Dear Sir
As per latest updates from EMEA, Health Canada and Australian TGA, the limit of N-Nitroso perindopril revised from 1500ng/day to NMI ICHQ3. However as per USFDA last update march 2026, it still looks as 1500ng/day. Please confirm what limit we must follow in our product for this impurity. If it is as per ICH Q3, shall we follow 0.5% as limit in product considering dose as 10 mg?
This is our challege with FDA. The entire world is on one side and FDA on the other. I tried to question this issue in the generic meeting two weeks back and got cut out.
FDA has its own speed for working. So, my proposal is go with tighter limit which will be helpful later on, and also in market expansion, if desired.
I have often seen two product lines that are in fact the same product, but for different regions, and thus, two different specifications. This would be the only course I would recommend to ensure an unnecessarily rejected batch.