Pharmaceutical intermediates refer to intermediate chemicals made in the process of chemical drug synthesis, which are fine chemical products, and their upstream industry is the basic chemical raw material manufacturing industry, and the downstream industry is the chemical drug raw materials and preparation manufacturing industry. This article will take you to a comprehensive understanding of the basic knowledge of pharmaceutical intermediates and the development status, advantages and disadvantages of pharmaceutical intermediates in China.

01

In layman's terms, "pharmaceutical intermediates."

Pharmaceutical intermediates (intermediates) are a kind of fine chemical products in the production process from pharmaceutical and chemical raw materials to APIs or drugs, and the synthesis of chemical drugs depends on high-quality pharmaceutical intermediates. According to the regulations of the China Food and Drug Administration, pharmaceutical intermediates can be regarded as drug raw materials, and they do not need to be produced and approved in accordance with drug rules and apply for batch numbers, but when it is applied to drug synthesis, its product specifications and quality need to reach a certain level, and it usually needs to be audited by customers to become qualified suppliers. At the same time, pharmaceutical intermediates belong to fine chemicals, at present, the domestic fine chemical industry has achieved full competition in the market, the enterprises are independent in the market, and the China Chemical Industry Association carries out self-discipline management of the fine chemical industry.

The marketing and sale of APIs in China must obtain the API approval notice from the National Medical Products Administration (NMPA) and accept the national GMP inspection, while there are no such mandatory provisions for the sale of pharmaceutical intermediates. In regulated markets such as the United States, Europe, and Japan, you only need to submit the corresponding DMF documents and pass the official registration to export APIs, and there are no such mandatory requirements for the export of pharmaceutical intermediates, but you can also submit technical documents and pass the official registration.

02

Categories of pharmaceutical intermediates

According to the application field
,
pharmaceutical intermediates can be divided into antibiotic drug intermediates, antipyretic and analgesic pharmaceutical intermediates, cardiovascular system pharmaceutical intermediates, anticancer pharmaceutical intermediates and other large categories. There are many types of specific pharmaceutical intermediates, such as imidazole, furan, phenolic intermediates, aromatic intermediates, pyrroles, pyridines, biochemical reagents, sulfur-containing products, ammonia-containing compounds, halogen compounds, heterocyclic compounds, starch, mannitol, microcrystalline cellulose, lactose, dextrin, ethylene glycols, powdered sugar, inorganic salts, ethanol intermediates, stearate, amino acids, ethanolamines, potassium salts, sodium salts and other intermediates.

Classified by technical content

Pharmaceutical intermediates are subdivided into primary intermediates and advanced intermediates according to their technical content. Primary intermediate suppliers can only provide simple intermediate production, in the front end of the industrial chain, the competitive pressure and price pressure is the greatest, the price fluctuation of basic chemical raw materials has a greater impact on it, while the senior intermediate suppliers not only have strong bargaining power for primary suppliers, but more importantly, because they undertake the production of advanced intermediates with high technical content, and maintain closer ties with multinational companies, so the price fluctuations of raw materials have little impact on it.

03

The development of pharmaceutical intermediates in China

Pharmaceutical intermediates refer to intermediate chemicals made in the process of chemical drug synthesis, which are fine chemical products, and their upstream industry is the basic chemical raw material manufacturing industry, and the downstream industry is the chemical drug raw materials and preparation manufacturing industry. In the early stage of the development of the pharmaceutical intermediates industry, due to the small investment, the profit level is higher than that of ordinary chemical products, and the market access threshold is relatively low, resulting in a large number of small chemical enterprises to join the field of pharmaceutical intermediates.

At present, China's pharmaceutical intermediates industry has a high degree of marketization, and is characterized by small and medium-sized enterprises, concentrated production areas, stable business scale, low level of process technology, and serious product homogeneity. In recent years, the development of new pharmaceutical intermediates products has become more and more difficult, the competition of traditional products has become more and more fierce, coupled with the impact of national environmental protection policies, the overall scale of the pharmaceutical intermediates industry has shown a downward trend.

According to the data of Zhiyan Consulting, pharmaceutical intermediates are a single chemical substance with extremely high purity obtained through chemical or biological reactions, which is similar to the production method of chemical APIs, so China's chemical API manufacturers usually also produce pharmaceutical intermediates products, and their development level is closely related to the development of chemical APIs and chemical drug preparations. In the future, with the expiration of a large number of patented drugs, generic drugs will bring a broad market space and good development opportunities to pharmaceutical intermediates.

04

Development advantages of China's pharmaceutical intermediates industry

It has a unique cost advantage

(1) Low cost of environmental protection: China's current enterprise pollution cost is significantly lower than that of developed countries;

(2) Low labor costs: The salary level of both R&D personnel and industrial workers in China is significantly lower than that of developed countries;

(3) Low cost of raw materials: China has a strong petrochemical system, and the main chemical raw materials have achieved self-sufficiency, which can ensure the supply of cheap raw materials;

(4) Low investment cost: After years of progress, China has formed a relatively mature industrial system, and the cost of chemical equipment purchase, installation and construction is lower than that of developed countries.

It has the advantage of market space

The market of developed countries represented by the United States is growing slowly, and the market of developing countries will grow rapidly.

India is a big producer of generic drugs, China has room to chase, and big pharma is starting to get involved in the field of generic drugs. With the intensification of China's aging population, the domestic demand for related drugs will also increase year by year in the future, and domestic pharmaceutical intermediates enterprises will benefit from the rapid progress of the pharmaceutical industry market.

As an important industry in the field of fine chemicals, pharmaceutical production has become the focus of progress and competition in the past 10 years, and the discussion of new drugs in the world in the next few years will focus on the following categories of drugs: brain function improvement drugs, antirheumatoid arthritis drugs, anti-AIDS drugs, antihepatitis and other viral drugs, hypolipidemic drugs, antithrombotic drugs, antineoplastic drugs, platelet activating factor antagonists, glycoside inotropics, antidepressants, anti-schizophrenia and anti-anxiety drugs, etc. The development of these drugs is an important way to develop pharmaceutical intermediates and expand new market space in the future.

05

Challenges facing the development of the industry

The technical process iteration is fast

The pharmaceutical intermediates industry is a technology-intensive industry, the product update speed is fast, a product is generally on the market 3 to 5 years later, its profit margin will drop significantly, the company's ability to expand business largely depends on the success of research and development activities, which forces enterprises must continue to develop new products or continuously improve the production process, in order to maintain high production profits.

Environmental requirements are becoming more and more stringent

With the rapid development of China's economy, environmental pollution is becoming more and more serious. In recent years, the state has paid more and more attention to environmental protection, and a series of policies and regulations have been introduced to promote the development of environmental protection industry. Environmental protection work is becoming stricter and more intense, and the discussion about the relationship between environmental protection and the economy is becoming more and more intense. The production process of this industry involves a variety of complex chemical reactions, and the subsequent production of wastewater, waste gas, solid waste (collectively referred to as the "three wastes") and other polluting emissions, if not properly treated, will have a certain adverse impact on the surrounding environment.

Some enterprises in the pharmaceutical intermediates industry have weak financial strength

The development and technological progress of the pharmaceutical intermediates industry requires a large amount of R&D investment, whether it is new technology, new product development and transformation, all need financial support, but except for a few large enterprises, most of the enterprises in the industry are small and medium-sized enterprises, and there are certain deficiencies in financial strength, and their main sources of funds are their own business accumulation and bank loans, and there are certain deficiencies in the scale and source channels of funds, which limit the scientific and technological innovation of enterprises in the industry.

06

epilogue

China is an important participant in the global pharmaceutical supply chain, from the long-term development trend, China's pharmaceutical industry has a unique advantage, population aging, the increase in residents' income level and urbanization and other factors for the steady growth of the rigid demand of China's pharmaceutical manufacturing industry provides a guarantee, coupled with the continuous deepening of medical reform and national policies, China's pharmaceutical enterprises continue to increase the research and development of generic drugs, innovative drugs and the improvement of pharmaceutical level, the future development prospects are still good.

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