Lupin receives warning from USFDA for Mandideep facility

Lupin Limited informed the exchanges on Thursday that the company has received a warning letter from the USFDA for its Mandideep (Unit -1) facility. This is subsequent to an earlier intimation received from the USFDA in March 2019, wherein the agency had classified its inspection conducted at the said facility in December 2018 as "Official Action Indicated" (OAI).

There are no DMF and ANDA applications pending review or approval from the Mandideep (Unit-1) facility. Meanwhile, the company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility.

The company’s management is addressing the concerns raised by USFDA and is working to resolve these issues at the earliest. It is committed to be compliant with CGMP quality standards across all its facilities.

As per the management, all the plant facilities which are under the USFDA scanner will get cleared over the next 1-1.5 years.

On Thursday, stock of Lupin opened at Rs. 762.00. In the morning trading session, it dipped by 3.4 per cent to Rs. 733.85 level. At 11.15 am, the stock was trading at Rs. 750.00 on BSE.