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.
2. Is it possible that one can claim API in-house and product as "USP".
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.
--------------------------------------------
Kams
rules200012@yahoo.co.in
--------------------------------------------
|