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Dr Reddy’s Laboratories dipped 4.5% to Rs 2,299 on the BSE in intra-day trade after media reports suggested that the US Food and Drug Administration (USFDA) issues raised in Establishment Inspection Report (EIR) for the company's injectables unit in Duvvada, Andhra Pradesh.
The BSE said the exchange has sought clarification from Dr Reddy’s Laboratories on January 03, 2018 with reference to news flashed on www.moneycontrol.com dated January 03, 2018 quoting "Dr Reddy's cracks on buzz of issues raised in EIR for Duvvada plant".
The reply is awaited.
Dr Reddy's Laboratories on November 21, 2017, informed the stock exchanges that the company has received the EIR from the USFDA for its formulations manufacturing facility at Duvvada in Visakhapatnam. But the company was told that the inspection process was not over yet.
"In the cover letter to the EIR, FDA has explained that the inspection has not closed, and the site's status remains unchanged, but that FDA has released the EIR in order to be transparent about its regulatory process. We are planning to request a reinspection in 2018 after further discussion on scheduling with FDA," Dr Reddy's said in a filing.
It may be recalled that in November 2015, the US drug regulator had issued a warning letter against three of Dr Reddy's facilities, including the Duvvada plant, after its inspection teams found compliance issues.
Meanwhile, Dr Reddy’s on Monday, January 2, 2018 has informed the stock exchanges that a meeting of board of directors of the company will be held on Thursday, January 25, 2018, to consider the financial results of the company for the quarter and nine months ended December 31, 2017.
In past one month, the stock had outperformed the market by gaining 8% against 3% rise in the S&P BSE Sensex till Tuesday.
At 02:42 PM; it was trading 3% lower at Rs 2,339 as compared to 0.11% decline in the benchmark index. A combined 804,614 shares changed hands on the counter on the NSE and BSE so far.
The BSE said the exchange has sought clarification from Dr Reddy’s Laboratories on January 03, 2018 with reference to news flashed on www.moneycontrol.com dated January 03, 2018 quoting "Dr Reddy's cracks on buzz of issues raised in EIR for Duvvada plant".
The reply is awaited.
Dr Reddy's Laboratories on November 21, 2017, informed the stock exchanges that the company has received the EIR from the USFDA for its formulations manufacturing facility at Duvvada in Visakhapatnam. But the company was told that the inspection process was not over yet.
"In the cover letter to the EIR, FDA has explained that the inspection has not closed, and the site's status remains unchanged, but that FDA has released the EIR in order to be transparent about its regulatory process. We are planning to request a reinspection in 2018 after further discussion on scheduling with FDA," Dr Reddy's said in a filing.
It may be recalled that in November 2015, the US drug regulator had issued a warning letter against three of Dr Reddy's facilities, including the Duvvada plant, after its inspection teams found compliance issues.
Meanwhile, Dr Reddy’s on Monday, January 2, 2018 has informed the stock exchanges that a meeting of board of directors of the company will be held on Thursday, January 25, 2018, to consider the financial results of the company for the quarter and nine months ended December 31, 2017.
In past one month, the stock had outperformed the market by gaining 8% against 3% rise in the S&P BSE Sensex till Tuesday.
At 02:42 PM; it was trading 3% lower at Rs 2,339 as compared to 0.11% decline in the benchmark index. A combined 804,614 shares changed hands on the counter on the NSE and BSE so far.
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