Comprehensive understanding of "pharmaceutical intermediates"

Pharmaceutical intermediates refer to intermediate chemicals made during the synthesis of chemical drugs. They are fine chemical products. Its upstream industry is the manufacturing of basic chemical raw materials, and the downstream industry is the manufacturing of chemical raw materials and preparations. This article will give you a comprehensive understanding of the basic knowledge of pharmaceutical intermediates as well as the development status, advantages and disadvantages of pharmaceutical intermediates in my country.

01

Generally speaking, "pharmaceutical intermediates"

Pharmaceutical intermediates are a kind of fine chemical products in the production process from pharmaceutical chemical raw materials to APIs or drugs. The synthesis of chemical drugs relies on high-quality pharmaceutical intermediates. According to the regulations of the China Food and Drug Administration, pharmaceutical intermediates can be regarded as pharmaceutical raw materials and do not need to be produced and approved according to drug regulations or apply for a batch number. However, when it is used in drug synthesis, its product specifications and quality must reach a certain level, and it usually needs to be approved by the customer. Only through the audit can we become a qualified supplier. At the same time, pharmaceutical intermediates are fine chemicals. At present, the domestic fine chemical industry has achieved full market competition. Each enterprise operates independently in the market. The China Chemical Industry Association conducts self-discipline management of the fine chemical industry. The marketing and sales of raw materials in my country must obtain an approval notice for raw materials from the National Medical Products Administration (NMPA) and undergo national GMP inspections. However, there are no such mandatory regulations for the sale of pharmaceutical intermediates.

02 

Categories of pharmaceutical intermediates

Classified by application areas 

According to application fields, pharmaceutical intermediates can be divided into broad categories such as antibiotic drug intermediates, antipyretic and analgesic pharmaceutical intermediates, cardiovascular system pharmaceutical intermediates, and anti-cancer pharmaceutical intermediates. There are many types of specific pharmaceutical intermediate products, such as imidazole, furan, phenolic intermediates, aromatic intermediates, pyrrole, pyridine, biochemical reagents, sulfur-containing compounds, ammonia-containing compounds, halogen compounds, heterocyclic compounds, starch, mannitol , microcrystalline cellulose, lactose, dextrin, ethylene glycols, sugar powder, inorganic salts, ethanol intermediates, stearates, amino acids, ethanolamines, potassium salts, sodium salts and other intermediates, etc. .

Classified by technical content 

Pharmaceutical intermediates are subdivided into primary intermediates and advanced intermediates according to technical content. Since primary intermediate suppliers can only provide simple intermediate production, they are at the front end of the industrial chain and have the greatest competitive and price pressures. Price fluctuations of basic chemical raw materials have a greater impact on them, while advanced intermediate suppliers not only It has strong bargaining power over primary suppliers. More importantly, because it is responsible for the production of advanced intermediates with higher technical content and maintains closer ties with multinational companies, fluctuations in raw material prices have less impact on them. .

03 

Development status of pharmaceutical intermediates in China 

Pharmaceutical intermediates refer to intermediate chemicals made during the synthesis of chemical drugs. They are fine chemical products. Its upstream industry is the manufacturing of basic chemical raw materials, and the downstream industry is the manufacturing of chemical raw materials and preparations. In the early stages of the development of the pharmaceutical intermediates industry, due to small investment, higher profit levels than ordinary chemical products, and relatively low market entry barriers, a large number of small chemical companies joined the field of pharmaceutical intermediates. At present, my country's pharmaceutical intermediates industry has a high degree of marketization and is generally 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, it has become increasingly difficult to develop new products for pharmaceutical intermediates, and competition from traditional products has become increasingly 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 Zhiyan Consulting data, pharmaceutical intermediates are single chemical substances of extremely high purity obtained through chemical or biological reactions. They are similar to the production methods of chemical raw materials. Therefore, chemical raw material manufacturers in my country usually also produce pharmaceutical intermediate products. The development level is closely related to the development of chemical raw materials and chemical drug preparations. In the future, as a large number of patented drugs expire, generic drugs will bring broad market space and good development opportunities to pharmaceutical intermediates.

04 

Development advantages of China's pharmaceutical intermediates industry 

Has unique cost advantages 

(1) Low environmental protection costs: The current pollution discharge costs of enterprises in my country are significantly lower than those in developed countries; 

(2) Labor costs are low. The salary levels of both R&D personnel and industrial workers in my country are significantly lower than those in developed countries;

(3) Low cost of raw materials: my country has a strong petrochemical system and has achieved self-sufficiency in major chemical raw materials, which can ensure low-cost supply of raw materials; 

(4) Low investment cost: After years of development, our country has formed a relatively mature industrial system, and the cost of investment in the purchase, installation and construction of chemical equipment is lower than that in developed countries. 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. Discussions of new drugs worldwide in the next few years will focus on the following categories of drugs: brain function improving drugs, anti-rheumatoid arthritis Drugs, anti-AIDS drugs, anti-hepatitis and other viral drugs, hypolipidemia drugs, anti-thrombotic drugs, anti-tumor drugs, platelet activating factor antagonists, glycoside cardiotonic drugs, anti-depressants, anti-schizophrenia and anti-anxiety drugs, etc. Developing intermediates for these drugs is the future direction of pharmaceutical intermediate development and an important way to expand new market space.

05 

Challenges facing industry development 

Fast iteration of technology and process

The pharmaceutical intermediates industry is a technology-intensive industry with rapid product updates. Generally, 3 to 5 years after a product is launched, its profit margin will drop significantly. The company's ability to expand business depends to a large extent on the success and success of R&D activities. No, this forces companies to continuously develop new products or continuously improve production processes in order to maintain high production profits. 

Environmental protection requirements are becoming increasingly stringent

With the rapid development of my country's economy, environmental pollution has become increasingly serious. In recent years, the country has paid more and more attention to environmental protection and has issued a series of policies and regulations to promote the development of the environmental protection industry. Under this situation, the construction of ecological civilization has risen to a national strategic level. Environmental protection work is becoming more and more stringent, and discussions on the relationship between environmental protection and economics are becoming more and more intense. The production process of this industry involves various complex chemical reactions, and subsequently produces polluting emissions such as wastewater, waste gas, and solid waste (collectively referred to as "three wastes"). If not handled properly, it will have certain adverse effects on the surrounding environment.

Some companies in the pharmaceutical intermediates industry have weak financial strength

The development and technological progress of the pharmaceutical intermediates industry require a large amount of R&D investment. Whether it is new technology or new product development and transformation, financial support is required. However, except for a few large enterprises, most enterprises in the industry are small and medium-sized enterprises. In terms of financial strength, There are certain deficiencies that limit the technological innovation of enterprises in the industry.

06

China is an important participant in the global pharmaceutical supply chain. From the perspective of long-term development trends, my country's pharmaceutical industry has unique advantages. Coupled with the continuous deepening of medical reform and national policies, my country's pharmaceutical companies continue to increase their investment in generic drugs and innovative drugs. With the improvement of R&D and pharmaceutical levels, future development prospects remain good.