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USFDA issues warning letter to Ipca Labs for 3 plants

USFDA issues warning letter to Ipca Labs for 3 plants

Drug firm Ipca Laboratories said it has received a warning letter from the health regulator USFDA for three of its facilities. The US regulator had earlier imposed an import ban for not adhering to the good manufacturing norms.

“USFDA carried out inspections at Ipca’s laboratories our manufacturing units situated at Ratlam (Madhya Pradesh), SEZ Indore (Pithampur) and Piparia (Silvassa), during which these manufacturing units received import alert. USFDA has now issued a warning letter to these manufacturing units,” the company informed the BSE.

“We have already informed you that the company has voluntarily suspended shipments of its APls and formulations for the US market till USFDA inspection observations are resolved,” it said. Since July 2014 the company has not shipped any APls or formulations to US market except the products which are exempted from import alert.

The company has responded to the USFDA inspection observations with its remediation measures and has been since working also with external consultants to ensure that its remedial activities are undertaken in a proper and timely manner, it said.

The company’s shares closed 2.02 per cent down at Rs 655.35 apiece on Monday.

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