An article to let you understand the "pharmaceutical intermediate industry"
1. Pharmaceutical intermediates
The so-called pharmaceutical intermediates are actually chemical raw materials or chemical products that need to be used in the synthesis process of drugs. Such chemical products can be produced in ordinary chemical factories without obtaining a drug production license. As long as the technical indicators meet certain level requirements, they can be used to participate in the synthesis and produce drugs. Although the synthesis of pharmaceuticals also belongs to the chemical industry, it is more stringent than general chemical products. Manufacturers of patent medicines and APIs need to accept GMP certification, but manufacturers of intermediates do not, because intermediate products are only the synthesis and production of chemical raw materials, which are the most basic and bottom-end products in the pharmaceutical production chain, and cannot be called It is a drug, so it does not require GMP certification, which also lowers the industry's entry threshold for intermediate manufacturers.
2. Pharmaceutical intermediate industry
Refers to those chemical companies that use chemical synthesis or biosynthesis methods to produce and process organic/inorganic intermediates or raw materials for pharmaceutical companies to manufacture finished drugs in accordance with strict quality standards. Here, pharmaceutical intermediates are divided into two sub-sectors, CMO and CRO.
3. CMOs
Contract Manufacturing Organization refers to entrusted contract manufacturing enterprises, which means that pharmaceutical companies outsource the production process to partners. The business chain of the pharmaceutical CMO industry generally starts with dedicated pharmaceutical raw materials. Industry companies need to purchase basic chemical raw materials and classify and process them into special pharmaceutical raw materials, and then process them to gradually form raw material drug starting materials, cGMP intermediates, raw material drugs and preparations. At present, major multinational pharmaceutical companies tend to establish long-term strategic partnerships with a small number of core suppliers. The survival of companies in this industry is basically clear through their partners.
4. CROs
Contract (Clinical) Research Organization refers to entrusting a contract research organization, and pharmaceutical companies outsource research links to partners. At present, the industry mainly uses customized production, customized research and development, and pharmaceutical contract research and sales as the main cooperation methods. Regardless of the method, regardless of whether the pharmaceutical intermediate product is an innovative product, the core competitiveness of an enterprise is still judged based on R&D technology. Elements, side reflected as the company's downstream customers or partners.
5. Classification of pharmaceutical intermediates
According to the application field, pharmaceutical intermediates can be divided into antibiotic drug intermediates, antipyretic and analgesic pharmaceutical intermediates, cardiovascular system pharmaceutical intermediates, anticancer pharmaceutical intermediates and other major categories. There are many types of specific pharmaceutical intermediates, such as imidazole, furan, phenolic intermediates, aromatic hydrocarbon intermediates, pyrrole, pyridine, biochemical reagents, sulfur-containing, nitrogen-containing, halogen compounds, heterocyclic compounds, starch, mannitol , microcrystalline cellulose, lactose, dextrin, ethylene glycol, powdered sugar, inorganic salts, ethanol intermediates, stearate, amino acids, ethanolamines, potassium salts, sodium salts and other intermediates, etc. wait.