China The US Food and Drug Administration announced the survey on February 26th, 2008. According to the investigation, Changzhou Cape Company, the supplier of Baxter Company in the United States, is a foreign-invested enterprise established by American Science protein Laboratory Company (SPL) and Changzhou Pu Tian Company on June 20 14, 5438+099965438+February. It belongs to a non-pharmaceutical production enterprise, and its legal representative is an American. American SPL holds 55% of the shares.
Changzhou Cape Company's production technology of heparin sodium comes from American SPL Company, and the product standard is implemented according to the specific requirements of American Pharmacopoeia and American Baxter Company. The raw material of heparin sodium was directly supplied by Cape Company to SPL Company in the United States, and was supplied by SPL Company to Baxter Company in the United States for the production of heparin sodium injection. In August, 2004, FDA confirmed Changzhou Cape Company as the raw material producer of heparin sodium of SPL Company in the United States, and provided raw materials for Baxter Company in the United States to produce heparin sodium injection.
Two inspectors sent by FDA arrived in Changzhou Cape Company for on-site inspection on February 20th, 2008. China The US Food and Drug Administration has sent observers to cooperate with the US inspection.
China The US Food and Drug Administration stressed that the China administration is very strict in the management of chemical raw materials. The State Food and Drug Administration of the United States has repeatedly reiterated and reminded enterprises and organizations engaged in pharmaceutical trading that they should engage in pharmaceutical trading activities with pharmaceutical production and marketing enterprises in China with pharmaceutical production and marketing qualifications. The information of all pharmaceutical production and operation enterprises can be obtained on the website of the State Food and Drug Administration.
According to international practice, the legality, quality and safety of imported APIs should be inspected by the importing country according to its relevant laws. Nevertheless, China has been actively strengthening cooperation with relevant countries in the management of export APIs. On June 5438+February, 2007, China and the United States signed the Agreement on Safety Cooperation of Drugs and Medical Devices, one of the main contents of which is to further strengthen cooperation in the supervision of the import and export of APIs. At the same time, China has also signed a framework agreement with the European Union and other countries or regions to strengthen cooperation in drug supervision.