Understand the Pharmaceutical Intermediate Industry

 

Pharmaceutical intermediates

The so-called pharmaceutical intermediates, in fact, is the drug in the synthesis process requires the use of chemical raw materials or chemical products. Such chemical products, without obtaining a drug production license can be produced in ordinary chemical plants, as long as the technical indicators meet certain level requirements, can be used to participate in the synthesis and production of drugs. Although the synthesis of drugs also belongs to the chemical class, but more stringent than the general requirements of chemical products. Manufacturers of pharmaceuticals and APIs need to accept GMP certification, while manufacturers of intermediates do not need to, because intermediates are only the synthesis and production of chemical raw materials, which are the most basic and bottom products in the drug production chain and cannot be called drugs, so they do not need GMP certification, which also lowers the entry threshold of the industry for intermediates manufacturers.


A Text to Understand the Pharmaceutical Intermediate Industry


Pharmaceutical intermediate industry

It refers to those chemical enterprises that produce and process organic/inorganic intermediates or APIs for pharmaceutical companies in accordance with strict quality standards by chemical synthesis or biosynthesis methods for manufacturing finished drugs. Here the pharmaceutical intermediates are divided into CMO, CRO two sub-industries.


CMO

Contract Manufacturing Organization refers to the contract manufacturing enterprise, which means that the pharmaceutical company will outsource the production process to the partner. The business chain of pharmaceutical CMO industry generally starts from specialized pharmaceutical raw materials. Industry companies need to purchase basic chemical raw materials and sort and process them into specialized pharmaceutical raw materials, and then process them gradually to form API starting materials, cGMP intermediates, APIs and formulations. At present, major multinational pharmaceutical companies tend to establish long-term strategic partnerships with a few core suppliers, and the survival of companies in the industry is basically evident through their partners.


CRO

Contract (Clinical) Research Organization refers to the commissioning of contract research institutions, pharmaceutical companies will outsource research links to partners. At present, the industry mainly takes custom production, custom R&D and pharmaceutical contract research and sales as the main way of cooperation, no matter which way it is, whether the pharmaceutical intermediates products are innovative products or not, the core competitiveness of the judging company still takes R&D technology as the first element, which is laterally reflected as the company's downstream customers or partners.

A Text to Understand the Pharmaceutical Intermediate Industry

High Purity Valerophenone CAS No. 1009-14-9

Classification of pharmaceutical intermediates

Pharmaceutical intermediates can be divided into big categories according to application fields, such as intermediates for antibiotics, intermediates for antipyretic and analgesic drugs, intermediates for cardiovascular system drugs and pharmaceutical intermediates for anti-cancer. There are many kinds of pharmaceutical intermediates, such as imidazole, furan, phenolic intermediates, aromatic intermediates, pyrrole, pyridine, biochemical reagents, sulfur-containing, nitrogen-containing, halogen compounds, heterocyclic compounds, starch, mannitol, microcrystalline cellulose, lactose, dextrin, ethylene glycol, sugar powder, inorganic salts, ethanol intermediates, stearate, amino acids, ethanolamine, potassium salts, sodium salts and other intermediates, etc.

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