Teva’s ItalFarmaco connection—below is an excerpt from Exhibit “B” (a letter from MNTA’s lawyer to Teva’s lawyer) in MNTA’s motion to the US District Court for expedited discovery (see page 27 of the pdf file in #msg-59484899):
“Finally, I understand from your letter that you believe that certain documents may be in possession of a third party in Italy. Please let us know the status of your investigation into the prompt availability of such documents including, in particular, batch records and certificates of testing and/or analysis for the manufacture of generic enoxaparin.”
thanks for posting - and thanks mouton for posting the FDA document
while the latter may be redacted to some degree it still might provide some useful information, so as i see it there are 2 shots on goal to get some information regarding where the other generic applicants are visa vie FDA approval