Ipca Laboratories, a Rs.3,100 crore plus Mumbai based pharma major, has received warning letter from US FDA for its facilities at Ratlam, Madhya Pradesh, SEZ Indore (Pithampur) and Piparia (Silvassa). These units received certain inspection observations in Form 483 and which subsequently resulted in issuance of import alert. Ipca scrip declined sharply in the morning session to Rs.630.20 on BSE as against its previous close of Rs.655.35.

The company has voluntarily suspended shipments of its APIs and formulations for the US market till US FDA inspection observations are resolved. Therefore, since July 2014 the company has not shipped any APIs or formulations to US market except the products which are exempted from import alert.

Ipca has responded to the US FDA inspection observations with its remediation measures and has been since working also with external consultants to ensure that its remedial activities are undertaken in proper and timely manner.