Under the heavy document, the API industry will face up to the uphea change!

"Pharmaceutical Network Market Analysis" Recently, the Ministry of Industry and Information Technology in response to the "support for the establishment of a national-level API production base in Lianyungang" this question, which again mentioned the heavy documents of the API industry: In December 2019, the Ministry of Industry and Information Technology in cooperation with the National Health and Health Commission, the Ministry of ecological environment, the State Drug Administration and other departments formulated and issued the "guidance to promote the green development of the API industry", to further promote the green development of the API industry and promote the development of the pharmaceutical industry.
now, more than half a year has passed since the release of the opinion, under the influence of this policy, it is expected that the API industry or to face up to the uphea changes, some small and medium-sized API enterprises do not have the conditions for survival will accelerate the phase-out.
China is a global API production country, currently has more than 1500 API production enterprises, in the product species has more than 1600, 2019 output reached more than 3 million tons, the main business income of 380 billion yuan, to protect people's health, maintain social stability played an important role in international competition has a certain advantage.
But at present, there are still some problems in the API industry, such as environmental protection problems, some API factories are more serious risks of safety accidents and environmental pollution risks;
, there is also due to the lack of professional and technical personnel, low investment in research and development led to the lack of innovation capacity of API enterprises, low level of production technology phenomenon.
, the transformation and upgrading of the API industry is imminent.
, in recent years, with the introduction of a series of policies, API manufacturers have been facing higher and higher requirements.
e.g., the new version of the drug management law, generic drug consistency evaluation, the original auxiliary package and drug implementation of the joint review and approval system, these policies forced API enterprises to pay more attention to the quality of RAW drugs and process innovation.
in particular, the original auxiliary package related review and approval system, API enterprises and preparation enterprises will pay more attention to cooperation, joint research and development and improvement, and constantly improve the quality and process level of API.
and the introduction of the Guidance on Promoting the Green Development of the API Industry will further promote the upgrading of the API industry.
opinion clearly, by 2025, the basic realization of park-based production of raw materials, to create a number of centralized production base of raw materials, the technical level effectively improved, breaking through more than 20 green key common technologies, the basic realization of the industry green production technology replacement.
At the same time, in view of the serious homogenization of products in the API industry, low industrial concentration, relatively backward production technology and high environmental costs, the opinions put forward to speed up green product development and technological progress, eliminate backward production capacity in accordance with the law, and promote the promotion of green development level of the industry.
in addition, it is proposed to adjust the industrial structure of API, gradually improve the concentration and large-scale production level of THEP industry, optimize the layout of THEP industry, gradually improve the level of green development in the main producing areas of API, accelerate technological innovation and application, break through a number of key core green technologies, implement green production standards, promote the promotion of green development level of the industry, and promote the construction of centralized production base in these directions.
it is learned that the next step, the Ministry of Industry and Information Technology will work with relevant departments to develop RAW production base identification standards and working procedures to support regional space independence, strong environmental carrying capacity of the region to build a centralized API production base.
Overall, under the series of policies, the API industry is ushering in the accelerated elimination of backward production capacity, this trend will continue to expand, the future concentration of the industry will continue to improve, the industry will be towards high-quality, green direction of development.