CN

API Development Service

We have years of experience on API development, GMP Process Validation Protocols and Manufacture, successfully cooperation with many well-known pharmaceutical companies. We can process the API Synthesis from mg to kg with multiple reactors. Standardization and efficiency are our superiority. Our development and manufacture are meeting the most stringent US FDA regulation and ICH requirement. We can apply tech support and transfer integrallty for global customers.

API Development:

· Evaluating the API Synthesis Route if satisfy GMP requirement

· QbD based Process Optimization

· Impurity Profile Study

· Scale Up & Tech Transfer Protocol

GMP manufacture:

· API for IND, NDA & ANDA submission

· Commercial Products approved by US FDA

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