The production process of pharmaceutical chemistry include two parts: raw material production and pharmaceutical preparation production. APIs are the material basis of drug production, they must be processed and manufactured into suitable pharmaceutical preparations before produced. In China, the pharmaceutical industry also includes the production of traditional Chinese medicine.
According to the sources of raw materials and production methods,
chemicals can be classified into phytochemicals, synthetic drugs, antibiotics, semi-synthetic antibiotics, biochemical drugs etc,.
There are many kinds of raw materials and drugs, and the related production process is different. Some are total synthesis, fermentation and extraction technology, synthesis and biotechnology, and some are used chemical processing of fermenting, and also the ways of separation and purification.
The general characteristics of API production are mainly as follows:
(1) Long production lead time and complex process.
(2) Various materials are needed for raw and auxiliary materials. Many raw materials and intermediates in the production process are flammable, explosive, toxic or corrosive substances. There are strict requirements on fire prevention, explosion proof, labor protection, technology and equipment.
(3) Strictly control on the quality for the high quality standards (high purity, minimal allowable content of impurities)
(4) Low pure output. Only a few tons or hundreds of tons of raw materials can produce single ton products. so there are many by-products and wastes.
(5) Much kinds of medicines, also updated fast, different demands, long production Lead Time, the preparations needs qualified personnel, plant space, equipment, testing instruments and good sanitary environment, as well as kinds of necessary pharmaceutical accessories and suitable internal and external packaging materials.