Lupin slips 4% as Goa plant gets 7 observations from the USFDA

These observations which has been under regulatory oversight for 4 years, and can impact investor sentiment although revenue will not be impacted in the near term, ICICI Securities note stated

Shares of Lupin dipped 4 per cent to Rs 913 on the BSE in intra-day trade on Monday after the pharmaceutical company said on Sunday that its Goa facility has received seven observations from the US drug regulator. The Goa plant was inspected in March 2017 and received a warning letter for the facility from the US Food and Drug Administration (USFDA). The stock had hit a 52-week low of Rs 856 on 10 November, 2020.

“The USFDA has concluded an inspection at our Goa facility in India. The inspection was carried out from September 6, 2021 to September 18, 2021 and closed with seven observations,” Lupin said in a statement. “We are confident of addressing the observations satisfactorily and are committed to be compliant with Good Manufacturing Practice standards across all our facilities,” the release added.

Lupin also has Mandideep, Pithampur and Somerset facility under warning letter while the Tarapur facility is under an official action indicated status. These seven observations for the Goa facility, which has been under regulatory oversight for four years, can impact investor sentiments although revenue will not be impacted in the near term, ICICI Securities said in a note.

At 10:04 am; the stock was down 1.4 per cent at Rs 937.40 on the BSE, as compared to 0.12 per cent decline in the S&P BSE Sensex. A combined 1.8 million equity shares changed hands at the counter on the NSE and BSE.