The U.S. FDA grants Lupin an EIR for its Nagpur Unit-1 Manufacturing Facility

3 Oct 2023 , 11:16 AM

Lupin Limited (Lupin), said on Friday that its Nagpur Unit-1 production facility, which creates oral solid dosage forms, has obtained the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA). 

The EIR was released following the facility’s most recent inspection, which took place in July 2023. The facility’s inspection categorization has been found by the U.S. FDA to be Voluntary Action Indicated (VAI).

‘We are grateful to the U.S. FDA for providing the EIR with a VAI status for their recent inspection of our Nagpur Unit-1 facility. Nilesh Gupta, Managing Director of Lupin, stated that this accomplishment ‘underscores our commitment to quality and compliance and also mirrors our core values, reaffirming our commitment to providing high-quality healthcare solutions to our patients around the world.’

The company creates and promotes a wide variety of branded and generic formulations, biotechnology goods, and APIs in more than 100 markets throughout the Americas, Europe, the Middle East, India, and South Africa.

The company has a strong presence in the anti-infective, gastrointestinal (GI), central nervous system (CNS), and women’s health sectors and holds a leadership position in the cardiovascular, anti-diabetic, and respiratory segments. By prescriptions, Lupin ranks as the third-largest pharmaceutical firm in the United States. In FY23, the business spent 7.9% of its revenue on research & development.

With 15 production facilities, 7 research facilities, and over 20,000 employees worldwide, Lupin has received regular recognition as a ‘Great Place to Work’ in the biotechnology and pharmaceutical industry.

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