I don’t get your logic. Unless a new CMC module is submitted and approved, Amphastar has to manufacture commercial Lovenox in the same manner as in the CMC section of its ANDA.
Hypothetical example:
Suppose I discover via MNTA's tech that L is pure water. I am certain that I could get a CMC though that makes said product.
I do agree with you that if A needed to use MNTA's tech to characterize their own process (run time) then MNTA is home free.
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