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    Home > Active Ingredient News > Drugs Articles > The introduction of new guidance will further promote the optimization and upgrading of API industry

    The introduction of new guidance will further promote the optimization and upgrading of API industry

    • Last Update: 2020-02-19
    • Source: Internet
    • Author: User
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    [policies and regulations of pharmaceutical network] as the upstream of the pharmaceutical industry chain, API is not only an important part of the pharmaceutical enterprise production sector, but also the basis for ensuring the drug supply and meeting the drug demand of the people But at the same time, the API industry belongs to the heavy pollution industry The pollutants produced in the production process are difficult to deal with and expensive to deal with, which also makes many small and medium-sized enterprises hold back and forced to stop production or withdraw from the market It is understood that since the formal implementation of the environmental protection tax law in January 2018, Jiangsu, Zhejiang, Hebei and other major API production provinces have successively issued documents to strictly deal with enterprises with serious pollution, and a large number of API and intermediate enterprises that fail to meet the environmental protection standards have to stop production for rectification or shutdown In the context of current environmental protection tightening, China's chemical API production declined significantly after reaching a peak of 3.478 million tons in 2017 In 2018, China's API production reached 2.823 million tons, a year-on-year decrease of 18.83% In 2019, China's API production reached 2.523 million tons, a year-on-year decrease of 10.63%   The author learned that in order to further promote the green upgrading of API industry and promote the high-quality development of pharmaceutical industry, the Ministry of industry and information technology and other four departments jointly issued the guiding opinions on promoting the green development of API industry (hereinafter referred to as the opinions) The opinions put forward that by 2025, the industrial structure will be more reasonable and the proportion of API produced by green process will be further increased The market share of high-end characteristic APIs has been significantly increased; the industrial layout has been further optimized, and the APIs have basically realized Park production, and a batch of API centralized production bases have been built It is understood that due to the lack of research and development capacity in the early stage, China's API enterprises have the advantages of mainly some bulk API products with mature technology and long product chain, mainly focusing on vitamins, antipyretics and analgesics, antibiotics and corticosteroids In recent years, the policy dividend has expanded the scale of generic drug market, and the demand for new characteristic APIs has expanded rapidly, which has greatly promoted the international production transfer process of China's characteristic APIs, and the proportion of characteristic APIs in export products has also increased rapidly The industry said that the gradual promotion and implementation of the opinions will further help the optimization and upgrading of API industry, help the pharmaceutical industry to develop to high quality, and bring greater opportunities for pharmaceutical enterprises with greater relevance In this process, some domestic enterprises with strong technical strength gradually upgrade the product pipeline, and become more and more important in the fields of characteristic APIs For example, a company has been persisting in the development of characteristic API technology for a long time to meet the growing demand of basic medical and health care in China with high-quality and cheap generic drugs On the basis of characteristic API business, it actively expanded new opportunities, extended its advantages to preparations, established a solid oral preparation production line and passed the GMP inspection of EU and China It is understood that with the introduction of the policy, the API industry has undergone great changes, which are mainly reflected in two aspects: on the one hand, environmental protection continues to tighten, small and medium-sized enterprises are cleared, the situation of "small scattered" is improved, project approval is strict, industry entry barriers are increased, and competition is optimized; on the other hand On the one hand, drug audit policy reform + centralized procurement normalization, cost control has become one of the core competitiveness of generic pharmaceutical enterprises The quality of API is directly related to the preparation approval and the API manufacturers can not be changed at will The position of API industry in the industrial chain has been improved, the demand for high-quality API enterprises has increased, and the products of high-quality API enterprises are expected to continue to be released Volume, high-quality API enterprises usher in the golden development period The industry expects that in the future, with the gradual integration of domestic drug audit policies with international standards, and the gradual globalization of national enterprises, Chinese pharmaceutical enterprises are expected to play an increasingly important role in the international API market  
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