(CBN - Global) April 20 -- The US government's Food and Drug Administration has added both Xinxiang Pharmaceutical Holdings Ltd. and Xinxiang Tuoxin Biochemical Technology and Science Co. onto its list of banned imports, bringing the number of blacklisted Chinese drug firms to forty.
During an inspection in March last year, the FDA found that the raw materials produced in a factory owned by Zhejiang Hisun Pharmaceutical Co. [SHA:600267] severely deviated from international good manufacturing practices standards. The FDA also reported incidences where laboratory data was not recorded in a timely manner.
As a result, the FDA prohibited the import of 13 raw materials produced by Zhejiang Hisun. Sales of these raw materials in the US were worth CNY177 million (USD27.37 million) between January to August last year, and sales estimates for the remainder of the year were CNY62 million. In the first half of 2015, Zhejiang Hisun's net profit fell by 78.33 percent.
Between 2012 and 2014, many customers also complained that Zhejiang Hisun products were less than the quantities stated and that they had plenty of impurities. The original data on this has since been erased.
The FDA has stepped up its monitoring of China's raw material and drug production from random checks to regular inspections.