Lupin gets EIR from USFDA for Somerset manufacturing plant
News: Lupin has received the establishment inspection report (EIR) from USFDA for its Somerset, manufacturing facility, after the inspection of the facility in March 2022. USFDA has determined that the inspection classification of the facility is voluntary action indicated (VAI)
Views: The Somerset facility is earmarked for potent products, controlled substances, tablets, capsules, powders, liquids and unit dose nasal sprays. On big ticket launch front, Suprep which is a first-to-file with US market size of ~ US$200 million, would likely come from Somerset facility in Q3FY23. Regulatory clearance and high value launches is key to drive Lupin’s margin profile from H2FY23
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