State Food and Drug Administration requires strict prevention of substandard chemical raw materials entering pharmaceutical companies

Recently, media reported that some companies use soybean oil mixed with "ditch oil" to produce 7-aminocephalosporanic acid (7-ACA) and sell it to pharmaceutical companies. The State Food and Drug Administration has paid high attention to this issue and has sent an investigation team to investigate. It also requires that pharmaceutical companies strictly control the purchased raw materials according to regulations and conduct audits of supply companies to prevent unqualified chemical materials from entering the pharmaceutical industry.

7-ACA is an intermediate for the production of cephalosporin antibiotics and belongs to chemical raw materials. There are two steps in the production of 7-ACA by chemical companies: First, cephalosporin C is obtained through cephalosporin fermentation. Soybean oil is one of the components of the fermentation process. Soybean oil spiked with "flood oil" is used in this step. In the second step, 7-ACA is separated and purified by enzymatic or chemical cleavage.

The production of cephalosporin antibiotics by pharmaceutical companies using 7-ACA requires complicated and elaborate manufacturing processes, including: derivatization, protection, access to side chains, deprotection and salt formation, as well as separation and purification, recrystallization, and other steps to become cephalosporins. Antibiotic raw materials, through the preparation process, can produce oral, injectable cephalosporin antibiotic drugs.

The State Food and Drug Administration is organizing experts to retrieve relevant domestic and foreign literature to assess the impact of soybean oil quality on the quality and safety of cephalosporin antibiotic drugs and to understand the practice of using recycled oil abroad. Experts believe that the formulation of “ditch oil pharmaceuticals” is not appropriate, and it is easy for the public to misunderstand; the antibiotic drug production chain has long and many links, and any link to adulteration should be condemned and assume responsibility.

The State Food and Drug Administration requires drug manufacturers to take effective measures to prevent unqualified raw materials from flowing into the production process, and at the same time strengthen the inspection of raw and auxiliary materials for fats and oils to ensure that the quality of drugs is safe and effective.