Lupin's Somerset manufacturing plant receives EIR from US FDA

The US Food and Drug Administration (US FDA) had inspected the facility in March 2022, the company said in a regulatory filing.

PTI

July 07, 2022 / 11:32 IST

Lupin: Lupin receives USFDA nod for Paliperidone tablets that used to treat schizophrenia. The pharma company has received approval from US FDA for its Abbreviated New Drug Application (ANDA) - Paliperidone extended-release tablets. The drug is a generic equivalent of Invega extended-release tablets of Janssen Research and Development, LLC. The product will be manufactured at Lupin's facility in Goa. The drug had estimated annual sales of $152 million in the US as per IQVIA MAT March 2022 data. The drug is used in the treatement of schizophrenia, a mental disorder.

26 Aug, 2025 12:21

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Homegrown pharma major Lupin Ltd on Thursday said it has received establishment inspection report (EIR) from the US health regulator for its manufacturing facility at Somerset, New Jersey.

The US Food and Drug Administration (US FDA) had inspected the facility in March 2022, the company said in a regulatory filing.

"The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI), it added. As per the USFDA, VAI classification is given when objectionable conditions were found and documented during the inspection but the agency is not prepared to take or recommend regulatory action.

"We are very happy to have received the EIR from US FDA with satisfactory VAI classification for our Somerset facility. This is a significant milestone for our Somerset site, and an important step in our journey to build back our reputation as best in class in Quality and Compliance," Lupin Ltd CEO Vinita Gupta, CEO said. She further said, "We are committed to manufacture and supply products of the highest quality for the patients we serve."

Lupin Ltd Managing Director, Nilesh Gupta said the company remains committed to meet and exceed global standards of quality and compliance at all its manufacturing sites. "With this positive development, we now look forward towards building a sustainable business from our Somerset facility, and carry this momentum to positive outcomes for our other sites," he added.