INDIA – Global pharma major Lupin has announced that the US Food and Drug Administration (FDA) has issued an Establishment Inspection Report (EIR) for its new injectable facility situated in Nagpur, India.
The USFDA issues an EIR to an establishment that is the subject of an FDA or FDA-contracted inspection when the agency decides to close the inspection.
A pre-approval inspection (PAI) is performed to contribute to the FDA’s assurance that a manufacturing establishment named in a drug application is capable of manufacturing a drug, and that submitted data are accurate and complete.
In a press release, Lupin said: “The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).”
The pharmaceutical company said that US FDA had conducted an inspection at its injectable facility in Nagpur from 17th October 2022 till October 29th October 2022.
Commenting on the successful EIR from the US FDA, Nilesh Gupta, Managing Director of Lupin, stated: “We are very happy to have received the EIR for our Nagpur injectable facility from the US FDA.”
He reaffirmed to the clients that Lupin’s state-of-the-art injectable facility at Nagpur is designed to the highest quality standards and adheres to international regulations with advanced technology and equipment.
“We are committed to bringing an important portfolio of injectables addressing unmet needs from the facility,” added Gupta.
US FDA issues an EIR for the Nagpur plant barely a year after Lupin received an Establishment Inspection Report from the regulatory body for its Somerset manufacturing facility in New Jersey.
In addition, the US FDA recently approved generic human immunodeficiency virus (HIV) antiretroviral drugs developed by Lupin.
The US-based agency cleared Lupin’s antiretroviral medications, Dolutegravir and Rilpivirine Tablets.
Lupin pointed out that its novel HIV medicines will be available in the form of hard capsules in strengths of 25 mg, and 50mg.
The Indian company has expanded its diverse portfolio in the cardiovascular, anti-diabetic, and respiratory segments with the launch of its novel HIV antiretroviral tablets.