Shares of Lupin rose 2 percent intraday on March 14 despite USFDA classified the inspection at Mandideep (Unit 1) facility as Official Action Indicated (OAI).
US Food & Drug Administration (USFDA) has classified inspection at the company's Mandideep Unit 1 in Madhya Pradesh as OAI, blocking product approvals from the site on concerns over manufacturing practices.
"USFDA stated that this facility may be subject to regulatory or administrative action and that it may withhold approval of any pending applications or supplements in which this facility is listed," the company said in an exchange filing.
The management said there are no new drug master files (DMF) and abbreviated new drug applications (ANDA) pending review or approval from the Mandideep (Unit 1) facility.
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Lupin said it is in the process of sending further updates of its corrective actions to the USFDA and remains hopeful of a positive outcome.
Foreign brokerage house Nomura has maintained buy call on Lupin with a target at Rs 1,017 per share.
Macquarie has maintained buy call with a target of Rs 716 per share.
At 1105 hours, Lupin was quoting at Rs 768.45, up Rs 4.55, or 0.60 percent on the BSE. First Published on Mar 14, 2019 11:53 am
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