API Products

An active substance is the main active ingredient in a drug. Take a simple aspirin for example. Acetyl salicylic acid is synthesized through chemical process and purified to a specified purity. The synthesis of acetyl salicylic acid is made by adding various excipients, such as fillers, adhesives, disintegrating agents, etc., and then pressing it into tablets. The production of apis is generally either pure chemical synthesis, biological fermentation, or semi-synthesis, with biological fermentation followed by extraction followed by synthesis. Not all pharmaceutical enterprises make API by themselves, and many manufacturers do not have the scale to produce API. Even if there is large-scale production, the cost of production may be much higher than that of procurement. Therefore, most manufacturers buy bulk drugs, and then make preparations, so that the production of drugs can be completed without a very large scale. At present, China and India have become the two largest API producers in the world. Many European and American pharmaceutical companies, even some of their own original drugs, will give up the production of API as the patent expires and the market matures, and turn to purchase apis from China and India,API production generally go through laboratory, generated through laboratory bottle container canister, taking after successful, pilot magnification, which is to enlarge the quantity of the production, then no problem tends to be faced with a lot of small scale experiment, a very simple example, the heating process, due to the relatively small amount in the laboratory, uneven heating cases is less, But if it is scaled up to a few tons of pot, at this time the heating may be not hot in this place, where the paste pot, at this time you need to stir, but the speed of mixing is appropriate, this process needs to calculate or grope. Finally from the pilot test, and then to the formal production, the volume of further amplification, and will face a lot of new problems. Therefore, although some drugs are generic, the research and development of the whole process from small test, pilot test to the final mass production is indispensable, so even generic drugs have very high research and development costs.