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

The U.S. drug regulator has flagged quality and procedural lapses at Lupin Ltd.’s drug product and active pharmaceutical ingredients manufacturing facility in Mandideep, Madhya Pradesh.

“U.S. FDA inspected Lupin’s Mandideep Unit-1 facility from Nov. 14, 2022 to Nov. 23, 2022,” the company said in a Nov. 24 exchange filing. “The inspection of the facility closed with issuance of a Form 483 with eight observations each for the drug product facility and API facility at the site.”

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

“We are committed to addressing the observations and will work with the U.S. FDA to resolve these issues at the earliest. We do not believe that this will have an impact on disruption of supplies or the existing revenues from operations of this facility,” the company said.

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

Here are the key highlights:

Lupin has yet to respond to BQ Prime’s emailed queries on the implications of the observations, the steps being taken to address these issues, the expected timelines for resolution, whether there are any pending approvals from the facility and would they get impacted.

Shares of Lupin were trading 2.33% higher, as of 3:22 p.m., compared with a 0.84% rise in the Sensex.