• Tianjin-Plant

CMC Overview

Pharmaron CMC provides fully integrated, high quality, cost-effective and efficient drug development and manufacturing services to our world-wide clients. Our experienced and dedicated process chemistry team brings the innovative solutions to design and discovery of new scalable routes, optimization of existing routes for quick scale up and development of robust manufacturing processes. Our state-of-the-art facilities and equipment, and experienced engineers ensure the successful scale-up and manufacturing of intermediates to hundreds of kilograms scale, and GMP API up to 20-kilogram scale. Our CMC services also include analytical development, stability evaluation, pre-formulation, formulation development and CMC regulatory filing document for both China and Global submission. We have state-of-the-art analytical instruments and experienced expertise to support process development and GMP manufacturing and perform release testing, stability study and CMC regulatory filing. We have strong capability in physical characterization, polymorph screening, salt screening and selection, and other preformulation studies of the API, formulation development for early stage compound.