Lupin Gets EIR From U.S. FDA For Somerset Facility
The U.S. FDA has determined that the inspection classification of Lupin's Somerset, UK, facility is “voluntary action indicated”.
Shares of Lupin Ltd. gained after the U.S. drug regulator didn’t recommend any action after an inspection at the company’s Somerset, New Jersey facility.
Lupin has received an establishment inspection report from the U.S. Food and Drug Administration for its formulation manufacturing facility at Somerset, inspected in March 2022, according to an exchange filing. The regulator has determined that the inspection classification of the facility is “voluntary action indicated”.
The VAI classification is given when objectionable conditions or practices were found, and the agency is not prepared to take or recommend any administrative or regulatory action. This is unlike the official action indicated status where the regulatory and/or administrative actions are recommended.
The U.S. FDA had earlier flagged 13 quality control and procedural lapses, as well as deficient equipment and laboratory standards at the company’s wholly owned subsidiary Novel Laboratories, Inc., according to Lupin’s March 31 filing.
BQ Prime had obtained a copy of the observations from the FDA. Five of the 13 observations were a repeat.
Yet, the drugmaker had then said it doesn’t expect this to impact revenue or disrupt supplies from operations of this facility. This unit contributes less than 5% to the company’s global revenue.
Shares of Lupin rose more than 3.3% in early trade on Thursday, the most in over two weeks, before trimming the gains. The stock was trading 0.2% down around noon. Trading volume was 2.6 times the 30-day average.
Of the 43 analysts tracking the company, 13 recommend a ‘buy’ and 15 each suggest a ‘hold’ and a ‘sell’, according to Bloomberg data. The average of the 12-month consensus price target implies an upside of 9.7%.