Colloquially, "pharmaceutical intermediates

Pharmaceutical Intermediates are fine chemical products in the production process from pharmaceutical chemical raw materials to raw materials or drugs. The synthesis of chemical drugs depends on high-quality pharmaceutical intermediates. According to the provisions of the China Food and Drug Administration, pharmaceutical intermediates can be regarded as drug raw materials, do not have to submit for approval in accordance with the drug rules, apply for batch number, but when it is applied to drug synthesis, its product specifications and quality need to reach a certain level, usually need to be audited by customers in order to become qualified suppliers. At the same time, pharmaceutical intermediates are fine chemicals, the domestic fine industry has achieved full competition in the market, the enterprises operate independently for the market, the China Chemical Industry Association for the fine chemical industry self-discipline management.

The marketing and sale of apis in China must obtain the approval notice of apis from the State Drug Administration (NMPA) and accept the national GMP inspection, while the sale of pharmaceutical intermediates has no such mandatory provisions. In the United States, Europe, Japan and other standardized markets, just submit the corresponding DMF documents and through the official registration can be exported apis, export pharmaceutical intermediates without such mandatory provisions, but you can also submit technical documents, through the official registration.