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The U.S. drug regulator flagged procedural lapses at Lupin Ltd.’s injectable manufacturing facility in Nagpur, Maharashtra.
“US FDA inspected Lupin’s Nagpur Unit-2 injectable manufacturing facility from Oct. 17 through Oct. 29, 2022,” the company said in an Oct. 30 exchange filing. “The inspection was a pre-approval inspection of the injectable facility. The inspection closed with issuance of a Form-483 with five observations.”
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.
“We are committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the U.S.,” the company said.
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, any impact on existing revenues and the impact on the pending 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 trading 0.05% higher as of 1:54 p.m., compared with a 0.26% decline in the Sensex.
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