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Hello ,
To overcome the technical difficulties (picking) during tablet compression , it is required to use plain die – punch, replacing the debossing (identification mark) of the tablet (IR) /approved ANDA and instead the coated tablet will be imprinted with the same identification tag.
Actually, it will be addition of ink with an approved ANDA formulation .
Please note that RLD is having debossing (not imprinting) on the tablet.
Is it acceptable to go for this change on the approved ANDA ?
As per guidance on " Incorporation of Physical Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anti-counterfeiting" it may fall under CBE 30 (based on impact of change).
Is it okay to submit "01 exhibit batch with 03M stability along with comparative dissolution data of the proposed Vs approved ANDA" .
Please suggest
Thank you.