Lupin's Vizag API facility concludes USFDA inspection with 5 observations

The inspection was carried out between 13 and 17 January 2020.

Pharma major Lupin on Saturday (18 January) announced the completion of an inspection carried out by the United States Food and Drug Administration (USFDA) at its Vizag API (active pharmaceutical ingredient) manufacturing facility. The inspection was carried out between 13 and 17 January 2020. The inspection for the API facility at Vizag closed with five 483 observations.

Commenting on the outcome of the inspection, Nilesh Gupta, managing director, Lupin said, "We are fully committed to adherence with cGMP (current good manufacturing practice) regulations and uphold high quality standards across all our manufacturing sites. We are confident of addressing the observations to the USFDA's satisfaction."

On 13 January 2020, Lupin said that it has received a communication from the 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.

On 11 January 2020, 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.

Shares of Lupin rose 1.6% to settle at Rs 766.25 on Friday, 17 January 2020. The stock has risen 5.49% in last three months, underperforming the Nifty Pharma index's 10.78% rise in the same period.

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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