What are pharmaceutical intermediates, APIs

1, intermediates

The so-called pharmaceutical intermediates are actually some chemical raw materials or chemical products used in the process of drug synthesis. This chemical product, do not need a production licence for drugs, in the ordinary chemical plant can produce, as long as the level of some, can be used for drug synthesis. This is what the concept of pharmaceutical intermediates is crucial for pharmaceutical professionals.

At present, China needs more than 2000 kinds of raw materials and intermediates with chemical industry every year, and the demand reaches more than 2.5 million tonnes. After more than 30 years of development, China's pharmaceutical production of chemical raw materials and intermediates required by the basic supporting, only a small part of the need to import. And because of China's rich resources, raw material prices are lower, there are many intermediates to achieve a large number of exports. So, China's pharmaceutical intermediates in the field of what development opportunities?

At present, China has developed and put into mass production of quinolone antimicrobial drugs, mainly including norfloxacin, ciprofloxacin, ofloxacin, enrofloxacin, lomefloxacin, flerofloxacin, etc. Among them, norfloxacin, ciprofloxacin and flerofloxacin are the most popular ones. Among them, Norfloxacin, Ciprofloxacin and Oxyfloxacin have the largest production volume, accounting for about 98% of the total domestic production of fluoroquinolone antimicrobials.

Quinolones are generally obtained by the condensation of fluorinated quinoline compounds with piperazine (or methyl piperazine) after the synthesis of fluorinated benzene ring. Due to the rich fluorite reserves in China, it is one of the countries with the largest production of fluorine-containing drugs and intermediates in the world, and more than 80% of fluorine-containing intermediates are supplied for export. On the whole, China's fluorobenzene intermediates have been developed earlier, and now there is a general surplus of production capacity; trifluorotoluene intermediates have been developed later, but the development speed is faster in recent years; for heterocyclic aromatic compounds, especially fluorinated pyridines, there are only a few research units and manufacturers in China who possess the synthesis technology of fluorinated pyridine intermediates, so fluorinated pyridine intermediates will be one of the main directions for the research and development of fluorine intermediates in China in the next few years. Therefore, fluorinated pyridine intermediates will become one of the main directions of domestic fluorinated intermediates R&D in the next few years. This is what is a reasonable explanation in the pharmaceutical intermediates.

Throughout the industry, China's pharmaceutical intermediates production has six characteristics: First, most of the production enterprises are private enterprises, flexible management, investment scale is not large, basically in the millions to one or two million yuan; Second, the geographical distribution of the production enterprises are more concentrated, mainly in Zhejiang Taizhou and Jiangsu Jintan as the centre of the region; Third, with the increasing attention of the State on environmental issues, the production enterprises to build environmental protection treatment facilities under increasing pressure; Third, with the increasing attention of the State on environmental issues, production enterprises to build environmental protection treatment facilities; Third, with the increasing attention of the State on environmental issues, production enterprises to build environmental protection treatment facilities under increasing pressure. Increased pressure on the facilities; Fourth, the speed of product updates. A product is generally on the market 3 to 5 years later, its profitability will decline significantly, which forces enterprises must continue to develop new products or continuously improve the production process in order to maintain high production profits; Fifth, due to the production of pharmaceutical intermediates higher than the profitability of chemical products, the two production process is basically the same, so there are more and more small-scale chemical enterprises to join the ranks of the production of pharmaceutical intermediates, resulting in the industry disorderly Increasingly fierce competition; Sixth, compared with APIs, the production of intermediates, low profit margins, and APIs and pharmaceutical intermediates are similar to the production process, so some companies have not only the production of intermediates, but also to take advantage of their own advantages, began to produce APIs. Above from several aspects of what is a pharmaceutical intermediates, for pharmaceutical job seekers is a compass; seven is the patent will expire in the western countries of the product is prone to become a market hotspot, most of the technical strength of the manufacturers will be at this stage of the research to apply for patents.

2, API

Commonly known as the raw materials of drugs. The drugs we usually eat are processed finished drugs.

Here for western medicine and pCms: each drug has its own API.

Example:

New Contac

Drug Name

Common name: compound pseudoephedrine hydrochloride extended-release capsules

Trade Name: New Contac (CONTAC NT)

Ingredients]: This product is a compound preparation, each capsule contains 90 mg of pseudoephedrine hydrochloride; chlorpheniramine maleate

(Paracetamol) 4 mg. Excipients: starch, sucrose, hydroxypropyl methyl cellulose, ethyl cellulose polymer, Obaday yellow dry spray, Obaday pink dry spray.

Among them: pseudoephedrine hydrochloride 90 mg; is the main API of this product.

API in China is mainly supplied by manufacturers with GMP certificate, only to be production qualification are available for production and supply.