企业简称:联创医药,股权代码:800055
Consistency evaluation

Generics consistency evaluation will bring about a revolution, make the industry back on track.

Policy and Historical Status

99% of the domestic enterprise production medicine is generic, due to historical reasons, drug quality levels not neat, the clinical curative effect on obvious gap with foreign branded drugs. To close the gap, the national drug safety "twelfth five-year" plan, clear requirements for the 2007 revision of the "drug registration management measures for approval prior to implementation of tens of generic drugs, by instalments with the generic quality consistency evaluation, the task enormous challenge.

Foreign Experience

This kind of problem also exists in the United States and Japan and other developed countries, the United States in 1971 to start the evaluation of bioequivalence, 10 years, phase out 6000 kinds of medicine; "Drug quality evaluation of Japan began in 1997 project", has completed about 730 varieties;

Critical Mission

Although the task is very difficult, but this is the only way to guarantee people's safety, at the same time, a new version of GMP, drug quality designated China as the higher "pass", only by constantly upgrading GMP drug quality standard, such as continued compliance and ensure that enterprises can effectively improve the quality of Chinese medicine.

Company Features

My company's long-term commitment to the industrialization of medical technology, accumulated rich experience in new drug research and development: generic drugs and generic drugs of curve fitting, impurity profile in-depth study, the industrialization of etc.

High-qualified drugs can be sured

New drug research of the final goal is to produce perfect products, to ensure safe, effective and quality is stable and controllable. Therefore need to attach great importance to industrial pharmacy, to narrow the gap with foreign products.

Welcome interested companies to discuss cooperation.

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