Please refer to my comments below
Thanks, Ketan
For drug product/drug substance having USP orificial monograph
effective currently please clarify with respect to following with
respect to US ANDAs and DMF.
1. Is it possible that I can claim the API inhouse despite of having
monograph in USP.
[Ketan Agravat] No. it is mandatory in USA to comply with USP monograph if
any.
2. Is it possible that one can claim API in-house and product as "USP".
[Ketan Agravat] No. it is mandatory in USA to comply with USP monograph if
any.
3. What are the obligation to ANDA holder in case during submission
there was no USP monograph exist for drug substance and drug product
but after approval monograph appeared for both the drug substance and
drug product. Where shall I find the reference to these obligations.
[Ketan Agravat] If DS/DP become official in USP post submission then you
have to revise your specifications/methods of analyses to comply with USP
monograph and then onwards DS/DP will be claimed as USP compliant.
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