After a series of regulatory setbacks, Dr Reddy's Laboratories got some respite with its Srikakulam facility getting only two observations by USFDA after a recent inspection. The fact that the company's Duvvada facility inspections a few weeks ago had led to 13 observations, many of which are said to be serious in nature had kept the Street nervous. The stock that had fallen to of Rs 2,560, has seen some recovery and is currently trading at Rs 2,711 levels.The Srikakulam facility is among the three facilities for Dr Reddy's that had received warning letters. Majority of important filings for US launches by the company are from this plant. Thus reacting to completion of FDA audit at Srikakulam, analysts at Kotak Institutional Equities say that this is a positive outcome. However, Ithey still believe that the facility will take 5-6 months to get a complete clearance. With the inspections behind it, the attention of Street and analysts will now shift to regulatory clearance of its ...
The company has launched only 3 new products during 2015 when compared to 14 launches in 2014
BS ReporterHyderabad, 9 MarchIn a continued set back to drug major Dr Reddy's Laboratories Limited's remediation efforts, its oncology formulations facility at Duvvada in Visakhapatnam of Andhra Pradesh has received Form 483 with 13 observations from the US Food and Drug Administration(US FDA) following a fresh audit that was concluded on Thursday.This is the second unit that has failed to clear the re-audit after the company had invited the drug regulator for a fresh evaluation of all the three facilities that were issued a warning letter in November 2015 over some lapses in current good manufacturing practices(CGMPs)."The US Food and Drug Administration (FDA) has issued a Form-483 with 13 observations, which we are addressing," the company said in a statement without providing any further details on nature of these observations.The company recently announced that all the commitments as part of the warning letter response have been completed. However the fresh observations, which ...
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