• GMPlab2small_副本

GMP API

Pharmaron provides cGMP services for development and production of small molecule APIs in our state of the art facility at Beijing campus. Since the inception of GMP operations in 2010, Pharmaron has a track record of completion of dozens of large-scale GMP API projects for Phase 1-3 studies clinical trials as well as toxicology studies. We provide fully integrated services for GMP APIs within our CMC platform. Our integrated services include process R&D and analytical development, quality control, quality assurance and regulatory services. These services are provided as standalone services, or as a part of integrated projects that also include components such as medicinal chemistry, DMPK, in vivo pharmacology and toxicology.

Our GMP synthesis area comprise of

  • Experienced leadership with domestic and international experience and expertise
  • Excellent team of process chemists, who could develop robust processes APIs with complex structures and with long synthesis sequence
  • Excellent team of analysts with extensive experience in method development and method validation including genotox impurity identification and quantitation.
  • Well versed team of QC and QA with expertise in handling projects for USFDA, CFDA and other major international markets

 

Future expansion: A new manufacturing plant is under construction in Tianjin which will increase Pharmaron’s GMP manufacturing capability significantly when complete in 2016. The new GMP API manufacturing center would have multiple reaction suites with >3,000 L reactor capacity for commercial scale production.