Drug major Lupin has committed to to close the corrective action at its Goa facility, which had received nine observations from US health regulator, by December.
It said that even if the US Food and Drug Administration decides to hold back approvals from the Goa facility it won’t have much impact on the company as majority of pending approvals are from its other manufacturing sites.
“We have actually committed till December to the FDA, but we are trying internally to actually make it happen even sooner,” Lupin Managing Director Nilesh Gupta told CNBC-TV18.
The company has responded pretty comprehensively to the FDA and also sent an update thereafter as well, he added.
“We sent in May and we will likely to follow it up with another one in June.
And the plan is right now, just about these are all the things we have committed and this is the update on that and we are actually adding new stuff along the way as well,” Gupta said.
Elaborating further, he said: “I think it is going to be another three odd months before we close everything we have committed to. To the FDA we are committed till December, but we are really trying to see how we can do it even sooner.”
The company has put its best foot forward, Gupta added.”We have asked for a meeting with the FDA. They have not granted us that (meeting) yet. To me, that will be a critical event.
If they do grant us that, and if they determine one way or the other before that, then we will know,” he added.
Gupta said in the eventuality of FDA holding back approvals from the Goa facility, it will not affect its business as majority of the 100 approvals pending with the FDA now are from non-Goa sites.
“If the FDA does hold back approvals, in the meanwhile, obviously we will not get new approvals from Goa. It does not affect any of the existing business the key products that we wanted to launch have actually launched already, including from Goa.
I would not say the lion’s share but a majority of the approvals that we have pending with the FDA now are from non-Goa sites,” Gupta said.
The Mumbai-based company’s other plants at Mandideep (Madhya Pradesh) and Aurangabad (Maharastra) have already received inspection closure for the FDA, he added.