US FDA issues import alert to 2 plants of IPCA Laboratories

Drug maker IPCA Laboratories today said the US FDA has issued import alert to two of its facilities at Pithampur in Madhya Pradesh and Piparia in Silvassa, which will affect its exports to the US.
Already, the US FDA had issued import alert to the company's active pharmaceutical ingredients (APIs) production unit at Ratlam in Madhya Pradesh in January this year for non-compliance of prescribed manufacturing norms.
"Subsequent to the inspection of our Ratlam API manufacturing unit, US FDA also inspected our formulations manufacturing units situated at SEZ Indore (Pithampur) and Piparia (Silvassa) and had issued their inspection observations in Form FDA 483 to the said manufacturing units," the company said in a filing to the BSE.

In Form 483, US FDA inspectors raise concerns related to compliance of good manufacturing practise norms.
"We now wish to inform you that the US FDA has issued import alert to the company's said formulations manufacturing units situated at SEZ Indore (Pithampur) and Piparia (Silvassa) on March 24, 2015," it added.
IPCA Labs said it had voluntarily decided to suspend API shipments from Ratlam manufacturing unit for the US market till the US FDA inspection observations issue is resolved.

"Since the company's formulations manufacturing units situated at SEZ Indore (Pithampur) and Piparia (Silvassa) use the APIs from the Ratlam manufacturing unit for formulations manufactured at these units for the US market, the voluntary stoppage of API shipments from the Ratlam manufacturing unit for the US market will also have impact on the company's formulations export business to the US market," it added.

IPCA further said that said since July 2014, it has not shipped any APIs or formulations to the US market except the products that were exempted from the import alert.
"The company is fully committed in resolving this issue at the earliest. The company is also committed to its philosophy of highest quality in manufacturing, operations, systems, integrity and cGMP culture," it added.
IPCA Laboratories shares were trading 12.23 per cent down at Rs 667.05 per scrip during afternoon trade on the BSE.