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Drug maker Ipca Laboratories Ltd has received a warning letter from the US Food and Drug Administration (FDA) outlining manufacturing quality lapses observed at three of its Indian factories.
The warning came after inspection at Ipca’s manufacturing units at Ratlam, Indore SEZ and Piparia in Madhya Pradesh.
In a statement to the BSE, Ipca said it has voluntarily suspended shipments of its APls and formulations for the US market till the US FDA inspection observations are resolved.
“Therefore, since July 2014 the company has not shipped any APls or formulations to the US market except the products which are exempted from import alert,” Ipca said.
While Ipca did not specify the concerns raised by FDA, the company said it has responded to the US FDA inspection observations and has also been working with external consultants to ensure that its remedial activities are undertaken in a proper and timely manner.
“Since the inspection, the company has regularly communicated with US FDA with periodic updates on remedial measures undertaken,” Ipca said.
Shares of Ipca fell 16 per cent on the BSE on Monday, before closing 2.02 per cent lower at ₹655.35.
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