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What is the difference between an API and a finished drug?

What is the difference between an API and a finished drug?

Now, many API companies have started or are preparing to transform and upgrade to make preparations. However, the difference between the two is not as far as outsiders see it, they are just medicines.

02

2022

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06

The development prospect of China's APIs?

The development prospect of China's APIs?

1. The global pharmaceutical market is expected to maintain a growth rate of more than 8% in 2014, the new pharmaceutical market is likely to maintain a greater growth rate, and the domestic market demand for APIs will continue to grow.

02

2022

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06

What are the raw materials of dye intermediates?

What are the raw materials of dye intermediates?

The raw material of the dye for dyeing cloth is a kind of dye for textile dyeing. Most of them are plant extracts such as plant fruits and tree sap, and also contain natural chemical extracts such as coal tar. Divided into natural dyes and synthetic dyes, most of which are synthetic dyes on the market.

02

2022

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06

What are the production characteristics of pharmaceutical intermediates?

What are the production characteristics of pharmaceutical intermediates?

Looking at the entire industry, there are currently six characteristics in the production of pharmaceutical intermediates in my country: First, most of the production enterprises are private enterprises, with flexible operation and small investment scale, basically between several million and 20 million yuan; second, the geographical distribution of production enterprises is relatively concentrated

02

2022

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06

What is the difference between pharmaceutical intermediates and APIs?

What is the difference between pharmaceutical intermediates and APIs?

As can be seen from the definition, the intermediate is the key product of the previous process of making the API, which is different in structure from the API. In addition, there are methods for testing APIs in the Pharmacopoeia, but there are no intermediates. When it comes to certification, currently FDA requires intermediates to be registered, COS does not, but the CTD file must have a detailed process description of the intermediate. In China, there is no GMP mandatory requirement for intermediates.

02

2022

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06

What are the classifications of APIs?

What are the classifications of APIs?

According to the source, it can be divided into chemically synthesized APIs and natural chemical APIs. (1) Chemical synthesis of APIs Chemically synthesized APIs can be further divided into inorganic synthetic APIs and organic synthetic APIs. Inorganic synthetic APIs are inorganic compounds, such as aluminum hydroxide used to treat stomach; organic synthetic APIs mainly refer to APIs (aspirin, caffeine, etc.) obtained from organic chemical raw materials through a series of organic chemical reactions.

02

2022

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06

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