On July 22, 2020, at present, China needs more than 2000 kinds of raw materials and intermediates matching with chemical industry every year, and the demand is more than 2.5 million tons. After more than 30 years of development, the chemical raw materials and intermediates needed for pharmaceutical production in China can be basically matched, and only a small part needs to be imported. Moreover, due to the rich resources and low price of raw materials, many intermediates have been exported. So, what are the development opportunities in the field of pharmaceutical intermediates in China?
After nearly 50 years of development, a complete production system of β - lactam antibiotics has been formed in China. At present, almost all β - lactam antibiotics (except the varieties within the patent period) can be produced in China, and the cost is very low. Penicillin production ranks first in the world, and a large number of exports are supplied to the international market; cephalosporins are basically self-sufficient, and can strive for some exports.
At present, all the intermediates matching with β - lactam antibiotics can be produced in China. Except for the mother core 7-ACA and 7-ADCA of semi synthetic antibiotics, all the side chain intermediates can be produced and exported in large quantities.
Taking phenylacetic acid, the main supporting intermediate of β - lactam antibiotics, as an example, there are nearly 30 phenylacetic acid manufacturers in China, with a total annual capacity of about 20000 tons. However, most enterprises are small in scale, with the largest annual output of 2000 tons, and most of the others produce hundreds of tons. In 2003, the total demand for phenylacetic acid in China was about 14000 tons. The consumption structure was as follows: Penicillin G accounted for 85%, other medicines accounted for 4%, spices accounted for 7%, and pesticides and other fields accounted for 4%.
With the development of domestic perfume, medicine, pesticide and other industries, the demand for phenylacetic acid will further increase. It is estimated that by 2005, China's pharmaceutical industry will consume about 14000 tons of phenylacetic acid, 500 tons of pesticide industry and 2000 tons of perfume industry. In addition to the consumption in other fields, it is estimated that the total domestic demand for phenylacetic acid will reach 18000 tons in 2005.
In fact, the synthesis of drugs also belongs to the chemical industry, but the requirements are more stringent than those of general chemical factories. Therefore, pharmaceutical factories need GMP certification, while chemical and pharmaceutical intermediates are raw materials for drug synthesis, which are not drugs. Therefore, the requirements are relatively lower than those of drugs. Manufacturers do not need GMP certification