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Probe reveals convoluted supply chain
Any attempt to track down the source of problems with the blood thinner heparin are likely to run into trouble following a convoluted supply trail in China, according to an article in The New York Times. Regulators are trying to determine if the active ingredient for the drug--which is extracted from the lining of pig intestines--became contaminated on the journey from Chinese slaughterhouses. The Chinese factory that makes the drug, which is majority owned by the U.S. company Scientific Protein Laboratories, insists its supply chain is safe and raw materials are sourced from only two reputable wholesalers whose suppliers are audited. But an investigation by the Times revealed a more complicated process that relied on multiple suppliers that had been roiled by an outbreak of pig disease. One wholesaler confirmed that he had obtained crude heparin from a variety of factories, which he did not inspect.
"We are not the government," he told the Times in a telephone interview. "We have no right to inspect their pigs or intestines or facilities."
Heparin has now been linked to more than 400 adverse events and no one has reached any determination on what could be the cause of those adverse events. But the incident is sure to raise fresh fears over the quality of pharma products manufactured in China.
- read the article in The New York Times
Related Articles:
China: Buyers on hook for drug safety. Report
Americans distrust drugs from China, India. Report
China to overhaul drug safety regulations. Report
FDA wants satellite offices overseas. Report
Overseas drugmaking goes unsupervised. Report
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