Simcere's Branded Generic Formulation Biqi Passes EU-GMP Inspection
NANJING, China, Aug. 23, 2011 /PRNewswire-Asia/ -- Simcere Pharmaceutical Group ("Simcere" or the "Company") (NYSE: SCR ), a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today announced that Biqi, a branded generic anti-diarrhea drug, has passed EU-GMP inspection.
The EU-GMP certificate was issued following a four-day EU-GMP audit conducted in April 2011. The inspection covered product formulation, manufacturing process, facilities and quality management systems. On August 16, 2011, the inspectors from the Fimea officially announced that Biqi meets the criteria of EU-GMP requirements for production and quality control, and issued the EU-GMP certificate to the Company.
In 2010, Simcere's manufacturing facility for diosmectite, the API in Biqi, successfully passed EU-GMP inspection.
Mr. Ren Jinsheng, Chairman of the Board of Simcere, said: "As a leading pharmaceutical company, it is our mission to provide excellent drugs for patients. We are pleased that Biqi has passed a high-standard quality control certification. This is a major milestone for Simcere."
About Simcere Pharmaceutical GroupSimcere Pharmaceutical Group (NYSE: SCR, Simcere) is a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China. In recent years, Simcere has been focusing its strategy on the development of innovative pharmaceuticals and first-to-market generics. The Company has introduced an innovative anti-cancer medication Endu, first-to-market generics such as Bicun and Anxin, and a first-to-market medication Sinofuan. Simcere manufactures and sells drugs in the oncological, cardiovascular, anti-inflammatory and anti-infection therapeutical areas. Simcere concentrates its research a