EIR is basically a factual report of all the activities that FDA investigators have carried out while in the manufacturing facility.
Image for illustration.
Aurobindo Pharma Ltd's shares gained nearly 19% on intraday trading Wednesday after one of the pharmaceutical company's units received an Operations Inspection Report (EIR) from the U.S. Drug Administration with no major negative effects.
"The company received the Establishment Inspection Report (EIR) status from the United States Food and Drug Administration (USFDA) with the status of" Voluntary Action Initiated "(VAl) for Unit IV," Aurobindo Pharma said in a Wednesday exchange application.
EIR is basically a factual report of all the activities that FDA investigators have carried out while in the manufacturing facility. VAI means that undesirable conditions or practices have been found, but the FDA does not take or recommend any administrative or regulatory action.
From November 4 to November 13, the USFDA inspected Division IV of Aurobindo Pharma, a general injectable formulation manufacturing facility in Pashamylaram, Hyderabad. At the end of the inspection, the USFDA issued Form 483 with 14 observations.
On November 13, Aurobindo Pharma informed the exchanges that none of these observations were related to data integrity issues.
At 11:01 a.m., Aurobindo Pharma shares were trading at Rs 589.50 each, an increase of 17.8% after hitting the daily high of Rs 594. The stock lost nearly 17% last year, compared to a 13% increase in the Nifty 50 index.
Other pharmaceutical stocks traded in the positive zone on Wednesday. Piramal Enterprises grew 2.2%, Biocon 1.7%, Glenmark Pharmaceuticals 1.3% and Dr. Reddys Laboratories Ltd by 1%.
Get the best of News18 in your inbox – subscribe to News18 Daybreak. Follow News18.com on Twitter, Instagram, Facebook, Telegramm, TikTok and on YouTube and stay up to date with what's happening in the world around you – in real time.