Policy and the history of Chinese drug 99% generic drugs manufactured by a domestic, due to historical reasons, pharmaceutical quality level is not aligned with foreign original research clinical drug gap significantly. To close the gap, the national drug safety "Twelve-Five" programme, specifically requested for 2007 amended drug registration approval before the implementation of the measures for the administration of a hundred thousand of generics, batches and quality consistency with the generic drug evaluation, challenges of the task is enormous.
Foreign experience: this kind of problem in the United States and Japan and other developed countries, too, United States start bioequivalence evaluation in 1971, which lasted 10 years, out of 6000 drugs 1997 Japan starts "pharmaceutical quality assessment project", and has completed approximately 730 species;
Mission critical: while the task is daunting, but this is the only way to ensure medicine safety, at the same time, the new version of GMP for pharmaceutical quality drawn in "pass line", only the escalating drug quality standards such as GMP and ensure business continuity compliance in order to improve the quality of Chinese medicines.
Company characteristics: the industrialization of our long-term commitment to medical technology, has accumulated a wealth of experience in the drug development: generic drugs and generic curve fitting, spectral study of impurity, the industrialization of sustained and controlled release preparations.
Good medicine is designed for: research with the ultimate goal is to produce the perfect product to ensure safe, efficient and stable quality control. Therefore attaches great importance to industrial pharmacy, narrowing the gap with foreign products.