After a four-year wait, Lupin’s Goa facility was cleared by the US Food and Drug Administration (USFDA), with a voluntary action initiated (VAI) recommendation following an inspection in September. The facility had received a Warning Letter in 2017.
According to Siddhant Khandekar of ICICI Securities, the VAI could provide a significant respite in Lupin’s drive to address pending compliance issues. With the US contributing 38 per cent of total revenues in FY21, the inconsistent USFDA compliance track record of the company over the last four years had dented its prospects in that geography. He says that about 20 abbreviated new