Lupin dips 2% as USFDA classifies Tarapur unit as Official Action Indicated

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Shares of Lupin declined 2 per cent to Rs 741 on the BSE on Monday after United States Food and Drug Administration (USFDA) -- the US health regulator -- issued three observations to the drug company's Tarapur facility. The stock has fallen 3 per cent from the intra-day high level of Rs 764 touched in the early morning trade.

“The Company has received a communication from the USFDA, classifying the inspection conducted at its Tarapur manufacturing (API) facility between September 16 and September 20, 2019 as Official Action Indicated (OAI),” Lupin said in an exchange filing. The inspection at the Tarapur facility had closed with three observations. READ FILING HERE

The company, however, said it does not believe that this inspection classification will have an impact on disruption of supplies or the existing revenues from operations of this facility. 

In a separate regulatory filing, Lupin on Saturday said it has received two observations from the US FDA following the inspection of its Nagpur manufacturing facility.

“A PAI (Prior Approval Inspection) was carried out by the USFDA at the company's Nagpur oral solid dosage manufacturing facility between January 6-10, 2020. The inspection closed with two 483 observations," Lupin said in a filing to BSE.

“The Nagpur facility is our latest oral solid dosage facility, and this was the seventh USFDA inspection at the facility. We will address the observations raised by the agency satisfactorily and will submit our comprehensive response within the stipulated timeline” said Nilesh Gupta, Managing Director, Lupin.

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