ALSO READDr Reddy's rallies after receiving EIR from USFDA Dr Reddy's up 4% after receiving EIR from USFDA for Srikakulam Unit I Dr Reddy's gains on receiving EIR for Miryalaguda plant Dr Reddy's requests USFDA for re-inspection of Duvvada facility in 2018 Dr Reddy's Labs gains as Srikakulam SEZ Unit II get EIR from USFDA
“We have received EIR from the US Food and Drug Administration (USFDA) on December 11, 2017 as closure of audit, for formulations manufacturing plant-3 at Bachupally, Hyderabad,” Dr Reddy’s Laboratories said in a statement.
The above-referred facility was audited by USFDA in April 2017, wherein it issued a form 483 with 11 observations.
“These observations were mostly procedural in nature, reflecting the need to improve people capabilities and strengthen documentation and laboratory systems,” Dr Reddy Lab had said.
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