A comprehensive understanding of

Pharmaceutical intermediates refer to intermediate chemicals made in the process of chemical drug synthesis, which belong to fine chemical products. The upstream industry is the basic chemical raw material manufacturing industry, and the downstream industry is the chemical drug raw material and preparation manufacturing industry. This article takes you through a comprehensive understanding of the basic knowledge of pharmaceutical intermediates, as well as the development status, advantages, and disadvantages of pharmaceutical intermediates in China.

01 Generally speaking, "pharmaceutical intermediates

Medical intermediates are a fine chemical product in the production process from pharmaceutical chemical raw materials to raw materials 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 considered as raw materials for drugs, and there is no need to produce and apply for batch numbers according to drug rules. However, when it is applied to drug synthesis, its product specifications and quality must reach a certain level, and usually require customer audit to become a qualified supplier. At the same time, pharmaceutical intermediates belong to fine chemicals. Currently, the domestic fine chemical industry has achieved full market competition, and various enterprises operate independently in the market. The China Chemical Industry Association conducts self-discipline management on the fine chemical industry.

The marketing and sales of raw materials in China must obtain the approval notice for raw materials from the National Drug Administration (NMPA) and undergo national GMP inspection, while there are no such mandatory regulations for the sale of pharmaceutical intermediates. In regulated markets such as the United States, Europe, and Japan, raw materials can be exported by submitting corresponding DMF documents and obtaining official registration. There is no such mandatory requirement for exporting pharmaceutical intermediates, but technical documents can also be submitted and obtaining official registration.

02 Categories of Pharmaceutical Intermediates

Classification by application field

Medical intermediates can be classified into antibiotic drug intermediates, antipyretic and analgesic drug intermediates, cardiovascular system drug intermediates, and anticancer drug intermediates according to their application fields. There are many specific types of pharmaceutical intermediate products, such as imidazole, furan, phenolic intermediate, aromatic intermediate, pyrrole, pyridine, biochemical reagent, sulfur containing, ammonia containing, halogen compound, heterocyclic compound, starch, mannitol, microcrystalline cellulose, lactose, dextrin, ethylene glycol, sugar powder, inorganic salt, ethanol intermediate, stearate, amino acid, ethanolamine, potassium salt, etc Sodium salts and other intermediates.

Classified by technical content

Pharmaceutical intermediates are further divided into primary and advanced intermediates based on their technical content. Primary intermediate suppliers, as they can only provide simple intermediate production and are at the forefront of the industry chain, face the greatest competitive and price pressures. The price fluctuations of basic chemical raw materials have a significant impact on them, while advanced intermediate suppliers not only have strong bargaining power over primary suppliers, but more importantly, they undertake the production of advanced intermediates with high technological content, Maintaining closer ties with multinational corporations results in less impact from fluctuations in raw material prices.

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