Replies to post #127143 on Biotech Values

[DewDiligence]

Amphastar’s Chinese connection ought not to be surprising to anyone with a grasp of corporate culture in China. As you probably know, Amphastar stalked FDA executives (including Janet Woodcock) while lobbying members of Congress to steamroll the FDA into granting approval for Lovenox. Whether these actions influenced the FDA’s approval of Lovenox is debatable, but it’s a matter of fact that the actions occurred.

[oc631]

the amphastar-china website (amphastar nanjing pharmaceuticals) uses the same picture as the amphastar.com website so i'm assuming they are "closely related". looks ultra fishy.

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.



http://www.hpm.com/pdf/LOVENOX%20-%20Amphastar%20PI%20Motion.pdf




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.