Process Chemistry

Our specialized research team has extensive experience in the research of innovative drugs and generic drugs. The research content can meet the requirements of regulatory authorities such as those in China, the United States, and the European Union. We have successfully filed multiple ANDAs (Abbreviated New Drug Applications) and 5 IND (Investigational New Drug) projects for Class 1 innovative drugs. One of these IND projects was submitted to the US FDA, and all the filed projects were approved on the first try.

Process chemistry serves as a bridge between research chemistry and commercial production, and is a crucial guarantee for new drugs to move from the laboratory to clinical applications and the market. Our experienced team is capable of the following tasks:

• Design and screening of synthetic routes.

• Process development and optimization.

• Process safety assessment.

• Technology transfer.

• non - GMP and GMP production.

• Preparation of impurity reference standards and reference standards, and confirmation of their structures.

• Research on mutagenic impurities and nitrosamine impurities.

• Screening of salt forms/crystal forms and development of crystallization processes.

• Preparation of application documents.

According to the purpose of different research stages, we can offer the service of the design of formulation, drug-loading efficiency or specification, the development of formulation process and the manufacturing of drug products as follows：

·     Develop and manufacture the solid preparation, semisolid preparation, liquid preparation

·     Develop and manufacture the oral preparation for children

·     Develop and manufacture the sterilization and sterile preparations

·     Develop and manufacture the low dose and high value-added products

·     Manufacture the clinical products