Lupin plans to offer Somerset, Goa plants for USFDA re-inspection by March 2020

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26 Aug, 2025 12:21

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Lupin, India's third-largest drugmaker said it plans to seek USFDA re-inspection of its Goa and Somerset plants by the first quarter of the calender year 2020.

"I think there's another two months of work that we want to put in before we put them up for the re-inspection," Nilesh Gupta, Managing Director of Lupin told reporters in a post-earnings conference call.

While the Goa plant is under a warning letter since 2017 for violation of current good manufacturing practices, the Somerset plant was classified under official action indicated (OAI) status.

USFDA classifies OAI for plants found in an unacceptable state of compliance, attracting agency’s regulatory and administrative action such as withholding new approvals, warning letters and import alerts.

Both the warning letter and OAI status put a lid on new approvals.

Lupin US business has been hit by regulatory issues at four of its plants; Goa, Pithampur Unit-2, Mandideep Unit-1 and Somerset plant, which came into Lupin's fold through Gavis acquisition.

The regulatory actions have put a lid on several new approvals that are crucial for propelling growth.

"We're obviously not happy with the total compliance track record that we have at this point," Gupta said.

Gupta said the drugmaker launched a programme called Quality First, across its entire network of manufacturing sites to upgrade and strengthen quality and compliance systems

"The programme spans across all our sites, covers people processes, products, SOPs (standard operating procedures), training, it covers everything," Gupta said.

"There are key sets of people driving each of the initiatives across. Obviously, it's not something that you can complete across the company in six months. But there is a lot of ground that we will cover in Pithampur in the next six months," Gupta said.

Gupta said Pithampur Unit-2 and Mandideep Unit-will probably be in the second tranche of sites that we will offer for re-inspection.

To lead the quality function, Lupin appointed Johnny Mikell as President and Global Head of Quality of the company.

Mikell who was previously heading quality function at Canadian drugmaker Apotex will help steer the company towards enhanced standards of quality and compliance.