Pharmaceutical intermediates are actually some chemical raw materials or chemical products used in the process of drug synthesis. This chemical product, which does not require a production license for a drug, can be produced in an ordinary chemical plant, and can be used for the synthesis of a drug as long as it reaches a certain level.
At present, China needs about 2,000 kinds of raw materials and intermediates supporting 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 required for pharmaceutical production in China can basically be matched, and only a small part needs to be imported. Moreover, due to the abundant resources in China and the low prices of raw materials, many intermediates have achieved a large number of exports. So, what development opportunities does China's pharmaceutical intermediates face?
After nearly 50 years of development, China's β-lactam antibiotics have formed a complete production system. At present, almost all β-lactam antibiotics (except for the varieties in the patent period) can be produced in China, and the cost is very low. The production of penicillin is in the top position in the world, and a large number of exports are supplied to the international market; cephalosporins are basically self-sufficient. Can also fight for a part of the export.
At present, all the intermediates supporting β-lactam antibiotics can be produced by ourselves. Except for the partial import of semi-synthetic antibiotics, 7-ACA and 7-ADCA, all of the side chain intermediates can be produced, and a large number Export.
Taking phenylacetic acid, the main supporting intermediate of β-lactam antibiotics, as an example, there are nearly 30 phenylacetic acid producers in China with a total annual production capacity of about 20,000 tons. However, most companies are small in scale, with the largest annual output of 2,000 tons, and other large multi-year production of hundreds of tons. In 2003, the total domestic demand for phenylacetic acid was about 14,000 tons. The consumption structure was: 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 spices, medicines, pesticides and other industries, the demand for phenylacetic acid will further increase. It is estimated that by 2005, China's pharmaceutical industry will consume about 14,000 tons of phenylacetic acid, the pesticide industry will consume 500 tons, and the spice industry will consume about 2,000 tons. Coupled with consumption in other sectors, the total domestic demand for phenylacetic acid is expected to reach 18,000 tons in 2005.
In fact, the synthesis of drugs also belongs to the chemical industry, but it is stricter than the requirements of general chemical plants. Therefore, pharmaceutical companies need GMP certification, while pharmaceutical intermediates are raw materials for drug synthesis, non-pharmaceuticals, so relatively lower requirements than drugs. The factory does not require pharmaceutical GMP certification.