New Delhi: Drug firm Lupin said it has received a warning letter from the US health regulator for its manufacturing facilities in Goa and Pithampur, Indore.
The company had earlier received three form 483 observations for the Goa facility on April 7, 2017, and six form 483 observations for Pithampur (Unit II) on May 19, 2017, Lupin said, adding that it had responded to all the observations.
“The company has received a warning letter issued by the United States Food and Drug Administration (USFDA) on November 6, 2017, for our formulation manufacturing facilities at Goa and Indore (Pithampur Unit II)”, Lupin said in a filing to BSE.
The company is deeply disappointed to have received this outcome, it said, adding that while there will be no disruption 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 US health regulator in its warning letter.
“We plan to address the concerns raised by the USFDA expeditiously and will work with the USFDA to resolve these issues at the earliest,” Lupin said.
The company upholds quality and compliance issues with utmost seriousness and remains fully committed to be compliant with cGMP quality standards across all the facilities, it added.