MNTA follow-up:
This wording from the Momenta web-site makes me think that Lovenox and the generic from Momenta are "indistiguishable" only in their "active ingredients" so that Lovenox has much more other non-active saccharides present. To me it is much more plausible that Momenta only chemically synthesized those components of the mix that were important for activity.
Thanks again for the informative discussion.
DAK
M-Dalteparin
M-Dalteparin is designed to be a technology-enabled generic version of Fragmin (dalteparin), the second largest selling LMWH product in the United States.
As with M-Enoxaparin, we believe our ability to sequence and analyze complex sugars will allow us to analyze Fragmin and demonstrate that our generic product has the same active ingredients as Fragmin, thereby enabling ANDA regulatory approval.
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