 "Dr Reddy's gains 6% on receiving EIR from USFDA for Hyderabad facility")
Dr Reddy's Laboratories rallied 6% to Rs 2,328 on BSE in early morning trade after the company announced that it has received Establishment Inspection Report (EIR) from the US drug regulator for its facility in Hyderabad following the audit in April.
“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.
Earlier in December 1, the company had received EIR for Miyapur facility, Hyderabad, Telangana. The audit of the said facility has been completed by USFDA in September with zero observations.
At 09:33 AM; the stock was trading 4.3% higher at Rs 2,288 on the BSE, as compared to 0.32% decline in the S&P BSE Sensex. A combined 483,357 shares changed hands on the counter on the BSE and NSE.
“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.
Earlier in December 1, the company had received EIR for Miyapur facility, Hyderabad, Telangana. The audit of the said facility has been completed by USFDA in September with zero observations.
At 09:33 AM; the stock was trading 4.3% higher at Rs 2,288 on the BSE, as compared to 0.32% decline in the S&P BSE Sensex. A combined 483,357 shares changed hands on the counter on the BSE and NSE.
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