The semi-purified heparin detained by the FDA (from Amphastar) was sourced from Amphastar Nanjing Pharma (ANP) which leads me to believe they were one of the eleven unnamed Chinese companies being investigated during the tainted heparin scandal.
As applied to enoxaparin, Amphastar’s multiple-source strategy is as follows: Amphastar will have its subsidiary ANP refine crude heparin into semi-purified heparin. This semi-purified heparin will then be shipped to IMS, Amphastar’s subsidiary in California. IMS will then process the semi-purified heparin into Heparin sodium USP, the “starting material” for enoxaparin API.
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