Lupin announces USFDA warning letter resolution for Goa, Pithampur plants

Drug maker Lupin on Thursday said it has resolved manufacturing issues raised by the US health regulator regarding its Goa and Pithampur-based manufacturing facilities.

The company has received a correspondence from the US Food and Drug Administration (USFDA) that it (Lupin) has now addressed the concerns raised in the warning letter for its facilities in Goa and Pithampur Unit-2, the drug firm said in a statement.

This comes after the satisfactory evaluation of the corrective actions taken by the company in response to the Warning Letter issues by the USFDA on November 6, 2017, it added.

"We are pleased to be informed by the USFDA that we have addressed the concerns through our corrective actions related to the November 2017 warning letter. We are committed to being compliant with good manufacturing practices, and to uphold global quality standards and ensuring the quality of our products," Lupin MD Nilesh Gupta said.

A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.