Hepalink the entire process of entering the U.S. market

Hepalink 17th held a media conference in Shenzhen, the company's U.S. Drug Administration exclusive Agent-American Pharmaceutical Co., Ltd. CEO Hole, the U.S. customers commissioned by the United States, in 2002 to find a suitable supplier of raw materials, and ultimately chose the sea, to assist its FDA certification, to bring it into the U.S. market. DSC Referral Sea Pricon, commissioned by the United States in 2002, in China to look for stable production, reliable supply, competitive heparin suppliers of raw materials, after a year of market research, the goal of targeting the sea, and 9 months in advance of its Quality assurance system survey, the production process rigor, Stable reliability for verification. 2003 U.S. Pharmaceutical Co., Ltd. and the United States customers, Hepalink signed a tripartite cooperation agreement, the company was also recruited by the Sea as the United States Drug Administration exclusive agent.　　After 3 years of difficult and complex applications, Hepalink was approved by the U.S. FDA in 2005 to export heparin APIs to the United States. According to the introduction, the United States Pharmaceutical Co., Ltd. (DSC) mainly provide world-class quality and value level of raw materials, products in full compliance with the United States and Europe leading regulatory bodies in the quality requirements. Relevant data show that in the cooperation with the leading production enterprises in the World, DSC provides a wide range of services including APIs, pharmaceutical intermediates and finished products licensing, custom production and outsourced services.　　The DSC Department of Drug Administration provides technical support and regulatory support documents for manufacturing enterprises on a global scale. FDA certification to see the third phase of the market-related FDA certification, Hepalink issued a clarification notice on 15th, the meeting on 17th, DSC company vice President Loomis and the Director of Drug Administration Jinlui on FDA certification procedures to further explain. They said that when the API manufacturer declared the drug master document DMF and obtained the DMF number, the FDA would only conduct a format review, not take the initiative to review, only when the declared drug was used by the American manufacturer as the API for the production of the batch and the FDA application for the product,　　The DMF of the declared drug is activated as part of the application approval process for the preparation product, and the FDA will conduct a detailed and scientific review of the DMF. And Hai-Loomis announced that the 7 steps are different, the FDA certification process to conclude that, in fact, the API FDA certification includes three stages, the first is the application phase, the second is the DMF after the activation of manufacturers to accept GMP on-site inspection, The third is the use of raw materials pharmaceutical manufacturers and preparations by the FDA review and approval. Of these, the third stage is the most important.　　He said that at present all to the FDA to declare the domestic heparin API manufacturers, in addition to Hepalink, no one can complete the above three stages.　　To raise funds for the development of the main business the Secretary of the Board of Directors of Haihua in response to whether to use the funds to carry out industrial chain integration or expansion of the industry, will be disclosed by the prospectus use for the main business, to ensure Hepalink's leading edge. Step Haihua pointed out that the current raw material prices are rising, expanding to 10 trillion singleThe liquidity required for capacity is well above the liquidity expected when the prospectus was made.　　He also said that the company has been engaged in the production of raw materials, focus on this aspect of today's status and achievements, the future development is still bigger and stronger, there is no consideration of the development of low molecular weight heparin. Li Li, chairman of Hepalink, said in a meeting with the media that the introduction of strategic investors is the need for the development of the company, Goldman Sachs in the United States after the discovery of Hepalink, and then began contact with the firm. He argues that Goldman's stake makes Hepalink's strategic development a global and relevant move. Li Lithium did not respond too much to the questions raised by the media. He stressed that he is a technical worker, regardless of interest or responsibility, will be in the most adept at the laboratory work.