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[RegAffairs]Re: Query on stability studies

Dear Luv Wadhwani,

Investigation to the failure to be conducted as a 
preliminary action, which i think might have done 
from your end.
then basing on the stability study the storage 
conditions to be reassessed and basing on this 
you may provide the shelf life and the storage 
conditions.

I would also like to know if you have the 
stability studies conducted at 5±3°C and 25±2°C, 
if so this can also help you to evaluate the 
situation.

Regards
anil kumar singh


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