 "Nilesh Gupta, MD, Lupin")
Mumbai-based global pharmaceutical company Lupin announced on Friday that it has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (FDA) for its Nagpur Unit-I manufacturing facility. This facility is responsible for producing oral solid dosage forms.
The EIR was issued following an inspection of the facility conducted in July 2023. The FDA has classified the inspection outcome as "Voluntary Action Indicated" (VAI).
Nilesh Gupta, managing director of Lupin, stated, "We are pleased to receive the EIR with a VAI status from the FDA for the recent inspection of our Nagpur Unit-I facility."
Earlier this week, Gland Pharma also announced receiving an EIR following a US FDA inspection at its Pashamylaram facility in Hyderabad.
Lupin develops and commercialises branded and generic formulations, biotechnology products, and active pharmaceutical ingredients (APIs) in over 100 markets worldwide.
