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What are the requirements for APIs in generic drug research? How to evaluate the association review? What materials should be prepared?
Q: Import and export procedures and required documents for APIs?
Q: Does the crystal form of the raw material for injection need to be consistent with the reference?
Q: Do I need to compare with the original research products if I imitate the existing APIs in China?
Q: What is the main content of the API registration data?
Q: Do APIs for self-use still need to be registered?
Q: How do I fill in the preparation application form for the original and auxiliary package related declaration?
Q: The API is planned to be registered in September this year, and other formulation companies want to use the raw material for consistency evaluation related research work.
Q: Now that the preparations and APIs are reviewed in relation to each other, at the same time, the impurity profiles of the APIs are required to be studied.
Q: During the review process of an API (before the on-site assessment), it is found that the original supplier of a certain starting material has stopped production and needs to change the manufacturer.
Q: How long will there be an on-site audit after submitting the materials for APIs that are individually reviewed? Will it be reviewed by the state or at the provincial level? Is it dynamic? If the API and the preparation are related to the declaration, does the API need to be inspected on site? This API is imported from abroad
Q: Can 2 batches of API be used to make 3 batches of preparations?
Q: An injection product, the raw material is not produced by a domestic manufacturer, and an important starting material of a synthetic raw material is not produced by a domestic manufacturer.
If imported from abroad, it can only be food-grade, and foreign manufacturers will not accept audits, and relevant materials will not be provided.
, I bought the food grade by myself, refined first, and then synthesized the raw materials I wanted.
Is it okay to file and register myself? If so, do all studies on impurities need to be studied?
A: It is not recommended to buy it by yourself and refine it first, and then synthesize the raw materials you want
.
Because the synthetic route here is not clear, the quality is uncontrollable, and the risk is a bit high
.
The starting material is very important, and the entire synthesis process also needs attention
.
Q: Import and export procedures and required documents for APIs?
Q: Does the crystal form of the raw material for injection need to be consistent with the reference?
Q: Do I need to compare with the original research products if I imitate the existing APIs in China?
Q: What is the main content of the API registration data?
Q: Do APIs for self-use still need to be registered?
Q: How do I fill in the preparation application form for the original and auxiliary package related declaration?
Q: The API is planned to be registered in September this year, and other formulation companies want to use the raw material for consistency evaluation related research work.
Q: Now that the preparations and APIs are reviewed in relation to each other, at the same time, the impurity profiles of the APIs are required to be studied.
Q: During the review process of an API (before the on-site assessment), it is found that the original supplier of a certain starting material has stopped production and needs to change the manufacturer.
Q: How long will there be an on-site audit after submitting the materials for APIs that are individually reviewed? Will it be reviewed by the state or at the provincial level? Is it dynamic? If the API and the preparation are related to the declaration, does the API need to be inspected on site? This API is imported from abroad
Q: Can 2 batches of API be used to make 3 batches of preparations?
Q: An injection product, the raw material is not produced by a domestic manufacturer, and an important starting material of a synthetic raw material is not produced by a domestic manufacturer.
If imported from abroad, it can only be food-grade, and foreign manufacturers will not accept audits, and relevant materials will not be provided.
, I bought the food grade by myself, refined first, and then synthesized the raw materials I wanted.
Is it okay to file and register myself? If so, do all studies on impurities need to be studied?
A: It is not recommended to buy it by yourself and refine it first, and then synthesize the raw materials you want
.
Because the synthetic route here is not clear, the quality is uncontrollable, and the risk is a bit high
.
The starting material is very important, and the entire synthesis process also needs attention
.
