Lupin has received a warning letter from the US Food and Drug Administration relating to its US-based manufacturing plant located in Somerset, New Jersey.
The facility had been inspected by FDA officials between Sep 10 and Nov 5 of last year.
Prior to the inspection last year, the plant was under ‘official action indicated’ or OAI status. To address concerns, Lupin had requested for a reinspection.
The Somerset facility, acquired as a part of the 2015 takeover of Gavis Pharmaceuticals, contributes less than 5% of Lupin’s global revenues. Lupin acquired US-based Gavis Pharma for $880 mn in 2016, giving the Indian company its first manufacturing facility in a country that contributes more than a third of its revenue.
Gavis had 62 abbreviated new drug applications pending approval with the US FDA at the time of the acquisition and a pipeline of over 65 products under development.