Last Updated on July 15, 2023 by The Health Master
The US drug regulator classified the aforementioned unit as Voluntary Action Indicated (VAI).
“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.
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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