Lupin Secures EIR from US FDA For its Nagpur Unit

Global pharma major Lupin Limited (Lupin) announced that it has received the Establishment Inspection Report(EIR) from the United States Food and Drug Administration (FDA) for its Nagpur Unit-1 manufacturing facility that manufactures oral solid dosage forms. The EIR was issued post the last inspection of the facility conducted in July 2023. The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI). “We are pleased to receive the EIR with a VAI status from the US FDA for the recent inspection of our Nagpur Unit-1 facility.

This achievement 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,” said Nilesh Gupta, managing director, Lupin. Lupin is a worldwide pharmaceutical firm based in Mumbai, India that focuses on innovation. The firm develops and commercializes a diverse variety of branded and generic formulations, biotechnology products, and APIs in over 100 markets worldwide, including the United States, India, South Africa, and Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East, as per pharmabiz. Lupin's journey exemplifies the power of human creativity, compassion, and the relentless search of a better world. Lupin, which was founded in 1968 by our visionary founder, Dr. Desh Bandhu Gupta, has grown from humble beginnings to become a worldwide healthcare leader.