Lupin's Goa plant gets 7 observations from USFDA, firm unperturbed

Says confident of resolving matter, does not share nature of observations

Mumbai-based drugmaker said on Sunday that its Goa facility has received seven observations from the US drug regulator. At present, five sites of Lupin either have warning letters of Official Action Indicated (OAI) status from the US Food and Drug Administration.

In a stock exchange notification, Lupin said: “We wish to inform you that the US FDA 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.” Exact revenue contribution from the Goa facility is not known.

The company, however, is confident of resolving the matter with the FDA. “We are confident of addressing the observations satisfactorily and are committed to be compliant with Good Manufacturing Practice standards across all our facilities,” it added.

Lupin has not shared the nature of the observations made by the USFDA, and thus analysts feel that further impact analysis could be done, once the details are known.

The company’s Goa plant was inspected in March 2017 and subsequently, the company received a warning letter for the facility. The plant was again re-inspected in the beginning of 2019, and the FDA had then issued a ‘form 483’ with two or more observations.

In June Lupin had received a warning letter from the USFDA for its Somerset, (New Jersey) facility. This took the number of Lupin sites under warning letters or OAIs to five.

A Mumbai-based analyst said that the near term earnings guidance is not impacted much because of the latest observations, as its critical inhaler portfolio is manufactured at sites that are FDA compliant. “However, lesser physical inspections are now happening due to the pandemic. Thus, resolution may take some time,” the analyst added.

Vinita Gupta, Lupin CEO had told Business Standard earlier in August that, “We have built flexibility in manufacturing between our Pithampur site and the US site (Florida). Inhalation products are made at Pithampur site 3 which is already cleared by the FDA.”