U.S. FDA Flags Quality, Procedural Lapses At Lupin’s Pune Facility


The U.S. drug regulator flagged quality and procedural lapses at Lupin Ltd.’s biotech manufacturing facility in Pune, Maharashtra.

“The U.S. FDA conducted a prior-approval inspection at Lupin’s Biotech manufacturing facility in Pune, India in October 2022. The inspection concluded with the issuance of a Form 483 with 17 observations,” the company said in an Oct. 19 exchange filing.

A Form 483 is issued when investigators have observed any condition that in their judgment may constitute violation of the Food Drug and Cosmetic Act and Related Acts.

The Form 483 letter will not have any impact on the existing revenues from the operations of the facility, according to the filing. “We are committed to addressing the concerns raised by the U.S. FDA expeditiously.” The inspection was conducted between Oct. 3 and Oct. 14.

BQ Prime has obtained a copy of the observations from the FDA.

Lupin has yet to respond to BQ Prime’s emailed queries on the implications of the observations and its potential impact on future approvals and launch timelines. It’s also yet to comment on the steps being taken to address these issues and the expected timelines for resolution.

Shares of Lupin were up 2.20% as of 2:15 a.m., compared with a 0.27% gain in the Nifty 50.


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