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    The drug substance industry eliminates hidden dangers
    Source:Chinese websites PublishDate:2019-03-11

    Continuously extending and shifting to the downstream supply chain, domestic deep processing capabilities are gradually increasing. At the same time, domestic enterprises have also begun to actively obtain international certification, and the quality of raw materials has also been greatly improved. However, in real life, according to China's relevant regulations, only when chemical companies “spontaneously” apply to the State Food and Drug Administration for their products to be produced as “raw materials” and provide them to pharmaceutical companies, the products will be subject to the Food and Drug Administration. Supervision. If the relevant chemical companies do not file such an application, they are not covered by the drug regulatory department.


    This poses a safety hazard to the safety of drugs, and it also leads to many unreasonable factors in the production of domestic APIs. Therefore, strengthen the industry's bottom-up survey, have a clearer understanding of the industry's development status, and better develop industry development plans and promote industrial upgrading.
    Coupled with the continued rise in international oil prices, rising prices of raw materials, food shortages, environmental pressures caused by overcapacity, the implementation of new pharmacopoeia and new GMPs have increased investment and increased production costs of APIs. These will have certain adverse effects on the export of Chinese APIs.
    Therefore, industry insiders pointed out that to promote the healthy development of China's pharmaceutical industry, we must rely on innovation and innovation to achieve the transformation and upgrading of China's pharmaceutical industry and achieve leap-forward development to meet the growing health needs of the people. However, in order to realize the upstream transfer of domestic raw material drug production enterprises to the industrial ecological chain is the key goal of development, we must first have a clearer understanding of the current industry development status.