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A drug substance is any substance or mixture of substances used in the manufacture of a drug product
.
China is a major producer and exporter of APIs.
In recent years, with the advancement of new medical reform policies and the influence of factors such as the transfer of global orders, the scale of China's API industry has continued to expand
.
The industry predicts that by 2022, China's API market will exceed 400 billion yuan
.
However, while seeing the opportunity, it is also necessary to understand that the current industrial structure, industrial layout, and green production level of the domestic API industry are still prominent
.
Some market analysts pointed out that API companies face at least two major challenges, including technology and cost
.
First, the challenge of technological upgrading
.
In recent years, the cost of API companies has gradually risen, forcing companies to speed up technological upgrading
.
Some leading companies have been actively exploring automation, intelligence, continuous and miniaturized production, as well as the iteration of cutting-edge technologies such as enzyme catalysis and photochemistry, to continuously improve product quality and reduce manufacturing costs
.
The continuous production guidance document issued by the FDA clearly encourages API and generic drug companies to use continuous reactions in the production of small-molecule pharmaceutical products to improve product quality and reduce manufacturing costs
.
The industry believes that in the domestic API industry, continuous production will also become a trend
.
From batch production to continuous production, API enterprises can greatly shorten the production cycle, improve production efficiency, reduce labor costs, and obtain greater benefits
.
In addition, from the perspective of environmental protection, continuous production can also reduce the probability of contamination caused by material exposure and greatly improve the quality of API products
.
Second, investment in environmental protection costs
.
The pharmaceutical industry is a highly polluting industry.
In recent years, environmental protection policies have become stricter, and it has become the "Sword of Damocles" for pharmaceutical companies, especially API companies
.
Under the background of the environmental protection tax law, the implementation of the pollutant discharge permit system and the normalization of environmental protection inspections, API companies need to make preparations, including increasing investment in environmental protection, purchasing equipment, etc.
.
It is understood that some powerful leading raw material drug manufacturers have increased relevant investment.
For example, Huahai Pharmaceutical, Puluo Pharmaceutical and other enterprises have invested 500-1000 million yuan in environmental protection
.
And some small and medium-sized enterprises that fail to meet environmental protection standards are gradually eliminated from the market
.
According to incomplete statistics, a total of 17 pharmaceutical companies will be punished for environmental violations in 2021, many of which are API manufacturers
.
This also reminds API companies that they should pay attention to the concept of green environmental protection, more strictly fulfill their obligations of environmental information disclosure, and implement their responsibilities in environmental protection
.
The cost of environmental protection is a major difficulty faced by small and medium-sized API companies, especially the high input cost of environmental protection equipment has brought a heavy burden to many companies
.
The "Notice on the Implementation Plan for Promoting the High-Quality Development of the API Industry" clearly stated that by 2025, China will develop a number of high-value-added and high-growth varieties, and make breakthroughs in a number of green and low-carbon technology and equipment
.
With the accelerated upgrading of the API industry, the industry expects that the environmental protection equipment industry will also seize the opportunity to create more green, low-carbon and economical equipment to help the high-quality development of the domestic API industry
.
Conclusion In general, under the trend of technological upgrading, energy saving and environmental protection, the low-end production capacity of the domestic API industry will accelerate to clear, and will accelerate to the high-end in the future
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
China is a major producer and exporter of APIs.
In recent years, with the advancement of new medical reform policies and the influence of factors such as the transfer of global orders, the scale of China's API industry has continued to expand
.
The industry predicts that by 2022, China's API market will exceed 400 billion yuan
.
However, while seeing the opportunity, it is also necessary to understand that the current industrial structure, industrial layout, and green production level of the domestic API industry are still prominent
.
Some market analysts pointed out that API companies face at least two major challenges, including technology and cost
.
First, the challenge of technological upgrading
.
In recent years, the cost of API companies has gradually risen, forcing companies to speed up technological upgrading
.
Some leading companies have been actively exploring automation, intelligence, continuous and miniaturized production, as well as the iteration of cutting-edge technologies such as enzyme catalysis and photochemistry, to continuously improve product quality and reduce manufacturing costs
.
The continuous production guidance document issued by the FDA clearly encourages API and generic drug companies to use continuous reactions in the production of small-molecule pharmaceutical products to improve product quality and reduce manufacturing costs
.
The industry believes that in the domestic API industry, continuous production will also become a trend
.
From batch production to continuous production, API enterprises can greatly shorten the production cycle, improve production efficiency, reduce labor costs, and obtain greater benefits
.
In addition, from the perspective of environmental protection, continuous production can also reduce the probability of contamination caused by material exposure and greatly improve the quality of API products
.
Second, investment in environmental protection costs
.
The pharmaceutical industry is a highly polluting industry.
In recent years, environmental protection policies have become stricter, and it has become the "Sword of Damocles" for pharmaceutical companies, especially API companies
.
Under the background of the environmental protection tax law, the implementation of the pollutant discharge permit system and the normalization of environmental protection inspections, API companies need to make preparations, including increasing investment in environmental protection, purchasing equipment, etc.
.
It is understood that some powerful leading raw material drug manufacturers have increased relevant investment.
For example, Huahai Pharmaceutical, Puluo Pharmaceutical and other enterprises have invested 500-1000 million yuan in environmental protection
.
And some small and medium-sized enterprises that fail to meet environmental protection standards are gradually eliminated from the market
.
According to incomplete statistics, a total of 17 pharmaceutical companies will be punished for environmental violations in 2021, many of which are API manufacturers
.
This also reminds API companies that they should pay attention to the concept of green environmental protection, more strictly fulfill their obligations of environmental information disclosure, and implement their responsibilities in environmental protection
.
The cost of environmental protection is a major difficulty faced by small and medium-sized API companies, especially the high input cost of environmental protection equipment has brought a heavy burden to many companies
.
The "Notice on the Implementation Plan for Promoting the High-Quality Development of the API Industry" clearly stated that by 2025, China will develop a number of high-value-added and high-growth varieties, and make breakthroughs in a number of green and low-carbon technology and equipment
.
With the accelerated upgrading of the API industry, the industry expects that the environmental protection equipment industry will also seize the opportunity to create more green, low-carbon and economical equipment to help the high-quality development of the domestic API industry
.
Conclusion In general, under the trend of technological upgrading, energy saving and environmental protection, the low-end production capacity of the domestic API industry will accelerate to clear, and will accelerate to the high-end in the future
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
