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Below are Quote on Lupin received a warning letter from USFDA for Somerset, New Jersey (USA) facility by Mr. Yash Gupta Equity Research Associate, Angel Broking Ltd   

Lupin Limited has announced that the company has received a warning letter from USFDA for the company’s Somerset, New Jersey (USA) facility. The U.S. FDA had inspected the Lupin Somerset site from September 10, 2020 to November 5, 2020. Company said that they are addressing the concerns raised by the U.S. FDA and will work with the FDA and the New Jersey District to resolve these issues at the earliest.

We have seen this in the past with the Somerset plant warning letter issues for Lupin Limited. Somerset plant was under USFDA observation since 2019 and now it seems that it will remain under observation for at least next 3-6 months. This current observation letter will not impact the company’s current operation but the company cannot apply for any new ANDA from that facility. All hopes of getting Somerset USFDA clearance have been set aside fot the time being.

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