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Recent visit to FDA Web site, people will find the number of deaths caused by heparin, have noticeably increased. Earlier this year, FDA has said the recalled drug heparin anticoagulation may be associated with early last year after another reported 19 cases of death. But ended on April 7, suspected use of heparin death toll climbed to 62. The original FDA statistics Baxter has not limited the company's products, and according to this statistical standards, heparin-induced peak in the death of the unfortunate incident should be in November 2007 ~ February 2008 between. In the 4 months of which, a total of 47 deaths, and other victims had serious adverse drug reaction symptoms. In contrast, in 2006 only three cases of heparin-related deaths associated with these symptoms. Curiously, in March contaminated Baxter heparin were recalled after the deaths associated with heparin did not spawn again. Even Baxter is not clear, the new statistics out of the number of deaths, how many people with the recall of drug-related. France GroupePanpharma German sales subsidiary RotexmedicaGmbH heparin because of the quality and safety issues have recently been recalled. As a precaution, the FDA requested the recall in Europe, France, Italy and Denmark's heparin product, the latter two of heparin produced by the Italian Opocrin its Chinese suppliers is: HenzenHepalinkPharmaceuticalCompany, Shanghai No. 1 Biochemical medicine and Yantai Dongcheng Biochemicals Limited. According to reports, these API Baxter also detected a similar raw material impurities. Heparin samples for the detection of pollutants in chondroitin sulfate, FDA believes that this is not a natural product and should not be in heparin raw material, and the impurities cheaper, close to the structure and heparin, the use Pharmacopoeia Conventional methods of detection is not easy. FDA officials said the U.S. Congress in hearings, the production of such impurities are likely to be economic benefits, implying that it is artificial to add. But Baxter and API providers (ScientificProteinLaboratoriesLLC) which disagrees. ScientificProteinLaboratoriesLLC told the media, such impurities in the raw material plant outsourcing has existed for rough stage. Heparin supply of raw materials prices have been rising in recent years, companies need to take risks to do this without hands, "impurities such contamination appears to be extracted from pig tissue," and farmers if impurities are intentionally added, they require specialized equipment and technology is unbelievable. Heparin scare people now have far exceeded expectations, the problem is not limited to, a pharmaceutical supplier (possible drug contamination of raw materials), may cause shortage of drugs crisis. Confusing is that the detection of impurities are the real cause of death in patients with "murderer", how the ingredients in heparin raw materials, other materials not in the detection of drugs and injection drugs such pollutants can be fatal? FDA currently investigating the death of patients whether the taking of other drugs, are there any other serious reasons for adverse drug reactions. FDA recently announced that it has received State Department approval, supervision and inspection in the Chinese sent to U.S. exports bulk drugs and diagnostic products, medical devices Chinese companies. FDA seems to be urgent, saying in May to open office in China, and then set up similar institutions in India. Minister of Health of the United States to the Associated Press said the completion of all procedures, the office probably going to be opened this fall. I have asked the United States on this special industry veteran, FDA learned of the plan probably will not go smoothly. First of all, this involves that the diplomatic affairs, communication through official channels. So far, the Chinese Ministry of Health, the U.S. does not seem to be a formal application. Even if formal negotiations begin, according to the principle of reciprocity, if the Chinese Government has also requested to send their officials to examine all permanent U.S. pharmaceutical business in China, whether the U.S. government and pharmaceutical companies will agree to this? Moreover, FDA set up an office overseas, there is no precedent, even if the Chinese government to allow the creation of this body, eight full-time staff and five local employees of the staffing, it may not be able to take hundreds of companies on-site assessment work. We are high quality suppliers, our products such as China hot foil machine , slitter machines Manufacturer for oversee buyer. To know more, please visits slitting machinery.
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