Lupin: US FDA cites 9 observations on Goa plant, shares fall 7.6%
US FDA inspected Lupin's Goa plant and made nine observations related to inadequacies and adherence to standard operating procedures
Mumbai: Lupin shares fell more than 7% on Tuesday after the US Food and Drug Administration (FDA) inspected the company’s Goa plant and made nine observations related to inadequacies and adherence to standard operating procedures.
Lupin shares fell 7.59% to ₹ 1,726.60 on BSE, while the benchmark Sensex closed 1.02%, or 253.11 points, down at 24,551.17.
The news was first reported by CNBC-TV18 television channel.
Lupin has clarified that after FDA inspection at Goa facility on 11 March, the drug regulator had cited nine observations. “The observations are on aspects such as inadequacy and adherence to standard operating procedures (SOP). We are in the midst of putting together a response to address US FDA’s observations," Lupin said in a statement on BSE.
The facility in Goa manufactures a range of finished products for the US market including oral and injectable items.
Lupin had recorded a 30% growth in its consolidated net profit for the December quarter. Net profit for the quarter was ₹ 529 crore as compared with ₹ 409 crore a year ago. Net sales rose 6% to ₹ 3,358 crore.
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