Mumbai-based drugmaker said on Sunday that its Goa facility has received seven observations from the US drug regulator. at the 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 market notification, Lupin said: “We wish to tell you that the US FDA has concluded an inspection at our Goa facility in India. The inspection was administered from September 6, 2021 to September 18, 2021 and closed with seven observations.” Exact revenue contribution from the Goa facility isn’t 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 character of the observations made by the USFDA, and thus analysts feel that further impact analysis might be done, once the small print are known.
The company’s Goa plant was inspected in March 2017 and subsequently, the corporate received a warning letter for the power . The plant was again re-inspected within the beginning of 2019, and therefore 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 amount of Lupin sites under warning letters or OAIs to 5 .
A Mumbai-based analyst said that the near term earnings guidance isn’t impacted much due to the newest observations, as its critical inhaler portfolio is manufactured at sites that are FDA compliant. “However, lesser physical inspections are now happening thanks to the pandemic. Thus, resolution may take a while ,” 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 therefore the US site (Florida). Inhalation products are made at Pithampur site 3 which is already cleared by the FDA.”