GMP Manufacture Expertise

APAC Pharmaceutical specializes in process research, scale-up, and pilot-manufacturing, with a specific niche for complex multi-step synthesis and scale-up under cGMP conditions. We provide excellence from production of early stage clinical trial materials to product launch and commercialization.  We support all facets of chemistry manufacturing and controls (CMC) preparation related to APIs, including structure elucidation, specifications development, chemical and analytical methods validation, drug substance stability as well as preparation of documentation for submission.