Custom Synthesis

Your partner in the development of active pharmaceutical ingredients

Our company engages in total-support business for research and development of active pharmaceutical ingredients. We provide custom manufacturing and process research services for pharmaceutical ingredients and their intermediates from preclinical to commercial production stages. In addition, we offer analytical method development, stability testing, impurity identification, metabolite synthesis, and filing of drug master files (DMFs). Our company has various technologies for asymmetric synthesis, such as epoxidation, dynamic kinetic resolution, aldol reaction, and Michael reaction, for manufacturing optically active substances. We are involved in commercial production of prostaglandin derivatives through an original two-component coupling process. We specialize in multi-step synthesis, making best use of our experience in the manufacture of prostaglandins. We also specialize in production of heterocyclic compounds, utilizing our experience in the manufacture of original pharmaceuticals and agricultural chemicals.

Services

Custom manufacturing of APIs and their intermediates

We produce pharmaceutical ingredients and their intermediates after establishing processes suitable for scale-up production.

  • Manufacturing ingredients and their intermediates from preclinical to commercial production stages
  • Manufacturing under GMP conditions (experienced in FDA inspection)

Process research services

We establish production processes suitable for scale-up through determinate reaction analysis with confirmation of stability for every process.

  • Route scouting
  • Optimization
  • Scale-up

Related services

We offer various services for manufacturing and process research. We establish quantitative analysis methods by HPLC and GC.

  • Analytical method development
  • Establishing specifications
  • Stability testing
  • Impurity identification
  • Metabolite synthesis
  • Filing Drug Master Files (DMF)

Custom Synthesis Products

Custom Synthesis Technology