Active pharmaceutical ingredient in Biqi cleared for direct sale to EU countries
Chinese pharmaceutical company Simcere Pharmaceutical Group has announced that its diosmectite, the active pharmaceutical ingredient in its branded generic drug Biqi, has passed EU-GMP inspection. This enables Simcere to market diosmectite in the EU.
Simcere has been manufacturing and marketing diosmectite API and formulation under the Biqi brand name for many years in China. Diosmectite is made from a natural mineral material and its formulation is the leading antidiarrhoeal drug in China and France. Simcere owns a high grade diosmectite mine in China.
‘We are delighted that Simcere's diosmectite has passed EU-GMP inspection and been approved for sale in the EU,’ said Jinsheng Ren, chairman and ceo of Simcere Pharmaceutical Group. ‘This is an important start in driving our international business.’