1. Definition of Pharmaceutical Intermediates Industry
Pharmaceutical intermediates are a type of fine chemical product in the production process of pharmaceutical raw materials to active pharmaceutical ingredients or drugs. The synthesis of chemical drugs relies on high-quality pharmaceutical intermediates. According to the regulations of the China National Medical Products Administration, pharmaceutical intermediates can be regarded as raw materials for drugs and do not need to be produced and approved according to drug regulations or batch number applications.
2. Classification of pharmaceutical intermediate products
There are many types of pharmaceutical intermediate products, mainly including cephalosporin intermediates, amino acid protectant series, vitamin intermediates, quinolone drug intermediates, and other types of intermediates, such as medical disinfectant intermediates, antiepileptic drug intermediates, fluoropyridine intermediates, steroid pharmaceutical intermediates, etc.
There are currently hundreds of pharmaceutical intermediate products, and they are constantly innovating, forming numerous fine molecule industries within the pharmaceutical intermediate industry.
3. Analysis of Regulatory System for Pharmaceutical Intermediates Industry
The pharmaceutical intermediate industry is subordinate to the fine chemical industry. Currently, the industry regulatory authorities for the fine chemical industry in China are the National Development and Reform Commission, the Ministry of Commerce, and provincial and municipal economic and trade commissions. They are responsible for the research and formulation of industrial policies, government guidance for product development and promotion, project approval, and management of industrial support funds.
The China Chemical Industry Association is a national, comprehensive, and international social intermediary organization in the chemical industry, mainly serving chemical enterprises and institutions, and safeguarding the rights and interests of enterprises; Conduct industry economic development surveys and research, and provide opinions and suggestions on economic policies and legislation to the government; Conduct industry statistical surveys; Strengthen industry self-discipline; Standardize industry behavior and maintain fair competition in the market; Carry out domestic and international economic and technological exchanges and cooperation, organize exhibitions, technical exchange meetings, academic presentations, etc; Provide consulting services on intellectual property protection, anti-dumping, and anti smuggling; Recommend major scientific research projects, evaluate scientific and technological achievements, and promote their application; Organize quality management and participate in quality supervision. The National Fine Chemical Raw Materials and Intermediates Cooperation Group is a community organization in the intermediate industry, led by the China Petroleum and Chemical Industry Association. Its secretariat is affiliated with the China Chemical Industry Information Center, and its responsibilities include internal communication and collaboration within the community.
4. The correlation and impact between the pharmaceutical intermediate industry and upstream industries
The upstream industry of the pharmaceutical intermediate industry is mainly the chemical raw material production industry. The production capacity and price changes of upstream chemical raw materials have a significant impact on the production costs of enterprises in the pharmaceutical intermediate industry.
The correlation and impact between the pharmaceutical intermediate industry and downstream industries
The downstream industry of the pharmaceutical intermediate industry is mainly the chemical raw material industry, and the prosperity of the chemical raw material industry directly determines the demand for upstream pharmaceutical intermediates; At the same time, some chemical raw material production enterprises directly producing pharmaceutical intermediates will also have a certain impact on the pattern of the pharmaceutical intermediate industry.