Lupin’s Mandideep facility classified as OAI by USFDA

The USFDA has stated that this facility may be subject to regulatory or administrative action.

Mar 14, 2019 03:03 IST India Infoline News Service

Lupin in its filing to the exchanges informed that the company has received a letter from the USFDA classifying the inspection conducted at the company's Mandideep (Unit 1) facility in December 2018 as 'Official Action Indicated' (OAI). 

"The USFDA has 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 a press note after markets hours to the exchanges on Wednesday.

There are no new DMF and ANDA applications pending review or approval from the Mandideep (Unit 1) facility and the company does not believe that this classification will have an impact on disruption of supplies or the existing revenues from operations of this facility, the company added.

"The company is in the process of sending further updates of its corrective actions to the USFDA and remains hopeful of a positive outcome,” the company added.

Lupin Ltd's share price ended at Rs763.90, down by Rs36.95 or 4.61%, from its previous close of Rs800.85 on the BSE.
The scrip opened at Rs801 and touched a high and low of Rs805.40 and Rs758, respectively. A total of, 38,52,249 (NSE+BSE) shares have traded on the counter. The current market cap of the company is Rs34,565.19cr.

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