Irinotecan will sold in the United States with FDA certification

Chinese production of injection will be first sold to the world's most developed pharmaceutical market of American with highest quality requirements. It first fills the blank of China's exports of injection.

The U.S. food and drug administration referred to the FDA. It is composed of doctors, lawyers, microbiologists, pharmacologists, chemists and statisticians professionals committed to protect, promote and improve the health. It is a government health control monitoring agency. The U.S. food and plant extracts drug administration specializes in the highest law enforcement agencies, international reputation and authority of the highest drug regulatory agencies, the certification covers the six systems of production, quality. Received FDA certification means the products made in almost all countries in the world agree.

Irinotecan injection which produced in China uses sterilization filtration process. It is the most demanding, risk control in the chemical production process. And it is the most difficult in the U.S. FDA chemicals certification examination system to the highest levels of checking. In order to meet the FDA-approved, pharmaceutical companies invest a lot of manpower and financial resources, the introduction of high-level personnel from abroad, high-paying and sending the production of technical personnel to study abroad to learn from the acquisition of world-class equipment and glutathione instruments, for all the original hardware and software upgrade to improve. In July last year, the U.S. food and drug administration sent two national chemical prosecutors to come to China for a period of 13 days of the certification examination. To this end, pharmaceutical companies invested in the plant facilities, equipment, and a lot of money to transform compliance to ensure sterile conditions. In addition, strengthening personnel training, so that the entire production system to achieve the sterility assurance of the whole process can be fully realized.

After five years of hard work and dedication, irinotecan injection successfully passed the certification examination of the U.S. food and drug administration. In the future, the Chinese pharmaceutical companies will actively promote the amount of irinotecan injection on sale in the U.S. It will accelerate the drug product though the U.S. FDA and EU certified to further enhance the competitiveness of Chinese medicines in the international market. At the same time, it is necessary to further increase international efforts to promote the company's products, to establish a company overseas, to set up the sales team and to promote the overseas sales amount. It strives to break hundreds of millions dollars of sales in the international market in the next three years.

Source:http://www.cospcn.com