Production capacity and level of gradual improvement
Along with the gradual improvement of production capacity and level of Chinese pharmaceutical industry, it is essential for Chinese pharmaceutical enterprises to participate in international competition. However, according to EU regulations, marketing licenses for preparations are only issued to legitimate enterprises in the EU. To sell preparations to the EU market, foreign companies must set up local branches or through local partners. As a result, few Chinese pharmaceutical companies are able to sell their preparations to Europe.
Shenzhen Lijian Pharmaceutical in early June 2006 accepted the German medical Bureau EU GMP certification expert group for a week of on-site inspection, inspection process experts on the company's work to give a high evaluation.In July 2006, the company of the sterile powder injection, capsule, tablet, granules and dry suspension agent won the European GMP certification smoothly, also has obtained a series of products including cephalosporins rules to enter the European market permits, marks the state health pharmaceutical product quality and production management in shenzhen has reached the international advanced level, Become the first domestic non-terminal sterilization preparation through the EU GMP certification manufacturer.The first batch of cefuroxime sodium powder needles was exported to Germany in December 2006, marking the official entry of chemical preparations products of Chinese pharmaceutical enterprises into the world pharmaceutical mainstream market.
The overall standard of the EU GMP system is much higher
Domestic GMP requirements,Belong to the GMP standard of developed countries,
Mainly displays in:
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More stringent requirements:
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More perfect:
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The material of the equipment has material proof