API Process Development Services
Cost effective end-to-end project management
The API process department currently has a total area of about 6000 m2, including 2000 m2 of R&D lab, 800 m2 of non-GMP pilot scale up workshop, 1000 m2 of GMP API workshop and 1000 m2 of analysis and testing centre, 800 m2 of GMP compliant QC lab, and 200 m2 of microbiology lab. A strong R&D team supports API process development services covering areas such as synthesis, analysis, microbiology, project management and QA and QC. The team has rich experience in innovative drugs, consistency evaluation, successful R&D of improved new drugs, in China-US dual filing and in project management.
From pre-clinical trial synthesis, process development to commercial production stage and the whole supply chain system of R&D, procurement and production of enterprises, we provide innovative process development and large-scale production services for enterprises. With the establishment of GMP-compliant API workshops and the upgrading level of pharmaceutical production and quality management systems, we are able to provide customized services for GMP production, helping more R&D-oriented companies to carry out practical technology transformation, shorten time-to-market and promote commercialization.