The production of drug products that connect directly to the lives of human beings requires a high level of manufacturing and quality control. The R-Tech Ueno manufacturing plant in Sanda (Hyogo prefecture) conforms to the GMP standards set by the Japanese Ministry of Health, Labor and Welfare, the U.S. FDA and the European commission.

Manufacturing Facilities and Technology Features

Drug substance Plant

• Production of drug substance of Rescula®
• Production of drug substance of AMITIZA®
• cGMP-compliant facilities
• Japanese Ministry of Health, FDA and EU accreditation facilities
• Organic reactive synthesis technology
• Liquid chromatography purification technology

Drug Product Plant

• Production of Rescula® Eye Drops
• cGMP-compliance facilities
• Japanese Ministry of Health Labor and Welfare accreditation facilities
• Sterile production facilities (for eye drop production)
• Production capabilities for various dosage forms

Quality Control Division

• Testing methods comply with the Japanese Pharmacopoeia (JP), the United States Pharmacopoeia (USP), and European Pharmacopoeia (EP).