>>As noted in the thread on SI, there’s a serious side to this: an increased likelihood that MNTA/Sandoz will possess the sole generic Lovenox on the US market.
It seems to me that one of the lessons of contaminated UH is that the current manufacturers (of UH and Lovenox) have inadequate controls (for contamination or quality). They follow a manufacturing process, step by step, but cannot know with precision the nature of the product. This not only accounts for contaminated product but for the dramatic variation in the nature or Lovenox reported by MNTA.
How can TEVA and Amphastar demonstrate that they will not be subject to the same risk?
It appears that only MNTA offers meaningful tests of quality.
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