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Do you understand the classification of pharmaceutical intermediates?

Release time: 2024-04-01 21:09:45

How are pharmaceutical intermediates classified? The so-called pharmaceutical intermediates are actually chemical raw materials or products used for synthesizing drugs. This type of chemical product can be produced in regular chemical factories without obtaining a drug production license. As long as the technical indicators meet a certain level of requirements, they can be used to participate in the synthesis and manufacturing of drugs. Although the synthesis of drugs is also a part of the chemical industry, it is more stringent than general chemical products. Manufacturers of ready-to-eat drugs and APIs must accept GMP certification, while manufacturers of intermediates do not. Due to the fact that intermediates are only the synthesis and production of chemical raw materials, they are relatively basic and lower end products in the drug production chain and cannot be called drugs. Therefore, GMP certification is not required, which lowers the industry entry threshold for intermediate manufacturers.

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