[direct reporting network January 4 -- (21st Century Business Herald) on December 30, announcement of the CFDA (State Food and Drug Administration) said, in Changzhi City Sambo Biochemical Pharmaceutical Co., Ltd. and other 4 enterprises in the production of compound Liver Extract Tablets (capsules) in detection of chromium content is high, the detection value in 300-1200mg/kg, the existence of security risks.

The raw materials are from Chongqing city new Xiang Sheng Biological Pharmaceutical Co., Ltd., involving 17 provinces 40 pharmaceutical companies, including Beilu pharmaceutical, Hansen pharmaceutical, kangbide pharmaceutical and other more well-known pharmaceutical companies.

With the previous "poison capsule" incident is different, the trouble is in the capsule pharmaceutical raw materials. CFDA initially identified, Chongqing new Xiang Sheng Biological Pharmaceutical Co., Ltd., not on the production of ammonium iron citrate used iron raw material quality are adequately controlled. The citric acid iron finished ammonium and iron material field testing, the production of ferric ammonium citrate detected high content chromium (detection value in 643-1178mg/kg). The production used starting materials processing of 45 steel rods of iron also detected high content chromium (detection value in 149-342mg/kg), at a higher risk.

It is reported that the compound liver extract tablet (capsule) is the blood preparation, main component is iron, no limit standard chromium. But according to CFDA previously released "nutritional supplements and review of regulations (Trial)", the amount of trivalent chromium is only 15-150 g/ day. If the human body in a large number of long-term intake of trivalent chromium, will affect the body's antioxidant system, if excessive intake of hexavalent chromium, serious can lead to renal failure and even cancer.

CFDA the latest announcement shows that Chongqing new Xiang Sheng Biological Pharmaceutical Co., Ltd. is the production of ferric ammonium citrate have been sold 17 province 40 drug production enterprises.

The reporter found out, the 40 companies are listing Corporation and its subsidiaries figure. Such as Beilu pharmaceutical, Hansen pharmaceutical, just successful backdoor jiujiujiu Shaanxi will Kang Pharmaceutical Group Holding Co., Ltd, gold seed wine subsidiary "Anhui Jintaiyang Biochemical Pharmaceutical Co., Ltd.", Shuanghui development subsidiary "Huamao Shuanghui Industrial (Group) Co., Ltd. biochemical pharmaceutical factory." In addition, the new Sanban listed "Henan Lingyou Pharmaceutical Co., Ltd., Chongqing, Shanghai high Biochemical Pharmaceutical Co., Ltd.," the two companies also impressively in the column.

CFDA said that the 40 drug production enterprises should immediately stop using Chongqing new Xiangsheng Biological Pharmaceutical Co., Ltd. is the production of citric acid ferric ammonium production of drugs, and to use the raw material medicines for pharmaceutical production to conduct the investigation, identify all within the period of validity of drugs variety number of times the flow of sales, market sales of the product recall. Relevant circumstances should be released to the public in January 2016 4, and reported CFDA. The new drug GMP certificate Xiang Sheng Biological Pharmaceutical Co Ltd ferric ammonium citrate can be recovered immediately.

At the same time, CFDA asked the Chongqing Municipal Food and Drug Supervision Bureau immediately to recover the Chongqing new Xiangsheng GMP certificate by Biological Pharmaceutical Co., Ltd. citric acid ferric ammonium, supervision of enterprises to further ascertain the situation of production and sales, recall have been listed for sale within the validity period of the product, and the enterprise investigation. Enterprises should be released to the public in December 2015 31 sales flow and recall information.

Reporters call related enterprises understanding, most enterprises of CFDA this announcement is not known, expressed as Beilu pharmaceutical, it does have a ferric ammonium citrate as raw materials of medicines, but the proportion of sales ratio is very small, if received the relevant notification, according to the requirements of drug treatment.

Drug safety issues often arise CFDA in 2015 also increased the supervision on the quality and safety of drugs, such as in drug. Since July 22, 2015, to carry out drug clinical trial data for checking and verification work, respectively on the 7th of November 11, December announcement, of the clinical trial data exist to fail to be true and complete 22 enterprises 24 application for registration, not to grant the approval processing made. As of December 14th, the applicant voluntarily withdraw the drug registration application for a total of 727.