USFDA issues Form 483 to Lupin’s plant, stock dips 12%
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Mumbai: Shares of Mumbai-based pharmaceuticals firm Lupin Ltd fell about 12% on Tuesday after CNBC-TV18 reported that the US Food and Drug Administration (FDA) had voiced concerns about the company’s Mandideep manufacturing plant in Madhya Pradesh.
Shares of Lupin fell to Rs.1,317 in early trading, down 11.8% on the BSE while the benchmark Sensex index was down 0.07% at 24948.24 points.
The FDA issued its Form 483 to Lupin, conveying its concerns about manufacturing practices at the Mandideep plant, CNBC-TV18 said. Companies receiving Form 483 observations must respond to the FDA in writing with a corrective action plan they need to implement expeditiously. If the company fails to satisfy the FDA about corrective action, a warning letter may follow.
At an estimated $200 million, Mandideep is the second largest contributor to Lupin’s US revenue after its Goa plant, CNBC-TV 18 reported. “USFDA observations at Mandideep plant are serious in nature,” it said.
Lupin officials could not be reached for comment.
On 15 March, Lupin shares fell more than 7% after the FDA inspected the company’s Goa plant and made nine observations related to inadequacies and adherence to standard operating procedures.
“The observations are on aspects such as inadequacy and adherence to standard operating procedures. We are in the midst of putting together a response to address USFDA’s observations,” Lupin said in a statement to the BSE then.
Lupin recorded a 30% increase in its consolidated net profit for the December quarter. Net profit for the quarter was Rs.529 crore, as compared with Rs.409 crore a year ago. Net sales rose 6% to Rs.3,358 crore.
On Monday, shares of Natco Pharma Ltd fell 9% after the company said the FDA has made certain observations after inspecting two of its facilities.
The active pharmaceutical ingredients manufacturing facility at Manali, near Chennai, and the pharmaceutical formulations facility at Kothur, near Hyderabad, were inspected by the USFDA during February and March, the company said in a statement.