Why 3 different lots of innovator (RLD)should be cíharacterised for generic submission?
Hi @Praveen,
This is just to check the control and uniformity among different batches and to exhibit higher degree of consistence and equivalence with innovator reference listed drug (RLD) to submitted generic version.
Two approach can be taken either to go with ANDA (abbreviated new drug applications) or NDA (on requesting to FDA during submission), however ANDA is better if you want to put it as generic version.
as per USFDA predicate rule, three batch samples which may constitute as 3 pilot stage batches or 2 pilot stage batches with 1 small scale batch can be submitted along with satisfactory no less than 6 month stability data of both accelerated and long term.
Hope I answer your query,
for your quick reference please check the following links:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm370352.pdf
Thanks for your reply