EMA bans antibiotic APIs produced by drugmaker in Mongolia www.fiercepharma.com
European authorities have decided to block the amoxicillin trihydrate API produced by a company in Mongolia, China, whose manufacturing quality oversight has been found to be weak.
The steps against Inner Mongolia Changsheng Pharmaceutical followed an October inspection of its plant in Tuoketuo, Hohhot, Inner Mongolia in China by Belgium inspectors, according to a post on the European Medicines Agency's (EMA) Eudra site.
Inspectors listed one critical and eight major deficiencies. The critical deficiency was tied to the QA system, which inspectors called “weak” and incapable of establishing acceptable standards across the whole spectrum of processes. They specifically noted oversight of deviations, quality control, validation, complaint management and documentation, among others.
The EMA is suggesting that countries ban the company from shipping products unless producers have no alternative suppliers for the APIs. In that case, any shipped products should at least be retested, the EMA said.
Both U.S. and European authorities have stepped up oversight of Chinese companies as more are found shipping ingredients to the West. Last fall, the FDA banned products and slapped a warning letter on China’s Guangdong Zhanjiang Jimin Pharmaceutical after an inspection found it had shipped multiple lots of an OTC product to the U.S. containing the wrong API because the company messed up a translation.