Lupin slips after USFDA observations

Lupin fell 1.75% to Rs 745.70 after the company said it received three observations for its Tarapur facility and two observations for its Nagpur facility from the US drug regulator.

The drug maker said that it has received a communication from the US Food and Drug Administration (USFDA) classifying the inspection conducted at its Tarapur manufacturing (API) facility between 16 and 20 September 2019 as Official Action Indicated (OAI). The inspection at the Tarapur facility closed with three observations. The company does not believe that this inspection classification will have on impact on disruption of supplies or the existing revenues from operations of this facility.

Further, Lupin informed about the completion of a PAI (Prior Approval Inspection) carried out by the USFDA at the Nagpur oral solid dosage manufacturing facility from 6 to 10 January 2020. The inspection closed with two 483 observations.

Commenting on the outcome of the inspection, Nilesh Gupta, Managing Director, Lupin said, "We are committed to meeting the highest quality standards and are committed to full compliance with CGMP regulations at all our manufacturing facilities. The Nagpur facility is our latest oral solid dosage facility, and this was the seventh US FDA inspection at the facility. We will address the observations raised by the agency satisfactorily and will submit our comprehensive response within the stipulated timeline."

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

On a consolidated basis, the pharmaceutical company reported a net loss of Rs 127.07 crore in Q2 December 2019 compared with net profit of Rs 265.98 crore in Q2 December 2018. Net sales rose 10.4% to Rs 4296.90 crore in Q3 December 2019 over Q3 December 2018.

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