API enterprises will usher in dramatic changes!

This document, once again mentioned in December 2019, the Ministry of Industry and Information Technology in cooperation with the National Health and Health Commission, the Ministry of Ecological Environment, the State Drug Administration and other departments to develop and issue the "guidance to promote the green development of the API industry", the introduction of this guidance, the API industry will have a far-reaching impact! API enterprises will accelerate the phase-out, API industry will usher in dramatic changes!The reply said that China is the world's largest producer of chemical raw materials, more than 1500 api manufacturers, in the product species has more than 1600, in 2019 output reached more than 3 million tons, the main business income of 380 billion yuan, to promote economic development, protect people's health, maintain social stability played an important role in international competition has a certain advantage. The
reply again refers to the heavy document of API: In December 2019, the Ministry of Industry and Information Technology, together with the National Health and Health Commission, the Ministry of Ecological Environment, the State Drug Administration and other departments, formulated and issued the Guidance on Promoting the Green Development of the API Industry, further promoting the green upgrading of the API industry and promoting the high-quality development of the pharmaceutical industry.
the introduction of heavy-weight documents, API enterprises will accelerate the phase-out is the introduction of this document, API enterprises will accelerate the phase-out, the API industry will usher in dramatic changes! Opinions pointed out that by 2025, the basic realization of the park production of raw materials, to create a number of raw materials centralized production base;
, the raw materials industry still has serious product homogenization, low industrial concentration, relatively backward production technology, high environmental costs and other issues.
to accelerate green product development and technological progress, eliminate backward production capacity in accordance with the law, and promote the promotion of green development level of the industry.
document also pointed out: First, to adjust the industrial structure of raw materials.
Encourage the optimization of industrial resource allocation, promote the technological transformation of green production, increase the proportion of green products for bulk API, accelerate the development of specialty API and high-end customized API, strict quality, environmental protection, hygiene and other standards, eliminate backward technologies and products in accordance with the law, and gradually improve the concentration and scale of production level of the API industry.
is to optimize the layout of the API industry.
In accordance with the requirements of the ecological protection red line, the bottom line of environmental quality, the use of resources on-line, and the list of access to the ecological environment, reasonable planning of industrial regional layout, gradually improve the level of green development of the main production areas of raw materials and drugs, accelerate the upgrading and transformation of enterprises in environmentally sensitive areas and industrial transfer, environmental air quality non-compliant cities should formulate more stringent access standards.
is to speed up technological innovation and application.
Focus on the green development needs of the industry, accelerate the promotion of green technology and industrialization applications, promote the efficient extraction of purification, green enzyme synthesis, microchannel reaction and other green processes, break through a number of key core green technology, cultivate a number of high-quality innovative enterprises, to create a number of innovative platforms, strategic alliances, demonstration bases.
fourth is the implementation of green production standards.
Research and development of raw materials green factories, green parks, green management standards, and actively build a resource-saving, environment-friendly, ecological civilization of the green production system, the organization of industry associations to carry out the evaluation of the standard, play a leading role in high-quality enterprise benchmarks, promote the promotion of the industry green development level.
is to promote the construction of a centralized production base.
Rationally plan the layout of the API industry, guide the formulation of the industry green park evaluation standards, support local relying on the existing pharmaceutical and chemical industrial parks, through structural adjustment, industrial upgrading, optimization of the layout, to carry out the construction of a centralized production base of API, to achieve public system sharing, comprehensive utilization of resources, pollution centralized control and industrial development.
next step, the Ministry of Industry and Information Technology will work with relevant departments to develop standards and working procedures for the identification of API production bases, and support the construction of centralized API production bases in areas with independent geographical space and strong environmental carrying capacity.
Jiangsu Lianyun port in recent years, the pharmaceutical industry has developed rapidly, with a certain industrial base and regional advantages, infrastructure support is better, we will further guide the local strengthening of the development and cultivation of the API industry, to encourage the region to actively declare the state-level API production base under the conditions.
China's current problems in the API industry 1 environmental pressure increases the production process of API products complex, in order to produce a certain kind of API, usually need to use a large number of flammable and explosive, toxic and harmful raw materials, the current safety accident risk and environmental pollution risk of China's API factory are more serious, is one of the main objects of environmental protection management.
statistics, in 2011-2015, the number of enterprises above the scale of China's API industry increased year by year, but the growth rate of the number of enterprises showed a downward trend year by year.
2017, with the strengthening of environmental protection efforts by the Chinese government, the environmental protection costs of API manufacturers have soared.
2018, the Environmental Protection Tax Law was officially implemented, the introduction of environmental taxes and environmental inspection "look back" further increased the pressure on API enterprises, nearly 70% of API manufacturers because of difficulties to bear high environmental investment and stop production.
guidance will accelerate the elimination of backward production capacity and promote industry integration.
2 industry concentration is low, competition disorder China's API industry to small enterprises, new enterprises, industry concentration is low.
2018, There are 43 enterprises with more than US$100 million in API exports, accounting for only 0.38% of the total number of API export enterprises, and their cumulative export value accounts for only 23.24% of the total API exports.
production of raw materials in China is large, but the competition is in a disorderly state.
bulk API is the main production variety of China's API enterprises, due to the low entry threshold, technical requirements are not high, resulting in a large number of enterprises into which the phenomenon of low-cost competition.
china's annual production of Amoxirin in 2017 was 173,000 tons, while global demand in 2017 was only 15,000 tons.
in order to compete for the market, the relevant production enterprises have to compete for prices, the average export price of China's Amoxilin from the peak of $37/kg to 20 dollars/kg in 2017.
3 The research and development innovation ability is insufficient The raw materials produced in China are mainly generic raw materials, and most of the products are at the bottom of the value chain, which is closely related to the lack of research and development innovation ability of Chinese API enterprises.
lack of professional and technical personnel, low investment in research and development and other reasons, China's API enterprises research and development capacity is generally low, the level of production technology is not high.
, it is reported that the average research and development investment intensity (i.e. research and development expenditure/main income) of China's pharmaceutical manufacturing enterprises is about 1.7%, while the average research and development investment intensity of developed countries in Europe and the United States is 10% to 20%.
in the field of specialty API and patented api, developed countries continue to increase investment in research and development, research and development costs accounted for up to 15% of API sales, while china's enterprises accounted for 3% of this proportion.
with the introduction of a series of drug regulatory policies, THEA has put forward higher and higher requirements for API manufacturers.
Such as the introduction of new drug management law, generic drug consistency evaluation, the former CFDA as a member of ICH, the original auxiliary package and drug implementation of the joint review and approval system, as well as from the European Union officials and the United States FDA inspection of China's API enterprises, these regulations require enterprises to pay more attention to the quality of RAW drugs and process innovation.
In particular, the original auxiliary package associated review and approval system, API enterprises and preparation enterprises will be closer together, API and preparation enterprises jointly research and development, joint improvement, will also promote the quality of raw materials and technology progress.
because of the monopoly of RAW three pharmaceutical companies were fined 320 million API industry, due to industry restrictions, some API only a few production, or even exclusive production, resulting in the industry easy to form a monopoly.
according to public information, China has about 1500 kinds of raw materials, of which 50 are only one enterprise to obtain production qualifications, 44 are only two enterprises can produce, production resources by a small number of enterprises.
For the monopoly of raw materials, pharmaceutical companies are afraid to speak out, not only harm the interests of pharmaceutical manufacturers, but also, because of the increase in costs, the factory price will inevitably increase, and ultimately by consumers to bear.
from the monopoly of raw materials such as paracetam, ice acetic acid, nitrate glyceion, vitamin D3, calcium glucosate, with the state anti-monopoly investigation of raw materials, gradually exposed to the public.
▍ 2018, Erkang penalties totaled 10 million in 2018, Hunan Erkang Pharmaceuticals wholly-owned subsidiary Erkang Pharmaceuticals received the State Administration of Market Supervision and Administration of the "Notice of Administrative Penalties."
The State Administration of Market Supervision and Administration has determined that Erkang Pharmaceuticals has a dominant market position in China's Poermin API market and is suspected of abusing its dominant market position by selling goods at unfairly high prices.
ordered Erkang Pharmaceuticals to immediately stop the illegal activities, confiscated the illegal proceeds of 2.3947 million, fined 8.4794 million, and fined a total of 10 million.
▍ 2020, the three drug companies were fined 320 million yuan.
14, 2020, the General Administration of Market Supervision issued a penalty, because of monopoly of raw materials, the three pharmaceutical companies were fined 320 million.
This case took 6 months to investigate and collect evidence, its investigation and evidence-taking process is like a TV drama twists and turns, but also falsely claimed that the information was flooded, traffic accidents lost;
The circumstances of this case are serious and of a bad nature, and the General Administration of Market Supervision has decided to severely punish the parties involved in the case (the three companies have imposed a total penalty of 325.5 million yuan): The company confiscated 108.9 million yuan of illegal income from Shandong Kanghui Pharmaceutical Co., Ltd. and fined 10% of its 2018 sales, amounting to 143.8 million yuan;
confiscated 6.05 million yuan of illegal income from Weifang Puyunhui Pharmaceutical Co., Ltd. and fined 9% of its 2018 sales, amounting to 48.3 million yuan;
confiscated 6.05 million yuan of illegal proceeds from Weifang Sun God Pharmaceutical Co., Ltd. and fined 7% of its 2018 sales, amounting to 12.4 million yuan;
listed pharmaceutical companies to expand the production of RAW drugs Although China's API industry has many problems, but some enterprises are still optimistic about API, investment and expansion of production.
2020, four listed pharmaceutical companies in the A-share market have thrown out plans for a non-public offering of refinancing to expand the production of API, namely, Oxiang Pharmaceuticals (603229. SH), Unilever (002940. SZ), Guangsheng Hall (300436. SZ) and Fuxiang Pharmaceuticals (300497.SZ).
Specifically, of these four enterprises, the largest to be refinanced is Fuxiang Pharmaceuticals, the company plans to raise a total of not more than 1,064 million yuan, after deducting the cost of distribution will be used for high-efficiency Pernam antibiotic construction projects, an annual output of 616 tons of Navir intermediate project, the former belongs to the antibiotic category products, the latter is antiviral products.
Followed by Anlikang and Guangshengtang, both plan to raise funds in a non-public offering of about 500 million yuan, of which Anlikang plans to use for an annual output of 5 tons of polysols of tea base, 20 tons of potassium hydroxide and other RAWM projects;
, Oxiang Pharmaceuticals also plans to raise a total of no more than 350 million yuan for the construction of specialty API and key pharmaceutical intermediate production base.
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