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Lupin's Mandideep Unit-1 facility gets Form 483 from USFDA with 8 observations



Posted On : 2022-11-24 16:24:09( TIMEZONE : IST )

Lupin's Mandideep Unit-1 facility gets Form 483 from USFDA with 8 observations

The U.S. FDA inspected Lupin's Mandideep Unit-1 facility from November 14, 2022 to November 23, 2022. The inspection of the facility closed with issuance of a Form483 with eight observations each for the Drug Product facility and API facility at the site.

The company is committed to addressing the observations and will work with the U.S. FDA to resolve these issues at the earliest. The company upholds quality and compliance issues with utmost importance and remain committed to be compliant with cGMP quality standards across all its facilities.

Shares of Lupin Limited was last trading in BSE at Rs. 718.80 as compared to the previous close of Rs. 719.45. The total number of shares traded during the day was 23549 in over 866 trades.

The stock hit an intraday high of Rs. 729.30 and intraday low of 717.25. The net turnover during the day was Rs. 16979502.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 USFDA Form483 EightObservations Mandideep Unit1