Process Chemistry

Process chemistry is the bridge between research and commercial production. It is an important guarantee for new drugs from laboratory to clinical and market. We provide services such as research on synthetic route of API, process optimization, impurity and reference substance research, salt / crystal form research, structure confirmation, etc.

HitGen has a professional research team with rich experience in generic and innovative drug research. Several ANDA and three IND projects have been successfully applied so far.

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