Lupin declines after USFDA warning letter for Mandideep facility

Lupin fell 1.60% to Rs 747.35 after the US drug regulator issued warning letter for the company's Mandideep (Unit-1) facility.

Lupin said it received a warning letter from the US Food and Drug Administration (USFDA) for its Mandideep (unit-1) facility in Madhya Pradesh. This is subsequent to an earlier intimation received from the USFDA in March 2019 wherein the agency had classified its inspection conducted at the said facility in December 2018 as "Official Action Indicated" (OAI). There are no drug master file (DMF) and abbreviated new drug application (ANDA) applications pending review or approval from the Mandideep (Unit-1) facility and the company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility.

Lupin said it is committed to addressing the concerns raised by the USFDA and will work with the USFDA to resolve these issues at the earliest. The company said it upholds quality and compliance issues with utmost importance and remain committed to be compliant with Current Good Manufacturing Practice (CGMP) quality standards across all our facilities. The announcement was made during trading hours today, 19 September 2019.

On BSE, 66,000 shares were traded in Lupin counter, compared to a 2-week average of 55,000 shares. The stock hit an intraday high of Rs 762 and an intraday low of Rs 733.85.

It hit a 52-week high of Rs 941.10 on 19 September 2018 and a 52-week low of Rs 697.30 on 19 June 2019.

Lupin's consolidated net profit rose 49.5% to Rs 303.05 crore on a 15.4% increase in net sales to Rs 4,355.83 crore in Q1 June 2019 compared with Q1 June 2018.

Lupin is a pharmaceutical company which is engaged in producing, developing and marketing a range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) across the world.

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