What are "Pharmaceutical Intermediates Colloquially”

Pharmaceutical intermediates are fine chemical products used 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 Drug Administration, pharmaceutical intermediates can be considered as raw materials for drugs. They are not required to follow the same rules as drug production for reporting approval or applying for a batch number. However, when used in drug synthesis, the product specifications and quality must meet certain standards. Typically, the customer will audit the supplier to ensure they are qualified. Pharmaceutical intermediates are classified as fine chemicals. Currently, the domestic fine chemical industry is highly competitive in the market. The China Chemical Industry Association regulates the fine chemical industry through self-regulatory management.
 
In regulated markets such as the United States, Europe, and Japan, it is only necessary to submit the appropriate DMF documents and complete official registration in order to export APIs. While there are no mandatory requirements for the export of pharmaceutical intermediates, it is still possible to submit technical documents for official registration.

Categories of pharmaceutical intermediates

By Applications

Pharmaceutical intermediates can be categorised based on their application areas, including intermediates for antibiotics, antipyretic and analgesic drugs, cardiovascular system drugs, and anticancer pharmaceutical intermediates. Pharmaceutical intermediates include various types such as imidazole, furan, phenolic, aromatic, pyrrole, pyridine, biochemical reagents, sulphur-containing, ammonia-containing, halogenated, heterocyclic, starch, mannitol, microcrystalline cellulose, lactose, dextrin, glycols, icing sugar, inorganic salts, ethanol, stearates, amino acids, ethanolamines, potassium salts, sodium salts, and others.
High Quality Sermaglutide Powder Semaglutide CAS 910463-68-2

By technology

Pharmaceutical intermediates are classified as primary or advanced based on their technical content. Primary intermediate suppliers can only provide simple intermediate production at the front end of the industry chain. Therefore, competitive and price pressures are the largest factors affecting them. The price fluctuations of basic chemical raw materials have a greater impact on them. On the other hand, senior intermediate suppliers not only have a strong bargaining power over primary suppliers, but also produce senior intermediates with higher technological content. They maintain closer relationships with multinationals, which means that raw material price fluctuations have less of an impact on them. More importantly, as they undertake the production of advanced intermediates with higher technological content and maintain closer ties with multinational companies, raw material price fluctuations have less impact on them.

Development status of domestic pharmaceutical intermediates

Pharmaceutical intermediates are chemicals produced during the process of synthesising drugs. They are considered fine chemical products and are manufactured using basic chemical raw materials. The downstream industry for pharmaceutical intermediates includes the chemical drug API and preparation manufacturing industry. During the early stages of the pharmaceutical intermediates industry, many small chemical enterprises entered the field due to low market access thresholds, small investments, and higher profit levels compared to ordinary chemical products.
 
According to Wisdom Research Consulting, pharmaceutical intermediates are single chemical substances with high purity obtained through chemical or biological reactions, similar to the production method of chemical raw materials. Therefore, China's chemical raw materials manufacturers usually produce pharmaceutical intermediates, and their level of development is closely related to the development of chemical raw materials and chemical drug preparations. In the future, the expiration of many patented drugs will lead to the availability of generic drugs. This will create a broad market space and provide good opportunities for development in the pharmaceutical intermediates industry.