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If the original auxiliary packaging obtains the approval certificate before the implementation of the relevant approval policies and continues to be used for formulation, it shall be transferred to the registration platform by the SDA, and the registration number shall be indicated.The generic APIs that have been listed on the market in China may not be associated with pharmaceutical formulations when they are registered, that is, they are registered separately and reviewed independently. After review, the registration status is marked with 'A' and the registration status is ...
Date: 2019 / 04 / 13
1. List of reference formulationThe first step is to look at the list of reference formulations. So far, more than 1000 regulations have been promulgated in 18 batches.2. Principles of selection and determination and what to record?In short: those that are not published should be put on record, and only after the record is passed can they be used.3. What is the filing of reference formulation?Reference is made to the 'registration and recommendation procedures for reference formulations used to assess the consistency of the quality and efficacy of generic drugsThe manufacturer shall f...
Date: 2019 / 03 / 26
In the face of such strict requirements, many API enterprises are afraid, and some small enterprises have gradually withdrawn from the market due to various pressures. However, there may be some real powerful brand enterprises taking the high-end line in the world. Although some traditional enterprises have increased environmental inspection and infrastructure investment, transformation and upgrading are not inevitable. The so-called cold lip, in the face of the new storm of API, API equipment industry is also facing tremendous pressure and challenges, and relevant enterprises have to consider...
Date: 2019 / 03 / 19
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