USFDA makes 9 observations over Wockhardt's plant in Shendra
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New Delhi: The USFDA has made nine 'observations' highlighting violations of its norms at homegrown drug maker Wockhardt's new facility at Shendra in Aurangabad.
The company, whose shares slumped 15.04 per cent on NSE to close at Rs 1,287.00 today, however, said being a new unit, there is no export from the Shendra facility to the US.
"Inspection of our manufacturing unit at Shendra, Aurangabad by USFDA has since been completed. USFDA has made nine observations for which appropriate reply would be submitted to the inspecting authority in due course," Wockhardt Ltd said in a regulatory filing.
The company, whose shares slumped 15.04 per cent on NSE to close at Rs 1,287.00 today, however, said being a new unit, there is no export from the Shendra facility to the US.
"Inspection of our manufacturing unit at Shendra, Aurangabad by USFDA has since been completed. USFDA has made nine observations for which appropriate reply would be submitted to the inspecting authority in due course," Wockhardt Ltd said in a regulatory filing.
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