Dr Reddy’s Laboratories has said that the US Food and Drug Administration, which inspected active pharmaceutical ingredients (API) unit at Miryalaguda in Telangana in March this year, has given an ‘establishment inspection report’. After the news broke out, DRL stock was trading at Rs 2,679.70, up nearly 2 per cent, at 2 pm today. On February 21, the company informed that the FDA had issued form 483 with three observations.
“In that regard, we would now like to inform you that we have received an establishment inspection report (EIR) from the USFDA today as closure of audit for the above referred facility,” the drug maker said its filing last night. According to information provided by the FDA in its website, if no enforcement action is contemplated, or after enforcement action is concluded, the drug regulator provides inspected establishments with a final inspection report, called an EIR.
The EIR includes the brief history of prior inspectional findings, including any action taken by FDA or corrective action taken by the firm in response to a previous inspection, the investigator’s narrative report, any refusals, voluntary corrections, or promises made by the firm’s management and copies of forms the FDA issued to the firm during the inspection, including the FDA form 483.
Angel Broking’s vice president (research-pharma) Sarabjit Kaur Nangra said the EIR from the FDA indicates the successful closure of the agency’s audit. “The news is positive, however given the valuations, we are neutral on the stock,” she said.