Providing high-value-added services related to pharmaceutical products
At HighChem we engage in the import, export, and OEM manufacturing of pharmaceutical intermediates, active pharmaceutical ingredients (APIs), veterinary drugs, and medical devices. We hold various manufacturing and sales licenses related to pharmaceuticals, enabling us to provide a wide range of services.
Main business areas
CMO/CDMO/OEM for pharmaceutical intermediates,APIts Import and export of pharmaceuticals and veterinary drugs
As a domestic administrator, we register master files (MF registrations) and provide high-value-added services, such as handling generic drug substances that are high quality and cost-effective. We also strive to ensure a stable supply of products through close collaboration with Chinese manufacturers.
Application for foreign manufacturer certification
In-country administrator for Master File Registration (MF Registration)
Quality control and guidance for Chinese manufacturing plants
Searching for and importing pharmaceutical ingredients, and securing distribution stock
Permission for our manufacturing and sales
Export of pharmaceuticals to China
HighChem facilitates the export of Japanese pharmaceutical products to China, assisting clients in entering the Chinese market with their products. We are also capable of acting as an agent for complex new drug approval applications in China.
Export of Japanese products (pharmaceutical substances, preparations, additives, medical devices, etc.) to China
New drug approval application to China
OEM Production of Pharmaceutical Intermediates and Active Pharmaceutical Ingredients (APIs)
With regard to OEM manufacturing, we provide comprehensive quality control and guidance for Chinese manufacturing plants based on rigorous Good Manufacturing Practice (GMP) management. In addition, we have established close relationships with manufacturers capable of handling various specialized reactions, and possess an extensive track record in OEM production of both pharmaceutical intermediates and active pharmaceutical ingredients (APIs).
OEM manufacturing based on GMP management
Contract research and development and contract manufacturing (CRO, CMO) also available
[Contract results] General pharmaceutical raw materials, intermediates, important intermediates, pharmaceutical substances, formulations, etc.
