Last Updated on October 2, 2024 by The Health Master
Pharmaceutical major Lupin has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its Pithampur unit-2 manufacturing facility.
The US drug regulator classified the aforementioned unit as Voluntary Action Indicated (VAI).
“We are pleased to have received the EIR from the USFDA with a satisfactory VAI status for our Pithampur Unit-2 facility.”
“We look forward to new products approvals and launches, especially ophthalmic products from this facility now,” Nilesh Gupta, Managing Director, Lupin stated in an exchange filing.
The USFDA had conducted an inspection of the facility from March 21 to March 29, 2023.
The facility manufactures oral solids and ophthalmic dosage forms, and holds great significance for Lupin as around 30-35 of the drugmaker’s total 160 ANDAs (abbreviated new drug applications) are pending from the plant under question.
Lupin’s Pithampur manufacturing unit is among its largest plants, but the unit-2 of this facility has been under the lens of the USFDA since June 2017.
The unit had previously received a warning letter in November 2019 and was later classified as OAI (Official Action Indicated) in January 2019.
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