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Pharmaceutical intermediates are some chemical raw materials or chemical products used in the process of drug synthesis
.
Intermediates are the key products in the previous process of making APIs.
According to the regulations of the China Food and Drug Administration, pharmaceutical intermediates can be regarded as raw materials for pharmaceuticals.
Although it is not necessary to apply for approval and batch number according to the pharmaceutical regulations, the product quality needs to reach a certain level, usually It needs to be audited by the customer to become its qualified supplier
.
Our country needs more than 2,000 kinds of raw materials and intermediates for chemical industry every year, and the demand is over 2.
5 million tons
.
After more than 30 years of development, the chemical raw materials and intermediates required for China's pharmaceutical production can basically be matched, and only a small part of it needs to be imported
.
With the advancement of medicine, domestic and even global drug R&D and production are expected to continue to grow, and the market scale of pharmaceutical intermediates will also continue to expand
.
According to relevant data forecasts, the size of China's pharmaceutical intermediates market will reach 220 billion yuan in 2021; it is expected to grow to 231 billion yuan in 2022; and by 2026, the market size is expected to exceed 290 billion yuan
.
However, while the pharmaceutical industry has huge potential for development, pharmaceutical intermediate suppliers are also undergoing a qualitative transformation
.
According to the industry, the difficulty of developing new products has been increasing, and the competition of traditional products has become increasingly fierce.
Coupled with the influence of national environmental protection policies, the output of pharmaceutical intermediates in China has decreased
.
For example, from the perspective of environmental protection, since the manufacturing of APIs and pharmaceutical intermediates is a heavy-polluting industry, the requirements for environmental protection are higher than those of general industries
.
Analysts pointed out that with the increase of public awareness of environmental protection and the continuous improvement of the country's environmental protection requirements, the design of production processes of related enterprises and the investment in the treatment and discharge of pollutants will continue to increase substantially
.
Therefore, companies that do not have environmental technology advantages, scale advantages, and cost advantages will be gradually eliminated, and new entrants with insufficient strength will also be rejected by environmental barriers
.
At the same time, the pharmaceutical intermediate industry is also facing this technology and industry access barriers
.
Although the pharmaceutical intermediate industry faces barriers to environmental protection, technology and industry access, some industry insiders also pointed out that China's pharmaceutical intermediates industry is developing rapidly, and the overall supply capacity is constantly improving
.
Representative manufacturers in the field of pharmaceutical intermediates include Senxuan Pharmaceutical, Tianyu Co.
, Ltd.
, Fuxiang Co.
, Ltd.
, Lianhua Technology, and Tuoxin Pharmaceutical
.
As shown in the data, Fuxiang shares mainly research and development, production and sales of specialty antibacterial APIs and their intermediates, including sulbactam series, tazobactam series of β-lactamase inhibitor APIs and Intermediates, and two series of products including carbapenem antibacterial raw materials and intermediates
.
Tianyu Co.
, Ltd.
is a pharmaceutical company mainly engaged in the research and development of APIs and pharmaceutical intermediates; Senxuan Pharmaceutical is a manufacturer of chemical APIs in the pharmaceutical manufacturing category and involves the production and sales of various API intermediates and pharmaceutical chemical intermediates.
, Has a professional R&D team, production team, sales team and other management teams
.
In addition, Tuoxin Pharmaceuticals stated on the investor interaction platform on October 30 that the company’s anti-tumor pharmaceutical intermediates mainly include cytosine for the anti-tumor drug gemcitabine, and 5-fluorocytosine for the anti-tumor drug capecitabine.
, Cytidine is used in the anti-tumor drug cytarabine, uridine is used in the anti-tumor drug cytarabine hydrochloride, and hypoxanthine is used in the anti-tumor drug mercaptopurine
.
.
Intermediates are the key products in the previous process of making APIs.
According to the regulations of the China Food and Drug Administration, pharmaceutical intermediates can be regarded as raw materials for pharmaceuticals.
Although it is not necessary to apply for approval and batch number according to the pharmaceutical regulations, the product quality needs to reach a certain level, usually It needs to be audited by the customer to become its qualified supplier
.
Our country needs more than 2,000 kinds of raw materials and intermediates for chemical industry every year, and the demand is over 2.
5 million tons
.
After more than 30 years of development, the chemical raw materials and intermediates required for China's pharmaceutical production can basically be matched, and only a small part of it needs to be imported
.
With the advancement of medicine, domestic and even global drug R&D and production are expected to continue to grow, and the market scale of pharmaceutical intermediates will also continue to expand
.
According to relevant data forecasts, the size of China's pharmaceutical intermediates market will reach 220 billion yuan in 2021; it is expected to grow to 231 billion yuan in 2022; and by 2026, the market size is expected to exceed 290 billion yuan
.
However, while the pharmaceutical industry has huge potential for development, pharmaceutical intermediate suppliers are also undergoing a qualitative transformation
.
According to the industry, the difficulty of developing new products has been increasing, and the competition of traditional products has become increasingly fierce.
Coupled with the influence of national environmental protection policies, the output of pharmaceutical intermediates in China has decreased
.
For example, from the perspective of environmental protection, since the manufacturing of APIs and pharmaceutical intermediates is a heavy-polluting industry, the requirements for environmental protection are higher than those of general industries
.
Analysts pointed out that with the increase of public awareness of environmental protection and the continuous improvement of the country's environmental protection requirements, the design of production processes of related enterprises and the investment in the treatment and discharge of pollutants will continue to increase substantially
.
Therefore, companies that do not have environmental technology advantages, scale advantages, and cost advantages will be gradually eliminated, and new entrants with insufficient strength will also be rejected by environmental barriers
.
At the same time, the pharmaceutical intermediate industry is also facing this technology and industry access barriers
.
Although the pharmaceutical intermediate industry faces barriers to environmental protection, technology and industry access, some industry insiders also pointed out that China's pharmaceutical intermediates industry is developing rapidly, and the overall supply capacity is constantly improving
.
Representative manufacturers in the field of pharmaceutical intermediates include Senxuan Pharmaceutical, Tianyu Co.
, Ltd.
, Fuxiang Co.
, Ltd.
, Lianhua Technology, and Tuoxin Pharmaceutical
.
As shown in the data, Fuxiang shares mainly research and development, production and sales of specialty antibacterial APIs and their intermediates, including sulbactam series, tazobactam series of β-lactamase inhibitor APIs and Intermediates, and two series of products including carbapenem antibacterial raw materials and intermediates
.
Tianyu Co.
, Ltd.
is a pharmaceutical company mainly engaged in the research and development of APIs and pharmaceutical intermediates; Senxuan Pharmaceutical is a manufacturer of chemical APIs in the pharmaceutical manufacturing category and involves the production and sales of various API intermediates and pharmaceutical chemical intermediates.
, Has a professional R&D team, production team, sales team and other management teams
.
In addition, Tuoxin Pharmaceuticals stated on the investor interaction platform on October 30 that the company’s anti-tumor pharmaceutical intermediates mainly include cytosine for the anti-tumor drug gemcitabine, and 5-fluorocytosine for the anti-tumor drug capecitabine.
, Cytidine is used in the anti-tumor drug cytarabine, uridine is used in the anti-tumor drug cytarabine hydrochloride, and hypoxanthine is used in the anti-tumor drug mercaptopurine
.