From USFDA site - Drug Establishments Current Registration Site | FDA
Establishments must be registered within 5 days of beginning operations. (21 CFR 207.21(a) and 207.40 and FD&C Act sections 510(c), (d), & (i)). In addition, establishments must renew registration annually between October 1st and December 31st of each year. (FD&C Act sections 510(b) & (i)).
Firms that send their initial or annual registrations during October 1st to December 31st period are considered registered until the end of following year. If a firm submits its initial, updated or annual registration outside this time frame, it is considered registered until the end of the current year and shall renew before December 31.
Most likely scenario is -
They may have registered between Oct-Dec 2015, due to which they need to renew the registration for 2016.
What we do know is the following:
- Unlike Torrent which had FDA Inspection on April 2015, Ajanta has not had that 1st inspection yet.
- But since they are sending regulatory filing batches, they would have been allotted a FEI (Facility Establishment Identifier) which would imply they may have been registered.
- As for Torrent, since they had started commercial operations in Nov 2015, they would have been expected to register within 5 days as stated above.
I may be wrong with my assessment and others can correct me.