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Lupin announces USFDA warning letter resolution for Goa, Pithampur plants

Jul 28, 2023

By: BlinkX Research Team

On Thursday, the pharmaceutical company Lupin announced that it had addressed the production concerns made by the US health agency about its Pithampur and Goa-based manufacturing facilities.

According to a letter the business received from the US Food and Drug Administration (USFDA), Lupin has now rectified the issues identified in the warning notice for its Pithampur Unit-2 and Goa plants.

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.

Source: Media Reports