ChemPacific manufactures bulk active pharmaceutical ingredients (APIs) and advanced synthetic intermediates to support clinical trial studies in various stages of product development research, ranging from preclinical material to commercial production. FDA-approved commercial APIs or key intermediates in multi-kilogram to metric-ton quantities can be prepared, making us uniquely suited to handle your cGMP manufacturing needs seamlessly and through all phases of clinical trials without the need for technology transfer to another company. Our strength in process research and scale-up, coupled with our wide range of cGMP synthesis capabilities, is unmatched in the industry.
FDA-regulated cGMP synthesis requires significant analytical and quality control support. ChemPacific maintains well-equipped and experienced analytical chemistry resources, providing state-of-the-art analytical method development, structure elucidation, physical characterization and the ability to handle challenging analytical compounds.