A few manufacturers of the API 7-aminocephalosporanic acid have been recently accused of having used waste oil in the fermentative manufacturing process of this antibiotic. The oil in question was obviously ladled from gutters near restaurants. A company specialised in reprocessing waste oil mixed it with soybean oil before selling it in large quantities to food manufacturers, manufacturers of antibiotic APIs and pharmaceutical companies. This company already stood trial. During the trial, a range of renowned companies who used the waste oil were identified.
Meanwhile, China's SFDA has instructed all the pharmaceutical companies in the country to carefully scrutinize their suppliers of antibiotic APIs. This warning should also be taken seriously be European pharmaceutical companies who purchase these APIs from China.
Note: At the "15th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients" from 9-11 November 2012 in Budapest, a representative of Shanghai's FDA will give first-hand information about the monitoring of API manufacturers in China.
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)