1. Definition of pharmaceutical intermediate industry

Pharmaceutical intermediate is a fine chemical product in the production process from pharmaceutical chemical raw materials to APIs or drugs. The synthesis of chemical drugs depends on high-quality pharmaceutical intermediates. According to the regulations of the China Food and Drug Administration, pharmaceutical intermediates can be regarded as raw materials of drugs, and it is not necessary to apply for production approval and batch number according to drug rules.

2. Classification of pharmaceutical intermediates

There are many kinds of pharmaceutical intermediates, mainly including cephalosporin intermediates, amino acid protectant series, vitamin intermediates, quinolone pharmaceutical intermediates, and other types of intermediates, such as medical disinfectant intermediates, antiepileptic drug intermediates, fluoropyridine intermediates, steroid pharmaceutical intermediates, etc.

At present, there are about hundreds of pharmaceutical intermediates, and they are constantly innovating, forming many fine molecule industries in the pharmaceutical intermediates industry.

3. Analysis on the regulatory system of pharmaceutical intermediate industry

The pharmaceutical intermediate industry is subordinate to the fine chemical industry. At present, the competent authorities of 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, which are responsible for the research and formulation of industrial policies, government guidance on product development and promotion, project approval and management of industrial support funds.

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; Carry out investigation and research on industrial economic development, and put forward opinions and suggestions on economic policies and legislation to the government; Carry out industry statistical investigation;

Strengthen industry self-discipline; Standardize industry behavior and maintain fair market competition; Carry out economic and technological exchanges and cooperation at home and abroad, and organize exhibitions, technical exchanges and academic conferences; Carry out consulting services such as intellectual property protection, anti-dumping and anti smuggling; Organize the recommendation of major scientific research projects, the identification, promotion and application of scientific and technological achievements; Organize quality management, participate in quality supervision, etc. The National Fine Chemical Raw Materials and Intermediates Cooperation Group is a social organization in the intermediate industry, led by the China Petroleum and Chemical Industry Association. Its secretariat is attached to the China Chemical Information Center, and its responsibility is to communicate and cooperate within the community.

4. The relationship between pharmaceutical intermediate industry and upstream industry and its impact

The upstream industry of the pharmaceutical intermediate industry is mainly the chemical raw material production industry. The changes in the capacity and price of upstream chemical raw materials have a significant impact on the production costs of enterprises in the pharmaceutical intermediate industry.

The relationship between pharmaceutical intermediate industry and downstream industry and its impact

The downstream industry of the pharmaceutical intermediate industry is mainly the chemical API industry, and the prosperity of the chemical API industry directly determines the demand for upstream pharmaceutical intermediates; At the same time, the direct production of pharmaceutical intermediates by some chemical API manufacturers will also have a certain impact on the pattern of pharmaceutical intermediates industry.