Clinical Drug Substances
We provide a chemical synthesis and manufacturing services for our customers under the strict US and international cGMP guidelines. All facilities and manufacturing techniques used in manufacturing products for clinical use or for sale in the US must be operated in conformity with US FDA and international cGMP requirements. Our plants in Taiwan and Changshou, China, have the manufacturing equipment, isolation facilities, and storage areas with limited access requirements for cGMP mass production. Therefore, we can provide for phase 1 clinical trial (up to 10 kg), phase 2 and phase 3 clinical trials (10–100 kg), and commercial production (hundreds of kilograms to tens of tons).