New Delhi, Nov 7 (PTI) Drug firm Lupin today said it hasreceived warning letter from the US health regulator for itsmanufacturing facilities in Goa and Pithampur, Indore.
The company had earlier received three form 483observations for the Goa facility on April 7, 2017 and sixform 483 observations for Pithampur (Unit II) on May 19, 2017,Lupin said, adding that it had responded to all theobservations.
"The company has received a warning letter issued by theUnited States Food and Drug Administration (USFDA) on November6, 2017 for our formulation manufacturing facilities at Goaand Indore (Pithampur Unit II)", Lupin said in a filing toBSE.
The company is deeply disappointed to have received thisoutcome, it said, adding that while there will be nodisruption of product supplies from either of these locations,there is likely be a delay of new product approvals.
Lupin however did not share the concerns raised by the UShealth regulator in its warning letter.
"We plan to address the concerns raised by the USFDAexpeditiously and will work with the USFDA to resolve theseissues at the earliest," Lupin said.
The company upholds quality and compliance issues withutmost seriousness and remains fully committed to be compliantwith cGMP quality standards across all the facilities, itadded.
Lupin Ltd stock crashed over 17 per cent to about Rs 856on BSE in the afternoon. PTI AKTSA.
This is unedited, unformatted feed from the Press Trust of India wire.