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The quality of the active ingredient of the drug, the bulk drug, largely affects the safety and effectiveness of the drug. In order to ensure the production quality of medicines and the safe use of medicines for the people, it is necessary to pay attention to the GMP on-site management of the raw material medicineRead more

The active ingredient in the preparation, API, is intended to be used in any substance or mixture of substances in the manufacture of pharmaceuticals. Pharmaceutical intermediates are important raw materials for the production of APIs. The production of drugs can rely on the custom synthesis of intermediates. After the synthesis of APIs, mid-scale and industrializedRead more

In the development of innovative drugs, the progress of the process development of the IND phase of the API often directly affects the subsequent formulation development, preclinical and clinical research, and final commercialization. How to plan and manage the API process development in the IND phase, and how to do the quality control of theRead more