stock has lost nearly 17% in the last one year compared with a 13% rise in the Nifty 50 index.
On Wednesday, other pharma stocks were also trading in the positive zone. Piramal Enterprises was up 2.2%, Biocon rose 1.7%, Glenmark Pharmaceuticals inched up 1.3%, while Dr Reddys Laboratories Ltd gained 1%.