Intermediates

Pharmaceutical intermediates are chemical raw materials or products used in the pharmaceutical synthesis process. They effectively promote the R&D process of new and generic drugs, and some key intermediates may also become critical factors restricting process development. In compliance with the regulations and guiding principles of the ICH and NMPA/FDA, our CMC Department can provide clients with integrated pharmaceutical services, including the development of pharmaceutical intermediate production processes and the optimization of commercial production, as well as all registrations and filings.

Medicilon’s services regarding intermediates or other chemical-related businesses

Intermediate synthesis route featuring intellectual property and cost advantagesRoute selection, process optimization, quality research, and process safety evaluationScale-up production (GMP or non-GMP)Development and validation of analytical methodsSynthetic route development, process optimization, and scale-up production for fine chemicals, especially the process development and production of some high value-added fine chemicals