Pharmaceuticals and Healthcare Department
Providing high-value-added services related to pharmaceutical products
At HighChem, we import and export pharmaceutical intermediates, active pharmaceutical Ingredients, veterinary drugs, and medical devices, diagnostic reagent etc. and manufacture them on an OEM basis. We have various manufacturing and marketing licenses for pharmaceutical products and can provide a wide range of services in Japan.
Main business areas
CMO/CDMO/OEM for pharmaceutical intermediates,APIts Import and export of pharmaceuticals and veterinary drugs
As the In Country Caretaker (ICC), we register the master file (MF registration) and provide high-value-added services such as handling high-quality and cost-effective generic pharmaceutical substances. We are also working to ensure a stable supply of products through close cooperation with Chinese manufacturers.
Application agency for foreign manufacturer certification
ICCDomestic administrator responsibility for Master files registration (MF registration)
Quality control and guidance for manufacturing plants in China
Import of pharmaceutical substances, securing of distribution inventory
Permission for our manufacturing and sales
Export of pharmaceuticals to China
HighChem exports Japanese pharmaceutical products to China to support the expansion of our customers' products into China. We are able to accept the highly difficult role of drug application in China.
Export of Japanese products (pharmaceutical substances, formulations, additives, medical devices, etc.) to China
New drug application in China
CRO/CMO/CDMO/OEM of pharmaceutical intermediates and pharmaceutical substances
Regarding CRO/CMO/CDMO/OEM manufacturing, we provide quality control and guidance for manufacturing plants in China based on strict GMP control or non-GMP control according to custom’s demand. In addition, we have built up close relationships with manufacturers that can handle various special reactions, and have achieved a wide range of OEM manufacturing results in pharmaceutical substances and intermediates.
[Contract results] General pharmaceutical raw materials, intermediates, important intermediates, pharmaceutical substances, formulations, etc.
Main Products and Services
Active pharmaceutical ingredients
|Dabigatran Etexilate Methanesulfonate|
|Dapagliflozin Propylene Glycolate |
|Dextromethorphan Hydrobromide Hydrate|