1. Pharmaceutical intermediates
The so-called pharmaceutical intermediates are actually chemical raw materials or chemical products used in the synthesis process of drugs. Such chemical products can be produced in ordinary chemical plants 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 production of drugs. Although the synthesis of drugs also belongs to the chemical industry, it is stricter than the general chemical products. Manufacturers of pharmaceutical products and apis need to accept GMP certification, while manufacturers of intermediates do not, because intermediate products are just the synthesis and production of chemical raw materials, and belong to the most basic and bottom products in the drug production chain. They cannot be called drugs, so they do not need GMP certification, which reduces the industry access threshold for intermediate manufacturers.
2. Pharmaceutical intermediate industry
Refers to those chemical enterprises that produce and process organic/inorganic intermediates or apis used in the manufacture of finished drug products for pharmaceutical enterprises by chemical synthesis or biosynthesis methods in accordance with strict quality standards. Here, medical intermediates are divided into CMO and CRO seed industries.
A Contract Manufacturing Organization means that a pharmaceutical company outsources production to a partner. The business chain of the pharmaceutical CMO industry generally begins with specialized pharmaceutical raw materials. Industry companies need to purchase basic chemical raw materials and classify them into special pharmaceutical raw materials, which are gradually reprocessed into active drug starting materials, cGMP intermediates, active drugs and preparations. At present, major multinational pharmaceutical enterprises tend to establish long-term strategic partnership with a few core suppliers, and the survival of companies in this industry can be basically clear through their partners.
Contract(Clinical)Research Organization refers to a contract research organization to which a pharmaceutical company contracts out research to a partner. At present, the industry mainly adopts customized production, customized research and development, pharmaceutical contract research and sales as the main cooperation modes. No matter in which way, no matter whether the pharmaceutical intermediates are innovative products or not, the core competitiveness of enterprises still takes R&D technology as the first factor, which is reflected as the downstream customers or partners of the company.
5. Classification of pharmaceutical intermediates
Pharmaceutical intermediates can be divided into antibiotic drug intermediates, antipyretic and analgesic medicinal intermediates, cardiovascular system medicinal intermediates, anti-cancer medicinal intermediates and other large categories according to application fields. There are a wide range of specific medical intermediates, Such as imidazole, furan, phenolic intermediates, aromatic intermediates, pyrrole, pyridine, biochemical reagents, sulfur, nitrogen, halogen compounds, heterocyclic compounds, starch, mannitol, microcrystalline cellulose, lactose, dextrin, ethylene glycol, sugar powder, inorganic salts, ethanol intermediates, stearates, amino acids, glycolamines, potassium salts, sodium salts and other intermediates and so on.
Post time: Nov-14-2022